Merck's Hepatitis C Drug Wins FDA Approval

The Food and Drug Administration on Friday approved Merck's new hepatitis C virus drug Victrelis (boceprevir), which shortens the treatment time for some patients. Two-thirds of HCV patients in clinical trials achieved a sustained viral response on Victrelis used in combination with standard therapy, compared with up to 40 percent for those using traditional treatment 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," said Dr. Edward Cox, director of FDA's antimicrobial products office.

While Victrelis is the first HCV protease inhibitor, FDA is expected to approve a second this month: Vertex Pharmaceutical's telaprevir. Like Victrelis, telaprevir offers some patients the promise of quicker successful treatment. These dramatic HCV treatment developments, likened to the advent of highly effective antiretroviral therapy for HIV/AIDS, have been closely watched by doctors and patients.

"Regardless of the ultimate success of this drug, it's a harbinger of a great new era in treating patients with hepatitis C," said Dr. Scott L. Friedman, chief of liver diseases at Mt. Sinai School of Medicine in New York.

Many HCV patients, including some who have previously failed on standard therapy, have delayed treatment while waiting for the new drugs to gain approval, said Dr. Ira M. Jacobson, professor of medicine at Weill Cornell Medical College in New York.

Victrelis is taken three times a day (12 capsules total a day). Traditional therapy also would be necessary, consisting of ribavirin taken two times a day (five or six pills daily) plus weekly pegylated interferon shots. In Merck's trial, 44 percent of treatment-naïve patients on Victrelis-based combination therapy achieved a sustained viral response within 28 weeks. Standard therapy alone requires 48 weeks of treatment.

For further treatment information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm255390.htm.

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