Randomized Controlled Trial of Entecavir Prophylaxis for Rituximab-Associated Hepatitis B Virus Reactivation in Patients With Lymphoma and Resolved Hepatitis B

Author:

Huang Yi-Hsiang1,Hsiao Liang-Tsai1,Hong Ying-Chung1,Chiou Tzeon-Jye1,Yu Yuan-Bin1,Gau Jyh-Pyng1,Liu Chun-Yu1,Yang Muh-Hwa1,Tzeng Cheng-Hwai1,Lee Pui-Ching1,Lin Han-Chieh1,Lee Shou-Dong1

Affiliation:

1. Yi-Hsiang Huang, Liang-Tsai Hsiao, Ying-Chung Hong, Tzeon-Jye Chiou, Yuan-Bin Yu, Jyh-Pyng Gau, Chun-Yu Liu, Muh-Hwa Yang, Cheng-Hwai Tzeng, Pui-Ching Lee, Han-Chieh Lin, Taipei Veterans General Hospital; Yi-Hsiang Huang, Liang-Tsai Hsiao, Tzeon-Jye Chiou, Yuan-Bin Yu, Jyh-Pyng Gau, Chun-Yu Liu, Muh-Hwa Yang, Cheng-Hwai Tzeng, Han-Chieh Lin, National Yang-Ming University School of Medicine; Shou-Dong Lee, Cheng Hsin General Hospital, Taipei, Taiwan.

Abstract

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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