Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
Patients with chronic hepatitis B who are undergoing anticancer chemotherapy are at risk of
HBV reactivation and hepatitis flare. Lamivudine (LAM) prophylaxis has been recommended in
such circumstance according to the practice guidelines despite of limited evidence. However,
failure of LAM prophylaxis including virologic breakthrough and withdrawal hepatitis occurs
occasionally, which may lead to liver-related morbidity and mortality as well as premature
interruption or a delay of chemotherapy. Given relatively frequent drug resistance of LAM,
studies on the proper prophylactic antiviral regimen is warranted. The present multicenter,
prospective, randomized study aims to compare the effect of entecavir (ETV) versus LAM for
the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic
malignancy undergoing cytotoxic chemotherapy.