Second Drug Wins Approval for Treatment of Hepatitis C

On Monday, the Food and Drug Administration approved Vertex Pharmaceuticals’ Incivek (telaprevir), the second new hepatitis C treatment OK’d this month. Incivek is taken with traditional HCV drugs and is approved for treatment-naïve patients and those whose infection has not responded adequately to previous therapies, FDA said.

In clinical trials, 79 percent of patients taking Incivek-based combination therapy achieved a sustained virologic response. This SVR rate is between 20 percent and 45 percent higher than that achieved by patients taking traditional interferon and ribavirin therapy alone, FDA said.

About half of patients taking Incivek-based combination therapy were able to finish treatment in 24 weeks rather than the typical 48 weeks. Of treatment-naïve patients, 60 percent achieved an early response, received only 24 weeks of therapy, and had an overall SVR of 90 percent.

Incivek is taken three times a day (six pills total), and an entire course of treatment is $49,200 wholesale. Merck’s HCV drug approved earlier this month, Victrelis (boceprevir), costs $26,400-$48,400 depending on the duration of treatment. Both of the new HCV protease inhibitors are taken with standard treatment, which costs about $15,000-$30,000, depending on treatment duration.

The most commonly reported side effects in patients taking Incivek-based combination therapy were rash, anemia, nausea, fatigue, headache, diarrhea, itching, and anal or rectal irritation or pain, FDA said. The rash can be severe enough to stop Incivek or all the drugs.

The new HCV drugs “represent a new direction in the treatment of hepatitis C and a significant improvement over the current standard of care,” said Dr. Margaret A. Hamburg, the commissioner of FDA.

Efforts to diagnose HCV are expected to get a boost, since many of the 3.2 million Americans with the virus are unaware of their infection. Vertex’s public awareness campaign may initially focus on New York City.

For more information, visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256299.htm.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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