Abstract

BackgroundStudies are limited on pegylated interferon (Peg-IFN) therapy for chronic hepatitis B (CHB) patients who failed or relapsed on previous antiviral therapy.ObjectivesWe aimed to investigate the effect of Peg-IFN therapy in treatment-experienced CHB patients.Study DesignA total of 57 treatment-experienced CHB patients at two medical centers were enrolled. All of the patients were treated with Peg-IFN α-2a at 180 μg weekly for 24 or 48 weeks. The hepatitis B serological markers and viral loads were tested every 3 months until 1 year after stopping Peg-IFN therapy. The endpoints were HBV DNA <2000IU/mL, hepatitis B e antigen (HBeAg) seroconversion, and a hepatitis B surface antigen (HBsAg) loss at 12 months post-treatment.ResultsIn HBeAg-positive patients, 25.0%, 29.2%, and 12.5% of the patients achieved HBeAg seroconversion, HBV DNA <2000 IU/mL and a combined response, respectively, at 12 months post-treatment. Prior IFN therapy, a high baseline ALT level, a low creatinine level, undetectable HBV DNA at 12 weeks and a decline in HBV DNA >2 log10 IU/mL at 12 weeks of therapy were factors associated with treatment response. In HBeAg-negative patients, 9.1%, 15.2%, and 6.1% of the patients achieved undetectable HBV DNA, HBV DNA <2000 IU/mL, and an HBsAg loss, respectively, at 12 months post-treatment. No factor was significantly associated with the treatment response in the HBeAg-negative patients. The median HBsAg level declined from 3.4 to 2.6 log10 IU/mL in all the patients, and the 5-year cumulative rate of the HBsAg loss was 9.8% in the HBeAg-negative patients. Overall, none of the patients prematurely discontinued the Peg-IFN therapy.ConclusionsPeg-IFN re-treatment is effective for a proportion of HBeAg-positive treatment-experienced patients; it has limited efficacy for HBeAg-negative treatment-experienced patients. Peg-IFN might facilitate HBsAg loss in HBeAg-negative treatment-experienced patients.

Highlights

  • Chronic hepatitis B (CHB) is a global health problem, with an estimated 350 million people being chronically infected.[1]

  • Studies are limited on pegylated interferon (Peg-IFN) therapy for chronic hepatitis B (CHB) patients who failed or relapsed on previous antiviral therapy

  • We aimed to investigate the effect of Peg-IFN therapy in treatment-experienced CHB patients

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Summary

Introduction

Chronic hepatitis B (CHB) is a global health problem, with an estimated 350 million people being chronically infected.[1]. For Hepatitis B e antigen (HBeAg)-positive patients, one year of Peg-IFN therapy achieved a 22–27% HBeAg seroconversion rate at the end of treatment, which increased to 35% 1–2 years after stopping treatment.[7] For HBeAg-negative patients, one year of Peg-IFN therapy achieved a 63% undetectable HBV DNA rate; the rate rapidly dropped to 15% at 1 year after stopping treatment.[8] NUC therapy has the advantage of having a potent antiviral effect, poor durability of the effectiveness after stopping NUC therapy is encountered in the majority of patients. [9] One-year and 3-year relapse rates of 44% and 52%, respectively, were reported in HBeAgnegative patients after lamivudine therapy was stopped.[10] Another recent study investigating the off-therapy durability of ETV in HBeAg-negative CHB patients showed that 45.3% of the 95 patients had a clinical relapse within 1-year after stopping ETV therapy.[11]. Studies are limited on pegylated interferon (Peg-IFN) therapy for chronic hepatitis B (CHB) patients who failed or relapsed on previous antiviral therapy

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