Abstract

Patients with low hepatitis B surface antigen (HBsAg) levels and hepatitis B virus (HBV) DNA suppression by nucleos(t)ide analogues (NAs) achieve high rate of HBsAg loss through switching to PegIFNα in pre-registration study. The aim of this study was to achieve higher rate of HBsAg loss through extended PegIFN treatment. 98 patients with HBsAg < 2,000 IU/ml and HBV DNA < 20 IU/ml were randomized to receive PegIFNα-2b or continuing NA therapy for 60 weeks. At the end of treatment (EOT) and end of follow-up (EOF), only patients who switched to PegIFNα-2b achieved HBsAg loss (32.6%) and HBsAg seroconversion (27.9% and 25.6%). Patients who switched to PegIFNα-2b also achieved higher HBeAg seroconversion rates (65.1%) and HBeAg loss (81.4% and 90.7%) than those who continued NAs treatment. On-treatment HBsAg declines predicted the responses at EOT, and HBsAg declines at post-baseline times predicted the responses at EOF. The rates of responses were not increased through extended PegIFNα treatment. For patients with low HBsAg and HBV suppression with NAs, switching to PegIFNα-2b significantly increased the rates of HBsAg loss and HBsAg seroconversion. HBsAg decline can predict the response of switching to PegIFNα-2b following from NAs.

Highlights

  • Safe and effective prophylactic vaccines have been available for the past 30 years, hepatitis B virus (HBV) infection remains an important public health problem and is the leading cause of chronic hepatitis B (CHB), cirrhosis and hepatocellular carcinoma (HCC) worldwide[1]

  • The results showed that patients achieved virological suppression with ETV and that switching to a finite course of PegIFNalfa-2a significantly increased the rates of hepatitis B e antigen (HBeAg) seroconversion and hepatitis B surface antigen (HBsAg) loss

  • The matched-pair set consisted of 47 patients treated with PegIFN alfa-2b therapy and 47 patients treated with nucleos(t)ide analogues (NAs) monotherapy

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Summary

Introduction

Safe and effective prophylactic vaccines have been available for the past 30 years, hepatitis B virus (HBV) infection remains an important public health problem and is the leading cause of chronic hepatitis B (CHB), cirrhosis and hepatocellular carcinoma (HCC) worldwide[1]. The combination of HBeAg loss and HBsAg < 1,500 IU/ml at the time of switching was associated with high rates of HBeAg seroconversion (33.3%) and HBsAg loss (22.2%) following PegIFN alfa-2a therapy. The extension of PegIFN treatment was not performed, longer treatment durations may lead to higher rates of HBsAg loss. These previous studies did not feature long-term follow-up after the cessation of the treatment or comparison with NA treatment alone. The aim of the current study was to prospectively evaluate whether the extension of switching to PegIFN from a stable NA regimen leads to a high loss of HBsAg in CHB patients with HBsAg < 2,000 IU/ml and HBV DNA < 20 IU/ml by nucleos(t)ide analogues

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