Weight-based high- and low-dose ribavirin in combination with peginterferon α-2b therapy for genotype 2 chronic hepatitis C: A randomized trial
Article first published online: 16 DEC 2011
© 2011 The Japan Society of Hepatology
Volume 42, Issue 4, pages 351–358, April 2012
How to Cite
Kagawa, T., Kojima, S.-i., Shiraishi, K., Takashimizu, S., Nagata, N., Shiozawa, H., Nishizaki, Y., Ikeda, A., Tei, Y., Atsukawa, K., Kamochi, J.-i., Wasada, M., Numata, M., Arase, Y., Hirose, S., Yamada, T., Hata, Y., Watanabe, N., Morizane, T. and Mine, T. (2012), Weight-based high- and low-dose ribavirin in combination with peginterferon α-2b therapy for genotype 2 chronic hepatitis C: A randomized trial. Hepatology Research, 42: 351–358. doi: 10.1111/j.1872-034X.2011.00944.x
- Issue published online: 23 MAR 2012
- Article first published online: 16 DEC 2011
- Received 11 October 2011; revision 2 November 2011; accepted 9 November 2011.
- chronic hepatitis C;
- genotype 2;
- randomized trial;
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.