CAMBRIDGE (MASSACHUSETTS) (dpa-AFX) - Vertex Pharmaceuticals Inc. (VRTX) said Wednesday that the New England Journal of Medicine published data from a Phase 3 study of INCIVEK (telaprevir) tablets in people with genotype 1 chronic hepatitis C who were new to treatment.
In ILLUMINATE, INCIVEK was given for the first 12 weeks in combination with pegylated-interferon and ribavirin. Nearly two-thirds of patients responded early to INCIVEK combination treatment and were randomly assigned to receive an additional 12 weeks or 36 weeks of treatment with pegylated-interferon and ribavirin alone.
Similarly high rates of sustained viral response were achieved by people in both treatment groups. Rash and anemia were the most common side effects reported with INCIVEK in this study.
ILLUMINATE was an open-label, randomized Phase 3 study that evaluated INCIVEK in combination with Pegasys (pegylated-interferon alfa-2a) and Copegus (ribavirin) in 540 people with genotype 1 chronic hepatitis C who were new to treatment.
INCIVEK was approved by U.S. Food and Drug Administration in May 2011 and by Health Canada in August 2011 for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.
INCIVEK is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication.
Vertex developed telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America where it will be marketed under the brand name INCIVEK.
Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Telaprevir, which will be known as INCIVO in Europe, received accelerated review by the Committee for Medicinal Products for Human Use, which issued a positive opinion in July 2011.
Telaprevir was approved in Switzerland in September 2011. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
Copyright RTT News/dpa-AFX