Entecavir and peginterferon alfa‐2a in adults with HBeAg‐positive immune tolerant chronic hepatitis B virus infection

Abstract

Background/Aim

Monotherapy with interferon or nucleoside analog is generally not recommended during the immune tolerant (IT) phase of chronic hepatitis B virus (HBV) infection. Recognition that high HBV DNA levels are associated with hepatocellular carcinoma has increased interest in treating HBV in the IT phase. Small pediatric studies reported efficacy with combination nucleoside analog and interferon therapy.

Aim

To evaluate the safety and efficacy of the combination of entecavir and peginterferon in adults in the IT phase of chronic HBV infection.

Methods

HBeAg‐positive adults with HBV DNA>107 IU/mL and ALT≤1.5x ULN: (M≤45, F≤30 U/L) received entecavir 0.5 mg daily for 8 weeks followed by addition of peginterferon alfa‐2a 180 μg/week to entecavir for an additional 40 weeks. The primary endpoint was HBeAg loss and HBV DNA≤1000 IU/mL 48 weeks post‐end‐of‐treatment (EOT).

Results

Among 28 participants from 11 sites, median age was 37.2 (range 22‐61) years, 54% were male and 96% were Asian. Nearly all were infected with genotype C (64%) or B (32%). Median baseline HBV DNA was 8.2 log10 IU/mL and ALT 0.9xULN. While one (4%) participant cleared HBeAg, none met the primary endpoint of both HBeAg loss AND HBV DNA ≤1,000 IU/mL 48 weeks post‐EOT. ALT elevations >5xULN occurred in 8 (29%) participants, none associated with icterus. 48 weeks post‐treatment, HBV DNA rebounded to baseline levels in all participants including the participant who lost HBeAg, and ALT values returned to near‐baseline levels in all but 4 participants.

Conclusion

A lead‐in strategy of 8 weeks of entecavir followed by combination peginterferon and entecavir therapy for 40 weeks had limited efficacy in adults in the IT phase of chronic HBV infection and cannot be recommended.

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