Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic hepatitis C: Some issues

Authors

  • Ming-Lung Yu,

    1. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
    2. Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
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  • Chia-Yen Dai,

    1. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
    2. Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
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  • Jee-Fu Huang,

    1. Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
    2. Department of Internal Medicine, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung, Taiwan
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  • Ming-Yen Hsieh,

    1. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
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  • Wan-Long Chuang

    1. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
    2. Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
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  • Potential conflict of interest: Nothing to report.

Pegylated Interferon Alpha-2b Plus Ribavirin in Patients with Genotype 4 Chronic Hepatitis C: Some Issues

To the Editor:

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.

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.

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