60070
document
Randomized controlled trial of entecavir prophylaxis for rituximab-associated hepatitis B virus reactivation in patients with lymphoma and resolved hepatitis B . PURPOSE The role of antiviral prophylaxis in preventing hepatitis B virus ( HBV ) reactivation before rituximab-based chemotherapy in patients with lymphoma and resolved hepatitis B is unclear . PATIENTS AND METHODS Eighty patients with CD20 ( + ) lymphoma and resolved hepatitis B were randomly assigned to receive either prophylactic entecavir ( ETV ) before chemotherapy to 3 months after completing chemotherapy ( ETV prophylactic group , n = 41 ) or to receive therapeutic ETV at the time of HBV reactivation and hepatitis B surface antigen ( HBsAg ) reverse seroconversion since chemotherapy ( control group , n = 39 ) . RESULTS Fifty-eight patients ( 72.5 % ) were positive for hepatitis B surface antibody , and HBV DNA was undetectable in 50 patients ( 62.5 % ) . During a mean 18-month follow-up period , one patient ( 2.4 % ) in the ETV prophylactic group and seven patients ( 17.9 % ) in the control group developed HBV reactivation ( P = .027 ) . The cumulative HBV reactivation rates at months 6 , 12 , and 18 after chemotherapy were 8 % , 11.2 % , and 25.9 % , respectively , in the control group , and 0 % , 0 % , and 4.3 % in the ETV prophylactic group ( P = .019 ) . Four patients ( 50 % ) in the control group had HBsAg reverse seroconversion after HBV reactivation . The cumulative HBsAg reverse seroconversion rates at months 6 , 12 , and 18 since chemotherapy were 0 % , 6.4 % , and 16.3 % in the control group , respectively , which were significantly higher than those in the ETV prophylactic group ( P = .032 ) . Patients with detectable or undetectable viral load could develop HBV reactivation and HBsAg reverse seroconversion . CONCLUSION Undetectable HBV viral load before chemotherapy did not confer reactivation-free status . Antiviral prophylaxis can potentially prevent rituximab-associated HBV reactivation in patients with lymphoma and resolved hepatitis B .
60071
Intervention_Pharmacological
entecavir prophylaxis
60072
Intervention_Pharmacological
antiviral prophylaxis
60073
Intervention_Pharmacological
rituximab-based chemotherapy
60074
Intervention_Pharmacological
prophylactic entecavir ( ETV
60075
Intervention_Physical
) before
60076
Intervention_Pharmacological
chemotherapy
60077
Intervention_Physical
to 3 months after completing
60078
Intervention_Pharmacological
chemotherapy
60079
Intervention_Physical
( ETV prophylactic group , n = 41 )
60080
Intervention_Physical
receive therapeutic ETV at the time of HBV reactivation and hepatitis B surface antigen ( HBsAg ) reverse seroconversion since chemotherapy ( control group , n = 39 )
60081
Intervention_Physical
ETV
60082
Intervention_Pharmacological
Antiviral prophylaxis
60083
Outcome_Physical
cumulative HBV reactivation rates
60084
Outcome_Physical
HBsAg reverse seroconversion
60085
Outcome_Physical
cumulative HBsAg reverse seroconversion rates
60086
Outcome_Physical
HBV reactivation
60087
Outcome_Physical
HBsAg reverse seroconversion