In a recent issue of HEPATOLOGY, Kamal et al.1 reported the results of a randomized, controlled trial for 368 patients with chronic hepatitis C virus (HCV) genotype 4 infection treated with peginterferon alpha-2b (1.5 μg/kg/week) plus ribavirin (10.6 mg/kg/day) for a fixed duration of 48 weeks (control group, n = 50) or for a variable duration according to on-treatment virological response (n = 318). In the variable-duration group, patients with rapid virological response (undetectable HCV RNA at week 4 of therapy) were treated for 24 weeks (group A, n = 69), patients with complete early virological response (undetectable HCV RNA at week 12) were treated for 36 weeks (group B, n = 79), and patients with partial early virological response (HCV RNA–seropositive with a minimum 2-log10 decrease from the baseline in HCV RNA at week 12) were treated for 48 weeks (group C, n = 160). The remaining 10 patients who did not achieve undetectable HCV RNA or a 2-log10decline from the baseline of HCV RNA at week 12 were classified as nonresponders and discontinued treatment. “Similar to previous studies on HCV-12, 3 and HCV-2/3,4–6 the present study1 strongly suggested that RVR at week 4 could be a signpost of decision-making for shorter treatment duration of peginterferon/ribavirin without compromising the treatment efficacy. Although the conclusions appear to be justified by the presented data, some issues should be clarified. First, the variable-duration group excluded 10 nonresponders from the final analysis, but the fixed-duration controls included 16 nonresponders for the final analysis. It would be inappropriate to make a noninferiority comparison of the two groups in such a situation because only 3 of 14 (21.4%) nonresponders in the fixed 48-week group achieved a sustained virological response. After the exclusion of 16 nonresponders, the sustained virological response rate in the fixed-duration group would be 79.4% (27/34) instead of 58%. Second, the variable-duration group had a significantly higher proportion of patients achieving partial early virological response (50.3%, 160/318 versus 22%, 11/50, P < 0.0001) and a significantly lower proportion of nonresponders (3.1%, 10/318 versus 32%, 16/50, P < 0.0001) than the fixed-duration group. It would be better for the authors to provide more data in detail to clarify the difference and discuss the results before addressing the conclusions.
To the Editor:
Ming-Lung Yu* , Chia-Yen Dai* , Jee-Fu Huang* , Ming-Yen Hsieh*, Wan-Long Chuang* , * Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan, Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan, Department of Internal Medicine, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung, Taiwan.