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F.D.A. Approves New Drug for Hepatitis C - Boceprevir HCV Protease Inhibitor
 
 
  Boceprevir (Victrelis) FDA label:
 
Victrelis (boceprevir) Capsules, Schering Corp, Approval
 
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
 
View the label approved on 05/13/2011 (PDF) for VICTRELIS, NDA no. 202258
 
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf
 
NY Times By ANDREW POLLACK
Published: May 13, 2011
 
The new drug, Merck's Victrelis, effectively cured more than 60 percent of patients in clinical trials when used along with the existing drugs. That compared to 20 to 40 percent of patients cured by the existing drugs alone. "This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients hepatitis C infection compared to currently available therapy," Dr. Edward Cox, director of the F.D.A.'s office of antimicrobial products, said in a statement.
 
An estimated 3.2 million Americans have a chronic infection of the hepatitis C virus. The virus can cause serious liver disease, including cirrhosis and liver cancer, though these problems may take decades to develop and may not develop at all.
 
The existing treatment consists of nearly a year of weekly injections of longlasting alpha interferon combined with ribavirin, a pill taken daily. The regimen is considered extremely harsh, with side effects including flu-like symptoms, depression and anemia. It is not entirely clear how those drugs work. Victrelis, also known as boceprevir, inhibits an enzyme, called protease, made by the virus. By blocking viral enzymes, Victrelis borrows a page from the strategy that has been successful in treating H.I.V.
 
Vertex Pharmaceuticals is expected to win F.D.A. approval later this month for its own hepatitis C protease inhibitor, and a fierce marketing war with Merck is expected. Both drugs received unanimous recommendations from an F.D.A. advisory committee late last month.
 
And many other companies are not far behind, making hepatitis C one of the hottest areas in the pharmaceutical industry.
 
While both Victrelis and Vertexs drug, called telaprevir, must be used with the existing drugs, the hope is that in several years, three or four new drugs might be combined, as is done for H.I.V., doing away with the need for the interferon injections.
 
For now, though, the Merck and Vertex drugs could allow some patients to clear the virus from their bodies with shorter durations of treatment. In Merck's clinical trial, 44 percent of patients who had not previously been treated were able to complete their treatment in 28 weeks instead of the usual 48.
 
Doctors, pharmaceutical companies and Wall Street analysts say that many people with hepatitis C are being "warehoused," meaning they have forgone treatment with the existing drugs in order to wait for approval of the new drugs. "There are thousands and thousands of patients who have just been waiting," Dr. Eliaz Barr, vice president for infectious diseases clinical research at Merck, said in an interview.
 
There are also estimated to be a few hundred thousand Americans for whom the existing treatment has not been successful. Some of them might try again.
 
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FDA NEWS RELEASE
For Immediate Release: May 13, 2011
FDA approves Victrelis for Hepatitis C

The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.
 
The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response (i.e., the hepatitis C virus was no longer detected in the blood 24 weeks after stopping treatment), compared to pegylated interferon and ribavirin alone, the current standard of care.
 
When a person sustains a virologic response after completing treatment, this suggests that HCV infection has been cured.
 
Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocelluar carcinoma), and decreased mortality.
 
"Victrelis is an important new advance for patients with hepatitis C," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy."
 
According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.
 
Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C virus (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.
 
People can get the hepatitis C virus in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor, toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.
 
Victrelis is a pill taken three times a day with food. The therapy is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
 
The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count (anemia), nausea, headache and taste distortion (dysgeusia). Victrelis is marketed by Whitehouse Station, N.J.-based Merck.
 
 
 
 
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