Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Pharmacy, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Hepatol Commun. 2022 Sep;6(9):2431-2440. doi: 10.1002/hep4.1994. Epub 2022 May 20.
The appropriate prophylaxis for hepatitis B virus reactivation (HBVr) during gestation for immunocompromised pregnant women has yet to be determined. The prophylactic efficacy and safety of tenofovir disoproxil fumarate (TDF) in hepatitis B surface antigen (HBsAg)-positive patients and the HBVr risk in hepatitis B core antibody (HBcAb)-positive patients during gestation were investigated. Eligible pregnant women were diagnosed with rheumatic diseases and were administered prednisone (≤10 mg daily) with permitted immunosuppressants at screening. HBsAg-positive participants were instructed to take TDF; those unwilling to take TDF were followed up as the control group. Propensity score matching was applied to control for differences in confounding factors between the HBcAb-positive and uninfected groups. Hepatopathy, maternal, pregnancy, and safety outcomes were documented as endpoints. A cohort of 1292 women was recruited from 2017 to 2020, including 58 HBsAg-positive patients (29 in each group). A total of 120 pairs in the HBcAb-positive and noninfection groups were analyzed. Among HBsAg-positive patients, 6 (20.7%) cases of hepatitis flare (hazard ratio [HR]: 7.44; 95% confidence interval [CI]: 1.50-36.89; p = 0.014) and 12 (41.4%) cases of HBVr (HR: 8.71; 95% CI: 2.80-27.17; p < 0.001) occurred in the control group, while 0 occurred in the TDF prophylaxis group. The HBV level at delivery was the lowest (1.6 log IU/ml) for those who received TDF during the pregestation period with a good safety profile. More adverse maternal outcomes were observed in the control group (odds ratio: 0.19, 95% CI: 0.05-0.77, p = 0.021), including one death from fulminant hepatitis and two cases of vertical transmission. No HBVr was recorded in HBcAb-positive participants. Among immunocompromised pregnant women, prophylactic TDF during pregestation was necessary for HBsAg-positive women, whereas regular monitoring was recommended for HBcAb-positive women.
在免疫功能低下的孕妇中，乙型肝炎病毒再激活（HBVr）的适当预防措施尚未确定。本研究旨在评估替诺福韦二吡呋酯（TDF）在乙型肝炎表面抗原（HBsAg）阳性患者中的预防疗效和安全性，以及在妊娠期间乙型肝炎核心抗体（HBcAb）阳性患者中的 HBVr 风险。符合条件的孕妇被诊断为患有风湿性疾病，并在筛查时接受了泼尼松（≤10mg/天）和允许使用的免疫抑制剂治疗。HBsAg 阳性的参与者被指示服用 TDF；那些不愿意服用 TDF 的人作为对照组进行随访。采用倾向评分匹配来控制 HBcAb 阳性组和未感染组之间混杂因素的差异。记录肝病史、母婴、妊娠和安全性结局作为终点。从 2017 年至 2020 年共招募了 1292 名女性，包括 58 名 HBsAg 阳性患者（每组 29 名）。对 HBcAb 阳性组和未感染组的 120 对患者进行了分析。在 HBsAg 阳性患者中，对照组有 6 例（20.7%）肝炎发作（风险比 [HR]：7.44；95%置信区间 [CI]：1.50-36.89；p=0.014）和 12 例（41.4%）HBVr（HR：8.71；95%CI：2.80-27.17；p<0.001），而 TDF 预防组则无上述情况发生。在接受 TDF 治疗的患者中，分娩时 HBV 水平最低（1.6logIU/ml），且安全性良好。对照组观察到更多的不良母婴结局（比值比：0.19，95%CI：0.05-0.77，p=0.021），包括 1 例暴发性肝炎死亡和 2 例垂直传播。HBcAb 阳性患者中未发生 HBVr。在免疫功能低下的孕妇中，HBsAg 阳性孕妇在妊娠前需要预防性 TDF，而 HBcAb 阳性孕妇则需要定期监测。
