FDA approves second new hepatitis C treatment

The _Wall Street Journal_



(5/24, Gryta, Subscription Publication) reports the Food and Drug Administration approved Incivek (telaprevir), a new hepatitis C medication, from Vertex Pharmaceuticals. Incivek is the second hepatitis C drug to be approved by the FDA in less than two weeks after decades without new treatments for the disease.

The _New York Times_



(5/24, B2, Pollack, Subscription Publication) reports Merck's Victrelis (bocepravir) was approved by the FDA on May 13. "Both products borrow from the strategy used by HIV drugs of inhibiting the action of a viral enzyme -- in this case, the hepatitis C protease enzyme."

The _AP_



(5/24, Seaman) reports, "In clinical trials, patients were treated with a combination of Incivek and standard therapies for 12 weeks. They continued on the standard treatments for another 36 weeks, but many of them were cured within 24 weeks." The company said about 79 percent of previously untreated patients were cured after treatment with the drug. "The drug was also much more effective in patients who had relapsed, had some response but not a cure, or had no response to other drugs."

The _Los Angeles Times_



(5/23, Maugh) "Booster Shots" blog reported that like boceprevir, telaprevir "is meant to be used only in conjunction with the standard therapy of peginterferon-alpha and ribavirin." The most common "reported side effects of the combination therapy included rash, anemia, nausea, fatigue, headache, diarrhea, itching and anal or rectal irritation and pain." Notably, Vertex "said it will provide the drug free to people with no insurance and a household income" under $100,000 per year.


from AMA