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Weight‐based high‐ and low‐dose ribavirin in combination with peginterferon α‐2b therapy for genotype 2 chronic hepatitis C: A randomized trial
Author(s) -
Kagawa Tatehiro,
Kojima Seiichiro,
Shiraishi Koichi,
Takashimizu Shinji,
Nagata Naruhiko,
Shiozawa Hirokazu,
Nishizaki Yasuhiro,
Ikeda Akihiko,
Tei Yoshihiro,
Atsukawa Kazuhiro,
Kamochi Junichiro,
Wasada Mitsuru,
Numata Makoto,
Arase Yoshitaka,
Hirose Shunji,
Yamada Takuji,
Hata Yasuo,
Watanabe Norihito,
Morizane Toshio,
Mine Tetsuya
Publication year - 2012
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/j.1872-034x.2011.00944.x
Subject(s) - ribavirin , medicine , tolerability , gastroenterology , randomized controlled trial , anemia , confidence interval , dose , odds ratio , combination therapy , hepatitis c virus , adverse effect , immunology , virus
Aim: The optimal ribavirin dose in the treatment of patients infected with hepatitis C virus (HCV) genotype 2 remains to be elucidated. We aimed to seek the optimal ribavirin dose required for this genotype in a randomized trial. Methods: We compared the efficacy and tolerability of the 24‐week peginterferon α‐2b (1.5 µg/kg/week) therapy in combination with a weight‐based higher dose (600–1000 mg) and lower dose (400–800 mg) of ribavirin for genotype 2 patients. Noninferior margin was set at 10%. Results: A total of 120 patients were randomized to a higher‐dose or a lower‐dose group. Sustained virological response (SVR) by intention‐to‐treat analysis was achieved in 47/58 (81.0%, 90% confidential interval [CI]: 72.6–89.5) patients in the higher‐dose group and 41/60 (68.3%, 90% CI: 58.5–78.2) patients in the lower‐dose group (difference, −12.7%; 90% CI, −25.7 to 0.3). Relapse rates were 10% and 21.6% in the higher‐dose and the lower‐dose groups, respectively. Multiple logistic regression analysis showed that ribavirin dose/kg body weight was the only significant predictor of SVR (≥9.5 mg/kg per day vs <9.5 mg/kg per day; odds ratio = 3.34; 95% CI, 1.41–7.92; P = 0.006). Twenty‐one (36.2%) in the higher‐dose group required ribavirin dose reduction because of anemia, whereas seven patients (11.7%) did in the lower‐dose group ( P < 0.01). Three of the higher‐dose group and two of the lower‐dose group required premature termination of therapy. Conclusions: Weight‐based lower‐dose ribavirin regimen was not equivalent to the higher‐dose counterpart in the treatment of HCV genotype 2. We discourage treating these patients with low‐dose ribavirin regimens. The peginterferon therapy in combination with ribavirin at a weight‐based higher dose (600–1000 mg) remains the standard‐of‐care treatment for this genotype.