Efficacy of pegylated interferon plus ribavirin combination therapy for hepatitis C patients with normal ALT levels: a matched case–control study
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The antiviral effect of pegylated interferon (Peg-IFN) plus ribavirin combination therapy in chronic hepatitis C (CHC) patients with normal alanine aminotransferase (ALT) levels (N-ALT) has been reported to be equivalent to that for patients with elevated ALT levels (E-ALT). However, the actual antiviral effect in N-ALT patients remains obscure because efficacy can be overestimated in patients with an advantageous background.
In this study, 386 patients were extracted, for a matched case–control study, from 1320 CHC patients treated with Peg-IFN alpha-2b plus ribavirin combination therapy; 193 N-ALT patients [116 with hepatitis C virus genotype 1 (HCV-1), 77 with HCV genotype 2 (HCV-2)] were matched with 193 E-ALT patients by a propensity score method using the variables of age, sex, IFN treatment history, body mass index, and platelet counts.
On multivariate analysis for sustained virological response (SVR) in N-ALT patients, younger age, low HCV RNA level at baseline, and HCV-2 were significant factors. The matched case–control study showed that the SVR rates of N-ALT patients were equivalent to those of E-ALT patients; at 49 and 40% in the HCV-1 group (P = 0.146), and 78 and 81% in the HCV-2 group (P = 0.691). However, in N-ALT patients with non-SVR, approximately 40% showed ALT elevation at 24 weeks post-treatment.
Our findings indicate that the antiviral effect of Peg-IFN plus ribavirin therapy in N-ALT patients is comparable to that for E-ALT patients irrespective of their advantageous background; however, the application of this therapy for N-ALT patients, especially for those with HCV-1, should be considered carefully.
KeywordsHepatitis C virus Normal alanine aminotransferase Pegylated interferon plus ribavirin combination therapy Propensity score method Matched case–control study
Other institutions and participants in the Osaka Liver Forum are: Higashi Osaka General Hospital, S. Iio; Sumitomo Hospital, A. Yamada; Osaka General Medical Center, A. Inoue; Toyonaka Municipal Hospital, M. Inada; National Hospital Organization Osaka Minami Medical Center, T. Hijioka; Yao Municipal Hospital, H. Fukui; Kinki Central Hospital of Mutual Aid Association of Public School Teachers, E. Hayashi; Osaka Koseinenkin Hospital, T. Ito; Itami City Hospital, T. Kashihara; Suita Municipal Hospital, T. Nagase; Ashiya Municipal Hospital, K. Kiriyama; Saiseikai Senri Hospital, K. Suzuki; NTT West Osaka Hospital, A. Kaneko; National Hospital Organization Minami Wakayama Medical Center, M. Kato; Otemae Hospital, Y. Doi; Kano General Hospital, S. Kubota; Nishinomiya Municipal Central Hospital, H. Ogawa; and Osaka Kaisei Hospital, N. Imaizumi. This work was supported by a Grant-in-Aid for Research on Hepatitis and BSE from the Ministry of Health, Labour and Welfare of Japan, and Scientific Research from the Ministry of Education, Science, and Culture of Japan. All authors have no financial relationship relevant to this study to disclose.
Conflict of interest
The authors declare that they have no conflict of interest.
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