Abstract

Entecavir requires long-term administration. Pegylated interferon (PEG-IFN) therapy leads to significant reduction of hepatitis B surface antigen (HBs Ag) levels. This study aimed to assess the safety and efficacy of adding PEG-IFN-α-2a to entecavir toward cessation of entecavir. A total of 23 patients treated with entecavir underwent add-on PEG-IFN-α-2a therapy (90 μg per week) for 48 weeks. Viral response (VR) was defined as more than 50% reduction of baseline hepatitis B surface antigen (HBs Ag) level at 72 weeks from the start of therapy. Complete response (CR) was defined as the decline of HBs Ag levels <100 IU/mL. Hepatitis B e antigen (HBe Ag) seroconversion rate was 25% (2/8), and VR rate was 52% (12/23). CR was observed in four patients (17%). However, CR rate in baseline HBs Ag level <2000 IU/mL and HBe Ag negative patients was 50% (4/8). Univariate analysis showed that the percentage of HBs Ag level reduction at week 12 was significantly associated with VR. The area under the curve value was 0.848. Adding PEG-IFN-α-2a to entecavir has limited efficacy. The percentage reduction of HBs Ag level at week 12 may be a useful predictor for VR.

Highlights

  • The current standard treatment for patients with chronic hepatitis B (HB) is pegylated interferon alpha-2a (PEG-IFNα-2a) or nucleoside analogs (NAs)

  • No hepatitis B surface antigen (HBs Ag) disappearance was seen, Complete response (CR) was observed in 4 patients (17%), and all of them were Hepatitis B e antigen (HBe Ag) negative patients

  • Liaw et al reported that a dose of 180 μg Pegylated interferon (PEG-IFN)-α-2a was efficacious and beneficial for patients infected with Hepatitis B virus (HBV) genotype B or C compared with a dose of 90 μg dose [12]

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Summary

Introduction

The current standard treatment for patients with chronic hepatitis B (HB) is pegylated interferon alpha-2a (PEG-IFNα-2a) or nucleoside analogs (NAs). In Japan, entecavir has been approved by the national health insurance in 2006. At present, it is the most widely used first-line NA because of its low risk of resistant viruses compared with lamivudine [1]. Because relapse risk of severe hepatitis after discontinuation is high, long-term administration is needed [2,3,4]. There are some notable problems associated with long-term administration of entecavir such as increased risk of resistant viruses, safety concerns, teratogenicity, and high medical costs. The antiviral effect of interferon (IFN) is inferior to that of NAs, IFN activates antiviral immunity and can lower hepatitis B surface antigen (HBs Ag) level compared with entecavir [5]

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