Pegylated Interferon-á-2a plus Ribavirin for Treatment-Naive Asian Patients with Hepatitis C Virus Genotype 1 Infection: A Multicenter, Randomized Controlled Trial

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http://www.journals.uchicago.edu/doi/abs/10.1086/592579

Clinical Infectious Diseases 2008;47:1260-1269

1058-4838/2008/4710-0003$15.00

DOI: 10.1086/592579

MAJOR ARTICLE

Pegylated Interferon-á-2a plus Ribavirin for Treatment-Naive Asian Patients with

Hepatitis C Virus Genotype 1 Infection: A Multicenter, Randomized Controlled

Trial

Chen-Hua Liu,1

Chun-Jen Liu,1

Chih-Lin Lin,4

Cheng-Chao Liang,5

Shih-Jer Hsu,7

Sheng-Shun Yang,9

Ching-Sheng Hsu,6

Tai-Chung Tseng,6

Chia-Chi Wang,6

Ming-Yang Lai,1,2,3

Jun-Herng Chen,8

Pei-Jer Chen,1,2,3

Ding-Shinn Chen,1,3 and

Jia-Horng Kao1,2,3

Departments of 1Internal Medicine and 2Medical Research and 3Hepatitis Research

Center, National Taiwan University Hospital, 4Department of Internal Medicine,

Taipei Municipal Hospital, Ren-Ai Branch, 5Department of Internal Medicine, Far

Eastern Memorial Hospital, and 6Department of Internal Medicine, Buddhist Tzu

Chi General Hospital, Taipei Branch, Taipei, Departments of 7Internal Medicine

and 8Pathology, National Taiwan University Hospital, Yun-Lin Branch, Douliou,

and 9Department of Internal Medicine, Taichung Veterans General Hospital,

Taichung, 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-á-2a (180 ìg 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%; ). Among patients with a baseline serum HCV RNA level