Peginterferon plus weight-based ribavirin for treatment-naïve hepatitis C virus genotype 2 patients not achieving rapid virologic response: a randomized trial

Chen-Hua Liu, Chung-Feng Huang, Chun-Jen Liu, Chia-Yen Dai, Jee-Fu Huang, Jou-Wei Lin, Cheng-Chao Liang, Sheng-Shun Yang, Chih-Lin Lin, Tung-Hung Su, Hung-Chih Yang, Pei-Jer Chen, Ding-Shinn Chen, Wan-Long Chuang, Jia-Horng Kao, Ming-Lung Yu, Chen-Hua Liu, Chung-Feng Huang, Chun-Jen Liu, Chia-Yen Dai, Jee-Fu Huang, Jou-Wei Lin, Cheng-Chao Liang, Sheng-Shun Yang, Chih-Lin Lin, Tung-Hung Su, Hung-Chih Yang, Pei-Jer Chen, Ding-Shinn Chen, Wan-Long Chuang, Jia-Horng Kao, Ming-Lung Yu

Abstract

Hepatitis C virus genotype 2 (HCV-2) slow responders poorly respond to 24 weeks of peginterferon (Peg-IFN) plus ribavirin (RBV). We evaluated the efficacy of extended 48-week regimen and the role of interleukin-28B (IL-28B) genotype in this clinical setting. Treatment-naïve HCV-2 patients not achieving rapid virologic response (RVR) by Peg-IFN alfa-2a 180 μg/week plus weight-based RBV (1,000-1,200 mg/day, cutoff body weight of 75 kg) were randomly assigned to receive a total duration of 48 (n = 94) or 24 (n = 93) weeks of therapy. The primary endpoint was sustained virologic response (SVR). Baseline patient characteristics to predict SVR were analyzed. Patients receiving 48 weeks of treatment had a greater SVR rate than those receiving 24 weeks of treatment (70.2% versus 46.2%, P = 0.001). Compared to patients treated for 24 weeks, the SVR rate in those treated for 48 weeks increased by 10.9% [95% CI: -5.9% to 27.7%] and 65.6% [95% CI: 44.5% to 86.7%] if they had IL-28B rs8099917 TT genotype, and GT/GG genotype, respectively (interaction P = 0.002). In conclusion, 48-week treatment with Peg-IFN plus weight-based RBV provides a greater SVR rate than 24-week treatment in treatment-naïve HCV-2 patients with unfavorable IL-28B genotypes who fail to achieve RVR.

Trial registration: ClinicalTrials.gov NCT00532701.

Conflict of interest statement

Chen-Hua Liu: consultant for Abbott, Abbvie, Bristol-Myers Squibb, Roche; on speaker’s bureau for Abbott, Roche, Bristol-Myer Squibb, GlaxoSmithKline, Novartis. Jia-Horng Kao: consultant for Abbott, Abbvie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche; on speaker’s bureau for Abbott, Abbvie, Roche, Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Novartis; Ding-Shinn Chen: consultant for Novartis and GlaxoSmithKline; Pei-Jer Chen: consultant for Novartis and Roche; Ming-Lung Yu and Wan-Long Chuang: consultants for Merck Sharp & Dohme Abbott and Abbvie; grants support from Abbott and Roche; on speaker’s bureau from Bristol-Myers Squibb, Roche, Merck Sharp & Dohme, GlaxoSmithKline, Novartis, and Gilead Sciences. All other authors declare no competing interests.

Figures

Figure 1. Study Flow Diagram. Peg-IFN: peginterferon,…
Figure 1. Study Flow Diagram. Peg-IFN: peginterferon, RBV: ribavirin; RVR: rapid virologic response, AE: adverse event.
Figure 2. Study Design. Peg-IFN: peginterferon, RBV:…
Figure 2. Study Design. Peg-IFN: peginterferon, RBV: ribavirin; RVR: rapid virologic response, ETV: early virologic response, ETVR: end-of-treatment virologic response, SVR: sustained virologic response, SD: weight-based dosing, W: week.

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Source: PubMed

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