Original Article—Liver, Pancreas, and Biliary Tract

Journal of Gastroenterology

, Volume 46, Issue 11, pp 1335-1343

First online:

Efficacy of pegylated interferon plus ribavirin combination therapy for hepatitis C patients with normal ALT levels: a matched case–control study

  • Naoki HiramatsuAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine Email author 
  • , Yuko InoueAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
  • , Tsugiko OzeAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
  • , Nao KurashigeAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
  • , Takayuki YakushijinAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
  • , Kiyoshi MochizukiAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
  • , Takuya MiyagiAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
  • , Tomohide TatsumiAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
  • , Shinichi KisoAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
    • , Tatsuya KantoAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
    • , Akinori KasaharaAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
    • , Tetsuo TakeharaAffiliated withDepartment of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
    • , Masahide OshitaAffiliated withOsaka Police Hospital
    • , Eiji MitaAffiliated withNational Hospital Organization Osaka National Hospital
    • , Hideki HagiwaraAffiliated withKansai Rosai Hospital
    • , Yoshiaki InuiAffiliated withHyogo Prefectural Nishinomiya Hospital
    • , Kazuhiro KatayamaAffiliated withOsaka Medical Center for Cancer and Cardiovascular Diseases
    • , Shinji TamuraAffiliated withMinoh City Hospital
    • , Harumasa YoshiharaAffiliated withOsaka Rosai Hospital
    • , Yasuharu ImaiAffiliated withIkeda Municipal Hospital
    • , Norio HayashiAffiliated withKansai Rosai Hospital

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Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.

Keywords

Hepatitis C virus Normal alanine aminotransferase Pegylated interferon plus ribavirin combination therapy Propensity score method Matched case–control study