Hepatitis B Clinical Trial
Official title:
A Randomized, Open Labeled, Multicenter Study Comparing Entecavir Versus Lamivudine as Antiviral Prophylaxis for Patients With Hepatitis B Infection Undergoing Cytotoxic Chemotherapy for Malignant Tumors
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.
Chronic hepatitis B virus (HBV) carriers who are undergoing anticancer chemotherapy are at
risk of HBV reactivation and hepatitis flare, and lamivudine (LAM) prophylaxis is
recommended according to the practice guidelines despite of limited evidence. However,
failure of LAM prophylaxis defined as virologic breakthrough during LAM therapy and
withdrawal hepatitis after discontinuation of LAM therapy occurs occasionally, which may
lead to liver-related morbidity and mortality as well as premature interruption or a delay
of chemotherapy. Considering that LAM therapy showed relatively higher rates of drug
resistance and of withdrawal hepatitis, studies on the better choice of prophylactic
antiviral regimen is warranted.
The purpose of our study is to conduct a multicenter, prospective, randomized study
comparing 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.
A total one hundred eighty HBV carriers with malignancy undergoing chemotherapy will be
randomly assigned to each prophylactic therapy arm of ETV and LAM group. The primary
endpoint of the study is the HBV reactivation rate during antiviral therapy and 6 months
after discontinuation of prophylactic antiviral therapy.
If the prophylactic efficacy of ETV is superior to that of LAM, ETV will be the preferred
prophylactic therapy for HBsAg-positive cancer patients undergoing chemotherapy.
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