Preventing hepatitis B reactivation in HBsAg-positive patients with untreated diffuse large B-cell lymphoma with R-CHOP chemotherapy: A prospective study to compare entecavir and lamivudine.

Abstract

8503 Background: Hepatitis B reactivation is a serious complication in lymphoma patients treated with rituximab-contained chemotherapy despite lamivudine prophylaxis. The optimal prophylactic antiviral protocol is undetermined. This prospective study was designed to compare the efficacy of prophylactic entecavir and lamivudine in preventing hepatitis B reactivation in HbsAg-positive patients with untreated diffuse large B cell lymphoma (DLBCL) under R-CHOP treatment. Methods: HBsAg carriers with untreated DLBCL, normal liver function and low serum HBV DNA levels (less than 103copys/ml)were randomized to receive entecavir or lamivudine during R-CHOP treatment and for 6 months after completion of chemotherapy. HBsAg, HBsAb, HBeAg, HBeAb and HBcAb were performed prior to initiation of treatment. Serum alanine aminotransferase (ALT), and HBV-DNA levels were prospectively monitored before every cycle of chemo and every month after completion of chemotherapy. Results: Between February 2008 and December 2012, a total of 229 patients older than 18y with newly diagnosed DLBCL were included. The present analysis is based on 121 HBsAg-positive patients, including 61 patients randomly assigned to entecavir and 60 patients to lamivudine .The primary efficacy end point was the incidence of HBV-related hepatitis. The secondary end point was chemotherapy disruption due to hepatitis. Compared with the lamivadine group, the entecavir group had significantly lower rates of hepatitis(8.2% vs 23.3%,P=0.022), hepatitis B reactivation (0 vs 13.3%,P=0.003),HBV reactiviation(6.6% vs 30.0%,P=0.001), delayed HBV-related hepatitis (0 vs 8.3%,P=0.027) and disruption of chemotherapy (1.6% vs 18.3%,P=0.002). 7 of 8 patients with hepatitis B reactivation had advanced stage(III–IV) disease. Conclusions: In HBsAg-positive DLBCL patients undergoing R-CHOP chemotherapy, entecavir is more effective than lamivudine in preventing hepatitis B reactivation. For patients with advanced stage disease, entecavir should be considered the primary preventive therapy. Clinical trial information: CTR-TRC-11001687.

Hepatitis B Reactivation in Patients with Hematological Malignancies and Stem Cell Transplantation

“…A total of 229 patients were included in this study. Compared with the lamivudine group, the entecavir group had significantly lower rates of hepatitis (8.2% vs. 23.3%, P=0.022), HBV reactivation (6.6% vs. 30.0%), delayed HBV-related hepatitis (0 vs. 8.3%) [19]. Therefore, entecavir is the recommended prophylactic antiviral agent of choice.…”

Expanding the armamentarium for chronic lymphocytic leukemia: A review of novel agents in the management of chronic lymphocytic leukemia

“…Patients with a positive hepatitis B virus surface antigen and core antigen should receive entecavir prophylaxis, which is preferred over lamivudine. 28 Adverse effects include neutropenia, infections such as pneumonia and upper respiratory tract infections, hypogammagloblinemia, B-cell aplasia, infusion-related reactions, cough, diarrhea, anemia, and fatigue.…”

Estrategias para el tratamiento de pacientes con infección por el virus de la hepatitis B sometidos a terapia inmunomoduladora: ¿es suficiente usar lamivudina?

“…Las interrupciones de la quimioterapia también fueron menos frecuentes en los pacientes tratados con entecavir (1,6 % vs . 18,3 %). En estudios de cohortes de varios antivirales empleados en pacientes con TIM (en base a la preferencia del médico), las tasas de reactivación del VHB para entecavir fueron de 0 % a 12 %.…”