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NEJM publishes data from Vertex INCIVEK Phase 3 study on genotype 1 chronic hepatitis C

March 09, 2017

According to the Centers for Disease Control, an estimated 3.2 million people in the United States have chronic hepatitis C virus infections. The disease is spread through virally infected blood, often by sharing of syringes or other equipment to inject drugs; prior to 1990, some infections can be attributed to blood transfusions. Some rare infections can be traced to medical procedures. Chronic hepatitis C is the leading cause of liver cancer and cirrhosis and is the chief reason for the need for liver transplants in the U.S. The disease is linked to as many as 10,000 deaths each year.

In the new telaprevir study, funded by Vertex Pharmaceuticals in Cambridge, Mass., a total of 540 patients were enrolled. They took a 12-week course of 750 milligrams of telaprevir three times a day in addition to therapy with pegylated interferon and ribavirin. Patients eligible for shortened treatment - meaning the virus was not detectable in the first month of treatment - were randomized to receive either 24 weeks or 48 weeks of treatment. The high cure rates among both groups showed that there was no benefit to additional treatment for early responders.

For patients, the shorter course of treatment means decreased costs, fewer side effects and less disruption to their daily lives, as this therapy requires intensive monitoring and laboratory visits.

Dr. Poordad has received research grants and served as an adviser and consultant for Vertex Pharmaceuticals, which makes telaprevir, and Merck, which makes boceprevir.

Source: New England Journal of Medicine