Center for Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
NYU Langone Medical Center, New York, New York, United States of America.
PLoS One. 2021 May 13;16(5):e0251552. doi: 10.1371/journal.pone.0251552. eCollection 2021.
BACKGROUND/PURPOSE: Use of tenofovir disoproxil fumarate (TDF) improves patient outcomes in preventing mother-to-child transmission (pMTCT) of the hepatitis B virus (HBV) in mothers with chronic HBV and high viral loads. Given the lack of data for tenofovir alafenamide (TAF) in pMTCT, rates of early viral suppression with TAF and TDF were evaluated in women of childbearing potential (WOCBP) participating in 2 randomized, double-blind, Phase 3 studies in chronic HBV.
In a patient subset meeting WOCBP criteria and with baseline HBV DNA >200,000 IU/mL, rates of viral suppression with TAF or TDF in achieving the target of HBV DNA <200,000 IU/mL at weeks 12 and 24 were assessed. Multivariate logistic regression was used to identify factors predictive of failure to suppress HBV DNA to the target level.
In 275 of 1298 (21%) patients meeting WOCBP criteria with high viral load, 93% and 96% had HBV DNA <200,000 IU/mL at weeks 12 and 24, respectively. Results for TAF (n = 194) vs TDF (n = 81) treatment were similar at weeks 12 and 24 (94% vs. 90% and 97% vs. 93%), respectively. High baseline HBV DNA level, genotype D infection, and prior interferon (week 24 only) were predictive of failure to achieve the target level. Both treatments were well tolerated with TAF showing less impact on renal and bone parameters.
In WOCBP with high VL, no differences were found between TAF and TDF in reducing HBV DNA to levels associated with lower transmission risk. These data support ongoing studies of TAF for pMTCT.
背景/目的：富马酸替诺福韦二吡呋酯（TDF）的使用改善了患有慢性乙型肝炎（HBV）且病毒载量较高的母亲母婴传播（pMTCT）的患者结局。鉴于替诺福韦艾拉酚胺（TAF）在 pMTCT 方面的数据缺乏，本研究评估了 TAF 和 TDF 在参加慢性 HBV 两项随机、双盲、3 期研究的生育能力妇女（WOCBP）中实现 HBV DNA<200,000 IU/ml 目标的早期病毒抑制率。
在符合 WOCBP 标准且基线 HBV DNA>200,000 IU/ml 的患者亚组中，评估 TAF 或 TDF 治疗在第 12 周和第 24 周达到 HBV DNA<200,000 IU/ml 的目标时的病毒抑制率。采用多变量逻辑回归分析确定预测 HBV DNA 未能达到目标水平的因素。
在 1298 例符合 WOCBP 标准且病毒载量高的患者中，有 275 例（21%）符合 WOCBP 标准，分别有 93%和 96%的患者在第 12 周和第 24 周时 HBV DNA<200,000 IU/ml。TAF（n=194）和 TDF（n=81）治疗在第 12 周和第 24 周的结果相似（分别为 94%比 90%和 97%比 93%）。高基线 HBV DNA 水平、基因型 D 感染和先前的干扰素（仅第 24 周）是未能达到目标水平的预测因素。两种治疗方法均具有良好的耐受性，TAF 对肾功能和骨参数的影响较小。
在病毒载量高的 WOCBP 中，TAF 和 TDF 在降低 HBV DNA 水平以降低传播风险方面无差异。这些数据支持 TAF 用于 pMTCT 的正在进行的研究。
