Investigational drug, Victrelis™ (boceprevir) for the treatment of chronic hepatitis C genotype 1 infection combined with standard therapy (pegylated interferon and ribavirin) has been recommended unanimously by the FDA's Antiviral Drugs Advisory Committee. Victrelis, a protease inhibitor was being reviewed by the Food and Drug Administration (FDA) for chronic HCV (hepatitis C virus) genotype 1 infection in adults with compensated liver disease who have not benefited from standard therapy.

The Committee called Victrelis a ". . . a game-changing advance in the treatment of the disease."

Boceprevir blocks an enzyme (protease) that helps the hepatitis C virus to replicate.

The Committee only advises the FDA on what it thinks should be done. However, the Agency usually goes along with its recommendations.

Merck & Co, the makers of Victrelis, believes a final decision by the FDA will be made by the end of May 2011.

Peter S. Kim, Ph.D., president, Merck Research Laboratories, said:

"The positive recommendation brings us one step closer to bringing VICTRELIS to men and women who need it, and reinforces our ongoing commitment to developing innovative therapies to treat chronic hepatitis C. We're pleased with the panel's decision and look forward to working with the FDA as it continues to evaluate the application for Victrelis."

Victrelis was granted priority review status - this is given to experimental drugs for unmet needs. The drug has also been granted a MAA (Marketing Authorization Application) by EMA (the European Medicines Agency).

The FDA's Antiviral Drugs Advisory Committee evaluated the Victrelis Phase III clinical program. HCV SPRINT-2 and HCV RESPOND-2, two clinical trials, involving 1,500 patients with chronic HCV genotype 1 infection - this is the most difficult to treat and the most widespread form of the virus in the USA.

HCV-SPRINT-2 involved 1,097 patients who had never been treated - treatment-naïve patients. The HCV RESPOND-2 trial involved 403 patients who had not responded properly to standard treatment; the trial included a separate results analysis for African-American patients who do not usually respond well to standard treatment.

According to the director of the antiviral-drugs division of the FDA, Victrelis seems to increase sustained virologic response rates (cure rates) to more than 30% above what we currently have.

According to the FDA, approximately 3.2 million people in the USA are infected with hepatitis C.



View drug information on Victrelis.