Journal of Hepatology
Volume 49, Issue 2 , Pages 163-169, August 2008

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

  • Eric Lawitz

      Affiliations

    • Alamo Medical Research, 621 Camden Suite 202, San Antonio, TX 78215, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 210 253 3426; fax: +1 210 227 6951.
    • Contributed equally to the study.
    • ,
  • Maribel Rodriguez-Torres

      Affiliations

    • Fundacion de Investigacion de Diego San Juan, Puerto Rico, NC, USA
    • Contributed equally to the study.
    • ,
  • Andrew J. Muir

      Affiliations

    • Duke Clinical Research Institute, Division of Gastroenterology, Duke University, Durham, NC, USA
    • ,
  • Tara L. Kieffer

      Affiliations

    • Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA
    • ,
  • Lindsay McNair

      Affiliations

    • Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA
    • ,
  • Ariya Khunvichai

      Affiliations

    • Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA
    • ,
  • John G. McHutchison

      Affiliations

    • Duke Clinical Research Institute, Division of Gastroenterology, Duke University, Durham, NC, USA

Received 25 August 2007; received in revised form 23 February 2008; accepted 13 March 2008. published online 29 April 2008.

Associate Editor: M.P. Manns

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-naı¨ve patients with chronic genotype 1 hepatitis C virus infection received telaprevir (750mg q8h), peginterferon alfa-2a (180μg/week), and ribavirin (1000 or 1200mg/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.

Abbreviations: SVR, sustained viral response, RVR, rapid viral response, LOD, limit of detection

Keywords: Combination therapy, Hepatitis C therapy, Telaprevir

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☆ This study was supported by Vertex Pharmaceuticals Incorporated. The authors who have taken part in the research of this paper declared that they have a relationship with the manufacturers of the drugs involved either in the past or present and that they received funding from the manufacturers to carry out their research. Drs. Kieffer, McNair and Khunvichai are employees of Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA.

PII: S0168-8278(08)00281-X

doi:10.1016/j.jhep.2008.03.027

Journal of Hepatology
Volume 49, Issue 2 , Pages 163-169, August 2008

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