Hepatitis C Drug
May 14, 2011 by USA Post
Hepatitis C Drug, Merck & Co. Inc. (MRK: News) said Friday that the U.S. Food and Drug Administration has approved its Victrelis investigational drug for the treatment of certain adults with chronic hepatitis C. The drug has been approved for use in combination with peginterferon alfa and ribavirin. Merck said it would begin shipping Victrelis to pharmacies within a week.
Another drug for the treatment of hepatitis C is likely s Vertex Pharmaceuticals Inc. (VRTX) Telaprevir, for which the FDA is expected to announce a decision in the coming days.
“This is an exciting day for doctors and patients, as Victrelis is the first breakthrough for the treatment of chronic hepatitis C approved in a decade.” Said Bruce Bacon, Professor of Internal Medicine, Saint Louis University School of Medicine and a clinical investigator for Victrelis.
“Compared to current standard therapy, significantly Victrelis may increase the likelihood of a patient achieving undetectable virus levels, thereby obtaining a sustained virological response. For many patients, Victrelis may allow lower total treatment duration. “Bacon said.
Victrelis is approved for patients who still have some liver function, and either has not been previously treated with chemotherapy for hepatitis C or who have no treatment.
Hepatitis C is caused by the hepatitis C virus mortal. Currently, no vaccine to prevent infection, but are not approved antiviral drugs to treat hepatitis C. An estimated 3.2 million people in the U.S. have chronic hepatitis C
The current standard treatment for hepatitis C is a combination of pegylated interferon alfa-2a or pegylated interferon alfa-2b as an injection and given the antiviral drug ribavirin as a pill.
Peg-Intron/Rebetrol manufactured by Schering-Plough Corp, which is wholly owned by Merck, and Pegasys / Copegus Swiss pharmaceutical giant Roche Holding AG (RHHBY.PK) are the main treatments for hepatitis C in the U.S. In 2010, Peg-intron generated worldwide sales of 737 million while Pegasys booked sales of 1.6 billion Swiss francs.
Victrelis was adopted on the basis of security of two late stage and efficacy studies involving 1,500 adult patients. All patients who received Victrelis in these studies were first treated with peginterferon alfa-2b and ribavirin (P / R) for 4 weeks followed by the addition of Victrelis.
The trials showed that patients with treatment failure, adding Victrelis P / R resulted in an increase of almost three times in sustained virologic response rates to 59 percent for TMN arm and 66 percent for the arm treatment of 48 weeks, compared to 23 percent of P / R alone. A sustained virologic response means that the HCV infection has been cured.
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