NUC in Preventing HBV Reactivation in HCV/HBV Co-infected Patients Receiving DAA for CHC

HBV reactivation is common in HCV/HBV coinfected patients receiving DAA therapy for chronic hepatitis C. How to prevent HBV reactivation remains unclear. In this trial, we aim to investigate whether prophylactic nucleos(t)ide analogue (NUC) at the start of DAA could prevent HBV reactivation or not. And whether prolonged NUC prophylaxis (24 weeks) would be better than 12-week prophylaxis. This will be a three-arm, open-label, randomized, active controlled, study. Totally, 60 HBV/HCV co-infected treatment-naïve or treatment-experienced patients without decompensated liver cirrhosis will be included in this study. Group 1 patients (n=20) will receive 12-week ETV from the start of DAA therapy. Group 2 patients (n=20) will receive 24-week ETV from the start of DAA till 12 weeks after end of DAA. Group 3 patients (n=20) will not receive ETV during the period of DAA and will serve as controls. The rate of HBV reactivation and clinical reactivation will be compared among 3 groups of patients. Expected outcomes: The rate of HBV reactivation and clinical reactivation will be lower in the ETV prophylaxis group, and will be the lowest in the group receiving 24-week ETV prophylaxis.