Monday, October 24, 2011

Vertex starts trial to shorten treatment for certain hepatitis patients

By Lori Valigra, Mass High Tech correspondent

Vertex Pharmaceuticals Inc. of Cambridge said it has started a Phase 3b trial to evaluate a shorter treatment period for its Incivek (telaprevir) therapy combined with pegylated-interferon and ribavirin for patients with a specific type of hepatitis C.

The treatment is for the approximately one-third of hepatitis C patients who have genotype 1 chromic hepatitis C with the “CC” variation near the IL28B gene. That variation has been associated with faster and higher sustained viral cure rates to interferon-based treatment, the company said. Hepatitis C is a contagious virus that affects the liver.

An estimated 3.2 million Americans have chronic hepatitis C, according to the Centers for Disease Control and Prevention. Most people are unaware they are infected. Vertex cited statistics noting that by 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double to about $85 billion from $30 billion in 2009.

Vertex developed telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America, where it is being marketed under the brand Incivek. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. In September 2011, telaprevir was approved in the European Union and Switzerland. The drug, which is called Incivo in Europe, was approved by the U.S. Food and Drug Administration in May and brought in revenue of $75 million in the first five weeks on the market. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries. In September 2011, telaprevir was approved in Japan and is known as Telavic.

In the new study, Incivek will be taken twice a day. The study is expected to enroll 350 people in the United States and Europe who are new to treatment or who have relapsed after at least one prior course of treatment with pegylated-interferon and ribavirin alone. The primary endpoint of the study is the proportion of patients who achieve a sustained viral response 12 weeks after the last planned dose of study drug. With the combination therapy, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks. All other patients receive a total of 48 weeks of treatment, the company said.

“Incivek combination therapy is a significant advance over the previous standard of care for the treatment of hepatitis C,” Robert Kauffman, MD, chief medical officer for Vertex, said in a statement. “One of our goals is to offer patients a high chance for a cure in the shortest amount of time.”