Game Changers in Gastroenterology: 2011

David A. Johnson, MD


November 23, 2011

In This Article

Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection

Jacobson IM, McHutchison JG, Dusheiko G, et al.
N Engl J Med. 2011;364:2405-2416.

This international, phase 3, double-blind, placebo-controlled trial included 1088 patients with hepatitis C virus (HCV) genotype 1 infection who were naive for previous treatment. Patients were randomly assigned to 1 of 3 groups:

  • Telaprevir combined with peginterferon alfa-2a and ribavirin for 12 weeks (T12PR group), followed by peginterferon-ribavirin alone for 12 weeks if HCV RNA was undetectable at weeks 4 and 12 or for 36 weeks if HCV RNA was detectable at either time point;

  • Telaprevir with peginterferon-ribavirin for 8 weeks and placebo with peginterferon-ribavirin for 4 weeks (T8PR group), followed by 12 or 36 weeks of peginterferon-ribavirin on the basis of the same HCV RNA criteria; or

  • Placebo with peginterferon-ribavirin for 12 weeks, followed by 36 weeks of peginterferon-ribavirin (PR group).

Telaprevir (a protease inhibitor) when combined with peginterferon-ribavirin, compared with peginterferon-ribavirin alone, was associated with significantly improved rates of sustained virologic response in patients with naive HCV genotype 1 infection, with only 24 weeks of therapy.

Why Is This a Game Changer?

This new treatment approach is a major paradigm shift for curative treatment for hepatitis C.


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