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Peginterferon plus Ribavirin for 16 or 24 Weeks for Genotype 2 or 3 HCV Infections

Not all patients do well with a shorter treatment regimen.

Standard treatment for patients with genotype 2 or 3 hepatitis C virus (HCV) infections is 24 weeks of pegylated interferon (peginterferon) plus daily ribavirin (800 mg). However, small studies recently have suggested that shorter treatment durations of 12 to 16 weeks could provide comparable sustained virologic response (SVR) rates (e.g., Journal Watch Gastroenterology Jul 26 2005).

In this large industry-supported noninferiority study, SVR rates were compared among 1469 genotype 2 or 3 HCV-positive adults who were randomized to standard or shortened regimens. Patients without coinfections, major psychiatric illnesses, or other major comorbid diseases were recruited from 132 centers worldwide and were stratified by genotype and country of origin. The primary study hypothesis was that 16-week treatment would yield SVR rates similar to those with 24-week treatment, as defined by a noninferiority margin of 6%.

The SVR rate with 16-week therapy was significantly lower than the rate with 24-week therapy (62% vs. 70%; P<0.001). Although discontinuation rates were lower in the 16-week arm, relapse rates (by 24 weeks after treatment ended) were significantly higher in that arm than in the 24-week arm (31% vs. 18%), which led to the lower SVR rate. However, in patients with baseline viral loads <400,000 IU/mL, SVR rates were similar (about 81%) in the two arms. Furthermore, in patients who had undetectable viral loads by week 4 of therapy, SVR rates were high in both arms — 79% in the 16-week arm and 85% in the 24-week arm.

Comment: These findings demonstrate that, overall, 16 weeks of peginterferon plus ribavirin is inferior to 24 weeks of therapy in patients with genotype 2 or 3 HCV infections. Post hoc analysis revealed that, in patients with favorable prognostic variables such as low baseline viral loads and rapid virologic responses, SVR rates with 16 weeks of therapy might be similar to those with longer therapy; therefore, in certain genotype 2 and 3 patients who do not tolerate interferon therapy well, therapy reasonably might be stopped after 16 weeks. However, additional studies of this approach are necessary.

— Atif Zaman, MD, MPH

Published in Journal Watch Gastroenterology July 11, 2007

Citation(s):

Shiffman ML et al. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med 2007 Jul 12; 357:124-34.

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• Medline abstract (Free)

Liang TJ. Shortened therapy for hepatitis C virus genotype 2 or 3 — Is less more? N Engl J Med 2007 Jul 12; 357:176-8.

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• Medline abstract (Free)