::: HCV News :::

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

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.

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, 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.

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.

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.

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.

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:

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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)

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

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

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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.


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