Efficacy of 72-Week Treatment for Genotype 1 HCV-Positive Patients

Summary and Comment |
August 25, 2006

Efficacy of 72-Week Treatment for Genotype 1 HCV-Positive Patients

  1. Atif Zaman, MD, MPH

Overall, the SVR rate in genotype 1 HCV-positive patients did not improve with extended treatment.

  1. Atif Zaman, MD, MPH

Pegylated interferon plus ribavirin yields a sustained virologic response (SVR) in about 50% of patients with genotype 1 hepatitis C virus (HCV) infections. In a randomized prospective trial, German researchers evaluated whether extending treatment duration from 48 to 72 weeks would improve the SVR rate in 455 HCV-positive, treatment-naïve patients.

Subjects received weekly subcutaneous pegylated interferon-α-2a (180 μg) plus daily oral ribavirin (800 mg) for either 48 weeks or 72 weeks. Viral assays were performed at 4, 12, and 24 weeks and at the end of treatment to assess response. Patients without substantial drops (>log 2) in viral count at 24 weeks were considered to be nonresponders. Discontinuation rates were higher in the 72-week group than in the 48-week group — 41% versus 24%.

SVR was achieved in 54% of patients who received 72-week therapy and in 53% of those who received 48-week therapy. Patients with undetectable viral loads at weeks 4 and 12 had an excellent SVR rate regardless of treatment duration. However, patients with detectable viral loads, especially if counts were <6000 IU/mL, benefited from a longer duration of therapy: In these patients, SVR occurred in 29% of the 72-week group versus 17% of the 48-week group (P=0.04).

Comment

In this study, researchers demonstrated that SVR rates in genotype 1 HCV-positive patients generally do not improve with extended treatment duration, although a certain subgroup of patients with initial slow responses to therapy might benefit from extended treatment. However, use of a fixed dose of ribavirin, high discontinuation rates in the 72-week group, and findings based on subgroup analysis should temper enthusiasm for extended treatment until additional studies are completed.

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