Pegylated interferon-alpha-2a plus ribavirin for treatment-naive Asian patients with hepatitis C virus genotype 1 infection: a multicenter, randomized controlled trial

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Clin Infect Dis. 2008 Nov 15;47(10):1260-9.

Pegylated interferon-alpha-2a plus ribavirin for treatment-naive Asian patients

with hepatitis C virus genotype 1 infection: a multicenter, randomized

controlled trial.

Liu CH, Liu CJ, Lin CL, Liang CC, Hsu SJ, Yang SS, Hsu CS, Tseng TC, Wang CC,

Lai MY, Chen JH, Chen PJ, Chen DS, Kao JH.

Department of Internal Medicine, National Taiwan University Hospital, Taipei,

Taiwan.

BACKGROUND: Comparable sustained virologic response (SVR) rates have been

documented between Asian patients who received 24 weeks of pegylated interferon

(IFN) plus ribavirin and white patients who received 48 weeks of combination

therapy for hepatitis C virus genotype 1 (HCV-1) infection. Whether a 48-week

course of combination therapy shows a better SVR rate than a 24-week course of

such therapy among Asian patients with HCV-1 infection has not been confirmed in

multicenter, randomized studies. METHODS: In this multicenter, randomized trial,

308 treatment-naive HCV-1-infected Asian patients were randomly assigned to

receive either 24 or 48 weeks of pegylated IFN-alpha-2a (180 microg per week)

plus ribavirin (1000-1200 mg/day) therapy. The primary end point was SVR,

defined as an undetectable serum HCV RNA level 24 weeks after discontinuation of

therapy. In addition, rapid virologic response (RVR) was defined as an

undetectable serum HCV RNA level at week 4 of therapy, and complete early

virologic response was defined as an undetectable serum HCV RNA level at 12

weeks of therapy in the absence of RVR. RESULTS: By intention-to-treat analysis,

patients who received 48 weeks of therapy had a significantly higher SVR rate

than did those who received 24 weeks of therapy (76% vs. 56%; P < .001). Among

patients with a baseline serum HCV RNA level