April 28, 2011
A Food and Drug Administration panel on Wednesday unanimously approved the first of two hepatitis C treatments being considered during a two-day meeting on antiviral drugs. By an 18-0 vote, FDA's expert National Viral Hepatitis Roundtable (NVHR) agreed that the benefits of Merck & Co.'s boceprevir outweigh its risks.
Boceprevir, a protease inhibitor, is a tablet designed to be taken in combination with the standard hepatitis C virus drugs ribavirin and interferon-alpha. Studies show combination treatment with boceprevir boosts HCV sustained viral response rates to 60 percent-65 percent, compared with just 40 percent for standard therapy alone. Boceprevir also can cut HCV treatment time in half, to six months.
Panelists noted boceprevir's side effects include anemia and lower blood cell counts, and some expressed concern about patients' ability to adhere to the drug's three-times-a-day dosing regimen. Some patient populations have not shown a strong response to boceprevir and will need longer treatment, the panel said. These include African Americans, those with liver disease, and patients who have failed standard HCV treatment.
The panel will consider Vertex Pharmaceutical Inc.'s telaprevir, also a protease inhibitor, on Thursday. Like boceprevir, telaprevir is taken in a drug cocktail. The two medications represent more than 15 years of research to find more effective treatments for HCV, which infects approximately 3.2 million Americans.
"There are a lot of patients out there who have been waiting for this drug before seeking treatment," Martha Saly, director of NVHR, said of boceprevir. "But they're probably not going to be as excited when they realize it isn't replacing the older drugs."
FDA typically follows the recommendations of its panels; a final decision on boceprevir is expected next month.