Boceprevir Wins FDA Approval to Treat Hepatitis C

By Emily P. Walker, Washington Correspondent, MedPage Today
Published: May 13, 2011

WASHINGTON -- The FDA has approved the investigational drug boceprevir (Victrelis), to be used in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.
Boceprevir, made by Merck, will be the first HCV protease inhibitor to reach market and is expected to be a major advance in treating the disease, which affects between three and four million people in U.S.

"Victrelis is an important new advance for patients with hepatitis C," said Edward Cox, MD, MPH, director of antimicrobial products at the FDA in a press release. "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."

The move was expected after a committee of outside experts voted unanimously in April that the FDA should approve the drug.

The panelists all agreed that boceprevir seems to be a safe and effective new option to treat HCV.

The approval was based on Merck's clinical trials, which showed that, in the difficult-to-treat genotype 1 patients, boceprevir yielded sustained virological response rates as high as 67%.

In contrast, the rate for patients getting the standard regimen of pegylated interferon injections and ribavirin pills was about 40%.

Until now, treatment has relied on boosting the immune system rather than attacking the virus directly.

One panelist at the April meeting marveled at how far HCV treatment has come in the past several decades and said achieving a 60% or 70% sustained response "seems like a dream come true."

The drug carries a number of hematologic side effects, including anemia, neutropenia, and thrombocytopenia. But the advisory committee members said the anemia is a manageable side effect during treatment and is reversible after the drug has been stopped.

The FDA is widely expected to approve another protease inhibitor for HCV, telaprevir, made by Vertex Pharmaceuticals. The same panel that endorsed boceprevir also voted unanimously that telaprevir be approved for the same indication.

Merck said it planned to begin shipping the drug next week.

Eliav Barr, MD, vice president of infectious diseases for Merck, told MedPage Today that about 70% of the estimated four million HCV patients in the U.S. will be candidates for treatment with the drug.

He cautioned that patients must, however, undergo four weeks of peginterferon/ribavirin treatment before initiating boceprevir.

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