July 11, 2007

Woman tries unusual drug for hepatitis

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."

May 23, 2007

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.

February 14, 2007

Peregrine hepatitis C drug safe in test

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.

February 07, 2007

Vertex Nears Hit or Miss

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.