Vertex hepatitis C drug helps the hard-to-treat

Associated Press

CAMBRIDGE -- Vertex Pharmaceuticals Inc. said Tuesday that a late-stage clinical trial showed its hepatitis C drug candidate telaprevir proved effective for patients who hadn't been helped by other treatments.

Vertex said 65 percent of patients who were treated with a drug cocktail including telaprevir were cured, meaning the hepatitis C virus could not be detected in their bodies. That compares with just 17 percent of patients who were treated with only the drugs pegylated interferon and ribavirin.

The 48-week study included 662 people split up into three groups: some who were treated successfully in the past but later relapsed, some who had a partial response to other therapies, and some who had almost no response to other treatments. The study, called REALIZE, is the third and last of the planned late-stage trials of telaprevir. The others involved patients who had not taken other hepatitis C drugs.

For telaprevir and for the standard therapies, the best results came in patients who previously suffered relapses. The partial responders were the second most likely to be cured, followed by those who had almost no response to other drugs. The most common side effects for telaprevir were fatigue, itching, rash, flulike symptoms, nausea, and anemia.

The trial was conducted by Vertex's partner Tibotec, which has the commercial rights to telaprevir in Europe, South America, Australia, the Middle East, and some other countries. Mitsubishi Tanabe Pharma has the rights to sell the drug in Japan and some other Asian countries.

Vertex said it plans to complete regulatory filings for telaprevir later this year.

Analysts have estimated the total market for hepatitis C drugs at $9 billion. About 300,000 people in the US have hepatitis C, a virus that can cause liver damage. Other potential hepatitis C drugs in development include Merck & Co.'s boceprevir. Merck acquired the drug when it merged with Schering-Plough.