Telaprevir Therapy for 24 Weeks Appropriate for Many with HCV Infection

Response-guided treatment with telaprevir, peginterferon alfa-2a, and ribavirin for 24 weeks was noninferior to the standard 48-week course in patients with hepatitis C virus infection.


Recent FDA approval of telaprevir-based triple therapy for patients with hepatitis C virus (HCV) genotype 1infection was based on sustained virologic response (SVR) rates that were superior to those of peginterferon alfa-2a/ribavirin-only in phase III trials (JW Gastroenterol Jul 1 2011). Now, investigators have assessed whether a 24-week course of telaprevir therapy is noninferior to a 48-week course for treatment-naive patients with HCV genotype 1 infection and initial rapid virologic response (RVR).

In a multinational, industry-sponsored, randomized, phase III study, patients received 750 mg of telaprevir three times a day for the first 12 weeks plus 180 µg of peginterferon alfa-2a weekly and 1000 to 1200 mg of ribavirin daily for the full duration of therapy. Participants who achieved extended RVR (eRVR), defined as an undetectable HCV viral load at 4 and 12 weeks, were randomly assigned to either 24 or 48 total weeks of therapy. A difference of <10.5% in SVR constituted noninferiority.

Of the 540 patients enrolled, 65% had eRVR. Among those without eRVR, the SVR rate was 64%, whereas in patients with eRVR, the SVR rates were 92% in the 24-week group and 88% in the 48-week group (absolute difference, 4%; 95% confidence interval, –2%–11%), thus fulfilling the study's noninferiority criteria. Also, rates of serious adverse events were lower in the 24-week versus the 48-week group (2% vs. 10%; P=0.005), as were rates of discontinuation of all study drugs because of adverse events (1% vs. 12%; P<0.001).


Citation(s):

Sherman KE et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med 2011 Sep 15; 365:1014.