Panel recommends new hepatitis drug to FDA

An expert advisory panel unanimously recommended Thursday that the U.S. Food and Drug Administration approve a drug that treats hepatitis C in a new way.

All 18 committee members, who are outside medical experts, voted to recommend telaprevir. The new drug is a protease inhibitor, the same drug class that helped transform HIV into a manageable infection.

Protease inhibitors interrupt the way a virus commandeers a healthy cell to make thousands of new viruses. Telaprevir, manufactured by Massachusetts-based Vertex Pharmaceuticals, became the second protease inhibitor for hepatitis C recommended by the FDA's antiviral advisory committee this week.

On Wednesday, the committee unanimously voted in favor of a drug called boceprevir, produced by Merck & Co.

The FDA will decide May 23 whether to accept the panel's recommendations. The agency rarely goes against the decisions of its expert committees.

Currently, standard treatment for hepatitis C is a combination of ribavirin pill-therapy and injections of pegylated-interferon over 48 weeks. Only about half of patients are cured.

Experts think the new medications can help fill the gap.

Hepatitis C, like other hepatitis viruses, attacks the liver.

Dr. Melissa Palmer, a Plainview liver specialist, called the new drugs a breakthrough because they approach hepatitis C in an inventive way. "This is such an important and much-needed advance," she said, noting that the last medication approved for hepatitis C was ribavirin in 1998.

Skin rashes and anemia were side effects in clinical tests of both drugs. Palmer said not only are those effects manageable, the new treatment cycle would take just 28 weeks.