Antiviral effects and safety of telaprevir, peginterferon alfa-2a, and ribavirin for 28 days in hepatitis C patients.

Journal Article (Clinical Trial;Journal Article)

BACKGROUND/AIMS: This study assessed the safety and antiviral effects of telaprevir (VX-950) in combination with peginterferon alfa-2a and ribavirin. METHODS: Twelve treatment-naïve patients with chronic genotype 1 hepatitis C virus infection received telaprevir (750 mg q8h), peginterferon alfa-2a (180 microg/week), and ribavirin (1000 or 1200 mg/day) for 28 days. Patients could then start off-study treatment with peginterferon alfa-2a and ribavirin for up to 44 weeks, at the discretion of the investigator and patient. RESULTS: The combination of telaprevir, peginterferon alfa-2a, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. Rash or pruritus occurred in 5 of the 12 patients; all cases resolved either during or after the end of telaprevir treatment. All 12 patients had undetectable HCV RNA levels by day 28 (rapid viral response, RVR). Eight patients completed 44 weeks of off-study peginterferon alfa-2a and ribavirin treatment. Eight patients achieved a sustained viral response (SVR), including one patient who received only 22 weeks of treatment. CONCLUSIONS: The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR.

Full Text

Duke Authors

Cited Authors

  • Lawitz, E; Rodriguez-Torres, M; Muir, AJ; Kieffer, TL; McNair, L; Khunvichai, A; McHutchison, JG

Published Date

  • August 2008

Published In

Volume / Issue

  • 49 / 2

Start / End Page

  • 163 - 169

PubMed ID

  • 18486984

International Standard Serial Number (ISSN)

  • 0168-8278

Digital Object Identifier (DOI)

  • 10.1016/j.jhep.2008.03.027


  • eng

Conference Location

  • Netherlands