Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started
My Medicine

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Hepatitis Health Center

Font Size

FDA Panel Urges Approval of Hepatitis C Drug

Advisory Panel Recommends Approval of Boceprevir to Treat Chronic Hepatitis C
By Jamila Bey
WebMD Health News
Reviewed by Laura J. Martin, MD

April 27, 2011 -- In an18-0 vote, an FDA advisory panel recommended approval of the drug boceprevir to treat hepatitis C.

Panel members called boceprevir, manufactured by Merck & Co., a weapon in the fight against chronic hepatitis C virus (HCV) genotype 1 infection. Chronic HCV genotype 1 infection is the most common form of hepatitis in the U.S. and also the most difficult to treat.

If approved by the FDA, boceprevir will have the brand name Victrelis.

Boceprevir is an antiviral medication called a protease inhibitor that has proven effective in adults with liver disease who have been untreated or who have failed previous therapy. Protease inhibitors are commonly used to treat HIV infection. In the treatment of hepatitis C infection, boceprevir inhibits an enzyme, thereby suppressing replication of the hepatitis C virus.

Despite the committee’s affirmative vote, the advisors also had reservations about boceprevir’s widespread usage.

The drug has proven to reduce the viral load to levels that are undetectable in more than a third of the HCV patients who use it. But the main contention concerned increased incidents and severity of anemia when the drug is used in addition with a pair of commonly used HCV drugs, pegylated interferon and ribavirin.

Additionally, there was an increase in patients’ reported psychiatric symptoms and suicidal thoughts among participants in the drug’s trials.

The problem, according to panel members, is that the studies show great promise, but the small sample size of 1,500 patients among two trials and the lack of diversity among the trial’s participants raise questions. The committee raised nearly 40 points they wished to have Merck’s researchers investigate.

While praising the drug as the greatest advancement to date in any HCV regimen, Marc Ghany, MD, of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, summarized the feelings of his fellow advisory board members: "The data speak for themselves. The challenge is going be how to use this medication in the greater population."

Questions for Drugmaker

Boceprevir isn’t effective in every patient, and the advisory committee criticized Merck researchers for not having the answers to questions they felt should have been considered in advance of coming before them. Patient representative Lynda Marie Dee, JD, of Baltimore, pulled no punches in her displeasure. “There are no drug interaction studies. I’m shocked we don’t have studies on depression. It’s very disappointing that this hasn’t already been done.”

Today on WebMD

Hepatitus C virus
Types, symptoms and treatments.
liver illustration
Myths and facts about this essential organ.
woman eating apple
What you need to know.
doctor and patient
What causes it?
Hepatitis C Treatment
Syringes and graph illustration
liver illustration
passport, pills and vaccine
Scientist looking in microscope
Fatty Liver Disease
Digestive Diseases Liver Transplantation
Picture Of The Liver
Image Collection