Randomized Controlled Trial of Entecavir Prophylaxis for Rituximab-Associated Hepatitis B Virus Reactivation in Patients With Lymphoma and Resolved Hepatitis B
Randomized Controlled Trial of Entecavir Prophylaxis for Rituximab-Associated Hepatitis B Virus Reactivation in Patients With Lymphoma and Resolved Hepatitis B
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DOI：
10.1200/jco.2012.48.5938
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发表时间：
2013-08-01
影响因子：
45.3
通讯作者：
Lee, Shou-Dong
中科院分区：
文献类型：
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作者：
Huang, Yi-Hsiang;Hsiao, Liang-Tsai;Lee, Shou-Dong
80例CD20(+)淋巴瘤患者在化疗前至化疗结束后3个月内接受恩替卡韦(ETV)预防性治疗(ETV组，n=41)，或在化疗后乙肝表面抗原(HBs)反向血清转换的同时接受治疗性ETV(对照组，n=39)。结果58例(72.5%)患者在化疗前至化疗结束后3个月内接受ETV治疗。HBVDNA阴性者50例(62.5%)。在平均18个月的随访期内，ETV预防组有1名患者(2.4%)和对照组有7名患者(17.9%)出现了乙肝病毒的重新激活(P=0.027)。在化疗后6个月、12个月和18个月，对照组的累积乙肝病毒复活率分别为8%、11.2%和25.9%，而ETV预防组分别为0%、0%和4.3%(P=0.019)。对照组中有4例(50%)在乙肝病毒复活后出现了HBs Ag反向血清转换。对照组自化疗后6个月、12个月和18个月的累计乙肝表面抗原阳转率分别为0%、6.4%和16.3%，显著高于ETV预防组(P=0.032)。病毒载量可检测到或未检测到的患者可发生乙肝病毒再激活和HBs Ag反向血清转换。结论化疗前未检测到的病毒载量并不意味着无再激活状态。抗病毒预防可以潜在地防止淋巴瘤和乙肝缓解患者中与利妥昔单抗相关的乙肝病毒重新激活。(C)美国临床肿瘤学会2013年
PurposeThe 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 MethodsEighty 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).ResultsFifty-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.ConclusionUndetectable 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. (C) 2013 by American Society of Clinical Oncology