Incivek combination regimen reports efficacy in Phase 2 trial

6th March 2012 (Last Updated March 6th, 2012 18:30)

Vertex Pharmaceuticals has announced the interim results from an ongoing Phase 2 study intended to assess the safety and tolerability of Incivek (telaprevir) tablets along with pegylated-interferon and ribavirin in people who are co-infected with genotype 1 hepatitis C virus (HCV) and human immunodeficiency virus (HIV).

Vertex Pharmaceuticals has announced the interim results from an ongoing Phase 2 study intended to assess the safety and tolerability of Incivek (telaprevir) tablets along with pegylated-interferon and ribavirin in people who are co-infected with genotype 1 hepatitis C virus (HCV) and human immunodeficiency virus (HIV).

Approved by the Food and Drug Administration and Health Canada, Incivek is a direct-acting antiviral oral medicine that targets hepatitis C virus protease, an enzyme essential for viral replication.

The randomised double-blind placebo-controlled parallel group multi-centre study is a two-part (A and B) Phase 2 trial.

Part A is investigating people who are not currently being treated with antiretroviral therapy (ART) for HIV infection, while Part B is evaluating those who are taking an Atripla or Reyataz-based regimen for HIV.

In the trial, patients were treated with 12 weeks of Incivek, pegylated-interferon and ribavirin, followed by 36 weeks of pegylated-interferon and ribavirin alone.

The primary endpoint is to determine the safety and tolerability of Incivek combination therapy in people co-infected with HCV and HIV, and the secondary endpoint is to evaluate rates of sustained viral response (SVR) 12 and 24 weeks after the end of treatment.

The study data demonstrated that 74% of patients who were treated with Incivek combination therapy had undetectable HCV 12 weeks after the end of all study treatment (SVR12) compared to 45% who were treated with pegylated-interferon and ribavirin alone.

Interim data also showed that 68% of patients treated with Incivek combination therapy had a rapid viral response (RVR) compared to none of the patients who received pegylated-interferon and ribavirin alone.

Vertex senior vice president and chief medical officer Robert Kauffman said the new Incivek data are important as the company works towards the goal of helping cure people with hepatitis C.

"We're actively enrolling co-infected patients in a Phase 3 study and expect that data from this study will be included in a submission for a supplemental approval of Inicivek," Kauffman added.

In collaboration with Janssen, Vertex Pharmaceuticals conducted the Phase 2 study of Incivek.

Currently, Vertex is enrolling patients in a Phase 3 study of Incivek combination therapy designed to evaluate 24 and 48-week response-guided regimens in people co-infected with HCV and HIV.