Vertex: Data shows VX-950 with pegylated interferon achieves dramatic drop in hepatitis C viral levels

By E. Janene Geiss

Philadelphia, May 1 - Vertex Pharmaceuticals Inc. said data show that when VX-950, an investigational oral hepatitis C virus protease inhibitor, was dosed with pegylated interferon alfa-2a (Pegasys or peg-IFN), the combination was well-tolerated and achieved a dramatic reduction in plasma viral RNA levels in patients with chronic genotype 1 hepatitis C infection through 14 days of dosing.

At day 14, the majority of patients (six of eight) receiving the combination had hepatitis C RNA levels below the limit of quantitation, and four of eight patients had RNA levels below the limit of detection, according to a company news release.

All patients enrolled in the 14-day study subsequently received follow-on treatment with peg-IFN and ribavirin, officials said.

The company said that eight of eight patients who received VX-950 and peg-IFN in combination for 14 days have no detectable virus in their blood at the end of 12 additional weeks of peg-IFN and ribavirin dosing.

These patients continue to receive peg-IFN and ribavirin therapy. All patients were offered follow-on treatment according to clinical practice at the investigator sites, officials said.

The results were presented Saturday at the annual meeting of the European Association for the Study of the Liver in Vienna.

The 14-day, randomized, blinded, placebo-controlled phase 1b study enrolled 20 treatment-naïve patients with genotype 1 hepatitis C, the most prevalent and difficult to treat form of the infection.

Patients were randomized to receive a new tablet formulation of VX-950 at a dose of 750 mg every eight hours in combination with a standard dose of peg-IFN, the same dose of VX-950 administered alone or a standard dose of peg-IFN alone.

VX-950 is an investigational oral inhibitor of hepatitis C virus protease, an enzyme essential for viral replication, and is one of the most advanced investigational agents that specifically targets hepatitis C.

In early 2006, Vertex reported preliminary results from a 28-day phase 2 study of VX-950 dosed in combination with peg-IFN and ribavirin. In this study, 12 of 12 patients had plasma hepatitis C RNA levels below the limit of detection at 28 days, officials said.

Vertex is a Cambridge, Mass., biotechnology company that develops small molecule drugs for viral diseases, inflammation, autoimmune diseases and cancer.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.