The Korean Joumal of Peginterferon alfa-2a/ribavirin for 48 or 72 weeks in hepatitis C genotype 1 and 4 patients with slow virologic response

doi:2010.16.2.201

Korean J Hepatol > Volume 16(2); 2010 > Article

The Korean Journal of Hepatology 2010;16(2): 201-205.
doi: https://doi.org/10.3350/kjhep.2010.16.2.201

The Korean Joumal of Peginterferon alfa-2a/ribavirin for 48 or 72 weeks in hepatitis C genotype 1 and 4 patients with slow virologic response

In Hee Kim, M.D.

Department of Internal Medicine, The Research Institute for Medical Science, Chonbuk National University Medical School, Jeonju, Korea

ABSTRACT

Background/Aims
This randomized multicenter trial evaluated individualization of treatment duration with peginterferon alfa-2a 180 microg/wk plus ribavirin 1,000/1,200 mg/day in patients with chronic hepatitis C genotype 1/4 based on the rapidity of virologic response (VR). Methods: Patients with arapid VR (RVR, undetectable hepatitis C virus [HCV]-RNA level (<50 IU/ml at week 4) were treated for 24 weeks, those with an early VR (EVR, no RVR but undetectable HCV-RNA level or >or= 2-log(10) decrease at week 12) were randomized to 48 (group A) or 72 weeks of treatment (group B, peginterferon alfa-2a was reduced to 135 microg/wkafter week 48). Patients without an EVR continued treatment until week 72 if they had undetectable HCV-RNA levels at week 24. The primary end point was relapse, sustained VR (SVR, undetectable HCV-RNA level after 24 weeks of follow-up evaluation) was a secondary end point. Results: Of 551 genotype 1/4 patients starting treatment, 289 were randomized to group A (N=139) or group B(N=150). The relapse rate was 33.6% in group A(95% confidence interval [CI], 24.8%-43.4%) and 18.5% in group B (95% CI, 11.9%-27.6%, P=0.0115 vs group A) and the SVR rate was 51.1% (95% CI,42.5%-59.6%) and 58.6% (95% CI, 50.3%-66.6%, P>0.1), respectively. The overall SVR rate was 50.4% (278 of 551, 95% CI, 46.2%-54.7%), including 115 of 150 patients with an RVR treated for 24 weeks and 4 of 78 patients without an EVR. Conclusions: Extending therapy with peginterferon alfa-2a/ribavirin to 72 weeks decreases the probability of relapse in patients with an EVR. If they can be maintained on extended-duration therapy, SVR rates also may improve.

KeyWords: Hepatitis C virus; Peginterferon; Ribavirin; Slow virologic response