Investigational HCV Protease Inhibitor Telaprevir Now Being Studied in People with HIV/HCV Coinfection

		SUMMARY: The investigational hepatitis C virus (HCV) protease inhibitor telaprevir, which has demonstrated good antiviral activity in clinical trials of people with hepatitis C alone, is now being tested in HIV/HCV coinfected individuals -- a long awaited development for this often hard-to-treat group.

HIV/HCV coinfected people typically experience more rapid liver disease progression and respond less well to interferon-based therapy than those with HCV alone. Therefore, coinfected patients and their clinicians have eagerly awaited the first clinical trials of new directly targeted antiviral agents.

Telaprevir, the HCV protease inhibitor furthest along in development, is currently undergoing Phase 3 trials, and Vertex Pharmaceuticals has indicated that it plans to file for U.S. Food and Drug Administration (FDA) approval in the second half of 2010. Trials so far have tested telaprevir in combination with pegylated interferon plus ribavirin, but Vertex also plans to study an all-oral regimen of telaprevir plus its investigational HCV polymerase inhibitor VX-222.

The ClinicalTrials.gov web site now includes a trial of telaprevir, used with pegylated interferon alpha-2a (Pegasys) plus ribavirin, for HIV/HCV coinfected individuals.

In this Phase 2a trial, sponsored by Vertex, coinfected participants with HCV genotype 1 who have not previously been treated for hepatitis C will be randomly assigned to receive telaprevir or a matching placebo in combination with 180 mcg once-weekly pegylated interferon and 800 mg twice-daily ribavirin. Telaprevir or placebo will be taken for 12 weeks, with pegylated interferon/ribavirin continuing through 48 weeks.

In Part A of the trial, all participants assigned to the telaprevir arm will receive 750 mg every 8 hours. Participants in this part must have been off antiretroviral therapy (ART) for the past 12 months, either because they do not yet need HIV treatment or because they have interrupted treatment. In Part B, participants assigned to receive telaprevir will take either 750 or 1125 mg every 8 hours; people in this part may be on ART.

Participants must have chronic HIV (infected more than 6 months), but no HIV viral load or CD4 cell count criteria are listed. They must also have received a liver biopsy within the preceding 12 months showing evidence of liver disease progression (inflammation or fibrosis).

The study will enroll 60 participants at 10 or more sites including Baltimore, Boston, Chicago, Dallas, Miami, New York, Orlando, and San Francisco. For more information about the trial, including a full list of study sites, see www.clinicaltrials.gov/ct2/show/NCT00983853. To enroll at any site, contact the Central Contact Center at 877-634-VRTX or medicalinfo@vrtx.com.

3/12/10

Source
ClinicalTrials.gov. Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV.