Liver and Bile
Clin Gastroenterol Hepatol. 2022;20(12):2800–8
Entecavir prevents HBV reactivation during direct-acting antivirals for HCV/HBV dual infection: A randomized trial
Background and aims: A strategy to prevent hepatitis B virus reactivation (HBVr) and clinical reactivation during direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV)/HBV dual infection remains an unresolved issue.
Methods: Non-cirrhotic patients with dual HCV/HBV infection were enrolled and allocated randomly to 1 of 3 groups as follows: 12 weeks of DAA alone (group 1), 12 weeks of DAA plus 12 weeks of entecavir (group 2), or 12 weeks of DAA plus 24 weeks of entecavir (group 3). The entire study duration was 72 weeks. The primary end point was the occurrence of HBVr (defined by an increase of HBV DNA level > 10-fold with quantifiable HBV DNA at baseline or the presence of HBV DNA with prior unquantifiable HBV DNA) and clinical reactivation (defined by serum alanine aminotransferase level > 2-fold the upper limit of normal in addition to HBVr).
Results: 56 patients were allocated randomly as follows: 20 patients in group 1, 16 patients in group 2, and 20 patients in group 3. In group 1, HBV DNA levels increased significantly as early as 4 weeks after initiation of DAA and persisted until the end of the study. During DAA treatment, HBVr occurred in 50% in group 1 versus 0% in group 2 and 0% in group 3 (p < 0.001), whereas the majority of HBVr in groups 2 and 3 occurred 12 weeks after cessation of entecavir (cumulative incidence, 93.8% in group 2 and 94.7% in group 3). Three patients (5.4%; 1 in each group) showed clinical reactivation at week 48 and did not receive entecavir treatment.
Conclusions: 12 weeks of entecavir is suggested to be co-administered with direct-acting antivirals for hepatitis C virus/hepatitis B virus dually infected patients.