::: HCV News :::

Twice Daily Dosing Of Vertex Hep C Drug Works Well

2009-11-01T11:22:00.000-08:00

Vertex Pharmaceuticals Inc's closely watched hepatitis C drug telaprevir proved nearly equally effective in a twice daily regimen as three times a day, knocking out the virus in more than 80 percent of patients in both groups in a small study.

All previous Phase II studies of the highly promising experimental drug tested the medicine at three times a day dosing given at eight-hour intervals. This study hoped to show telaprevir could be administered twice a day 12 hours apart, which would be more convenient for patients.

Patients who received telaprevir twice a day in combination with the standard treatments of pegylated-interferon and ribavirin had a sustained viral response (SVR) of 82 percent in one arm and 83 percent in another, depending on which brand of interferon they received.

That compared with 81 percent and 85 percent of patients who were given telaprevir in the three times daily regimen, according to data to be presented at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston.

The percentage of patients in whom the virus is undetectable 24 weeks after completing treatment yields the critical measure known as sustained viral response, or SVR, which is considered tantamount to a cure.

"SVR rates of 75 to 80 percent (in twice daily dosing) would be very well received by investors," Sanford Bernstein analyst Geoffrey Porges said prior to release of the data.

"I was expecting around 70 percent," Dr Patrick Marcellin, the study's lead investigator, said in an interview.

"This is the highest we have observed with this triple therapy and the major conclusion is that the rate of SVR is similar in those patients who received bid (twice daily) and those who received it three times daily," said Marcellin, a professor of medicine at the University of Paris and head of Viral Hepatitis Research Center in Hospital Beaujon.

Importantly, Marcellin noted, even though the telaprevir dose was higher in the twice daily regimen, there were "no new side effects, and that is very encouraging."

Investors may also be encouraged by the low 3 percent dropout rate due to serious rash, which had been a source of some concern in earlier studies. Just four of 161 patients discontinued treatment due to rash, with another three pulling out due to anemia.

Marcellin said doctors have learned how to manage the rash and are now less likely to discontinue treatment as a result.

The open label study tested treatment naive patients, or those who had not received prior treatment for the serious liver disease. Treatment duration depended on how quickly patients responded to the medicines, an approach known as response-guided therapy.

Patients who achieved rapid viral response, defined as undetectable levels of virus at week four, and who maintained undetectable levels through week 20, were able to stop all treatment after 24 weeks of therapy -- 12 weeks on the three- drug combination and 12 more of standard therapy.

They were then followed for six months post treatment to determine whether they achieved SVR.

Eighteen percent of patients in the study did not meet that rapid response criteria and received a total of 48 weeks of treatment with the standard drugs.

Three percent of patients in the study relapsed during post-treatment follow-up, the company said.

"This study confirms that 24 weeks can be used in the large majority of patients with with high efficacy. Shorter duration means less side effects and better quality of life," Marcellin said, noting that "tailoring treatments according to the very early response improves the management of the patient and the chance of the patient to be cured."

There has been high hope that telaprevir will allow for 24 weeks of treatment for many patients. The current drugs must be taken for 48 weeks and are often difficult to tolerate, with many patients suffering flu-like symptoms for the duration.

"Many of these patients are relatively young and very active, so to treat shorter is a real benefit," Marcellin said.

He cautioned that this was a small study and that much larger Phase III clinical trials must confirm the results.

But he added: "As a clinician for our patients, this is an important hope for the future. This is a big step in the history of the treatment hepatitis C."

Vertex Hep C Drug Cures 80% at New Dose: Study

2009-11-01T09:47:00.000-08:00

More than 80% of hepatitis C patients were cured after treatment with a new twice-daily dose of the experimental drug telaprevir made by Vertex Pharmaceuticals, according to data from a phase II study.

Data from the new study demonstrates that a more convenient twice-daily dose of telaprevir is just as effective and safe as the thrice-daily dose, Vertex said.

The hepatitis C cure rates of greater than 80% across all four patient groups of the study are also the highest ever recorded in any telaprevir study to date and exceed the cure rates reported in separate studies of boceprevir, a competing hepatitis C drug under development by Schering-Plough(SGP Quote).

Generally speaking, investors were looking for telaprevir cure rates of greater than 70%, with a difference between the twice-daily and three-times-daily dosing group of 10% or less. The data from the telaprevir study exceeded those expectations on both measures.

"These data greatly enhance the potential for twice-daily telaprevir dosing," said Vertex chief medical officer Bob Kauffman.

Vertex and partner Johnson & Johnson will formally present data from this new telaprevir study -- dubbed "C208" -- Tuesday at the annual meeting of the American Association for the Study of Liver Disease, a large gathering of hepatitis C researchers.

Investors are keenly interested in the outcome of the C208 study because it has the potential to strengthen telaprevir against competing hepatitis C drugs that while still in earlier stages of testing are being dosed once or twice a day.

Vertex Hep C Drug Improves Cure Rates

2009-11-01T09:46:00.000-08:00

Vertex Pharmaceuticals released additional clinical data Wednesday demonstrating the potential for its experimental hepatitis C drug telaprevir to significantly improve the cure rates in patients who failed prior treatment.

nterim data from an ongoing phase II study showed that treatment with a telaprevir-based regimen resulted in rates of sustained viral responses (SVR), or hepatitis C cures, ranging from 55% to 90% across four different patient groups, all of whom failed to respond to prior therapy to varying degrees.

To put these results in perspective, last March, Vertex presented data from a different phase II study that treated patients who also failed prior therapies. In that study, 55% of patients re-treated with a telaprevir-containing regimen achieved an SVR, or cure, compared with 14% of patients who were re-treated with current standard of care.

The new data released Wednesday, therefore, appear to bolster Vertex's claim that telaprevir can improve the cure rate for even the most difficult-to-treat patients -- those who don't respond to standard hepatitis C therapy of long-acting interferon and ribavirin.

That claim needs to be proven, of course, which is why Vertex is running telaprevir through an extensive phase III trial program. Results from studies in both treatment-naive and treatment-failure hepatitis C patients are expected in the middle of next year.

Vertex has competition in the race to develop the first new drug that acts directly against the virus causing hepatitis C. Schering-Plough also has a drug, boceprevir, in phase III studies which has shown promising results in earlier studies. However, boceprevir doesn't appear to work as well as telaprevir in treatment-resistant patients

Fluvastatin: New treatment for hepatitis C

2008-05-18T15:40:00.000-07:00

Oklahoma City: Researchers at the University of Oklahoma Health Sciences Center have found a new use for an old drug. Their findings appear online in the American Journal of Gastroenterology.

The drug, Fluvastatin, has been approved since 1993 by the U.S. Food and Drug Administration for the treatment of elevated cholesterol in adults. Millions of patients have taken Fluvastatin for cholesterol without difficulty.

In a study of 31 veterans at the Veteran’s Administration Medical Center in Oklahoma City, researchers found that Fluvastatin significantly lowered the viral load, or levels of hepatitis C virus, for up to six weeks when used alone. Hepatitis C is the disease that claimed the life of Oklahoma and Yankee baseball great Mickey Mantle.

“This research is the first to demonstrate the antiviral activity of Fluvastatin in human beings infected with hepatitis C, most of whom were non-responders to the standard of care treatment,” said Ted Bader, M.D., the principle investigator on the project and the director of liver diseases at the OU Health Sciences Center.

Since Fluvastatin will not completely clear the hepatitis C virus by itself, researchers have started a phase II randomized, controlled trial that combines Fluvastatin with the standard treatment of peg-interferon and ribavirin. They hope to use the combination of medicines to significantly improve the cure rate for hepatitis C. After further required testing and approval, the drug could be available as a new treatment for hepatitis C far sooner than any other anti-hepatitis C drug currently under research and development.

“We need additional drugs to add to this regimen to improve the cure rate,” Bader said. “When patients are cured, they feel dramatically better, their health care costs plummet, their risk of liver cancer drops dramatically, and if they do not have cirrhosis, they will not need a liver transplant. Moreover, they are no longer infectious.”

In the initial investigative study funded by the VA Research Foundation of Oklahoma City and Dr. Michael Bronze at the University of Oklahoma College of Medicine, veterans with chronic HCV were given oral doses of Fluvastatin daily for two to 12 weeks. Within a month, half of the patients showed a reduction of the virus. One patient’s viral load was about 50 times lower than before taking Fluvastatin.

Hepatitis C is a significant problem for Oklahoma. More than 80,000 Oklahomans have chronic hepatitis C (HCV), but less than 5 percent have been treated. HCV is the leading cause of liver-related deaths in our state and also is the cause for the majority of the 70 liver transplants performed in Oklahoma each year.

Nationwide, 2 percent of Americans (about 4 million) are infected with chronic hepatitis C, which is four times the number of patients infected with HIV. Chronic hepatitis C is often asymptomatic and can lead to progressive liver disease.

Most people with hepatitis C contracted the disease through blood transfusions before 1992 when a test was implemented to screen for the disease. You also can get the virus by injecting drugs with contaminated needles and, less commonly, from contaminated needles used in tattooing and body piercing.

Japan accepts hepatitis C blame

2007-12-25T21:43:00.001-08:00

State to hold itself liable in hep C bill
The Japan Times - Japan
A bill to aid people who contracted hepatitis C through tainted blood products will mention that the government bears certain responsibility for the ...

Poll worries prompted govt HCV U-turn
The Daily Yomiuri - Osaka, Japan
Prime Minister Yasuo Fukuda's announcement Sunday that the ruling parties would introduce a bill to compensate all hepatitis C virus sufferers who ...

Japan accepts hepatitis C blame
Aljazeera.net - Qatar
The Japanese government has said it bears the ultimate responsibility for hepatitis C infections caused by tainted blood products. ...

Vertex's Mixed Bag

2007-10-02T23:04:00.000-07:00

According to a Reuters report,

A closely watched hepatitis C drug being developed by Vertex Pharmaceuticals Inc continues to promise improvement over current treatments, according to analysts who have viewed brief summaries of data from highly anticipated clinical trials.

The summaries, known as abstracts, of data to be presented in full next month at the American Association for the Study of Liver Diseases annual meeting also suggest some limitations and side effects from the drug, telaprevir, analysts said.

"The incremental information provided by Vertex and the (study's) investigators continues to suggest that telaprevir will deliver a sustained virological response (SVR) of 70 percent, or thereabouts, in real world efficacy," Geoff Porges, an analyst with Sanford Bernstein, wrote in a research note.

Other analysts also said the available data appears to add up to an SVR of at least 70 percent in the clinical trial known as PROVE-2. An SVR rate higher than 50 percent is considered to be positive and 75 percent would be viewed as a major success, analysts have said.

SVR is a measure of patients in whom the hepatitis C virus has reached undetectable levels and appears to have been cleared from the system.

The studies are also attempting to show that by adding telaprevir to standard therapy of pegylated interferon and ribavirin there would be a lower relapse rate and significantly shorter treatment duration than without the Vertex drug.

"These results continue to show the potential that telaprevir has to enhance the efficacy of the current standard of care and provide a higher cure rate for patients with hepatitis C virus," said Jason Kolbert, an analyst for Susquehanna Financial Group.

Kolbert did note a potentially worrisome higher patient dropout rate with the PROVE-2 trial than in the earlier PROVE-1 study - 12.5 percent versus 10.9 percent - and the persistence of a troublesome rash seen with many patients who receive the Vertex drug.

Porges said data in the abstracts appear to debunk Vertex assertions that telaprevir could be effectively used without ribavirin, and that ribavirin was the cause of the rash seen in earlier combination studies.

Based on available PROVE-2 data, Porges said, within 12 weeks 25 percent of patients in the telaprevir-plus-interferon group saw the virus rebound from previously low levels compared with 4 percent in the triple-therapy group.

"This means that pegylated interferon with telaprevir but without ribavirin is a non-starter as a regimen for further study," Porges said.

He added that from further analysis of the data, "it is now clear that telaprevir, not ribavirin, was the cause of the rash observed in combination treated patients in PROVE-1."

The limitations "do leave the window open for competitors to enter the market" but do not affect telaprevir's immediate market potential, Porges said.

Vertex shares were up 56 cents, or 1.5 percent, at $39.00 in early afternoon trade on Nasdaq.

Bangladesh's ticking time bomb

2007-10-02T22:57:00.000-07:00

Bangladesh is a poor country - always having to suffer the wrath of the tropical storms and floods. It has an estimated population of 150,448,339 as on July 2007.

The Daily Star Newspaper reports, 10% population infected with hepatitis B

It also says, THREE per cent of the population are infected with Hep C - about 4.5 million people!

Around 10 percent of the country's total population is infected with hepatitis B virus and 3 percent with hepatitis C virus, said the experts at a discussion yesterday.

They said 3.5 percent of the pregnant mothers in the country are affected with hepatitis B.

The discussion was organised by Liver Foundation of Bangladesh to mark the World Hepatitis Awareness Day at Birdem auditorium in the city.

Speaking as chief guest at the discussion, Health Adviser Maj Gen (Retd) Dr ASM Matiur Rahman stressed the need for creating mass awareness about hepatitis B and C to prevent the deadly diseases.

He said suffering from hepatitis B for a long time increases the risk of liver cirrhosis, liver cancer and liver failure.

The adviser said the government is going to include hepatitis B vaccine with national immunisation programme.

"As the treatment of liver diseases is very expensive, its prevention should be our main strategy," said Prof AK Azad Khan of Diabetic Association of Bangladesh (Dab).

He said if the liver diseases reach an advanced stage, only transplantation of liver could be the solution.

Dab is going to start liver transplantation soon at a reduced cost, he added.

Prof AQM Mohsen presented the keynote paper at the discussion chaired by Prof SN Samad Chowdhury.

The experts said it is possible to cure 30 to 60 percent of hepatitis B patients if treated properly.

But the treatment of hepatitis C in our country is not so optimistic and the vaccine of hepatitis C is yet to be invented, they added.

Using disposable syringe and needle can help prevent the spread of the diseases, said the experts, adding that nobody should use toothbrush and razors of others.

They said there is less possibility of transmitting the viruses from sexual intercourse and breast-feeding.

Around 600 million people in the world are infected with hepatitis B and C. Of them, 350-400 million people are infected with hepatitis B and 180 million infected with hepatitis C.

Maj Gen (Retd) Prof AR Khan, Brig Gen (Retd) Prof Abdul Malik, Emad Ul Ameen, Zeba Rasheed Chowdhury, Prof Mohammad Ali of Liver Foundation and Prof M Anisur Rahman also spoke on the occasion.

This was the first time that Bangladesh observed the day with the slogan 'Get Tested.'

European Liver Patient Association (ELPA) and World Health Organisation, Europe have been observing the day since 2004 through different programmes.

This year around 40 countries observed the World Hepatitis Awareness Day.

HCV Update

2007-09-29T14:48:00.001-07:00

Most people don't know much about hepatitis C -- until they're diagnosed. Yet infection and mortality rates for hepatitis C are disturbingly higher than they are for HIV:

* 3.5 million people in the U.S. suffer from CHC (chronic hepatitis C); 700,000 are infected with HIV
* 400 million people are infected worldwide with CHC (that's 1 in every 15 people); 20 million have HIV
* 150,000 new cases of CHC are reported in the U.S.; compared to 40,000 for HIV
* 80 million people worldwide will die from CHC; compared to 20 million from HIV (that's four times as many deaths worldwide from CHC as from AIDS)
* Hepatitis C has been linked to increased mortality among persons with HIV

Hepatitis C can seriously damage the liver and affect its ability to function correctly. It is spread via the blood of an infected person, commonly through sharing needles. It can also be contracted through non-sterile tattoo or piercing equipment, pre-1991 blood transfusions (before blood was screened), unprotected sex and sharing razors or toothbrushes with a carrier.

Virus experts step closer to treatment for hepatitis C

2007-09-13T13:00:00.000-07:00

Nine hundred of the world's hepatitis C experts are meeting in Glasgow this week to discuss the latest research into the disease at the 14th International Symposium on Hepatitis C Virus and Related Viruses.

Among more than 400 studies being discussed, it will be revealed that scientists working on hepatitis C have discovered a powerful new drug, which has been shown to inhibit the virus in laboratory tests. The research findings represent an early but promising step towards treating the 170 million people worldwide estimated to be infected with hepatitis C.

The compound, developed by Arrow Therapeutics, has already successfully cleared Phase I clinical trials and Phase II trials are due to begin in the coming months.

Clinicians and scientists from around the world attending the conference will tackle a broad range of topics including fundamental research on the virus, the diseases that result from long-term infection and new approaches to eradicate or counter the effects of hepatitis C. Presentations on possible new anti-viral agents are expected to be among the most exciting sessions of the 5-day event, being held in the UK for the first time.

An estimated 285,000 people in the UK are infected, and around 9,000 new cases are diagnosed each year. Scotland has the highest infection levels of hep C in the UK, with a particularly high prevalence rate in Glasgow. Currently, there is no vaccine to protect against infection.

In an effort to ensure that the research presented at the conference reaches people living with the infection, organisers have given free access and exhibition space to a number of hep C patient support groups, including Glasgow-based C-Level and national groups Mainliners and The Hepatitis C Trust.

"Estimates suggest that there are four times more people infected with hepatitis C compared to HIV in the UK. Many people remain undiagnosed and are unaware of the possibility that they could develop serious liver complications arising from the virus" explained virus expert and conference organizer, Dr John McLauchlan who heads one of the two hepatitis C research programmes at the MRC Virology Unit in Glasgow. "The presence of such a high profile, international event in Scotland gives us the opportunity to draw the public's attention to this deadly virus, and the ongoing need for research into how we can combat it."

The 14th International Symposium on Hepatitis C Virus and Related Viruses takes place in the Glasgow Royal Concert Hall from 9 - 13 September 2007. Further information on the conference is available at www.hcv2007.com

New vaccine for Hepatitis C in development

2007-09-12T05:29:00.001-07:00

A team at the University of Saskatchewan's Vaccine and Infectious Disease Organization has produced a vaccine candidate that decreased the amount of a carrier virus expressing hepatitis C virus -- HCV -- protein in mice by 100,000 times compared to the control.

The study was published in this month's Journal of General Virology.

"This technique uses the body's own cells, called dendritic cells, to vaccinate against hepatitis C," said Bhagirath Singh, scientific director of the Canadian Institutes of Health Research.

Dendritic cells are key components of the immune system, activating and shaping the immune response.

"The vaccine reduced the amount of hepatitis C protein in a highly significant manner," said Singh. "This offers a very promising approach to prevent liver disease caused by the virus and to ultimately eliminate it from the body."

HCV is the leading cause for liver transplants in the Western world, and its annual death toll is expected to triple in the next 10 years, the study said.

Pharmasset says hepatitis C drug meets trial goals

2007-09-11T00:35:00.000-07:00

10th September 2007
By Sarah Routledge

Pharmasset has reported preliminary safety and potent antiviral activity with its investigational drug following 14 days of monotherapy in 40 patients chronically infected with hepatitis C virus who had failed prior interferon therapy.

The candidate, R7128, is a prodrug of PSI-6130, an oral cytidine nucleoside analog polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche. The Phase I multiple ascending dose study of R7128 was designed to evaluate safety, tolerability, pharmacokinetics and preliminary antiviral activity.

R7128 demonstrated potent, dose-dependent antiviral activity across the four patient cohorts receiving 750mg or 1500mg administered either once-daily or twice-daily for 14 days as monotherapy. The greatest mean decrease in HCV RNA from baseline was demonstrated in the patient cohort that received 1,500mg twice-daily, the highest dose of R7128 administered in this study. These patients demonstrated a mean 2.7 log10 IU/mL (>99%) decrease in HCV RNA. There was no evidence of viral rebound in any dose cohort during the 14 days of dosing.

R7128 was generally safe and well tolerated in this Phase I multiple ascending dose study. There were no serious adverse events, no adverse events requiring dose modification, no dose-related gastrointestinal adverse events and no clinically significant changes in vital signs, electrocardiograms, hematologic, renal or other laboratory parameters.

Based on the results of this study, Pharmasset and Roche plan to initiate a 28-day study of R7128 in combination with Pegasys (pegylated interferon) plus Copegus (ribavirin) in treatment-naive patients chronically infected with HCV genotype 1. Patient recruitment for this combination study is expected to begin in late September 2007

Anita Roddick is no more

2007-09-11T00:16:00.000-07:00

Anita Roddick, founder of The Body Shop, has died at the age of 64. Anita was suffering from cirrhosis of the liver after contracting Hepatitis C from blood given during the birth of her youngest daughter, in 1971.

BBC reported in February this year:

She was diagnosed with Hepatitis C two years ago and cirrhosis, a long-term effect of the disease, recently.

"It's a bit of a bummer... I had no idea I had this virus. I was having routine blood tests when it showed up."

In a statement posted on her website, she added: "What I can say is that having Hep C means that I live with a sharp sense of my own mortality, which in many ways makes life more vivid and immediate.

Hopes for a hep C jab within 10 years

2007-09-06T05:38:00.000-07:00

A vaccine for hepatitis C (HCV) could be available within 10 years, according to research presented this week at the Society for Microbiology's 161st meeting at Edinburgh University.

Up to 500,000 patients in the UK are infected with HCV and it is the leading cause of liver transplant in the UK.

However, although vaccines for hepatitis A and B are available, no vaccine has yet been developed that can prevent infection with any strain of HCV

There are many strains of HCV and often many thousands of different strains can be found in a single patient. This is because HCV is an RNA virus, and mutates very rapidly. Now, UK researchers are designing a vaccine that will target a specific region of the virus which is the same across all variants, and which the virus needs in order to infect cells.

Researchers from Nottingham University isolated strains of the virus from around the world and extracted the genes for the glycoproteins E1 and E2 which are found on the surface of the envelope of the virus. The virus uses these proteins to attach itself to human cells and to gain entry and infect the cells.

They showed that these glycoproteins were dependent on a single receptor molecule on the surface of the cell to gain entry to it. Using human monoclonal antibodies developed by other groups, they then showed in vitro that preventing the interaction between the HCV and this receptor molecule neutralised the virus and prevented infection.

Dr Alexander Tarr, from the virus research group at the University of Nottingham, said: 'We showed that every variant was dependent on a single receptor molecule on the surface of the cell to gain entry to the cell.

'If you disable that entry mechanism with monoclonal antibodies, you knock out the viruses' infectivity completely.Now we're trying to identify which combinations of these antibodies could be used in a vaccine.' The clinical potential of this work cannot be overstated, added Dr Tarr.

Courtesy Healthcarerepublic.com

Dentist with HCV loses his registration

2007-09-06T05:31:00.000-07:00

This is a weird case.

HEP C DENTIST STRUCK OFF

06 September 2007

A swedish dentist who put thousands of people at risk of catching Hepatitis C by working for almost a decade with the disease has been struck off.

Sigvard Hicks concealed the fact he was infected with the virus from patients, staff and colleagues while based at two dental practices in Torbay between 1997 and May 2006.The General Dental Council held the entire three day case behind closed doors to protect the dentist's privacy over his health.

But the decision to erase Hicks from the register was announced in public.

The GDC upheld all five charges against Hicks including allegations he had practised with Hepatitis C, that he failed to take appropriate advice and about his condition and to act on it, and that he failed to notify his patients, staff and colleagues.

They also found he had not taken adequate precautions to protect patients and colleagues from exposure to the disease.

It is true that Hicks should have informed his Hospital, colleagues etc. What worries me is that HCV is known to be transmitted only through blood contact. Is it possible for the Dentist to get cuts or nicks, while wearing a glove and doing a dental procedure?

The real danger is that the human society seems to be in a hurry to ostracise HCV patients; the social stigma can cause more damage than the disease itself.

If any reader of this blog lives in Sweden, I urge you to contact the General Dental Council to find out what are the chances of a doctor can pass on HCV.

Woman tries unusual drug for hepatitis

2007-07-11T22:42:00.000-07:00

By keri brenner

Mary Findley might be one of the few people in the country to cure herself of hepatitis C, a virus-caused inflammatory liver condition, using a drug designed to treat Parkinson's disease.

Findley, 56, a Eugene, Ore., natural cleaning products retailer, suspects she contracted the potentially lethal liver disease from a blood transfusion 21 years ago during a hysterectomy. She said that was the only time she had some sort of blood-to-blood contact - the only way to get hepatitis C.

The disease - which Washington officials in May said was one of the top state health concerns - can be contracted by sharing injection drug needles with an infected user. Health practitioners also can contract it from a needle stick during a medical procedure with an infected patient.

Other sources could be sexual contact if there are open sores on both partners, tattoos or from sharing a razor or a toothbrush with an infected person whose gums or skin are bleeding. There is no vaccine, although people at risk are advised to be vaccinated for Hepatitis B.

"Hepatitis C is the most common blood-borne infection in the U.S. and is the leading cause of liver transplants," said Wendy Dillon, hepatitis C coordinator for the state Department of Health. "There are eight times as many hepatitis C cases as there are cases of HIV/AIDS infection in our state."

The standard drug treatment is a cocktail made from two potent antiviral drugs, interferon and ribavirin. A study reported in May indicates that about half of the patients who try the cocktail could be "cured" of the disease - meaning the virus is eradicated.

But Findley said the down sides of interferon are its side effects and expense.

"Interferon is not an option. It's a death threat," she said. "They stick you with this needle which you are going to pay out your nose for. It will destroy your liver, put your life on total hold for a year, possibly kill you, cause many to commit suicide," she said.

Findley says she was cured by amantadine, an inexpensive, less-harsh antiviral drug used for Parkinson's patients.

Findley said she went to several doctors before she found one willing to prescribe the amantadine for her. She had to threaten to go to Mexico to get the drug before her doctor would write the prescription, she said.

Despite its side effects - which include dry mouth, jitters and irritability - amantadine was worth the effort, she said.

"It was not so bad compared to the horrible side effects of interferon," she said.

Findley also adhered to a natural, chemical-free unprocessed foods diet, an exercise regimen to promote liver detoxification, and other protocols such as sweating out toxins in a hot bath.

Thomas Griffith, an Olympia naturopathic physician, said he has never heard of using amantadine for hepatitis C.

"It's very much an off-label use," Griffith said.

However, he agreed with Findley that interferon therapy, while appropriate in some cases, can be "fraught with side effects, is very expensive, can damage the immune system, and is like having a flu all the time."

Griffith said the best therapy for hepatitis C "really depends on how progressive a person's disease is and the lab parameters," he said. "Not everybody who has hepatitis C is a candidate (for interferon)."

Griffith said he consults with a liver disease specialist to determine whether interferon would be the best treatment option - and will have the specialist administer the drug if appropriate.

For his part, Griffith offers herbal and supplement therapies that can complement - but don't interfere with - the prescription drug regimen.

That could include milk thistle, a liver-protective herb, or phosphatidylcholine, a form of unrefined lecithin. Phosphatidylcholine is a main constituent of cell membranes and useful in inflammatory conditions such as hepatitis, Griffth said.

"You should contact your practitioner for dosages," Griffith said. "And be careful of the supplements you buy - some of the ones with raw materials from India or China could have contaminated products in them."

Findley was symptom-free for most of the last two decades until January 2002. That was when she saw a doctor because of a yellowish tint in her eyeballs - a sign of jaundice.

"I was getting tired at that time, and losing memory, but I attributed it to aging," said Findley, who owns and operates Mary Moppins Co.

A blood test, however, showed Findley had 1.2 million copies of the hepatitis C virus in one milileter of blood - a heavy viral load.

Now, five years later, in February of this year, a blood test found no detectable signs of the virus. Findley feels great, she said.

"Had I not done the research, stuck to my guns and insisted on the amantadine, my stomach would be bloated, my kidneys and liver failing, and I would be bed-ridden," she said. "There are times I'm glad I was born in Missouri and as stubborn as their mules."

Hepatitis C: Efficient Treatment Developed

2007-05-23T23:04:00.000-07:00

Marta Gómez Ferrals*

Havana, May 21 (Prensa Latina) Cuban biotechnology took a new and very important step in obtaining an efficient treatment for Hepatitis C, a disease that affects about 200 million persons in the world.

Herbeviron is the name given to this novel drug that is the basis of a new therapy. It is part of a kit prepared by specialist of the Engineering Genetic and Biotechnology center (CIGB in its Spanish acronym), one of the pillars of the science region in the outskirts of the capital.
It is produced by the Heberbiotec factory in Cuba that is in charge of commercialization of its biotechnological products.

Interferon Alfa-2B and Rivavirma, both made in the country, are components of Heberviron and it is used not only to combat the causative virus of Hepatitis C in blood but, in the long range, eliminates lesions in the liver and totally cures the disease.

Doctor in Pharmaceutical Sciences of CIGB, Hugo Nodarse, told the press that Cuban patients have a treatment that increases the possibility to control the disease that tends to become chronic and very damaging in the majority of cases.

Heberviron successfully attacks the virus in circulation, according to tests made in the National Institute of Gastroenterology. In its advanced phase of treatment, forecasts are of a cure of liver lesions and recovery of the enzymes of that vital organ.

Information should be available about Hepatitis C to understand the significant importance of this new Cuban therapy.

Hepatitis, in a general sense, is an illness that produces inflammation of the liver and may have an inflammatory, toxic or viral etiology.

Hepatitis C is a devastating disease that can cause death through cirrhosis or liver collapse shortly after contracting the infection.

However, infected persons who do not present visible signs and symptoms are alarmed about the disease.

Contagion is through contact with the blood of an infected person and can occur as with HIV, through non-protected sexual relations, use of infected needles or contaminated blood transfusions. Also by sharing toothbrushes, shaving blades and manicure equipment that has not been sterilized.

The most general symptoms are a yellowish tinge of the skin, sclerotic eyes, fatigue, loss of appetite, nausea and vomiting, pain in the right side of the abdomen, under the ribs or weight loss although there are more or less asymptomatic persons. It can only be detected through a blood test for Hepatitis C virus.

In the United States Hepatitis C is the first reason for a liver transplant due to hepatic cirrhosis and in Egypt 15 percent of the population suffer the disease.
Cuban science has been working hard on the prevention and treatment of different types of hepatitis.

During the 90s a national vaccine was made against the B variant; also transfusions have greatly improved with top quality technology developed by scientists in the country.
Since the 80s Cuba began the technique of liver transplants that, today, shows good results with more than 100 persons operated.

Scientific research on preventive and therapeutic vaccines against illnesses has amazed nationally and worldwide. It has also received strong governmental investment and support in its broadest sense.

That is the reason behind the interest to obtain the Haemophilus influenzae vaccine that protects the infant population against pneumonia, meningitis and otitis covering Cuban needs and also satisfying requests from abroad.

By the end of this year there will be production of an anti-lung cancer vaccine developed by the Molecular Immunology Center and whose clinical studies are in the final phase. Tests are also being done in the United States.

Work is also underway to obtain vaccines or monoclonal antibodies that open up new hope for the treatment of breast, neck, head, prostate and colon cancers.

In addition Cuba has successfully completed its last clinical assay of a quintuple vaccine against diphtheria, whooping cough, hepatitis B, tetanus and Haemofhilus influenzae.

There is also one prepared against cholera and work is underway to obtain the same results against dengue, hepatitis A and tuberculosis.

(*) The author is a journalist of the Science and Technology Editorial board of Prensa Latina.

Peregrine hepatitis C drug safe in test

2007-02-14T12:09:00.000-08:00

Biopharmaceutical company Peregrine Pharmaceuticals Inc. said Wednesday preliminary data from a Phase Ib test show its hepatitis C drug is safe and well-tolerated.

Bavituximab seeks to treat the disease by targeting infected cells rather than traditional treatments that stimulate a general immune response.

The results confirm those in a Phase Ia test.

Peregrine shares added 3 cents to $1.26 in early trading on the Nasdaq.

Editor's note: It is the share value pegged to the treatment of Hep C that worries me a lot. Where are the fucking governments? Aren't they supposed to fund for medicines and healthcare? Why do they spend our money on building nukes to destroy this world?

I have one thing to say to those pseudo nationalists and patriots of these nations which has "borders" drawn by people... The virus knows no borders, they are winning this war - borderless war - without the nukes.

Vertex Nears Hit or Miss

2007-02-07T03:08:00.000-08:00

By Adam Feuerstein

Source: thestreet.com

Vertex Pharmaceuticals (VRTX) is pushing ahead with an aggressive drug development plan that, if successful, will drastically improve how hepatitis C is treated across the world -- and make boatloads of money for the company and investors in the process.

If Vertex stumbles, however, the blowup will be spectacular, even by biotech standards.

The drug in question is called telaprevir. Vertex is in the midst of an ambitious phase II clinical study program that will yield crucial data over the next 10 to 12 months.

Most importantly, we'll soon know whether: 1) telaprevir can shorten treatment time for most hepatitis C patients to as little as three months, compared with about a year for current treatments; and 2) whether telaprevir can boost cure rates for hepatitis C patients to 70% to 80% or higher from about 50% today.

If the telaprevir pill can achieve all that, the drug might easily generate $2 billion to $3 billion in revenue and could double or even triple the value of Vertex shares, which closed Monday at $32.52. Likewise, the downside risk is eye-popping: Wipe telaprevir off Vertex's map, and the stock could head quickly back to the teens.

While Vertex has other drugs in the oven, the company's near-term fortunes are tied tightly to telaprevir, which is why investors need to pay attention to the outcomes of these ongoing clinical trials, which the company has dubbed PROVE 1 and PROVE 2.

But first, here's why the drug has generated so much excitement already.

Telaprevir is designed to attack hepatitis C by inhibiting the protease enzyme, one of the key enzymes used by the virus to make copies of itself. This "direct antiviral" approach differs from current hepatitis C drugs, which work by boosting the body's immune system to tamp down and eliminate the virus.

A weekly injection of alpha interferon (Schering-Plough's (SGP) PEG-Intron or Roche's (RHHBY) Pegasys) combined with daily oral doses of a generic drug ribavirin is the current standard of care for hepatitis C patients. A normal treatment course for Type 1 hepatitis C (the most prevalent form) takes 48 weeks to complete. But only about half of patients are cured, and the side effects can be difficult to tolerate, including flulike symptoms, anemia and depression.

Vertex believes that adding telaprevir to the current standard of care will increase cure rates and shorten the length of treatment. Early clinical data have backed that view, although final proof will only come from longer studies in more patients. That's what Vertex intends to do with its PROVE 1 and PROVE 2 studies, which are being run in the U.S. and Europe, respectively.

For now, let's focus on PROVE 1, since that's the study that will soon yield some important data. The study has enrolled 260 patients spread across four arms:

*
Arm 1: 12 weeks of telaprevir plus 12 weeks of alpha interferon and ribavirin (which I'll now refer to by its shorthand, PEG-IFN/RBV)

*
Arm 2: 12 weeks of telaprevir plus 24 weeks of PEG-IFN/RBV

*
Arm 3: 12 weeks of telaprevir plus 48 weeks of PEG-IFN/RBV

*
Arm 4: A "control" or comparison treatment of 48 weeks of PEG-IFN/RBV (no telaprevir).

The most important data coming from this trial will be "cure" rates, defined as the number of patients in which the level of hepatitis C virus becomes undetectable, as measured by a highly sensitive blood test. In medical parlance, this is known as the rate of "sustained virologic response," or SVR, and it is typically assessed six months after the end of treatment.

In PROVE 1, all patients have completed their 12 weeks of telaprevir dosing. Arm 1 patients are off treatment altogether (having also finished their 12 weeks of PEG-IFN/RBV), while patients in Arms 2, 3 and 4 continue to get PEG-IFN/RBV.

Vertex's stated intent is to use medical meetings as the forum for the release of clinical data, as opposed to simply issuing press releases. The first likely opportunity, then, is the European Association for the Study of Liver Disease, being held April 11 to April 15 in Barcelona. At this meeting, we're likely to get an interim update on treated patients, which will include some shorter-term measure of SVR, or cure, rates.

Looking further ahead, expect additional data at the Digestive Disease Week conference May 19 to May 24 in Washington, D.C., and the American Association for the Study of Liver Disease annual meeting Nov. 2 to Nov. 6 in Boston. (Mark your calendars.)

Vertex's stock has been weak since December, when shares were trading above $44, in part because the release of the first slug of data from PROVE 1 proved a bit disappointing to some and also raised the specter of unacceptable toxicity.

After 12 weeks of treatment, Vertex reported that 88% of patients on a telaprevir-containing arm had undetectable levels of the hepatitis C virus in their system, compared with 52% of patients in the control arm. But when these results were adjusted for the 9% of patients who dropped out for adverse events, the undetectable rate in the telaprevir arm was reduced to 80%, below the 90%-plus rate that many investors were expecting at this stage of the trial.

A higher-than-anticipated dropout rate due to toxicity was also a bit unexpected, raising concerns that telaprevir, despite its high efficacy, might have safety issues. Specifically, some anecdotal reports of severe skin rash in patients taking telaprevir raised alarm bells on Wall Street, although Vertex has vehemently denied that any such problems exist.

Vertex believes that the data generated by PROVE 1 and its sister trial in Europe, if positive, will be enough to form the basis of an approval filing with the Food and Drug Administration in the middle of 2008. The company does plan on running a phase III trial, starting in the second half of 2007, to add to the drug's safety database.

If Vertex can hold to this aggressive time line, telaprevir could be on the market by early 2009.

Additional clinical trials of telaprevir are also under way, including studies in hepatitis C patients who have failed or responded poorly to current treatment.

Few doubt that telaprevir is a real drug or that it will increase cure rates for hepatitis C patients -- but by how much? And will the drug's benefits outweigh its risks? The answers to these questions are still unknown but will come fairly soon from data generated in the PROVE 1 and PROVE 2 studies.

Only after that data are released will investors be able to answer the risk/reward question for considering Vertex shares.

-----------------

Blog Editor's Note:
In the meanwhile, the HCV patients can count on the stockmarket to find the cure for this unthinkable disease.

Telaprevir Monotherapy Induces Rapid Resistance

2006-11-02T01:17:00.000-08:00

BOSTON, Nov. 1 -- Apparently telaprevir (VX-950) needed a little help to be effective against hepatitis C virus.

Drug-resistant viral strains developed rapidly when exposed to telaprevir, the investigational protease inhibitor against HCV, but both wild-type virus and mutants were controlled by follow-on therapy with interferon and Rebetol, researchers reported here.

Action Points

* Explain to patients who ask about telaprevir/VX-950 monotherapy that as with therapy for HIV/AIDS, antiviral drugs used alone often promote the rapid development of drug-resistant viral strains. This study shows that for patients treated with an investigational protease inhibitor against hepatitis C, follow-on with interferon and Rebetol (ribavirin) helped to suppress both wild-type and drug-resistant viral clones.

* These studies were published as abstracts and presented orally and as a poster at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.

In a phase Ib trial of telaprevir, also known as VX-950, drug resistant viral strains cropped up in six of eights patients within two weeks of starting on monotherapy with the protease inhibitor.

But both these new strains and wild-type virus were significantly suppressed when the patients received follow-on combination of Pegasys (pegylated interferon α-2a) and Rebetol (ribavirin), reported Tara Kieffer, Ph.D., of Vertex Pharmaceuticals. and colleagues, at the American Association for the Study of Liver Diseases meeting here.

The findings suggest that as with protease inhibitors for HIV infection, protease inhibitors against HCV are likely to be used as just one element in a cocktail of therapies aimed at knocking down virus while preventing the development of drug-resistant virus.

"In all patients, we have observed that telaprevir has demonstrated a rapid and profound reduction in HCV RNA," said Dr. Keefer. "In a subset of patients dosed with telaprevir alone we did see a clinical breakthrough associated with resistant variants. However, these variants were suppressed in all patients after they began interferon and ribavirin follow-on therapy."

No clinical breakthroughs were seen in patients who were initiated on telaprevir and interferon, including those in whom resistant variants were detected using a sensitive detection method, she noted.

The investigators used a highly sensitive sequencing assay to detect minor populations of viral variants (≥ 5%) in 14 patients. They isolated plasma HCV RNA was isolated at days four, eight, 12, and 14 during dosing, and at days seven and 10 after the end of the dosing phase. The NS3 protease domain cDNA targeted by telaprevir was amplified by nested polymerase chain reaction, cloned and sequenced with a lower limit of detection of 100 IU/mL. Sequence changes were analyzed from about 75 clones per patient per time point.

They found that in patients initially dosed with telaprevir/Pegasys, wild-type virus was detected at day four. On day eight, either wild-type or resistant virus was seen on in four of eight patients with HCV RNA levels above the lower limit of detection. All eight of these patients began standard therapy with Pegasys/Rebetol and their HCV RNA levels were undetectable three months after the 14-day study period, the authors reported.

All eight patients had undetectable HCV RNA at 24 weeks of follow-on treatment. Six of these patients stopped therapy at 24 weeks, and five of the six had undetectable HCV RNA at 12 weeks post-treatment. Two of the six eventually resumed follow-on therapy out to 48 weeks.

Only one of four patients initially treated with Pegasys alone had undetectable RNA at 12 weeks, while three of four had no discernible RNA at 24 weeks.

In a separate study presented in a poster session, Maribel Rodriguez-Torres, M.D., of the Fundacion de Investigacion de Diego in Puerto Rico reported on the status of 12 patients who were originally enrolled in a 28-day trial of telaprevir, Pegasys, and Rebetol.

At the end of 24 weeks of follow-on with Pegasys/Rebetol, eight patients who were continuing on the follow-on treatment had undetectable HCV RNA. These patients continue to receive the drugs out to 36 weeks of follow-on therapy.

One patient stopped treatment at week 18 and had no detectable HCV RNA six weeks after stopping therapy.

Two other patients had detectable HCV RNA and stopped treatment at week 24 of follow-on therapy. In these patients, viral sequencing analyses at week 24 showed predominantly wild-type virus, with a minority population of R155K variants also detected.

The remaining patient had undetectable HCV RNA at week 12, but had been lost to follow-up by week 18 of follow-on therapy, Dr. Rodriguez-Torres reported.

Dr. Kieffer is an employee of Vertex and owns company stock. Dr. Rodriguez-Torres receives grant support from the company.

Vertex presents mixed results in hepatitis C drug

2006-11-01T23:26:00.000-08:00

30th October 2006
By Victoria Harrison

Vertex has presented mixed results from its phase Ib trial of its hepatitis C drug, saying that some patients still had the virus when combined with ribavirin.

The study examined Vertex's investigational hepatitis C virus protease inhibitor, telaprevir in combination with pegylated interferon (peg-IFN) with or without ribavirin.

The hepatitis C virus was suppressed in patients when pegylated interferon was added to telaprevir in the phase Ib clinical study.

When the follow on combination therapy of ribavirin was administered subsequent to telaprevir dosing some patients continued to show signs of the hepatitis C virus.

Clinical investigators said that some of these patients have stopped therapy, and that a proportion of them continued to have undetectable hepatitis C after stopping therapy.

When taken without ribavirin, the treatment alleviated both wild-type hepatitis C virus and resistant variants.

Vertex Pharmaceuticals is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

Vertex: A Promising Hep-C Play

2006-10-10T03:55:00.000-07:00

Standard & Poor says the pharma company's VX-950 could not only become part of a new standard hepatitis C treatment, but also alter the treatment "paradigm"

The World Health Organization estimates that as many as 170 million people are infected with the hepatitis C virus (HCV) and that an additional 3 million to 4 million are infected each year. The American Association for the Study of Liver Disease has estimated that about 3.4 million people in the U.S. are infected with HCV and that 10,000 to 12,000 Americans die of the disease each year.

Based on preliminary clinical trial results, we believe that Vertex Pharmaceuticals' VX-950 protease inhibitor could become part of a new standard of care for the treatment of hepatitis C, and capture a large portion of an estimated $5 billion worldwide market. Additionally, we think VX-950 may have the potential to greatly improve patient compliance and may create a new paradigm in the treatment of HCV viral infection.

In our opinion, investor confidence would be boosted should forthcoming data remain positive. In turn, we think the share price would move higher. The stock carries Standard & Poor's highest investment recommendation, 5 STARS (strong buy). Vertex is a biotech company and, therefore, carries a relatively high degree of risk. We also note VX-950 is still several years away from Food & Drug Administration (FDA) approval.

"FAST TRACK" STATUS. Founded in 1989, Vertex Pharmaceuticals is a biotechnology company that is focused on discovering, developing, and commercializing small molecule drugs for the treatment of a variety of diseases. The company utilizes a drug design approach that integrates biology, biophysics, chemistry, and automation and information technologies throughout the research process, which the company believes makes the discovery process more efficient and productive. The company has an extensive pipeline of drug candidates targeting a broad array of diseases and several important industry partnerships.

Vertex's principal focus is on its VX-950 oral hepatitis protease inhibitor for the treatment of chronic hepatitis C viral infections. VX-950 is designed to inhibit NS3-4A serine protease, an enzyme needed for HCV replication. The FDA has granted "Fast-Track" designation to VX-950, because HCV infection is an unmet, life-threatening disease. VX-950 has partnered with Janssen Pharmaceutica, a Johnson & Johnson (JNJ: Strong Buy: $65) company.

The current standard of care for HCV infection is a combination of pegylated interferon and ribavirin, administered for up to 48 weeks. The regimen has significant side effects, however, including fatigue, flu-like symptoms, depression, and anemia, and most patients drop out of before completing the full course of treatment. As a result, even though HCV is a curable illness, only about 3% of diagnosed patients are actually cured. We believe there is a large market opportunity for a new drug if it can reduce treatment time and/or reduce or eliminate the side effects associated with the current standard of care.

POSITIVE TRIALS. In early 2006, Vertex reported preliminary results from a 28-day, Phase II trial of VX-950 in combination with pegylated interferon and ribavirin, which included 12 treatment-naive (i.e., not previously treated) patients infected with genotype 1 HCV (the most common type of infection in the U.S.). In the study, patients received VX-950 every eight hours for 28 days, in combination with standard pegylated interferon and ribavirin. Following the VX-950 dosing (after 28 days), all 12 patients showed undetectable viral load, with no treatment discontinuations, no serious adverse events, and no evidence of viral breakthrough.

In the second quarter of 2006, Vertex initiated the PROVE 1 (260 treatment-naive patients dosed with VX-950 compared with standard care in the U.S.) and PROVE 2 (320 patients in the EU) trials. The PROVE 1 trial is fully enrolled, and the company expects to release 12-week safety data for 80 patients by the mid- to late fourth quarter 2006. We believe that, based on prior safety data already presented, the odds favor a positive result from this trial. We think further positive results will have a favorable impact on the shares.

In the first quarter of 2007, the company expects to release three-month sustained viral response (SVR) data, which will measure the viral load 12 weeks after 12 weeks of treatment is stopped. In our view, this will be the key data for VX-950, as preliminary SVR is considered indicative of longer-term sustained response.

By mid-2007, Vertex expects to have 12-week treatment data for 180 patients and some follow-up data that it will use to design the Phase III trials. In all, the company believes that more than 1,000 patients will be enrolled in clinical trials by mid-2007.

DEVELOPMENT PIPELINE. Turning to the company's other compounds under development, VX-702 is its oral p38 MAP kinase inhibitor for the treatment of rheumatoid arthritis. Vertex is conducting a Phase II program to assess the efficacy of the drug, while its partner, Kissei Pharmaceuticals, is conducting a Phase I trial in Japan. Preliminary results from the first trial supported a second Phase II trial, which is expected to begin in late 2006.

VX-770 is an oral CFTR potentiator for the treatment of cystic fibrosis. It is a small molecule compound that targets the cystic fibrosis transmembrane regulator (CFTR) protein that is defective in patients with cystic fibrosis. The company expects to complete a proof-of-concept trial in 2007. VX-770 is being developed in conjunction with Cystic Fibrosis Therapeutics.

The company is collaborating with Merck (MRK: Buy; $37) in the development of VX-680, an aurora kinase inhibitor for the treatment of cancer. Vertex believes that VX-680 could be a "backbone" therapy as well as monotherapy in certain cancers. Anecdotal data recently published showed positive results in chronic myeloid leukemia (CML) and acute myelogenous leukemia (AML) patients who had failed standard treatment. Merck is conducting three Phase I trails of VX-680 in hematologic cancers and solid tumors.

The company also has an agreement with GlaxoSmithKline (GSK: Buy, $54) covering the development of HIV protease inhibitors. GSK currently pays Vertex a royalty on sales of Agenerase, Lexiva, and Telzir and will pay additional development milestones for the development of other candidates, including brecanavir.

FOCUSED ON R&D. Vertex receives royalties on several products marketed by its partners, but the company is still primarily engaged in research and development. In 2006, we expect Vertex to receive about $38 million in product royalties and approximately $171 million in collaborative R&D revenues and milestone payments, for total revenues of around $209 million. R&D should constitute the bulk of the company's expenses, coming in at approximately $385 million for the year. We see Vertex generating a net loss of about $239 million, or $2.14 per share for 2006. Our net loss per share forecast for 2007 is $1.88.

The company is well funded. At the end of June, 2006, the company had about $316 million in cash and marketable securities on hand. In addition, in July, Vertex received a payment of $165 million from Janssen Pharmaceutica for the development and commercialization of VX-950. Lastly, the company completed an offering of 9.1 million shares on Sept. 20, which netted an additional $281 million. Given the company's current cash burn rate, we believe that Vertex has sufficient funds for at least the next two years of operation.

We estimate peak potential sales for VX-950 in the U.S. at about $2.5 billion under the assumption that VX-950 becomes part of standard of care for HCV treatment. We derive this estimate by assigning a 25% premium to projected sales of current treatments PEG-INTRON (Schering-Plough: SGP: Buy; $22) and PEGASYS (Roche), which had combined 2005 sales of about $1.9 billion. We believe such a premium will be justified if VX-950 can produce SVR levels that are higher than those elicited by current regiments, and/or shorten duration of therapy. We estimate the global market potential for VX-950 at about $5 billion.

PROFIT PROJECTION. We see the company's first year of profitability in 2010. In that year, we expect U.S. sales of $600 million for the HCV treatment. We think total Vertex revenues could exceed $800 million in 2010, and that Vertex will report net income of $349 million and EPS of $2.88 per share.

To arrive at our 12-month target price of $42, we employ net present value analysis. We are assuming that VX-950 is launched in late 2008, and that sales reach about $1.6 billion in 2012. For 2012, we forecast that Vertex will earn $4.91 per share. We assigned a p-e multiple of 25 times to our 2012 EPS estimate and discounted this result by a 20% rate for five years. We believe a 20% discount is appropriate, given the high degree of risk inherent in the shares.

We view Vertex Pharmaceuticals' corporate-governance practices as generally sound. We view the following factors favorably. The board is controlled by a supermajority (greater than 75%) of independent outsiders, and the nominating and compensation committees are comprised solely of independent outside directors. Also, the company has a committee that oversees governance issues, a board-approved CEO succession plan is in place, and a simple majority of shareholders is required to approve a merger.

BIOTECH RISK. On the negative side, the company has a poison pill in place, and its auditors were not re-elected at the most recent annual meeting in March.

Risks to our recommendation and target price include any delay in the development timeline for VX-950, the possibility that VX-950 fails to gain FDA approval due to a lack of efficacy in larger clinical trials or other adverse developments, or any combination of these issues. Other risks include new competition in the HCV treatment market, possible need for additional financing to fund the development pipeline, and lower-than-expected sales for the company's current and prospective product candidates.

Lastly, Vertex is a biotech company and, therefore, carries a relatively high degree of risk. We also note VX-950 is still several years away from FDA approval. Additionally, while we view results from the small, preliminary clinical trial favorably, we note that outcomes from the subsequent larger trials could vary, given larger patient populations.

Phase-3 trial of Albuferon begins

2006-10-05T03:54:00.000-07:00

Human Genome Sciences tests Hep C drug

ROCKVILLE, Md., Oct. 4 (UPI) -- U.S. firm Human Genome Sciences said Wednesday it has begun a phase 3 trial of Albuferon in patients with chronic hepatitis C.

The company said it would test its albumin-interferon alpha 2b in more than 2,000 treatment-naive patients with the disease.

"We believe that Albuferon could become the best-in-class immunomodulator in treatment regimens for chronic hepatitis C, and we are pleased to move this important program forward," said H. Thomas Watkins, HGS's president and chief executive officer. "Advancing Albuferon to Phase 3 development is a major step toward the transformation of HGS into a development and commercialization company."

The phase 3 development program will compare therapy with Albuferon in combination with ribavirin, versus PEGASYS, or PEG-IFN alpha 2a, in combination with ribavirin.

The testing will consist of two separate clinical trials -- ACHIEVE 1, which will enroll at least 1,278 patients with chronic hepatitis C genotype 1 -- and ACHIEVE 2/3, which will involve a minimum of 918 subjects with chronic hepatitis C genotype 2 or 3.

The studies will assess the drug's efficacy, safety and impact on health-related quality of life.

HCV RNA detected by TMA

2006-09-30T00:21:00.000-07:00

Hepatitis C virus RNA can be detected by PCR-based test

Health & Medicine Week - Oct. 02, 2006

A study from the United States has reported that hepatitis C virus (HCV) RNA was detected by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial.

"For making treatment decisions related to chronic hepatitis C, the utility of HCV RNA tests with increased sensitivity has not been defined," wrote C. Morishima and colleagues, University of Washington.

"Prior interferon nonresponders with advanced fibrosis (n=1,145) were retreated with peginterferon alpha-2a and ribavirin. Patients who were HCV RNA-negative by a polymerase chain reaction (PCR)-based assay (Roche COBAS Amplicor HCV Test, v. 2.0; lower limit of detection [LOD] 100 IU/mL) at week 20 (W20) received treatment for 48 weeks.

"Stored specimens were tested using the Bayer VERSANT HCV RNA Qualitative (TMA) Assay (LOD 9.6 IU/mL) and compared to PCR results for the ability to predict sustained virological response (SVR, defined as undetectable HCV RNA by PCR at W72)," the investigators explained.

"Nearly all PCR-positive samples (1006/1007, 99.9%) were positive as assessed by TMA. Among 1,294 PCR-negative samples, 22% were TMA-positive. Negative TMA results were more predictive of SVR than were negative PCR results at W12 (82% vs. 64%, p<.001) and at W20 (66% vs. 52%, p=.001). SVR was more likely the earlier TMA had become negative during treatment (82% at W12, 44% at W20, 20% at W24). "Among 45 patients who were TMA-positive but were PCR-negative at W20 and W24, none achieved SVR (95% CI: 0%-8%). Approximately 10% of patients with a single positive TMA result at the end of treatment still achieved SVR," the researchers observed. The authors concluded, "Negative TMA results at or after W12 were superior to negative PCR results for predicting SVR. In patients with negative PCR results during treatment, a single positive TMA test did not exclude SVR, although persistently positive tests did."

Morishima and colleagues published the results of their research in Hepatology (HCV RNA detection by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial. Hepatology, 2006;44(2):360-367). For additional information, contact C. Morishima, University of Washington, Department of Laboratory Medicine, Box 359690, Seattle, WA 98104, USA. The publisher of the journal Hepatology can be contacted at: John Wiley & Sons Inc., 111 River St., Hoboken, NJ 07030, USA.

Positive data for hepatitis C DNA vaccine

2006-09-22T00:55:00.000-07:00

Tripep reports positive data for hepatitis C DNA vaccine using Inovio's DNA delivery system

Inovio Biomedical Corporation (INO) announced that its partner, Tripep AB, Sweden, has reported added positive preclinical results showing its ChronVac-C DNA vaccine using Inovio's MedPulser DNA delivery system produced a strong immune response against hepatitis C virus (HCV) in a large animal model.

Ongoing toxicity studies of ChronVac-C delivered using Inovio's electroporation-based system showed that the combination induces a humoral response in rabbits that is comparable to results previously observed in mice.

Hepatitis is a disease characterized by inflammation of the liver. Hepatitis C virus (HCV) is a major cause of acute hepatitis. HCV is spread primarily by direct contact with human blood, the major causes worldwide being the use of unscreened blood transfusions, and re-use of needles and syringes that have not been adequately sterilized. As many as 70-90% of newly infected patients may progress to develop chronic infection (WHO: 2002). Of those with chronic liver disease, 5-20% may develop cirrhosis. About 5% of infected persons may die from the consequences of long term infection (due to liver cancer or cirrhosis).

Globally, an estimated 170 million people are chronically infected with HCV, which represents a reservoir sufficiently large for HCV to persist, and 3 to 4 million persons are newly infected each year. In the U.S., while new incidences of HCV have dropped dramatically, an estimated 4.1 million (1.6%) Americans have been infected with HCV, of whom 3.2 million are chronically infected (U.S. Centers for Disease Control and Prevention: 2006).

ChronVac-C is designed to be a therapeutic DNA vaccine that can stimulate the body's immune system. Animal experiments have demonstrated that ChronVac-C vaccination activates B cells and T-cells, the latter being regarded as the most significant to clearing the chronic infection relating to hepatitis C, that killed cells producing HCV protein. In humans, the ChronVac-C DNA plasmid would be injected into muscle tissue, where vaccinations are usually given, and taken up by muscle cells with the assistance of Inovio's electroporation-based DNA delivery system. These muscle cells would be expected to then produce predetermined proteins that may activate the body's immune system to attack all cells producing HCV proteins.

Tripep AB is a Swedish biotechnology research company that develops and commercialises candidate drugs based on patented and proprietary technologies. Its main focuses are research and clinical development of ChronVac-C.

Inovio Biomedical Corporation is a late stage biomedical company focused on commercializing its proprietary Selective Electrochemical Tumor Ablation (SECTA) therapy, which is a local treatment for solid tumors, with selective killing of cancer cells while preserving surrounding healthy tissue.

Hepatitis C Virus Genome Cloned

2006-09-14T12:34:00.000-07:00

Near Full-Length Hepatitis C Virus Genome Cloned from Clinical Samples

Gene Therapy Weekly - Sep. 14, 2006

Sept. 14, 2006 - (NewsRx.com) -- A study from the United States has reported that near full-length hepatitis C virus (HCV) genome can be cloned from clinical samples.

"Long RT-PCR (LRP) amplification of RNA templates is sometimes difficult compared to long PCR of DNA templates. Among RNA templates, HCV represents an excellent example to challenge the potential of LRP technology due to its extensive secondary structures and its difficulty to be readily cultured in vitro," wrote X.F. Fan and colleagues, St. Louis University.

"The only source for viral genome amplification is clinical samples in which HCV is usually present at low titers. We have created a comprehensive optimization protocol that allows robust amplification of a 9.1 kb fragment of HCV, followed by efficient cloning into a novel vector. Detailed analyses indicate the lack of potential LRP-mediated recombination and the preservation of viral diversity," the authors reported.

The researchers concluded, "Thus, our LRP protocol could be applied for the amplification of other difficult RNA templates and may facilitate RNA virus research such as linked viral mutations and reverse genetics."

Fan and colleagues published their study in Biochemical and Biophysical Research Communications (Efficient amplification and cloning of near full-length hepatitis C virus genome from clinical samples. Biochem Biophys Res Commun, 2006;346(4):1163-1172).

For more information, contact X.F. Fan, St. Louis University, School of Medicine, Division of Gastroenterology & Hepatology, Center Liver, Department of Internal Medicine, St. Louis, MO 63110, USA.

Publisher contact information for the journal Biochemical and Biophysical Research Communications is: Academic Press Inc. Elsevier Science, 525 B St., Ste. 1900, San Diego, CA 92101-4495, USA.

Pot helps cure hepatitis C

2006-09-13T05:19:00.000-07:00

By jrichman@angnewspapers.com

Medical marijuana users are more likely to finish hepatitis C treatment and so are more likely to be cured, according to a newly published study conducted in San Francisco and Oakland.

Other studies have shown marijuana relieves symptoms, but medical marijuana advocates said this could be the first to show improved cure rates for a life-threatening illness.

The study is by researchers at the University of California, San Francisco, and the Oakland-based Organization to Achieve Solutions in Substance Abuse (OASIS). It was published in the European Journal of Gastroenterology and Hepatology. It found marijuana users being treated for HCV three times more likely to have a "sustained virological response," meaning the virus can't be detected six months after treatment ends.

HCV treatment with ribavirin and interferon causes severe side effects, so many patients quit the long regimen too early.

Of 71 HCV patients studied, 21 finished with a sustained virological response: 12 of the 22 cannabis users and nine of the 49 nonusers.

"Modest cannabis use may offer symptomatic and virological benefit to some patients... by helping them maintain adherence to the challenging medication regimen," the study concluded.

Rob Kampia, executive director of the Marijuana Policy Project in Washington, D.C., issued a news release touting this as "a landmark study, showing that medical marijuana can literally save lives. Every day that our government continues punishing the sick for using this medicine is literally a crime against humanity."

=============

Additional Info:

Sometimes the disease remains at a point where it can be managed by lifestyle changes rather than medication — and that means giving up alcohol.

"Alcohol and hep C are a witches brew," said Dr. Rick Permutt, a gastroenterologist in Santa Rosa who developed its hepatitis C clinic 10 years ago. "It fuels the fire. Those who have hep C and are drinking go to complications sooner. You already have this disease insulting your liver, why add something more?"

T Cell-based Hepatitis C Vaccines

2006-09-06T05:02:00.000-07:00

New Perspectives for T Cell-based Hepatitis C Vaccines Are the Focus of Review

Vaccine Weekly - Aug. 30, 2006

Aug. 30, 2006--(NewsRx.com) -- A researcher reviews new perspectives for T-cell-based hepatitis C vaccines in a recent issue of the Journal of Hepatology.

According to the review, "Three percent of the world's population is chronically infected with the hepatitis C virus (HCV) and at risk of developing liver cancer. Effective cellular immune responses are deemed essential for spontaneous resolution of acute hepatitis C and long-term protection. Here, we describe a new T-cell HCV genetic vaccine capable of protecting chimpanzees from acute hepatitis induced by challenge with heterologous virus."

"Suppression of acute viremia in vaccinated chimpanzees occurred as a result of massive expansion of peripheral and intrahepatic HCV-specific CD8+ T lymphocytes that cross-reacted with vaccine and virus epitopes," said Carlo Ferrari at the University of Parma.

"These findings show that it is possible to elicit effective immunity against heterologous HCV strains by stimulating only the cellular arm of the immune system, and suggest a path for new immunotherapy against highly variable human pathogens like HCV, HIV, or malaria, which can evade humoral responses," stated the author.

Ferrari published the review in the Journal of Hepatology (New perspectives for T-cell-based HCV vaccines. J Hepatol, 2006;45(1):163-165).

For more information, contact Carlo Ferrari, Division of Infectious Diseases and Hepatology, Azienda Ospedaliero-Universitaria di Parma, I-43100 Parma, Italy. E-mail: cafer@tin.it.

Publisher contact information for the Journal of Hepatology is: Elsevier Science BV, PO Box 211, 1000 AE Amsterdam, The Netherlands.

Keywords: Parma, Italy, Hepatitis C Vaccine, Vaccine Development, Vaccine Efficacy, Hepatitis C Virus, Hepatology, Immunology, Immunotherapy, Liver Cancer Vaccine, Oncology, Virology.

Phynova's PYN17 granted UK Patent

2006-08-22T02:48:00.000-07:00

Botanical Hepatitis C treatment PYN17

LONDON (AFX) - Phynova Group PLC, which develops Western pharmaceuticals based on Chinese medicines, said it has received its first UK patent for PYN17, a botanical drug for the treatment of Hepatitis C.

PYN17 contains extracts of four plants that reduce liver inflammation, improves hepatic function and stimulates the immune system. It is designed to treat the symptoms of chronic hepatitis C viral infections.

There are no adequate treatments currently available to manage these disease symptoms. The global market for the treatment of Hepatitis C is estimated to be worth 9 bln usd by 2010.

Phynova is planning to have a multi-centred Phase IIb clinical trial underway in the US in early 2007.

Phynova currently has three other patent applications pending, PYN22, an anti-obesity product, PYN18, an antiviral for the treatment of Hepatitis C and PYN5c, a treatment for SARS.

HCV - Facts and Myths

2006-08-13T05:28:00.001-07:00

HEPATITIS C – FACTS & MYTHS

Facts: In order to contract hepatitis C you must have blood-to-blood contact with a person who has hepatitis C.

Contact may have happened by:

Sharing needles and/or other “works” used to mix, cook or shoot drugs
Sharing straws for snorting drugs
Receiving blood, blood products, or solid organs
Being on long-term kidney dialysis, without knowing you may have shared supplies / equipment
Working at a job where you have a lot of contact with blood
Being born to a mother who had hepatitis C at the time of your birth
Having sex with an infected person without using a condom
Living with someone who was infected and sharing items such as razors and toothbrushes

Myths: Hepatitis C is spread by:

Casual contact: shaking or holding hands, skin-to-skin contact, sneezing, hugging, coughing

Sharing silverware or drinking glasses, or through food or water
WHAT SHOULD I LOOK FOR?

Always tired *
Mental confusion or foggy feeling *
Lack of concentration, attention / focus *
Eating problems *
Depression (feeling sad and hopeless) *
On-and-off nausea and vomiting *
Stomach pain and swelling *
Loss of appetite *
Mood swings
Night sweats
Flu-like illness
Muscle and joint pain
Jaundice (yellowing of the skin and whites of the eyes)

* Most common signs / symptoms

Always Keep in Mind

Don’t share needles, syringes, water, cotton or cookers for shooting drugs, medication or vitamins
Don’t share straws for snorting drugs
Don’t share toothbrushes, razors, or other personal care products
Make sure any tattoos or piercings are done by licensed professionals using sterile equipment and using clean latex gloves each time
Limit sexual activity to one partner
Use latex condoms every time you have vaginal, anal, or oral sex

New hope for Hepatitis C research

2006-08-10T09:23:00.000-07:00

The mystery surrounding Hepatitis C, a disease that affects millions of people worldwide, is one step closer to being solved.

In a paper published in the August edition of Journal of Virology, scientists describe how they replicated, or reproduced the hepatitis C virus (HCV) in mouse cells. Working with different models, they showed a gene called protein kinase R (PKR) blocked the replication of HCV in mice.

"When a person becomes infected with HCV, the immune system produces a protein called interferon to fight the infection," said co-author and Director of the Monash Institute of Medical Research, Professor Bryan Williams.

"We now know genes interferon stimulates PKR to try to stop the virus spreading throughout the body."

HCV replicates at a very high rate – approximately one trillion viral particles are produced each day in an infected person. Professor Williams' research will provide a better understanding of how this replication occurs and how and why PKR blocks the production of the virus.

Hepatitis C affects 210,000 Australians. Worldwide, it is estimated more than 170 million people suffer from the disease. The virus attacks the liver, causing flu-like symptoms, fevers, abdominal pain, depression, and for two-thirds of patients, chronic liver disease.

The discovery may also shed light on why some hepatitis C patients respond better to treatment than others.

"As there is no vaccine or cure for HCV, the only treatment on offer for patients is interferon therapy, which aims to slow the progression of the disease. However, there are six different genotypes, or strains of HCV, which all react differently to treatment," Professor Williams said.

"We can now explore why some strains are more sensitive to interferon therapy, and how we can adapt treatment to the different strains of the disease."

"Our research is still in the early stages, but the research model we have created will be a valuable tool in understanding the underlying mechanisms of chronic HCV infection, and how the virus responds to interferon treatment" said Professor Williams.

###

Research collaborators were the Monash Institute of Medical Research, the Department of Microbiology, Immunology and Molecular Genetics, University of Kentucky College of Medicine, Kentucky, USA and the Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, USA.

A full copy of the research paper is available at: http://jvi.asm.org/current.dtl#VIRUS_CELL_INTERACTIONS
1. Hepatitis C Council of Victoria: http://www.hepcvic.org.au

More information / interview opportunities:
Contact Julie Jacobs
Public Relations Manager:
(+61 3) 9594 7109
0408 135 256.

HCV and Serum Proteome

2006-07-28T00:00:00.000-07:00

Hepatitis C virologic response predicted using serum proteome

A study from France has reported on the use of the serum proteome to predict virologic response in patients with hepatitis C treated by pegylated interferon plus ribavirin.

"Surface-enhanced laser desorption ionization time-of-flight mass spectrometry is a proteomic technique that enables the global profiling of proteins. We used this approach to monitor the kinetics of serum proteome in patients with chronic hepatitis C virus infection receiving a standard bitherapy regimen to predict treatment response," wrote V. Paradis and colleagues, Department of Pathology.

They explained. "Ninety-six patients with chronic hepatitis C were retrospectively selected. All patients received complete treatment with pegylated interferon in combination with ribavirin. Patients had serum sampling before starting treatment and at the end of treatment. Results were validated in an independent cohort of 5:1 patients."

"Comparison of protein profiles in pretreatment and after-treatment serum allowed us to characterize 50 protein peaks, the level of which significantly varied. In the group of patients with sustained virologic response, 37 peaks displayed significant variation during treatment, whereas only one peak differed in nonresponders.

"A logistic regression analysis allowed us to define an algorithm composed of 2 protein peaks (fibrosis stage and genotype) that correctly predicted, in pretreatment serum, response to treatment in 89% of all patients with an area under the receiver operating characteristic curve of 0.92," the investigators wrote.

"In the independent testing group, the same difference in proteome kinetics was observed between sustained responders and nonresponders. The algorithm correctly predicted treatment response in 81% of patients in the testing group," the scientists observed.

They concluded, "This study suggests that the kinetics of proteome are significantly different in serum of patients according to treatment response. Serum protein profiling allows prediction of response to antiviral treatment in a significant proportion of patients."

Paradis and colleagues published their study in Gastroenterology (Serum proteome to predict virologic response in patients with hepatitis C treated by pegylated interferon plus ribavirin. Gastroenterology, 2006;130(7):2189-2197).

For more information, contact V. Paradis, Department of Pathology, Clichy, France.

Publisher contact information for the journal Gastroenterology is: W B Saunders Co-Elsevier Inc., Independence Square West Curtis Center, Ste. 300, Philadelphia, PA 19106-3399, USA.

Cholesterol drugs may treat hepatitis C

2006-07-08T01:06:00.000-07:00

WASHINGTON (Reuters) - Cholesterol drugs called statins may help treat hepatitis C infections, Japanese researchers reported on Friday.

Tests in lab dishes suggest that some statin drugs may help stop the hepatitis C virus from replicating, they wrote in the journal Hepatology, published by the American Association for the Study of Liver Diseases.

An estimated 170 million people worldwide are infected with the hepatitis C virus. The standard treatment is a combination therapy of interferon and ribavirin but it only helps about 55 percent of patients.

The rest risk progression to cirrhosis and liver cancer.

Masanori Ikeda of Okayama University in Japan and colleagues tested several statin drugs against the virus in lab dishes.

All the drugs except pravastatin interfered with the virus to some degree. Fluvastatin, sold by Novartis under the name Lescol, had the strongest effect, they reported.

It may be that certain proteins are required for the hepatitis C virus to replicate and that some statins block the action of these proteins, the researchers said.

They tested the statins along with interferon, and found each worked even better when combined with the second drug.

"We clearly demonstrated that co-treatment of interferon and fluvastatin was an overwhelmingly effective treatment," the researchers wrote.

Statins -- which include Pfizer Inc.'s $10 billion-a-year Lipitor, Bristol-Myers Squibb Co.'s Pravachol and Merck and Co. Inc.'s Zocor -- are the world's best-selling drugs, taken by millions to reduce the risk of heart attack.

But they appear to affect many biological processes. An expert proposed last month that they may affect influenza viruses, including bird flu, and other research has shown they reduce the risk of cataracts.

Generic statins are available in many countries and have become increasingly inexpensive.

-----------------

Ed's Opinion:
When would the world start thinking about defeating the virus and not the profits of these big corporations? If it needs a revolution - let us get ready for it.

Human are a surplus commodity in today's world. 170 million HCV patients are all customers...

Goodbye Ribavirin?

2006-07-07T12:03:00.000-07:00

OKAYAMA, Japan (UPI) -- Japanese scientists say they`ve found statins, typically used as anti-cholesterol medications, can inhibit the replication of the hepatitis C virus.

The findings mean statins might be able to replace ribavirin in combination therapy with interferon. There are 170 million people worldwide infected with HCV.

The standard HCV treatment is a combination therapy of interferon and ribavirin, which is effective in about 55 percent of patients. The remaining 45 percent face a threat of the disease progressing to cirrhosis and liver cancer.

Aware of recent studies showing one statin, lovastatin, inhibits HCV replication, researchers led by Masanori Ikeda of Okayama University tested other statins in search of a more effective anti-HCV therapy.

They evaluated the anti-HCV activities of five statins: atorvastatin, fluvastatin, lovastatin, pravastatin and simvastatin. When the statins were tested alone, all except pravastatin inhibited HCV replication, with fluvastatin having the strongest effect; atorvastatin and simvastatin had moderate effects and lovastatin had a weak effect.

The findings are reported in the July issue of the journal Hepatology.

Graphic hepatitis C ads raise ethical qualms

2006-06-22T02:46:00.000-07:00

By John Sullivan
Inquirer Staff Writer

As the head of liver transplantation at Thomas Jefferson University Hospital, Victor J. Navarro has seen many ailing patients with hepatitis C. But they don't look like the man in a half-page, color newspaper ad with a battered and bruised face, his eyes glassy.

"If Hep C was attacking your face instead of your liver, you'd do something about it," the ad reads. "Ready to fight back?"

While Navarro and other experts applaud the ads for raising interest in the viral disease, they think the campaign by drugmaker Hoffmann-La Roche Inc. could cause unnecessary alarm, in part because the vast majority of hepatitis C patients will not die of it.

"It's a marketing tool to make people fearful of hep C," Navarro said.

Roche's drugs, which are improvements over past medications, also work on only half of all patients, and cause considerable side effects. The campaign could leave those who cannot benefit believing they will wind up like the man in the ad.

The ad also is part of a larger marketing effort by Roche to quietly sponsor hep C seminars for the public and support patient groups and many liver physicians. Ethicists say the financing raises questions about whether the advice at such seminars can be objective.

Roche spokesman Mike Nelson said the company was simply trying to get out the word about the disease so more people can be helped. Nelson says nearly 600,000 hepatitis C patients have been diagnosed but haven't been treated, and may not know about the company's current market-leading options: Pegasys (interferon and an antiviral substance) and Copegus (an antiviral).

Nelson also said the ad was meant to be strong "to break through the clutter."

Roche said nearly 56 million people had seen the ad as of April, and more would see the ad in the coming weeks, part of a national blitz Roche launched last year in 250 newspapers, including The Inquirer and Philadelphia Daily News, and seven major magazines, such as Time. The ads also are plastered on 4,000 billboards and in 40,000 posters.

Roche officials would not disclose the cost of the campaign, which will run through July, but such large newspaper ads cost as much as $50,000 a day.

Leonard B. Seeff, who oversees hepatitis research at the National Institutes of Health, originally thought the ad came from an advocacy group.

"I think the ad is awful. Patients with hepatitis C do not look like that," said Seeff, who has been working on a study partly funded by Roche. "On the other hand, if you're trying to get the message across, one way is to make it look bad."

Seeff, who said his opinion did not reflect that of the NIH, said that he also was concerned because only a few people will die from hepatitis C.

"They mostly die from all kinds of things other than chronic liver disease," he said. "They should not think it's a death sentence."

Some doctors and advocates see a strong profit motive behind the campaign. "Ultimately it sells more of their drug," said Sidney M. Wolfe, director of Public Citizen's Health Research Group.

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said it was not good policy for the United States to rely on companies to sponsor public-health campaigns. Such efforts tend to go to diseases for which companies have developed drugs, while other needy areas are ignored, he said.

Hepatitis C is a viral liver ailment that is the most common chronic blood-borne disease in the country.

The National Institutes of Health estimates that about four million people have hepatitis C in the United States. That number is expected to double in the coming decade as more people learn they are infected.

Many people got the disease from having received tainted blood or organs before adequate tests were developed in 1992. Most new cases are caused by intravenous drug use. A few contract the disease through high-risk sexual behavior, according to the Centers for Disease Control and Prevention.

Most people don't know they've been infected because the disease often doesn't cause symptoms for decades. The only way to confirm a diagnosis is to take a sample of the liver and examine it for scarring.

Only a fraction of those infected - from 1 percent to 5 percent - die of the disease. Yet it remains the No. 1 cause of liver transplants.

About 70 percent to 80 percent of those with the liver disease suffer from a stubborn genetic variant called genotype 1 that resists treatment.

The cocktail of antiviral drugs works in only 30 percent to 40 percent of those cases, and even less often in African Americans, according to the World Health Organization.

For the remaining 20 percent to 30 percent who have genotype 2 or 3, treatment works about 80 percent of the time. Averaging the two groups means that treatment only works in half the cases. Roche claims higher success rates.

While most insurance covers the therapy, uninsured patients must weigh that success rate against the cost, which can run up to $64,000 per year for some genotypes. The drugs are given several times a week, from 24 weeks to 48 weeks.

Still, hepatitis drug sales and advertising have been brisk. Over the last five years, drug company spending to advertise interferon, including Roche's drugs, has jumped from $14 million to $75 million. For Roche's Pegasys, ad spending rose from $30,000 in 2004 to more than $965,000 last year, according to Yardley, Pa.-based Verispan, which tracks pharmaceutical marketing.

The push has paid off. The company sold $1.4 billion worth of hepatitis C drugs, making it a top seller for the firm, according to its 2005 annual report.

Some hepatitis C activists, including those supported by the company, say the ads may seek to take advantage of a small window of opportunity. Roche now controls more than 60 percent of the hepatitis-therapy market, but that could change as other companies win approval for new antiviral treatments due out in coming years.

"We have been advising most people that they should probably wait for the next class of drugs," said Michael Ninburg, president of the National hepatitis C Advocacy Council, who heads the hepatitis Education Project in Seattle, which gets funding from Roche.

Also recommending that are HepTREC, a hepatitis education and support group started by Amy Jessop and a doctor and nurse at Temple University. Roche gave the group more than $250,000 in its first two years.

"I wish that there was public funding that we could turn to," said Jessop, who taught public health at Temple. "But the reality is there is no funding."

Earlier this year, about 15 people sat in a dimly lit auditorium at Graduate Hospital in Center City to hear a lecture on hepatitis C. Jessop told the group that Roche was a sponsor. She never promoted Roche products.

In the crowd sat Marc B. Saxe, a 46-year-old drug counselor from Philadelphia, who was diagnosed with hep C in 1998.

Saxe says he was "freaked out" by the diagnosis and went untreated until last year, about the time the Roche ad first appeared. It has worked, he said.

"I thought it was disgusting," he said of the ad. "But if it gets people to think about it, great."

"I just want to get fixed."

Hepatitis C At a Glance

About 3.9 million Americans are chronically infected with hepatitis C.

Prevalence rates are up to 8 percent to 10 percent of African Americans.

Dialysis patients, hemophiliacs, drug addicts and people transfused with blood before 1990 are particularly affected by the disease.

Injectable drug use remains the main route of transmission.

Sexual transmission is thought to be relatively infrequent.

Of every 100 people infected with hepatitis C:

About 55 to 85 people may develop long-term infection.

70 people might develop chronic liver disease.

5 to 20 people may develop cirrhosis over a period of 20 to 30 years.

1 to 5 people might die from the consequences of liver cancer or cirrhosis.

SOURCES: World Health Organization and the Centers for Disease Control and Prevention

Vertex verges on big time

2006-06-22T00:11:00.000-07:00

But hepatitis drug faces competition and some investors wary of stock
By Stephen Heuser, Globe Staff | June 21, 2006

Earlier this year, Joshua Boger , chief executive of Vertex Pharmaceuticals Inc. , stood before several hundred scouts from the country's top mutual funds and drug companies and delivered a piece of news that could make his 17-year-old Cambridge biotech firm profitable for the first time.

An experimental Vertex pill, he said, had dramatic effects in a group of eight patients with hepatitis C, a virus that infects millions of Americans and can lie dormant for years before destroying the liver.

``It's a tremendous responsibility to live up to a molecule like VX-950," Boger told the crowd at the JP Morgan Healthcare Conference . In the shorthand of biotechnology, he meant that he had a drug on his hands that wouldn't just make large amounts of money, but would change society.

In the audience, an investor leaned over to a reporter and whispered: ``He certainly doesn't lack for confidence."

Since news of Vertex's hepatitis drug emerged last year, this company known for its expert chemistry has found itself among the highest fliers in the biotechnology world, soaring from less than $1 billion in market value in early 2005 to nearly $5 billion in March. Yesterday, value had slipped back to about $3.4 billion, after shares closed at $31.18.

Vertex now plans to test its drug in hundreds more people and hopes to file for federal approval in 2008 . If the drug works as well in the larger trial, analysts project it could bring in as much as $2 billion to $3 billion annually -- making it a global blockbuster and vaulting Vertex out of its research-driven niche into a prominent new role carrying the banner for the idea that new science can turn into real profits.

``There's a lot of excitement about Vertex's drug, and rightly so," said Dr. Nezam Afdhal , a liver specialist at Beth Israel Deaconess Medical Center in Boston who helps run one of the company's clinical trials.

But Vertex faces sharp competition from some of the biggest drug makers in the world, who are racing to develop their own hepatitis C treatments. And some investors are eyeing Vertex's stock price warily and asking: Haven't we seen this before?

Hatched in 1989 to exploit the new analytical tools that chemists and biologists were starting to master, Vertex -- like many biotechnology companies -- has survived years of red ink on the promise of a future payday. The company attracted early investors with stories of how its smarter, faster approach to attacking diseases would lead to a rapid flurry of new drug applications. The company was even the subject of a book, ``The Billion-Dollar Molecule," which highlighted the relentless scientific salesmanship of its founder, Boger. Buoyed by a bull market and a biotech boom, its price crested near $100 a share in 2000.

But by 2003, with no significant drugs on the market, its share price had dropped by a factor of 10. The ``billion-dollar molecule," a potential immune-suppressive drug, never materialized. The company has racked up more than $1 billion in losses, and its hepatitis pill won't come to market till 2009 at the earliest.

``I think there are a number of investors who've been burned in the past on Vertex shares, and that's going to make some investors nervous," said stock analyst Joshua Schimmer of Cowen & Co.

Vertex kept itself afloat, however, with a series of science deals with big pharmaceutical companies, helping to defray $200 million in annual research spending, and through a pair of timely debt financings in 2000 that added almost $500 million to its bank account.

Today, the value of the company hangs on its next set of trials for the hepatitis treatment, simultaneous human tests in the United States and Europe. As many as 1,000 people with hepatitis will get the drug, and results are expected to emerge later this year .

Meanwhile, Vertex is hiring as fast as any company in Cambridge, planning to grow from about 800 employees at the end of last year to 1,000 by the end of this year. It hires a car fleet to shuttle employees from its Cambridgeport campus to a big chunk of newly occupied lab space in Kendall Square. And in anticipation of a major launch of a product, it has even hired the former marketing manager of Lipitor, the best-selling drug in the world.

It may sound unlikely that an eight-patient test could drive billions in stock-market growth, but that's the nature of the biotechnology industry, in which investors bet not on a company's earnings, but on its potential. One big success can turn a company from a perennial also-ran into a global name.

``I like the idea that Joshua and the management team are really swinging for the fences," said Craig Millian, the former Lipitor marketer who arrived from Pfizer in January.

The hepatitis C virus has emerged in the past few years as a top new target for drug makers. Identified in 1989, it infects people through blood contamination -- injectable drug use and transfusion are the most common means -- and can lurk undetected for years before its liver damage is discovered by a doctor. There is no vaccine.

``When you think about organs you can do without, we still haven't found a way to reproduce the function of the liver," said Raymond Chung , the director of hepatology at Massachusetts General Hospital. ``If you're out of liver, you're pretty much out."

Currently, the disease is treated with a year's worth of injected interferon, which boosts the immune system enough to help about half of those treated with it to clear the virus on their own. It costs $18,000 and has unpleasant side effects, which doctors describe as a terrible flu that can trigger anemia, mood swings, and depression as therapy drags on.

Vertex's pill, by contrast, takes a leaf out of the playbook that was developed to fight HIV: It shuts down a protease, a key enzyme the virus needs to infect the body. Without the protease, the hepatitis C virus can't make the set of protein tools it needs to reproduce itself and hijack other cells.

In the test results disclosed in January, the drug appeared extremely effective in knocking the virus below detectable levels when used in combination with interferon. (If patients' viral levels stay undetectable for long enough, they are considered cured.) In four of eight patients who took Vertex's pill late last year, the hepatitis virus was undetectable within two weeks.

If it shows similar results in the longer trial, it could open the door to a treatment that helps more people, and takes less time, than the current therapy.

It could also open the door to huge growth for whichever drug company gets a product to market first. Global drug giant Schering-Plough is also testing a protease inhibitor, although Vertex's appears to be ahead in effectiveness. Behind them, several other companies have similar drugs in the pipeline, including Bristol-Myers Squibb Co.

It's uncertain whether Vertex's larger trials will replicate impressive early results. Drug resistance and side effects can always crop up in larger and longer trials; an earlier protease inhibitor was pulled by a German drug company after heart problems showed up in animal tests.

But analysts believe that the first company to bring a drug to market will have a chance to set the price -- up to $30,000 for a course of treatment -- and claim a big share of the estimated 8 million patients in the United States and Europe.

``There are obviously no guarantees in drug development, said Schimmer, but Vertex has ``never had a drug that shows such efficacy before. Few companies have."

Vertex does have other products in the pipeline, including a possible pill for rheumatoid arthritis, a cancer treatment being developed with Merck, and a cystic fibrosis pill. But for now it is the hepatitis C pill that has transfixed both doctors and Wall Street.

``This is a drug that we believe is not going to launch quietly. There's going to be worldwide demand, and it's a disaster if you have spectacular results but limited supply," said Boger.

In anticipation, Vertex has already contracted out large-scale manufacturing of the pill, and promises to have produced two tons by the end of the year.

Boger said he is pleased at the prospect that the company he founded could turn the corner to profitability around the time it turns 20.

``To me it's not a surprise that we're 17 years old and in this position," he said. ``That's about how long I thought it would take."

Stephen Heuser can be reached at sheuser@globe.com.

Treatment of Acute Hepatitis C

2006-06-20T21:32:00.000-07:00

By Liz Highleyman

Past studies have shown that treatment of acute hepatitis C virus (HCV) infection is highly successful; a German study published in 2001, for example, found a sustained virological response (SVR) rate of 98% using conventional interferon monotherapy (Jaeckl 2001). However, many individuals with acute infection will clear HCV spontaneously, so if therapy is started too soon, there is a risk of treating patients who don't need it.

In the May 2006 issue of Hepatology, researchers reported on a study looking at the optimal duration of treatment for acute hepatitis C. The study initially evaluated 161 patients, of whom 30 refused treatment and 29 experienced spontaneous HCV clearance. The remaining 102 patients with persistent HCV were randomly assigned to 1.5 mcg weekly pegylated interferon alpha-2b (Peg-Intron) monotherapy for 8, 12, or 24 weeks.

Results

Using an intent-to-treat analysis, 67.6% patients who received treatment for 8 weeks achieved SVR; the rate was 82.4% after 12 weeks and 91.2% after 24 weeks.

All patients had undetectable HCV RNA 48 weeks after the end of therapy.

Treatment for 8 or 12 weeks was effective for patients with HCV genotypes 2, 3, or 4, but those with genotype 1 required 24 weeks.

Fewer adverse events were observed in patients receiving treatment for 8 or 12 weeks, compared with the 24-week group.

Conclusion

The authors concluded that pegylated interferon monotherapy "effectively induces high sustained virologic response rates in patients with acute hepatitis C virus infection, thus preventing development of chronic hepatitis C." They suggested that treatment duration should be further optimized based on genotype and rapid virological response at week 4.

Treating Acute HCV in Prison

The Hepatology study, and another recent study of HIV/HCV coinfected patients reported in the May 12, 2006 issue of AIDS, demonstrate that treatment of acute hepatitis C can be effective. However, many people with acute HCV infection do not experience symptoms, and most cases of hepatitis C are not identified at this stage.

A study reported in the June 15 issue of Clinical Infectious Diseases suggests that prisons and drug detoxification and treatment center may be appropriate settings for detecting and treating acute HCV infection among injection drug users.

In this study, on-site medical providers at prisons and detox facilities were educated about risk factors for and symptoms of hepatitis, and asked to refer all potential cases to a specialty clinic.

Results

During 30 months of observation, 21 individuals were diagnosed with acute hepatitis C, 3 with hepatitis B, and 1 with hepatitis A.

Of the 21 patients with acute hepatitis C, 19 were identified in prison shortly after incarceration.

Among 17 hepatitis C patients who received follow-up (for a mean 6.3 months), 8 experienced spontaneous HCV clearance.

5 patients with persistent HCV were treated with pegylated interferon monotherapy; 2 of these (40%) achieved SVR.

All patients agreed to receive HIV counseling and testing, as well as immunization against hepatitis A and B.

Conclusion

The authors concluded that, "Incarceration presents a unique opportunity to identify injection drug users with acute HCV infection, to initiate counseling regarding other blood-borne pathogens, and to facilitate immunizations and HCV treatment."

6/20/06

References

SM Kamal, KN Moustafa, J Chen, and others. Duration of peginterferon therapy in acute hepatitis C: a randomized trial. Hepatology. 43(5): 923-931. May 2006.

BH McGovern, A Wurcel, AY Kim, and others. Acute hepatitis C virus infection in incarcerated injection drug users. Clin Infect Dis. 42(12): 1663-1670. June 15, 2006.

E Jaeckel, M Cornberg, H. Wedemeyer, and others. Treatment of acute hepatitis C with interferon Alfa-2b. New England J Med. 345: 1452-1457. November 15, 2001.

Source: http://www.hivandhepatitis.com
Link: http://www.hivandhepatitis.com/hep_c/news/2006/062006_a.html

Hep C Stigma

2006-06-19T20:49:00.000-07:00

In a world of profitable living, where choices are made purely based on profits alone - the life and existence of a HCV patient is of profit to the pharma/medical community.

When it comes to people outside the medical community, the fear of getting hold of this disease is way too much. Fear of an unknown virus starts with the hatred we all carry for the common flu. It is not easy to inform the common person that Hep C is only transmitted through blood...

A few months back, I read about a school teacher - who developed HCV after a student bit her. That is a very scary prospect, and one can understand the apprehensions of other people.

Social awareness of the disease (No one is at ease with any disease) is the first step in fighting this virus. I believe HCV carriers must reveal the info about their disease to their close relatives, especially the spouse/partner.

There is no point giving the virus to another person.

If children of HCV patients are asked to move out of a school, that's when we know the society has completely failed. The virus would have then succeeded not only in destroying the liver of a person but also the soul of a society.

The compulsion most HCV patients feel about keeping their health status a secret is understandable too. But, then, in the battle against this dreadful virus, a lot of good karma will help a long way.

Good karma being a lot of positive energy.

Some of the relatives and friends might distance from the HCV patient. That also gives us a good idea - who really the best friend is.

There is a certain reality - that the virus resides inside - which cannot be conveniently forgotten.

After almost six months of researching, I am yet to understand what the medical community is doing about HCV. If we have 170 Million people infected with this virus, and if the numbers are increasing... it is time to act - NOW.

Ayurveda has very effective treatment for rejuvenating liver. The roots of Henna has been used in South India as a medicine to cure liver ailments, especially severe jaundice.

More needs to be done about this, a lot more. We all need to do a lot more honest work about HCV, else this virus will be our third world war.

Japan's Hep C Crisis

2006-06-19T20:43:00.000-07:00

First ruling near in suit over drug-caused hepatitis C debacle

By YOHEI SEKIand JUN NAGATA

OSAKA (Kyodo) Life changed drastically for Osaka resident Etsuko Morigami in 1987 when she was diagnosed with cirrhosis of the liver, some 13 years after being infected with hepatitis C through a tainted blood-clotting agent given to her while she was giving birth.

Morigami was treated with a blood-clotting product to stop her bleeding when she had her first son, Minoru, now 32.

After contracting cirrhosis, she developed diabetes and kidney damage. Insulin injections three times a day were a must.

"I often went out with my family and I was really in good shape," Morigami, 56, said of the time before the symptoms became severe, looking at the more than 10 kinds of drugs on a table beside her.

Considering her condition, treatment of hepatitis C with interferon, which eliminates the virus but whose side effects are severe, was halted. She developed liver cancer, and a long tube was inserted into her side to kill cancer cells with ethanol.

But she had relapses, with the intervals becoming shorter and shorter. Eventually she had no other option than a partial liver transplant, and Minoru was the donor.

"As you were infected when I was born, I will repay my debt to you," he told her.

Morigami underwent the transplant last June. To prevent rejection, she took an immuno-suppression drug, and to avoid infectious diseases she could not leave home, except to go to the hospital.

But her new liver gradually deteriorated, and the interferon treatments were resumed in February, now that there are more drugs available to control its side effects. Although she has also been diagnosed with lung cancer, it is inoperable.

"There is a time bomb inside you. If it explodes, you will blow up," a group of lawyers said in a statement aimed at trying to explain the plight of patients, many of them unwittingly infected with hepatitis C.

Although initial symptoms may not be critical, the hepatitis will eventually lead to cirrhosis and liver cancer.

"Swift measures should be taken before it is too late," said Morigami, one of the plaintiffs in a damages lawsuit against the government and Mitsubishi Pharma Corp.

Mitsubishi Pharma is the successor of Green Cross Corp., the firm that produced the blood product that caused her hepatitis C infection. The blood product was marketed under the brand name Fibrinogen-BBank.

The Osaka District Court will rule on the suit Wednesday in the first legal judgment involving tainted blood products leading to hepatitis C infections.

Besides the physical effects of hepatitis C, patients face discrimination often born out of ignorance and fear.

At a gathering in Tokyo's political center of Nagata-cho in late May, plaintiffs complained of discrimination and prejudice against them by employers and other sectors of society.

"I may not be employed if I tell (my employer) I am suffering from hepatitis C," a man in his 20s, one of the plaintiffs in a lawsuit filed with the Tokyo District Court, said.

A woman said, "I am hiding my disease because I fear that my children's friends' parents may tell them not to play with my kids."

Hepatitis C is caused mostly by direct infection of the blood and is not transmitted by ordinary social contact, but at the gathering many patients complained of the agony of not being able to tell people they have the disease.

Some reported having been refused dental treatment, and one woman was fired from her job in a company cafeteria. Management told her the disease was infectious.

Since the end of World War II, Japan has suffered several drug-induced disasters, including the childbirth deformities caused by thalidomide in the 1950s and '60s, SMON (a disease similar to polio), another disease caused by defective chloroquine in the 1950s, and the HIV/AIDS outbreak caused by contaminated blood products -- also marketed by Green Cross -- in the 1980s.

"The suffering can be said to be on a historically large scale, but the real situation is not well-known in society," said Kiyohiko Katahira, a professor of health and welfare at Toyo University.

Regarded as the largest of these drug-induced diseases is SMON, caused by the antiflatulence drug chinoform in the 1950s and 1960s, which affected some 10,000 people.

According to Mitsubishi Pharma, the number of patients since 1980 infected with hepatitis C as a result of taking the tainted blood product based on the naturally occurring protein fibrinogen is estimated at 10,000.

But as the product had been sold since its approval by the government in 1964, Katahira said, "The number of victims will be about 30,000 if the average annual number of victims before 1979 is assumed to be the same," making it much larger than the SMON disaster.

There is more than one similarity between this case and the HIV/AIDS fiasco, in which a doctor and a high-ranking official at the old Health and Welfare Ministry were prosecuted for allowing tainted products to stay on the market after being officially warned of their dangers. Victims in both cases have been plagued by discrimination and prejudice, and are waging lawsuits without revealing their real names.

In the case of hepatitis C, only 10 of the 96 plaintiffs across the country have made their real names public.

There are also many other victims who cannot become plaintiffs even if they wanted to, because their medical records have been lost and their link to tainted blood products cannot be proved.

Fibrinogen is a globulin in the blood that aids coagulation, and products containing it were widely used by obstetricians, gynecologists and surgeons. But the U.S. government canceled its approval for such blood products in 1977 because there was a danger that the products, made from donated blood, could be infected.

Despite that, 50,000 to 70,000 packages of the Green Cross product were sold annually between 1980 and 1986. When an epidemic of liver inflammation-infection cases erupted in Aomori Prefecture in 1987 and similar reports continued, Green Cross began to recall the product.

Although the government began to study ways to strengthen the medical examination and treatment system, Norio Hayashi, a professor at the graduate school of Osaka University, said the system is not satisfactory. "Hepatitis C patients are estimated to number 1.5 million in Japan, but there are only some 3,000 liver-specialist doctors," he said.

HCV treatment efficacy can be predicted

2006-06-19T06:50:00.000-07:00

New findings in hepatitis C virus described from Canada, Sweden and Austria

Hepatitis Weekly - Jun. 19, 2006

2006 JUN 19 - (NewsRx.com) -- Data on hepatitis C virus are outlined in reports from Canada, Sweden and Austria.

Study 1:
According to scientists from Canada, hepatitis C virus treatment efficacy can be predicted.

"In the past, antiviral therapy has been given to 15% to 30% of patients infected with hepatitis C virus (HCV). The efficacy of therapy has recently improved with the addition of ribavirin and pegylated interferon. The aim of the present study was to identify the clinical, socioeconomic and health-system predictors of antiviral treatment for HCV," wrote M. Witkos and colleagues, University of Toronto. "A retrospective analysis of compensation claims data of patients who acquired HCV through blood transfusions between 1986 and 1990 was performed. The patients consisted of 2456 Canadian HCV-positive individuals."

The researchers wrote, "The authors reviewed narrative comments from physicians, and constructed univariate and multivariate logistic regression models, using receipt of antiviral therapy with interferon or interferon/ribavirin as the primary outcome. Of the 2456 patients, approximately 30% appeared to be eligible, but only 16% received treatment.

"Univariate analyses suggested that the disease severity, age, HIV status and province of residence were associated with the likelihood of receiving treatment (p<.01). The final, multivariable model indicated that in patients with HCV. Intermediate disease severity (eg, fibrosis, p<.0001); middle age (p<.0001); HIV-negative status (p<.0001); and province of residence (Quebec, p<.0001; and Saskatchewan, p<.0001) were independent predictors of treatment."

"Narrative comments of physicians emphasized the importance of age, HIV status and patient preferences in clinical decision-making. Given the efficacy and cost-effectiveness of current antiviral therapy, treatment rates of HCV patients may be suboptimal," reported the authors.

They concluded, "Further work is required to understand barriers to treatment related to geography, organization of medical care, age, medical provider and patient preferences."

Witkos and colleagues published their study in Canadian Journal of Gastroenterology (Predictors of antiviral therapy in a post-transfusion cohort of hepatitis C patients. Can J Gastroenterol, 2006;20(2):107-111).

For additional information, contact M.D. Krahn, University of Toronto, Toronto General Hospital, Department of Health Policy Management & Evaluation, 200 Elizabeth St., EN 14-207, Toronto, ON M5G 2C4, Canada.

Study 2:
According to recent research from Sweden, translation efficiency correlates with therapy outcome in chronic hepatitis C virus (HCV) infection.

"Combination therapy with interferon-alpha (IFN-alpha) and ribavirin (RBV) in chronic hepatitis C demonstrates the best responses against HCV of genotype 3. Still, it has proven to be ineffective in 20-30% of patients infected with this genotype.

"In the present study," wrote A. Yasmeen and colleagues, Karolinska Institute, "we analyzed the translation efficiency mediated by the internal ribosome entry site (IRES) region in HCV genotype 3 genomes isolated from sustained responders (SR) and non-responders (NR), assuming that this may influence the outcome of treatment."

The authors reported, "Pretreatment isolates of genotype 3 from 22 individuals (15 SR, seven NR) were selected for such analyses. The IRES region [nucleotide (nt) 1-407] was cloned into a dual luciferase vector and IRES activity assessed following transfection into various cell lines.

"Low relative translation efficiency was observed for IRES elements derived from SR patients, whereas those of NR patients showed significantly greater translation efficiency (29.7±13 vs 69.4±22; p<.01). Subsequently, the effect of IFN-alpha plus RBV on IRES-driven translation in vitro was determined. A greater suppressive effect was observed on IRES activity isolated from seven SR patients, when compared with seven NR patients."

"IRES efficiency in vitro correlated with treatment response for HCV genotype 3. Further studies are warranted to investigate whether IRES efficiency in vitro, or sequence motifs associated with IRES efficiency, will be worthwhile to explore as prognostic tools for other HCV genotypes in the treatment of chronic HCV infection," the investigators concluded.

Yasmeen and colleagues published their study in the Journal of Viral Hepatitis (Correlation between translation efficiency and outcome of combination therapy in chronic hepatitis C genotype 3. J Viral Hepat, 2006;13(2):87-95).

For additional information, contact M.A.A. Persson, Karolinska Institute, Center of Molecular Medicine, Karolinska Hospital, Department of Medicine, S-17176 Stockholm, Sweden.

Study 3:
According to recent research from Austria, interferon therapy is promising in treatment of chronic hepatitis C.

"Combination anti-viral therapy achieves a sustained virological response (defined as HCV-RNA negativity 6 months after the end of therapy) of 56% of patients with chronic hepatitis C. Little is known about long-term durability of HCV-RNA negativity in patients treated with pegylated interferon."

E. Formann and colleagues, Medical University of Vienna, wrote that the study was done "to evaluate the durability of virologic response in patients with sustained virological response to anti-viral therapy treated at our center."

"A total of 187 sustained virological responses (50% genotype 1, 42% genotype 2 or 3 and 8% genotype 4; 20% with cirrhosis) with a follow-up of >12 months post-therapy were studied. Twelve patients received monotherapy with interferon-alpha2a or -2b. One hundred and seventy-five received combination therapy with ribavirin and standard interferon-alpha (n=73) or pegylated interferon-alpha2a or 2b (n=102)."

"Qualitative serum HCV-RNA was tested by COBAS AMPLICOR HCV test, v2.0. Median follow-up time was 29 months (range 12-172)," explained the authors.

"Recurrence of HCV infection was not observed in any of the 187 sustained virological responders. Ala aminotransferase values were normal in 90% and two patients showed minimal elevation of alpha-fetoprotein levels. No recurrence of HCV infection was seen in any patient."

"Thus," concluded the researchers, "longterm prognosis in chronic hepatitis C patients with a sustained virological response to therapy with pegylated interferon ± ribavirin is promising, but long-term studies need to continue."

Formann and colleagues published their study in Alimentary Pharmacology & Therapeutics (Long-term follow-up of chronic hepatitis C patients with sustained virological response to various forms of interferon-based anti-viral therapy. Aliment Pharmacol Ther, 2006;23(4):507-511).

For additional information, contact P. Ferenci, Department of Internal Medicine IV, Gastroenterology and Hepatology, Medical University of Vienna, Austria, Vienna, Austria.

Sexual Transmission of Hepatitis C

2006-06-19T05:32:00.000-07:00

Mike Youle, MBBS

We have spent the last 21 years fighting an emerging epidemic of HIV across the globe with a modicum of success, at least on the treatment front. Highly active antiretroviral therapy (HAART) has now allowed us some breathing room in which to develop better therapies and to address prevention issues that have been rather less successfully tackled in most countries. We have been slow to realize that hepatitis C virus (HCV) represents our next challenge; in fact, surveillance systems are not properly in place in most countries. In the United Kingdom there are an estimated 300,000 HCV cases, over 90% of which are as yet undiagnosed, in comparison to approximately 33,500 people living with HIV, about 30% of whom are undiagnosed. The significance of sexual transmission in the HCV epidemic has been a matter of controversy,^[1] although there is some evidence that it may be an important method of acquisition, at least among men who have sex with men (MSM).^[2]

In a study from a large UK hospital, Browne and colleagues^[3] presented circumstantial evidence that sexual transmission is responsible for an increasing incidence of HCV in HIV-infected individuals. Cases of HCV were identified among individuals with a previously negative HCV antibody result who attended sexual health services between 1997 and 2002. The number of these HCV seroconverters increased from zero during 1997 to 10 during the first half of 2002. A total of 23 cases were seen, of whom only 1 was female, and 21 of these were known to be HIV-infected, including 2 who seroconverted to both viruses concurrently. Although 4 subjects gave a classic history of injection-drug use and needle sharing, 19 did not; these were all MSM, 15 of whom reported recent unsafe sex. Eight subjects in this cohort developed syphilis temporarily associated with HCV seroconversion.

Further details were presented on the 21 subjects known to be coinfected with HIV and HCV. All of the HIV-infected individuals diagnosed with HCV were identified by screening for HCV RNA among those with abnormal liver function, using stored blood samples to try to identify the date of acquisition. Routine antibody tests were also performed which were initially negative, and the median time from detection of HCV RNA to HCV antibody positivity was 4 months (range, 3.0-9.5 months). The rate of diagnosis of HCV among HIV-infected subjects found to have elevated liver function tests increased during the study period from 10.7% to 40%, a statistically significant change (P = .035, Chi-squared test). Among this population of HIV-infected patients with elevated liver function tests, the rate of diagnosis of HCV in 2002 was 5.1 cases per 1000 patient-years (95% confidence interval [CI], 2.2-10.1), which appeared to be significantly higher than the rate in 1997 (0 cases per 1000 patient-years; 95% CI, 0-1.2). This would suggest that the HCV infection burden within the HIV-infected population increased during the study period.

This study raises a concern that the use of HCV antibody tests alone may not be sufficient to identify individuals who acquire HCV with only sexual risk factors or even in low incidence areas, potentially delaying the diagnosis of active infection and thus increasing the risk of onward transmission. The use of stored blood to retrospectively identify HCV seroconversion allows for an accurate identification of time of infection in epidemiologic studies, and further work addressing sexual acquisition is required to identify more clearly the risk factors for transmission as well as the outcomes of these infections. From a public health perspective, more aggressive surveillance studies should be performed, and health promotion messages need to be developed to educate those at risk.

References

Bernard EJ. Sexual transmission of hep C. In: AIDS Treatment Update.
London: NAM Publications. September 2002; Issue 117. Available at: http://www.aidsmap.com/publications/atu/atu117.pdf Accessed December 16, 2002.
Craib KJP, Sherlock CH, Hogg RS, O'Shaughnessy MV, Schechter MT. Evidence of sexual transmission of hepatitis c virus (HCV) in a cohort of homosexual men. Program and abstracts of the 8th Conference on Retroviruses and Opportunistic Infections; February 4-8, 2001; Chicago, Illinois. Abstract 561.
Browne R, Asboe D, Gilleece Y, et al. Increased incidence of HIV-positive individuals with acute hepatitis C due to sexual transmission: a new epidemic? Program and abstracts of the Sixth International Congress on Drug Therapy in HIV Infection; November 17-21, 2002; Glasgow, Scotland. Abstract P283.

Herbal solution underway

2006-06-16T01:20:00.000-07:00

Herbal solution undergoes Phase II clinical trial for hepatitis C

World Disease Weekly - Jun. 20, 2006

Chronic hepatitis C is associated with significant morbidity (liver cirrhosis and hepatocellular carcinoma) and mortality.

Current treatment is based on interferon and ribavirin. However, treatment options are limited for patients who are not candidates for interferon-based therapy, particularly for those who suffer from HCV genotype 1 infection.

Sho-saiko-to (SST), a standardized herbal formula, is under a clinical phase II trial by a leading New York cancer research institute to determine its effect on hepatitis C patients. The research group reported the preliminary results of 15 patients at the 2nd Society of Integrative Oncology Conference in San Diego on November 10, 2005. This study was titled "Sho-saiko-to for Patients with Chronic Hepatitis C Who Are Intolerant to or Have Contraindication to Interferon-Based Therapy: A Phase II Study."

SST is known to have anti-fibrotic effect by inhibition of lipid peroxidation in hepatocytes and stellate cells in animal studies. It has also been shown to reduce aminotransferase levels and the incidence of hepatocellular carcinoma in hepatitis and liver cirrhosis patients.

According to the design of the clinical trial, 31 patients will receive SST daily for 52 weeks. Fifteen patients have completed the treatment and the preliminary results have been reported. No serious adverse events have been attributed to SST among any patients who enrolled in the trial. Among the 15 patients who completed the study, reductions in alanine aminotransferase (ALT) were observed in 11 patients and aspartate aminotransferase (AST) in 10 patients. In 10 patients, the liver biopsy showed 20% improvement on histological assessment of the liver.

This is consistent with the findings by the Japanese researchers for its anti-inflammatory effect. More interestingly, the majority of the patients whom participated in the clinical trial were genotype 1 infection.

In Japan, over 75% of physicians use at least some of the traditional herbal formulas. Over 1.5 million Japanese patients with hepatitis have been treated with Sho-saiko-to. SST is available in capsules through HepCare Inc., a Phoenix-based company that has licensed the marketing right of SST from Honso Pharmaceutical Co. Ltd., the Nagoya-based Japanese manufacturer of the standardized herbal formula.

This article was prepared by World Disease Weekly editors from staff and other reports. Copyright 2006, World Disease Weekly via NewsRx.com.

US scientists isolate liver stem cells

2006-06-13T07:08:00.000-07:00

A stable line of human fetal liver stem cells has been isolated and characterized for the first time, U.S. scientists reported on Monday.

The liver stem cells, which have shown the ability to repopulate damaged livers in mice, could be valuable for the treatment of liver diseases in the future, said a research team at the University of Washington.

Their findings appeared in the June 12 issue of the Proceedings of the National Academy of Sciences.

The adult liver contains a reservoir of progenitor cells, which provide the organ with a high regenerative potential. But so far these cells have not been successfully isolated from human livers.

According Nelson Fausto, a professor at the University of Washington who led the study, the researchers derived for the first time progenitor cells from livers in human fetuses of 74 to 108 days.

First, they removed and maintained human fetal livers in culture. Then the researchers treated the colonies with a selective antibiotic, and mechanically isolated stem cells from the liver cells.

Like other stem cells, these liver progenitors displayed the ability for long-term self-renewal, and the capacity to differentiate into multiple cell types.

In laboratory conditions, the liver stem cells can differentiate into not only liver tissue cells (hepatocytes) and bile duct cells, but also fat, bone, and cartilage tissue cells, the researchers said.

When transplanted into mice with damaged livers, the human stem cells survived and repopulated part of the damaged tissue. "They can differentiate into functional hepatocytes in vivo, suggesting liver repopulation potential," the researchers wrote in the paper.

The liver stem cells have durable proliferative capability, according to the researchers. Even after being kept in culture for 6 months, the cells can still be induced to differentiate into functional hepatocytes and biliary duct cells in experiments.

"We anticipate that human fetus multipotent progenitor cells (liver stem cells) will be a valuable tool to study differentiation pathways in the human liver and may have important therapeutic applications in patients with liver failure," the researchers said.

They suggested that other organs, such as the pancreas and the kidney, in human fetuses may have similar stem cells.

"We are also exploring the use of this approach to isolate similar cell populations from other embryonic organs, such as the pancreas and the kidney."

Source: Xinhua

We must beat hepatitus C stigma

2006-06-09T05:52:00.000-07:00

People at risk include those who have used intravenous drugs, shared spoons, had blood transfusion before 1991, snorted cocaine, had unprotected sex, tattoos or body piercings where non sterile equipment was used.

A man who lived with the Hepatitis C virus for 20 years without knowing it is now at the centre of a campaign to raise awareness about the illness.

Mark McKay, who lives in Newmarket Road, Norwich, was diagnosed with Hepatitis C six years ago, but has no idea how he contracted the virus.

He was horrified when, on his 45th birthday, he received a letter from the Blood Transfusion Service to say it had detected the virus after he had given blood.

Mr McKay, 51, said: “When I first read the letter I did not know too much about Hepatitis C but when I found out later that it was potentially fatal I did get a bit worried. Information is also hard to come by.”

Mr McKay is one of several people with Hepatitis C who have agreed to appear in a national campaign to try to reduce the stigma attached to the virus.

An exhibition featuring giant photographic portraits of people living with Hepatitis C will be launched in Gentleman's Walk, Norwich, from tomorrow and will stay up for two days.

It is part of the Government's new Hepatitis C Action Plan for England launched in March 2005, which aims to improve the prevention, diagnosis and treatment of Hepatitis C.

It is estimated that 200,000 people in England have chronic Hepatitis C infection but the majority are unaware of their condition which can cause serious damage to the liver.

Mr McKay, a business analyst at Norwich Union, said: “I don't have any symptoms at all, but I know there has been liver damage.

“I don't know how I got it. I used to work in operating theatres at a hospital and I may have picked it up from a needle stick injury.”

He said he had agreed to take part in the campaign because he wanted to help raise awareness of the illness.

“If you can get people to consider what they have done in the past, they might think it was worth getting tested.

“I would rather know I had it than not know because at least then I can take steps to mitigate it.”

The father-of-three said he was discussing his treatment options at present with his doctors at the N&N because the first treatment he had tried had left him with nasty side effects.

Dr Martin Phillips, consultant gastroenterologist at the Norfolk and Norwich University Hospital, said he was treating more and more patients for Hepatitis C in Norfolk but there were many others who had not been diagnosed.

“I am treating all ages men women and children, but the problem is there are often no symptom until the disease is very advanced,” he added.

People at risk include those who have used intravenous drugs, shared spoons, had blood transfusion before 1991, snorted cocaine, had unprotected sex, tattoos or body piercings where non sterile equipment was used.

But Dr Phillips said the latest treatments had a 50 to 80 per cent success rate in curing it, depending on the type.

He said people who thought they may have put themselves at risk should have a simple blood test at their GP surgery.

For more information ring the Hepatitis C Information line on (0800) 451 451 or go to www.hepc.nhs.uk

Are you campaigning to raise the profile of an illness? Call Evening News health reporter Sarah Hall on 01603 772426 or email sarah.hall2@archant.co.uk

Hepatitis C may be the cancer suspect

2006-06-08T06:21:00.000-07:00

A new study conducted in Taiwan suggests that the hepatitis C virus is the true culprit behind the nation's rising rates of hepatocellular carcinoma (a common type of liver cancer), debunking theories that the hepatitis B virus was mostly to blame.

The study, entitled Secular trends and geographic variations of hepatitis B and hepatitis C virus-associated hepatocellular carcinoma in Taiwan, was conducted jointly by Chang Gung Memorial Hospital in Kaohsiung, National Taiwan University Hospital in Taipei and Changhua Christian Hospital in Changhua City.

The study reviewed 18,423 hepatocellular carcinoma cases in the country between 1981 and 2001, focusing on Yunlin and Tainan counties, and Chiayi City -- regions where liver cancer is especially prevalent.

Findings show that while the overall mortality rate in patients with liver cancer caused by hepatitis B had dropped, the number of deaths related to the cancer caused by hepatitis C had increased significantly. Specifically, hepatitis C-related hepatocellular carcinoma deaths shot up by approximately 66 percent in Taiwanese males, and deaths doubled for Taiwanese females.

Lu Sheng-nan, a physician at Chang Gung Memorial Hospital said that preventative measures for hepatitis B have been effective; however, more and stronger measures are needed to prevent the spread of hepatitis C, for which no vaccine is currently available.

The virus is transmitted by blood-to-blood contact, usually via intravenous drug injection or transfusions of unscreened blood.

Hepatitis B is usually trans-mitted through exchange of bodily fluids. This includes unprotected sex, blood transfusions and the use of contaminated syringes.

The study is scheduled to be published in the International Journal of Cancer, a prominent medical periodical.

Source: The Taipei Times

hepatitis C may be the cancer culprit

2006-06-07T23:24:00.000-07:00

The study, entitled Secular trends and geographic variations of hepatitis B and hepatitis C virus-associated hepatocellular carcinoma in Taiwan, was conducted jointly by Chang Gung Memorial Hospital in Kaohsiung, National Taiwan University Hospital in Taipei and Changhua Christian Hospital in Changhua City.

The study reviewed 18,423 hepatocellular carcinoma cases in the country between 1981 and 2001, focusing on Yunlin and Tainan counties, and Chiayi City -- regions where liver cancer is especially prevalent.

Findings show that while the overall mortality rate in patients with liver cancer caused by hepatitis B had dropped, the number of deaths related to the cancer caused by hepatitis C had increased significantly. Specifically, hepatitis C-related hepatocellular carcinoma deaths shot up by approximately 66 percent in Taiwanese males, and deaths doubled for Taiwanese females.

Lu Sheng-nan, a physician at Chang Gung Memorial Hospital said that preventative measures for hepatitis B have been effective; however, more and stronger measures are needed to prevent the spread of hepatitis C, for which no vaccine is currently available.

The virus is transmitted by blood-to-blood contact, usually via intravenous drug injection or transfusions of unscreened blood.

Hepatitis B is usually trans-mitted through exchange of bodily fluids. This includes unprotected sex, blood transfusions and the use of contaminated syringes.

The study is scheduled to be published in the International Journal of Cancer, a prominent medical periodical.

Source: The Taipei Times

Is Hepatitis C a luxury?

2006-06-06T12:42:00.000-07:00

Interferon Alfa-2B and Rivavirma, both produced in Cuba, are components of Heberviron. The drugt is used not only to combat the causative virus of Hepatitis C in blood but, in the long range, eliminates lesions in the liver and totally cures the disease.

The components of Heberviron were developed and are being produced by Cuba: the Interferon by the CIGB and the Center of Bio-products, and the Ribavirina by the Medicament Research and Development Center and Novatec Laboratories, which demonstrates the integration and cooperation of the institutions in the Scientific Complex.

In the meanwhile, Novartis AG says that it has signed an exclusive worldwide agreement with US biopharmaceuticals company Human Genome Sciences to acquire rights to hepatitis C drug Albuferon.

The investigational drug is expected to enter Phase III clinical trials by the end of 2006, Novartis said.
Under the terms of the agreement, Novartis will make an upfront payment of 45 mln usd, with milestones payable at specific stages of development and sales milestones payable following the drug''s launch.

Novartis and HGS will co-promote Albuferon (albumin interferon alfa-2b) in the US, while Novartis will have exclusive rights to market and promote it in the rest of the world.

The Novartis drug has an albumin prefixed to interferon alfa-2b, which even the Cubans have developed successfully in the fight against the dreadful Hep C Virus.

The western media has been harping about the massive market potential of the new drugs because of the 170 million people infected with HCV. Stocks has been rising and plunging with every detail made available of the research on HCV drugs... it is a scary secnario!

If companies are going to make a fortune out of the misfortune of 170 million people and their families, and if more people in different stock markets around the world are going to speculate and gamble on the stock value of these pharma companies it would only help the rich get richer and meaner.

Out of the 170 Million infected people, how many can actually afford a health insurance or even afford to pay for basic neccessities is something no one has really cared to ask.

Was it the MARKET that determined how we fought against Small Pox, Plague etc?

Anyone who buys a Novartis or Vertex share to make profits out of a HEP C patient is accumulating bad Karma score.

When it comes to medicare and education in a country -- the real profit to that country is a Healthy and Educated population. Outrageous Monetary Profits, by squeezing the ones who want to live without illness and the young ones who want to gain knowledge, is simply unacceptable.

HCV (Hepatitis) is not a luxury that one has to pay for, it is a misfortune that could knock on our doors too.

If the Cubans have got it right and if the drug is working... Thank You Cuba. Wish I could go to Cuba and check it out myself.

FAT and HEP C

2006-06-03T03:54:00.000-07:00

Obesity and hepatitis C infection act as a one-two punch on the liver, but treating the obesity may also improve the efficacy of antiviral therapy, reported researchers here.

In a review of the effects of obesity on antiviral therapies for hepatitis C (HCV) infection, a Mayo Clinic team found evidence that points to control of obesity as an important therapeutic adjunct.

"Patients who have chronic hepatitis C and are obese are more likely to be insulin-resistant and to have more advanced hepatic steatosis/steatohepatitis and fibrosis," wrote Michael R. Charlton, M.D., and colleagues, in the June issue of Hepatology.

"These latter conditions are independent predictors of non-response to combination therapy with peginterferon alpha and ribavirin [Rebetol], and obese patients are therefore more likely to be non0responders to combination therapy."

"Treatment strategies that focus on improving underlying metabolic factors associated with poor response to combination therapy are thus more likely to overcome the low sustained virologic response," wrote Dr. Charlton and colleagues.

According to the National Health and Nutrition Examination Survey (NHANES) III, about 2.7 million American have chronic HCV infections. Of this population about 20% are obese, putting them at increased risk for steatosis and the progression of fibrosis, the authors noted.

They explored some of the mechanisms whereby obesity and its consequence, the metabolic syndrome, may interfere with antiviral therapies directed against HCV.

For example, among patients with metabolic syndrome, which is associated with non-alcoholic fatty-liver disease, those who also have chronic HCV infections are significantly more likely to develop advanced liver disease than those who are free of HCV infection, and obese patients with chronic HCV are at a greater risk of developing co-existent steatosis and more advanced liver disease.

"Whereas both viral and host factors contribute to coexistent steatosis, clinical factors associated with the metabolic syndrome--including elevated waist-to-hip ratio, the presence of insulin resistance, and diabetes--have been shown to predict more advanced forms of chronic hepatitis C," the investigators wrote.

Obesity also appears to interfere, through a variety of mechanisms, with the efficacy of pegylated interferons plus Rebetol, which is the current gold standard for treating HCV infections, the authors noted.

Three main hypotheses have been proposed to explain how obesity may dampen the effect of antiviral therapy, the authors noted:

Because obesity is an inflammatory condition, it is associated with the release of pro-inflammatory cytokines that may alter the immune response to therapy
Insulin resistance and hepatic steatosis associated with obesity lead to steatohepatitis and hepatic fibrosis, which may in turn interfere with the action of interferons on hepatocytes.
High levels of subcutaneous fat in obese patients may impair absorption of peginterferon alpha by altering lymphatic uptake of the drug, thereby reducing its bioavailability in serum.

The evidence points to control of obesity as an important adjunct to treatment of HCV, the authors said.

"In formulating more effective treatment regimens for obese patients with chronic hepatitis C, it is important to use current knowledge of the metabolic effects of obesity," they wrote. "Thus, the most direct approach is to encourage weight loss and exercise before treatment."

They noted that people who are infected with HCV and who lose weight have been shown to have reductions in steatosis and significant decreases in fibrosis scores and activated stellate cells.

"Recently reported data suggest that treatment with the insulin-sensitizing medications metformin [Glucophage] and the thiazolidinediones (pioglitazone [Actos] and rosiglitazone [Avandia]) reduced serum alanine aminotransferase and histologic features of hepatic steatosis, inflammation, and fibrosis, as well as increased insulin sensitivity, in nondiabetic patients with nonalcoholic steatohepatitis; however, recent human data with metformin do not appear to be as promising," they noted.

Clinical trials will be needed to determine whether treating insulin resistance before or during antiviral therapy could be beneficial, the authors argued.

Other possible means for improving responses to combination therapy with pegylated interferons and Rebetol include longer duration of therapy "and, possibly, higher flat doses, which may counteract the decreased bioavailability of drug and increased resistance to interferon-based therapies," they added.

HCV - three more studies

2006-06-02T02:47:00.000-07:00

New findings in hepatitis C virus described from the United States, Canada and Germany

World Disease Weekly - Jun. 06, 2006

Data on hepatitis C virus are outlined in reports from the United States, Canada and Germany.

Study 1: According to recent research from the United States, early interferon therapy produces sustained hepatitis C virus (HCV) virologic response.

"Pegylated interferon therapy has not been adequately evaluated in acute HCV infection. This randomized trial assessed the efficacy, safety, and timing of pegylated interferon alfa-2b for treatment of acute hepatitis C," wrote S.M. Kamal and colleagues, Harvard University.

They explained, "One hundred seventy-five patients acutely infected with HCV were screened. Patients whose infection did not spontaneously resolve by week 8 were randomized to once weekly peginterferon alfa-2b monotherapy (1.5 mcg/kg per week) started at weeks 8, 12, or 20 for a duration of 12 weeks. The primary endpoint was undetectable HCV RNA 24 weeks after the end of treatment (sustained virologic response [SVR])."

"All patients were followed for 48 weeks after cessation of therapy. One hundred twenty-nine subjects started treatment at week 8 (group A, n=43), week 12 (group B, n=43), or week 20 (group C, n=43). By using an intent-to-treat analysis, the overall SVR rate was 87%. The SVR rates were 95%, 92%, and 76% with treatment onset at 8, 12, and 20 weeks, respectively. Overall, SVR rates were better for patients infected with genotypes 2, 3, and 4 than those infected with genotype 1.

"Earlier initiation of therapy improved SVR rates for patients infected with genotype 1 with high viral load. Peginterferon alfa-2b was well tolerated. Subjects with SVR maintained undetectable HCV RNA 48 weeks after therapy," wrote the researchers.

The scientists concluded, "Peginterferon alfa-2b monotherapy in acute hepatitis C induces high sustained virologic response rates, prevents chronic evolution, and is well tolerated. Initiation of treatment at week 8 or 12 results in higher sustained virologic rates than initiation at week 20."

Kamal and colleagues published their study in Gastroenterology (Peginterferon alfa-2b therapy in acute hepatitis C: Impact of onset of therapy on sustained virologic response. Gastroenterology, 2006;130(3):632-638).

For additional information, contact S.M. Kamal, Harvard University, Beth Israel Deaconess Medical Center, School of Medicine, Liver Diseases Center, 4 Blackfan Circle, Boston, MA 02115, USA.

Study 2: According to scientists from Canada, hepatitis C virus treatment efficacy can be predicted.

"In the past, antiviral therapy has been given to 15% to 30% of patients infected with hepatitis C virus (HCV). The efficacy of therapy has recently improved with the addition of ribavirin and pegylated interferon. The aim of the present study was to identify the clinical, socioeconomic and health-system predictors of antiviral treatment for HCV," wrote M. Witkos and colleagues, University of Toronto. "A retrospective analysis of compensation claims data of patients who acquired HCV through blood transfusions between 1986 and 1990 was performed. The patients consisted of 2456 Canadian HCV-positive individuals."

The researchers wrote, "The authors reviewed narrative comments from physicians, and constructed univariate and multivariate logistic regression models, using receipt of antiviral therapy with interferon or interferon/ribavirin as the primary outcome. Of the 2456 patients, approximately 30% appeared to be eligible, but only 16% received treatment.

"Univariate analyses suggested that the disease severity, age, HIV status and province of residence were associated with the likelihood of receiving treatment (p<.01). The final, multivariable model indicated that in patients with HCV. Intermediate disease severity (eg, fibrosis, p<.0001); middle age (p<.0001); HIV-negative status (p<.0001); and province of residence (Quebec, p<.0001; and Saskatchewan, p<.0001) were independent predictors of treatment." "Narrative comments of physicians emphasized the importance of age, HIV status and patient preferences in clinical decision-making. Given the efficacy and cost-effectiveness of current antiviral therapy, treatment rates of HCV patients may be suboptimal," reported the authors. They concluded, "Further work is required to understand barriers to treatment related to geography, organization of medical care, age, medical provider and patient preferences." Witkos and colleagues published their study in Canadian Journal of Gastroenterology (Predictors of antiviral therapy in a post-transfusion cohort of hepatitis C patients. Can J Gastroenterol, 2006;20(2):107-111). For additional information, contact M.D. Krahn, University of Toronto, Toronto General Hospital, Department of Health Policy Management & Evaluation, 200 Elizabeth St., EN 14-207, Toronto, ON M5G 2C4, Canada. Study 3: A study from Germany has reported that early monotherapy with pegylated interferon alpha-2b for acute hepatitis C infection leads to high virological response rates.

"Early treatment of acute hepatitis C with interferon alpha-2b for 24 weeks prevents chronic infection in almost all patients. Because pegylated interferons have replaced conventional interferon in the therapy of chronic hepatitis C, the aim of this study was to analyze the efficacy of an early treatment of acute hepatitis C with peginterferon alpha-2b," wrote J. Wiegand and colleagues, Hannover Medical School.

They continued, "Between February 2001 and February 2004, 89 individuals with acute HCV infection were recruited at 53 different centers in Germany. Patients received 1.5 mcg/kg peginterferon alpha-2b for 24 weeks; treatment was initiated after a median of 76 days after infection (range 14-150)."

The researchers explained, "End-of-treatment response and sustained virological response were defined as undetectable HCV RNA at the end of therapy and after 24 weeks of follow-up, respectively.

"In the total study population, virological response was 82% at the end of treatment and 71% at the end of follow-up. Of 89 individuals, 65 (73%) were adherent to therapy, receiving 80% of the interferon dosage within 80% of the scheduled treatment duration. End-of-treatment and sustained virological response rates in this subpopulation. were 94% and 89%, respectively."

"A maximum Ala aminotransferase level of more than 500 U/L prior to therapy was the only factor associated with successful treatment," the scientists explained.

"In acute HCV infection, early treatment with peginterferon alpha 2b leads to high virological response rates in individuals who are adherent to treatment. The high number of dropouts underlines the importance of thorough patient selection and dose monitoring during therapy," concluded the authors.

"Thus," they further noted, "future studies should identify factors predicting spontaneous viral clearance to avoid unnecessary therapy."

Wiegand and colleagues published their study in Hepatology (Early monotherapy with pegylated interferon alpha-2b for acute hepatitis C infection: the HEP-NET Acute-HCV-II Study. Hepatology, 2006;43(2):250-256).

Additional information can be obtained by contacting M.P. Manns, Hannover Medical School, Department of Gastroenterology, Hepatology & Endocrinology, Carl Neuberg Str 1, D-30625 Hannover, Germany.

Keywords: Hannover, Germany, Hepatitis C Virus, Pegylated Interferon, Ribavirin, Viral Clearance, Virological Response Rates.

This article was prepared by World Disease Weekly editors from staff and other reports. Copyright 2006, World Disease Weekly via NewsRx.com.

Hep C - three studies

2006-06-02T02:46:00.000-07:00

Data from India, the People's Republic of China and the United States advance knowledge in hepatitis C virus research

Genomics & Genetics Weekly - Jun. 09, 2006

Hepatitis c virus data are the focus of recent research from India, the People's Republic of China and the United States.

Study 1: According to recent research from India, hepatitis C virus (HCV) genotype 3 predominates in north and central India and is associated with significant histopathologic liver disease.

"HCV genotypes help to tailor the treatment response, but their influence on the disease severity and association with hepatic steatosis is not well understood. The prevalence of HCV genotypes and their correlation with the histopathological severity of liver disease and steatosis in Indian patients were studied," wrote S.S. Hissar and colleagues, GB Pant Hospital.

They continued, "HCV-RNA and genotyping was carried out in 398 patients with chronic hepatitis C. Liver biopsy was available in 292 (73.4%) patients. The severity of liver disease was graded on the basis of the histological activity index and the stage of hepatic fibrosis. The patients were categorized as having mild (histological activity index & le;5 and/or fibrosis & le;2) or severe (histological activity index & ge;6 and/or fibrosis & ge;3) liver disease.

"Steatosis was graded in 106 patients as 0 (no steatosis), 1 (<33%>66% of hepatocytes affected). HCV genotype 3 was detected in 80.2% patients (3a:24.4%, 3b:3.3%, 3c:0.5%, 3a/3b:36.7%, and unsubtypable 3:15.3%), genotype 1 in 13.1% (1a:3%, 1b:5.5%, 1a/1b:0.3%, and unsubtypable 1:4.3%), genotype 4 in 3% patients (4a:1.5%,4b:0.3%,4a/4c:0.5%, and un-subtypable 4:0.8%), 2 in 2.5% and mixed genotypes (more than one genotype) in 1.3% of patients."

"The median histological activity index and fibrosis scores were: 5 and 2 in genotype 1; 4 and 2 in genotype 2; 5 and 2 in genotype 3; 7 and 3 in genotype 4; and 5 and 2 in mixed genotypes, respectively. Severe liver disease was present in 17 of 38 (45%) with genotype 1; in 1 of 3 (33%) with genotype 2; in 128 of 236 (54%) with genotype 3; 7 of 10 (70%) with genotype 4; and in 1 of 4 (25%) with mixed genotype. Hepatic steatosis grade & ge;2 was found in 28.1% of genotype 3; 23.5% of genotype 1; 20% of genotype 4; and in none of genotype 2 and mixed genotypes," wrote the researchers.

The authors concluded, "Genotype 3 is the most prevalent genotype in patients with chronic hepatitis C in North and Central India and this is associated with significant hepatic steatosis and fibrosis."

Hissar and colleagues published their study in the Journal of Medical Virology (Hepatitis C virus genotype 3 predominates in north and central India and is associated with significant histopathologic liver disease. J Med Virol, 2006;78(4):452-458).

For additional information, contact S.K. Sarin, GB Pant Hospital, Department of Gastroenterology, Room 201, Academy Block, New Delhi 110002, India.

Study 2: Research from the People's Republic of China has documented that combination therapy is influenced by fatty liver in chronic hepatitis C (CHC).

"Hepatic steatosis is a histological feature in patients with CHC and adversely affects the virologic response rates to anti-hepatitis C virus (HCV) therapy. The aim of this study is to investigate whether the fatty liver and related factors have impact on the efficacy in CHC treated with peginterferon and ribavirin, and the associations between HCV genotyping and fatty liver," wrote J. Wu and colleagues, Harbin Medical College.

They continued, "Ninety-eight patients received subcutaneously 180 mcg peginterferon alpha-2a once a week plus ribavirin. HCV genotypes and the levels of plasma insulin of patients were measured. Fatty liver was detected by B ultrasound. The body mass index (BMI), waist-to-hip ratio (WHR) and homeostasis model assessment of insulin resistance (HOMA-IR) were calculated."

The researchers wrote, "Among 98 CHC patients, 38 (38.8%) were infected with genotype 1; 44 (44.9%) with genotype 2; 13 (13.3%) with genotype 3; 3 (3.0%) with indeterminate genotype. The prevalence of fatty liver was 10.5%, 11.4%, 38.5% in patients infected with HCV genotype 1, 2, 3, respectively, which suggested that the distribution of fatty liver in different HCV genotypes was imbalanced (chi2=6.758, p=.034).

"In univariate analysis, the efficacy of combination therapy was significantly associated with BMI (p=.011), WHR (p=.024), the levels of plasma insulin (p=.001), genotype (p=.036), presence of fatty liver (p=.028), treatment dosage and duration (p=.012) and HOMA-IR (p=.002). With binary logistic regression analysis, the plasma insulin levels and HOMA-IR showed independent predictors to the efficacy of antiviral therapy."

"The prevalence of fatty liver in HCV genotype 3 was markedly higher than that of other genotypes. The BMI, WHR, the levels of plasma insulin, genotype, presence of fatty liver, treatment dosage and duration and HOMA-IR were associated with the sustained virologic response," the authors reported.

They concluded, "The level of plasma insulin and HOMA-IR were independent factors for predicting effect of antiviral therapy."

Wu and colleagues published their study in Liver International (Effects of fatty liver and related factors on the efficacy of combination antiviral therapy in patients with chronic hepatitis C. Liver Int, 2006;26(2):166-172).

For additional information, contact S. Chen, Harbin Medical College, Affiliated Hospital 2, Department of Infectious Disease, Harbin 150086, People's Republic of China.

Study 3: According to researchers from the United States, intrahepatic cytokine expression is downregulated during hepatitis C virus HCV/HIV co-infection.

"HIV co-infection is associated with reduced HCV treatment response rates and accelerated HCV-related liver disease. Cytokines play an important role in regulating hepatic inflammation and fibrogenesis during chronic HCV infection, yet the roles of HIV and/or its therapies on cytokine expression are unknown," wrote J.T. Blackard and colleagues, Massachusetts General Hospital.

"Total RNA was extracted from liver biopsies of 12 HCV monoinfected and 14 HCV/HIV co-infected persons. We used real-time PCR to quantify cytokines that contribute to innate and adaptive immune responses, including IFNalpha, IFNgamma, TNFalpha, TGFbeta1, IL-2, IL-4, IL-8, IL-10, and IL-12p40. Positive- and negative-strand HCV RNA levels were quantified using a molecular beacon approach."

The researchers wrote, "Detection of positive-strand HCV RNA was 100% in both groups; negative-strand HCV RNA was detected in four (33%) HCV mono-infected persons and in nine (64%) HCV/HIV co-infected persons."

"Median strand-specific HCV RNA levels were not significantly different between the two groups. Detection rates of cytokine mRNAs were lower for the HCV/HIV co-infected group compared to the HCV mono-infected group; the detection rates for TNF alpha, IL-8, and IL-10 were statistically significant."

"Overall, cytokine mRNA quantities were lower for HCV/HIV co-infected compared to HCV monoinfected persons, with the exception of TGFbeta1," reported the authors.

They concluded, "These data suggest that a defect in cytokine activation may occur in HCV/HIV co-infected persons that limits efficient clearance of HCV from the liver."

Blackard and colleagues published their study in the Journal of Medical Virology (Intrahepatic cytokine expression is downregulated during HCV/HIV co-infection. J Med Virol, 2006;78(2):202-207).

For additional information, contact R.T. Chung, Massachusetts General Hospital, Gastrointestinal Unit, GRJ 825, Boston, MA 02114, USA.

Keywords: Boston, Massachusetts, United States, AIDS, Antiretroviral Therapy, Hepatitis C Virus, Human Immunodeficiency Virus, HIV, Cytokines, Downregulation, Co-Infections, RNA.

This article was prepared by Genomics & Genetics Weekly editors from staff and other reports. Copyright 2006, Genomics & Genetics Weekly via NewsRx.com.

PegIntron & Ribavirin experience

2006-06-02T01:55:00.000-07:00

Debbie, a resident of Peoria, Arizona, United States - writes in her blog Chronic Hepatitis C:

DARE I ASK, WHAT'S NEXT?

What a mind-blower! To discover that my treatment was actually working and killing me, at the same time. What the hell is that? How truly ironic this whole situation is. Just what exactly am I supposed to do now? Wake up everyday knowing that a deadly virus is slowly destroying my liver, and there is nothing I can do? I guess so. Oh what the hell! I can not change one single thing or a moment, can I? On the other hand, that damn treatment is over and I am starting to recover.

I had two attempts at the PegIntron & Ribavirin cocktail, over the past two years. As for me, I AM DONE!! I will never go through this again, nor will I ever put my husband and family through this. It is just not worth the pain and suffering we all had to endure. As most all of you know from my past blogs, "I HATE NEEDLES, remember? I knew, that you would! Well, my abhorrence for needles, has only gotten worse from the treatment; (weekly routine blood labs, 12 blood transfusions in 5 months, 2 weekly injections, etc.,) and just the thought of needles makes my skin crawl. I guess the 48/wk treatment wasn't the best option for me, but it was the only option I had or have even now.

I am not quite sure how I feel, at the moment. I have been struggling with many issues. My sister is in grave health back east. I moved out west 18 months ago and have been unable to return for a visit. I can not recall a time when I have been away for so long without seeing them. THIS ONE IS FOR MY BROTHER-IN-LAW,(who reads my blog): "Hey Dan, Love you, Take Care!" My sister is far worse than I. My chronic hepatitis C has been a cake walk, compared, to what she has to endure, and what she will be going through the rest of her life, as well.

In life you never know what each day holds, or what each hour may bring, and how each second, our lives hang in the balance. There are so many things that are out of our control, and there are times when great pain, suffering, despair and heartache, strikes all of our lives. All we truly have is this moment, right here, right now. As for anything else, well, I guess that remains to be seen. Does't it?

Hepatitis C calls top 700 in day

2006-06-01T14:32:00.000-07:00

Alert: if you have HEP C, please inform the same to your dentist and all other healthcare workers.

The hepatitis C virus is blood-borne

More than 700 patients of a former Gwynedd health care worker diagnosed with hepatitis C called a special hotline for advice on its first day.

About 5,000 patients have been sent letters with the phone number, and 400 people have now booked blood tests for hepatitis C and B and HIV.
Five of the 47 special clinics set up for blood testing were fully booked.
But the National Public Health Service for Wales has stressed the risk to patients is "very small indeed".

The NPHS discovered that the member of staff, who was understood to have worked at a dental surgery, had hepatitis C in October. Free testing is being offered to some 5,000 patients who may have concerns. The confidential hotline for patients to book blood tests was opened on Wednesday, and 717 people called on the first day.

Special blood testing clinics are being held around Gwynedd between 5 June and 17 July. Dr Sandra Payne, regional director for the NPHS for Wales, said: "Our lines are very busy and I am grateful to patients for the understanding they are showing.

"People are understandably concerned and I would like to emphasise that the risk of patients getting hepatitis C, hepatitis B or HIV is very small indeed."

Vertex Pharmaceuticals - 23 May 2006

2006-06-01T14:30:00.000-07:00

Vertex Pharmaceuticals Initiates the First of Two Major Phase II Studies of VX-950 in Treatment-Naïve HCV Patients

- PROVE 1 & PROVE 2 Studies Expected to Enroll 580 Patients -

Cambridge, MA, May 23, 2006 –– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported that it has initiated PROVE 1, a major Phase II study of VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor. In addition, the Company today announced it expects to initiate PROVE 2, a second major Phase II study in June. The studies will be conducted in the United States and Europe as part of a global Phase II development program for VX-950. Together, the two studies are expected to evaluate sustained viral response (SVR) rates in 580 treatment-naïve patients infected with genotype 1 HCV.

Vertex’s global Phase II development program in treatment-naïve patients has three objectives: to evaluate the optimal SVR rate that can be achieved with VX-950 therapy in combination with the current standard of care, to evaluate the optimal treatment duration for VX-950, and to evaluate the role of ribavirin in VX-950-based therapy. In addition to these two major studies, Vertex expects to begin additional clinical studies of VX-950 in the second half of the year, including a Phase IIb study in patients who failed prior standard of care treatment. Vertex anticipates this Phase IIb study to enroll approximately 400 patients. By the end of the first quarter of 2007, Vertex expects to have enrolled approximately 1,000 patients in clinical trials of VX-950.

“PROVE 1 is the largest clinical study to date of an HCV protease inhibitor in triple combination therapy in a treatment-naïve patient population, and provides us with the first opportunity to assess the potential to enhance sustained virologic response rates with a shortened treatment duration with VX-950, along with peginterferon and ribavirin,” said John McHutchison, M.D., Duke University and Lead Investigator for the PROVE 1 study. “Throughout this Phase II study, we will further develop a clinical and safety database and increase our experience with VX-950 among clinicians and patients.”

VX-950 Program Update
PROVE Studies
The two studies announced today are the initial studies in a program of the “Investigation of HCV Protease Inhibition for Viral Eradication” (PROVE). The PROVE 1 and PROVE 2 studies have been designed as major, complementary studies to be conducted in the United States and Europe that will evaluate the ability of VX-950 to achieve SVR with short duration combination therapy. Following consultations with regulatory authorities in the U.S. and Europe, trial designs have been completed. Vertex expects the PROVE 1 and PROVE 2 studies to enroll 580 patients at more than 55 centers worldwide. Vertex expects that these studies, taken together, will provide a substantial evaluation of the potential of VX-950-based therapy to achieve SVR.

PROVE 1 Study in the U.S.
Vertex has initiated in the U.S., a four-arm, 260-patient Phase II study of VX-950 known as PROVE 1. The first dosing of patients will occur in June. The primary objective of this study is to assess the proportion of patients in each study arm who achieve SVR, defined as undetectable (less than 10 IU/mL, as measured by the Roche TaqMan® assay) HCV RNA 24 weeks after the completion of dosing. In the study, there will be an initial randomization of 80 patients equally across all four treatment arms. There will be a second randomization of an additional 180 patients across three treatment arms focused on 24 and 48 weeks of therapy. The study will be conducted in approximately 35 centers in the U.S. The study arms include:

12 weeks of therapy, with VX-950 dosed at 750 mg every eight hours (q8h) in combination with standard doses of pegylated-interferon (peg-IFN) and ribavirin (RBV); or
24 weeks of therapy, with VX-950 dosed at 750 mg every eight hours (q8h) in combination with standard doses of peg-IFN and RBV for 12 weeks, then continuing for another 12 weeks with peg-IFN and RBV alone; or
48 weeks of therapy, with VX-950 dosed at 750 mg every eight hours (q8h) in combination with standard doses of peg-IFN and RBV for 12 weeks, then continuing for another 36 weeks with peg-IFN and RBV alone; or
A control arm with peg-IFN and RBV dosed for 48 weeks

Patients in the 12 and 24-week treatment arms who achieve a rapid viral response (RVR) defined as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who maintain this status through to either week 10 or 20 respectively, will stop all treatment at the 12 or 24-week time point and will be followed post-treatment to evaluate whether they achieve SVR. Patients in these treatment arms who do not meet the RVR criterion will continue on peg-IFN and RBV for a total duration of 48 weeks. The 48-week treatment arm that contains VX-950 will evaluate whether 36 weeks of additional treatment with peg-IFN and RBV adds substantially to the SVR rate compared to 12 weeks of additional treatment with peg-IFN and RBV.

PROVE 2 Study in Europe
In June, Vertex will initiate in Europe, a four-arm, 320-patient Phase II study of VX-950, known as PROVE 2. The primary objective of this study is to assess the proportion of patients in each study arm who achieve SVR, defined as undetectable (less than 10 IU/mL) HCV RNA 24 weeks after the completion of dosing. In the study, 320 patients will be randomized equally across all four treatment arms, providing a total of 80 patients per arm. The study will be conducted in more than 20 centers in Europe. The study arms include:

12 weeks of therapy, with VX-950 dosed at 750 mg every eight hours (q8h) plus a standard dose of pegylated-interferon (peg-IFN); or
12 weeks of therapy, with VX-950 dosed at 750 mg every eight hours (q8h) plus standard doses of peg-IFN and ribavirin (RBV); or
24 weeks of therapy, with VX-950 dosed at 750 mg every eight hours (q8h) plus standard doses of peg-IFN and RBV for 12 weeks, then continuing for another 12 weeks with peg-IFN and RBV alone; or
A control arm with peg-IFN and RBV dosed for 48 weeks

As in the PROVE 1 study, patients in the 12 and 24-week treatment arms who achieve a rapid viral response (RVR) defined as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who maintain this status through to either week 10 or 20 respectively, will stop all treatment at the 12 or 24-week time point and will be followed post-treatment to evaluate whether they achieve SVR. Patients in these treatment arms who do not meet the RVR criterion will continue on peg-IFN and RBV for a total duration of 48 weeks. The 24-week treatment arm will evaluate whether 12 weeks of additional treatment with peg-IFN and RBV adds substantially to the SVR rate compared to 12 weeks of VX-950 in combination with peg-IFN and RBV.

Additional Studies
In addition, Vertex expects to further broaden the VX-950 development program to evaluate VX-950 in other treatment regimens and patient populations. In the second half of the year, Vertex plans to initiate a Phase IIb study in patients who failed prior standard of care treatment. Vertex anticipates this Phase IIb study to enroll approximately 400 patients. The Company also expects to begin a multi-dose, drug-drug interaction study of VX-950 and low-dose ritonavir in the second half of this year. By the end of the first quarter of 2007, Vertex expects to have enrolled approximately 1,000 patients in clinical trials of VX-950.

“In clinical trials to date, VX-950 has consistently demonstrated rapid and dramatic reductions in HCV RNA levels,” said John Alam, M.D., Executive Vice President of Medicines Development and Chief Medical Officer for Vertex. “We believe the 2006 global Phase II program will establish VX-950’s clinical profile by answering key questions about SVR rates, treatment duration and the role of ribavirin. We will receive the first clinical data from this global Phase II program starting in Fall 2006.”

Data Presentations for VX-950
On May 21, 2006, Vertex announced results for a 28-day, Phase II study of VX-950 in combination with peg-IFN and RBV at the Digestive Disease Week® (DDW®) Conference in Los Angeles, California, which showed that plasma HCV RNA levels were below the limit of detection (10 IU/mL) in 12 of 12 patients at the end of 28 days of treatment with VX-950 in combination with peg-IFN and RBV. Researchers also reported that 11 of these patients continued to have no detectable virus in their blood at the end of 12 additional weeks of follow-on peg-IFN and RBV dosing. On April 29, 2006, at the 41st Annual Meeting of the European Association for the Study of the Liver (EASL), Vertex presented initial results for a 14-day, Phase Ib study of VX-950 and peg-IFN, which showed that at day 14, the majority of patients (6 of 8) receiving the combination had HCV RNA levels below the limit of quantitation (30 IU/mL), and 4 of 8 patients had HCV RNA levels below the limit of detection (10 IU/mL). Researchers reported for the first time at EASL that 8 of 8 patients who received VX-950 and peg-IFN in combination for 14 days had no detectable virus in their blood at the end of 12 additional weeks of peg-IFN and RBV dosing.

About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease. HCV, a serious public health concern affecting 3.4 million individuals in the United States, is spread through direct contact with the blood of infected people. Though many people with hepatitis C may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever. Hepatitis C significantly increases a person’s risk for developing long-term infection, chronic liver disease, cirrhosis or death. The burden of liver disease associated with HCV infection is increasing, and current therapies provide sustained benefit in only about 50% of patients with genotype 1 HCV, the most common strain of the virus.

About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company’s strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex’s product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
TaqMan® is a registered trademark of Hoffman-La Roche Inc.

Safe Harbor Statement
This press release may contain forward-looking statements, including statements that (i) Vertex expects to have the first clinical data from this Phase II program beginning in the fall of 2006; (ii) planned studies will build extensive clinical activity and safety experience with VX-950 among clinicians and patients; (iii) the PROVE 1 study will begin dosing patients in June; (iv) the PROVE 2 study will be initiated in June; (iv) the PROVE 2 study will be initiated in June; (v) Vertex will initiate later in 2006 a Phase II study of VX-950 in approximately 400 patients who have failed prior HCV therapy; and (vi) by the end of the first quarter of 2007, Vertex expects to have enrolled approximately 1,000 patients in clinical trials of VX-950. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause Vertex’s actual results to vary materially. These risks and uncertainties include, among other things, the risks that clinical trials for VX-950 may not proceed as planned due to technical, scientific, or patient enrollment issues, or disagreements with regulatory authorities over trial design or other matters, that the scale and scope of future clinical and nonclinical studies may change and will be determined in significant part by data collected in ongoing and future trials, that further clinical studies of VX-950 may not reflect the results obtained in early clinical and nonclinical studies, that ongoing nonclinical studies, including toxicology studies, will yield currently unanticipated negative outcomes that could adversely affect planned clinical trials, that results from the Company’s clinical trials commenced during 2006 will be insufficient to support a Phase III program without additional trials and consequent delay in the timetable for potential approval, and other risks listed under Risk Factors in Vertex’s form 10-K filed with the Securities and Exchange Commission on March 16, 2006.

Conference Call and Webcast: PROVE Study Update
Vertex Pharmaceuticals will host a conference call today, May 23, 2006 at 9:00 a.m. EDT to review the VX-950 global Phase II program. This call will be broadcast via the Internet at www.vrtx.com in the investor center. Alternatively, to listen to the call on the telephone, dial (800) 374-0296 (U.S. and Canada) or (706) 634-2224 (International). Alternatively, Vertex is providing a podcast MP3 file available for download on the Vertex website, www.vrtx.com.

The call will be available for replay via telephone commencing May 23, 2006 at 12:00 p.m. EDT running through 5:00 p.m. EDT on May 30, 2006. The replay phone number for the US and Canada is (800) 642-1687. The international replay number is (706) 645-9291 and the conference ID number is 9742527. Following the live webcast, an archived version will be available on Vertex’s website until 5:00 p.m. EDT on June 6, 2006.

Vertex Contacts:
Lynne Brum, Vice President, Strategic Communications, (617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Senior Media Relations Specialist, (617) 444-6470

Hep C Fibrosis - Non-inasive markers

2006-06-01T14:29:00.000-07:00

Chronic hepatitis C severe fibrosis diagnosed using non-invasive markers

Hepatitis Weekly - May. 29, 2006

2006 MAY 29 - (NewsRx.com) -- According to a study from Italy, chronic hepatitis C severe fibrosis can be diagnosed using non-invasive markers.

"In chronic hepatitis C, biopsy is the gold standard for assessment of liver fibrosis. Non-invasive markers have been proposed but their use is limited by diagnostic accuracy. Our aim was to increase the diagnostic performance of non-invasive markers of liver fibrosis by combining them in sequential algorithms," wrote G. Sebastiani and colleagues, University of Padua.

"One hundred and ninety patients with chronic hepatitis C were evaluated for AST to platelets ratio (APRI), Forns' index and Fibrotest at the time of liver biopsy and stepwise combination algorithms were developed and validated prospectively in 100 additional patients.

"Three algorithms were developed: (1) significant fibrosis (Fgreater than or equal to2 by METAVIR) was identified with high diagnostic performance (>94% accuracy) using APRI as screening test, followed by Fibrotest in APRI non-classified cases and restricting liver biopsy to patients classified F0-F1 by non-invasive tests. (2) A slightly modified algorithm had similar performance when applied to hepatitis C carriers with normal ALT. (3) Identification of cirrhosis (95% accuracy) was achieved using a dedicated algorithm with different cut-off, reducing by 60-70% the liver biopsies needed," reported the authors.

The researchers concluded, "Stepwise combination of non-invasive markers of liver fibrosis improves the diagnostic performance in chronic hepatitis C. Need for liver biopsy is reduced by 50-70% but cannot be completely avoided."

Sebastiani and colleagues published their study in the Journal of Hepatology (Stepwise combination algorithms of non-invasive markers to diagnose significant fibrosis in chronic hepatitis C. J Hepatol, 2006;44(4):686-693).

For additional information, contact A. Alberti, University of Padua, Department of Clinical & Experimental Medicine, Via Giustiniani, I-35100 Padua, Italy.

Publisher contact information for the Journal of Hepatology is: Elsevier Science BV, PO Box 211, 1000 AE Amsterdam, Netherlands.

Keywords: Padua, Italy, Chronic Hepatitis C, Hepatitis C Virus, Liver Fibrosis, Non-Invasive Markers, Screening Tests, Stepwise Combination Algorithms, Liver Biopsy, Diagnostics.

This article was prepared by Hepatitis Weekly editors from staff and other reports. Copyright 2006, Hepatitis Weekly via NewsRx.com.

Vertex rides the wave

2006-05-23T22:45:00.000-07:00

Editor's Note:

You are reading a report on a company that is in the forefront of developing drugs to fight Hep C. Once again, we find an amazing story of the capitalist model - of the greed for more profits - even when it comes to a matter of life and death.

Shouldn't the tax payer's money be used for R & D of these drugs - that when produced - it will be of a great help to the common people?

When you allow a Private Entity to run up a huge bill in developing a drug, here in this instance for HEP C, the danger is that the drugs they produce are going to be so expensive - that the government swill have to pay for it anyway.

I am all for competition, private enterprise and all that. But hey! Not in health-care and education.

The profit to a state by taking care of health-care and education is a population of Healthy and Educated people, a must for any nation building.

Is anyone listening to me?

Vertex jumps on hepatitis C drug advancement

BOSTON (MarketWatch) -- Shares of Vertex Pharmaceuticals jumped Tuesday on news that the company was preparing to initiate three key Phase IIb clinical trials for its hepatitis C drug candidate VX-950.

According to Vertex chief executive officer Joshua Boger, Vertex (VRTX :

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CUBA'S HEPC WAR

2006-05-22T15:17:00.000-07:00

Hepatitis C: Efficient Treatment Developed

Marta Gómez Ferrals*

Havana, May 21 (Prensa Latina) Cuban biotechnology took a new and very important step in obtaining an efficient treatment for Hepatitis C, a disease that affects about 200 million persons in the world.

Herbeviron is the name given to this novel drug that is the basis of a new therapy. It is part of a kit prepared by specialist of the Engineering Genetic and Biotechnology center (CIGB in its Spanish acronym), one of the pillars of the science region in the outskirts of the capital.

It is produced by the Heberbiotec factory in Cuba that is in charge of commercialization of its biotechnological products.

Interferon Alfa-2B and Rivavirma, both made in the country, are components of Heberviron and it is used not only to combat the causative virus of Hepatitis C in blood but, in the long range, eliminates lesions in the liver and totally cures the disease.

Doctor in Pharmaceutical Sciences of CIGB, Hugo Nodarse, told the press that Cuban patients have a treatment that increases the possibility to control the disease that tends to become chronic and very damaging in the majority of cases.

Heberviron successfully attacks the virus in circulation, according to tests made in the National Institute of Gastroenterology. In its advanced phase of treatment, forecasts are of a cure of liver lesions and recovery of the enzymes of that vital organ.

Information should be available about Hepatitis C to understand the significant importance of this new Cuban therapy.

Hepatitis, in a general sense, is an illness that produces inflammation of the liver and may have an inflammatory, toxic or viral etiology.

Hepatitis C is a devastating disease that can cause death through cirrhosis or liver collapse shortly after contracting the infection.

However, infected persons who do not present visible signs and symptoms are alarmed about the disease.

Contagion is through contact with the blood of an infected person and can occur as with HIV, through non-protected sexual relations, use of infected needles or contaminated blood transfusions. Also by sharing toothbrushes, shaving blades and manicure equipment that has not been sterilized.

The most general symptoms are a yellowish tinge of the skin, sclerotic eyes, fatigue, loss of appetite, nausea and vomiting, pain in the right side of the abdomen, under the ribs or weight loss although there are more or less asymptomatic persons. It can only be detected through a blood test for Hepatitis C virus.

In the United States Hepatitis C is the first reason for a liver transplant due to hepatic cirrhosis and in Egypt 15 percent of the population suffer the disease.

Cuban science has been working hard on the prevention and treatment of different types of hepatitis.

During the 90s a national vaccine was made against the B variant; also transfusions have greatly improved with top quality technology developed by scientists in the country.

Since the 80s Cuba began the technique of liver transplants that, today, shows good results with more than 100 persons operated.

Scientific research on preventive and therapeutic vaccines against illnesses has amazed nationally and worldwide. It has also received strong governmental investment and support in its broadest sense.

That is the reason behind the interest to obtain the Haemophilus influenzae vaccine that protects the infant population against pneumonia, meningitis and otitis covering Cuban needs and also satisfying requests from abroad.

By the end of this year there will be production of an anti-lung cancer vaccine developed by the Molecular Immunology Center and whose clinical studies are in the final phase. Tests are also being done in the United States.

Work is also underway to obtain vaccines or monoclonal antibodies that open up new hope for the treatment of breast, neck, head, prostate and colon cancers.

In addition Cuba has successfully completed its last clinical assay of a quintuple vaccine against diphtheria, whooping cough, hepatitis B, tetanus and Haemofhilus influenzae.

There is also one prepared against cholera and work is underway to obtain the same results against dengue, hepatitis A and tuberculosis.

(*) The author is a journalist of the Science and Technology Editorial board of Prensa Latina.

----

22 March 2006

Cuban combined therapy against chronic Hepatitis C

BY LILLIAM RIERA —Granma International staff writer—

• A Cuban combination therapy for the treatment of chronic Hepatitis C is to be put on the market by the Heber Biotec S.A. company in Latin America, Asia, Africa, the Middle East and Europe, where this firm has registered the Heberon Alfa R (human recombinant Interferon lfa 2b).

Heber Biotec S.A., certified with the ISO 9001:2000 standard, is the exclusive marketer and representative of the Genetic Engineering and Biotechnology Center (CIGB) as well as other institutions in the West Havana Scientific Complex.

Heberviron is the commercial name given to this combined therapy package for the treatment of a condition affecting approximately 300 million people around the world. It contains three doses of Heberon Alfa R, to be administered subcutaneously, three vials of water for the injection, and a bottle of Ribavirina 200 containing 42 capsules of 200 milligrams each, the dosage of which depends on body weight. It also includes three sterile disposable syringes, six needles and three alcohol swabs.

The package, containing a six-day course of treatment was launched on March 15 at the Hepatology 2006 event celebrated in Havana.

Mayda Mauri, general manager of Heber Biotec S.A., informed Granma International that in Cuba Heberviron has achieved a 30.8% increase in therapy response as compared to the Interferon single therapy, a fact which translates into a notable contribution to the control of chronic Hepatitis C.

Since November 2001, a total of 315 patients have been treated on the island with this combined therapy as part of a national program.

The components of Heberviron were developed and are being produced by Cuba: the Interferon by the CIGB and the Center of Bio-products, and the Ribavirina by the Medicament Research and Development Center and Novatec Laboratories, which demonstrates the integration and cooperation of the institutions in the Scientific Complex, Mauri affirmed.

Enzyme-blocking Drug Offers Hope

2006-05-22T15:05:00.000-07:00

Enzyme-blocking Drug Offers Hope for Hepatitis C Sufferers

By Alan Fein

(AXcess News) New York - ViroPharma, Inc. (Nasdaq: VPHM) said Sunday that data from a phase 1b trial of an enzyme-blocking drug showed a 97 percent success rate in preventing the Hepatitis C virus from replicating itself. The viral polymerase inhibitor, HCV-796, is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).

The findings were presented at the 2006 Digestive Disease Week (DDW) conference in Los Angeles, California.

Steve Villano, ViroPharma's vice president of clinical research and development called the findings of the phae 1b trial "exciting", saying that doses taken orally by patients for 14 days reduced the ALT count signifcantly in patients suffering from chronic hepatitis C who had never received any prior treatment.

"The decline in levels of ALT, an important marker of liver injury associated with hepatitis C infection, that appear to correlate with antiviral activity further support the potential benefit of longer treatment with HCV-796," said Villano.

Of the 16 patients involved in tthe phase 1b study, Seventy two percent were infected with genotype 1 HCV, which is the most common strain of Hepatitis C in the United States. Success rates of existing drug treatment of genotype 1HCV patients is one-in-five, making ViroPharma's results good news for chronic HC sufferers.

Peak antiviral response was achieved at doses of 500 mg twice daily and higher. The 500 mg, 1000 mg, and 1500 mg dose groups achieved peak mean HCV viral load reductions of 96 to 97 percent by the fourth day of a 14-day dosing period. The greatest reductions in serum ALT levels were seen in the 500 and 1000 mg dose groups.

Mild to moderate headache was the most frequently reported adverse event, unlike existing drugs which have severe side effects and can even make patients suicidal.

HCV-796 was given in combination with PEG-Interferon.

Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.

Several Interferon products are available and often given in combination with Ribavirin, but at best, its success rate is 50 percent and then in patients who are diagnosed early with the less debilitating genotypes of the virus.

If untreated, the results of Hepatitis C infection is death as the liver slowly fails. Finding a cure has become a race as more and more people throughout the world become infected with HCV. But the drug companies who developed Interferon and Ribavirin hold a monopoly and critics say they have held back the research of other companies, which they adamantly deny.

Interferon treatment in combination with Ribavirin cost over $1,000 per month just for the drugs, which are taken by hypodermic injection weekly and must be carried through for a full year.

In addition to the relatively poor treatment response in patients infected with genotype 1 HCV, the considerable side effects frequently associated with the use of Interferon can lead to discontinuation of therapy in approximately 20% of patients.

For Viropharma, a win with HCV-796 would be a big boost to the pharmaceutical company, that reported $8.2 million in earnings for the first quarter earlier this month. Analysts had expected Viropharma to report 20 cents a share in earnings instead of the 12 cents per share it earned. Viropharma said wholesalers had reduced their stocks of the antibiotic Vancocin.

Net sales of Vancocin had rose 38.8 percent to $29.2 million, though analysts were expecting Viropharma to report $40.2 million.

The company said that underlying prescription demand for Vancocin remains strong, and it therefore reiterated its forecast for net sales of the drug in 2006 of between $160 million and $170 million.

Friday, Viropharma's shares closed up 29 cents at $9.29 for a gain of 3.22 percent. Its shares had tanked when it announced its first quarter results, dropping 30 percent to $7.69 May 4th.