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Entecavir decreased HBV incidence, reactivation in patients undergoing R-CHOP for lymphoma

In a new phase 3 study, patients seropositive for the hepatitis B surface antigen with diffuse large B-cell lymphoma who underwent chemotherapy with rituximab plus CHOP had a lower incidence rate for hepatitis B virus infection-related hepatitis and reactivation after additional treatment with entecavir vs. patients who received additional treatment with lamivudine. 

“We conducted this randomized, multicenter study to compare the efficacy of prophylactic entecavir vs. lamivudine among untreated patients seropositive for the hepatitis B surface antigen with diffuse large B-cell lymphoma receiving R-CHOP chemotherapy,” the researchers wrote. “We also investigated the optimal antiviral treatment duration and identified risk factors for HBV reactivation.”

Among a cohort of 121 patients recruited from various clinical centers in China from 2008 to 2012, 61 patients received 0.5 mg entecavir per day and 60 received 100 mg lamivudine per day beginning a week before the initiation of rituximab (Rituxan, Genentech/Idec) plus CHOP until 6 months after chemotherapy ended. The last day of follow-up was in May 2013.   

All patients completed therapy for diffuse large B-cell lymphoma. More patients in the lamivudine group experienced HBV reactivation compared with the entecavir group (18 vs. 4; P=.001), as well as developed HBV-related hepatitis during the study period (8 vs. 0; P=.003). Patients in the lamivudine group also experienced more treatment-related adverse events (18 vs. 15; P=.5) and disruptions to chemotherapy (11 vs. 1; P=.002) compared with the entecavir group.  

“Among patients seropositive for the hepatitis B surface antigen with diffuse large B-cell lymphoma undergoing R-CHOP chemotherapy, the addition of entecavir compared with lamivudine resulted in a lower incidence of HBV-related hepatitis and HBV reactivation,” the researchers concluded. “If replicated, these findings support the use of entecavir in these patients.”

Disclosure: The study was funded through a grant from the Foundation of 5010 Clinical Trials of Sun Yat-sen University.