Merck announced that the FDA has approved Victrelis (boceprevir), a hepatitis C virus protease inhibitor, for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients ≥18 years of age with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. This approval was based on data from two Phase 3 clinical studies that evaluated approximately 1,500 adult patients with chronic HCV genotype 1 infection. Both studies included two treatment arms with Victrelis: a response-guided therapy (RGT) arm, in which patients with undetectable virus at treatment Week 8 were eligible for a shorter duration of therapy, as well as a 48-week treatment arm.
Adding Victrelis to peginterferon alfa-2b/ribavirin achieved a significant increase in sustained virologic response (SVR) rates compared to peginterferon alfa-2b/ribavirin alone. In treatment-failure patients the addition of Victrelis to peginterferon alfa-2b/ribavirin resulted in nearly a three-fold increase in SVR rates to 59% for the RGT arm and 66% for the 48-week treatment arm, compared to 23% for control. Relapse rates were 14% for the RGT arm and 12% for the 48-week treatment arm, compared to 28% for control.
In treatment-naïve patients the addition of Victrelis to peginterferon alfa-2b/ribavirin resulted in a significant increase (1.7 fold) in SVR rates to 63% for the RGT arm and 66% for the 48-week treatment arm, compared to 38% for control. Relapse rates were 9% for the RGT arm and 9% for the 48-week treatment arm, compared to 22% for control.
Victrelis capsules are expected to be available by the end of May 2011 in a 200mg dosage strength.
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