国内团队:治疗乙型慢活肝孕妇,替诺福韦艾拉酚胺安全有效
创作:尹小甜 审核:Epi汪 2022年01月14日
  • 纳入慢性活动性乙型肝炎的孕妇,随机分为替诺福韦艾拉酚胺 (TAF) 治疗组和富马酸替诺福韦酯 (TDF) 治疗组;
  • 在孕期服用TAF的耐受性良好,在治疗期间内最常见的不良反应事件是恶心(29.1%);
  • 值得注意的是,TAF治疗组中有1名胎儿因唇腭裂而进行人工流产,但是该事件与TAF服用无因果关联;
  • TAF治疗组在产后第6个月的乙肝e抗原血清转换率为20.7%,且婴儿的生长参数均正常,婴儿7个月时乙肝表面抗原均阴性。
主编推荐语
Epi汪
乙型肝炎病毒性慢活肝主要是因感染乙型肝炎病毒所致,并且因为失治、误治、过劳、饮酒、机体免疫功能失调等原因使其从急性乙型肝炎转变成慢性活动性肝炎。针对此类孕妇,如何治疗才能预防新生儿感染乙肝,并且不增加不良妊娠结局的风险,是值得研究的重要临床问题。本临床试验证明了替诺福韦艾拉酚胺的安全性和有效性。
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Tenofovir Alafenamide for Pregnant Chinese Women with Active Chronic Hepatitis B: A Multicenter Prospective Study

替诺福韦艾拉酚胺治疗中国孕妇慢性活动性乙型肝炎:一项多中心前瞻性研究

10.1016/j.cgh.2021.12.012

2021-12-10, Article

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BACKGROUND & AIMS: Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB, immune clearance and reactivation phases [currently and previously diagnosed]) and their infants are lacking.
METHODS: Pregnant women with active CHB treated with TAF and tenofovir disoproxil fumarate (TDF) were enrolled in this multicenter prospective study, and infants received immunoprophylaxis. The primary outcomes were rates of adverse (safety) events in pregnant women and defects in infants and fetuses. The secondary outcomes were virological responses in pregnant women, infants’ safety, hepatitis B surface antigen (HBsAg) status, and growth conditions.
RESULTS: One hundred three and 104 pregnant women were enrolled, and 102 and 104 infants were born in the TAF and TDF groups, respectively. In the TAF group, the mean age, gestational age, alanine aminotransferase level, and viral loads at treatment initiation were 29.3 years, 1.3 weeks, 122.2 U/L, and 5.1 log10 IU/ml, respectively. TAF was well tolerated, and the most common adverse event was nausea (29.1%) during a mean of two years of treatment. Notably, 1 (1.0%) TAF-treated pregnant woman underwent induced abortion due to noncausal fetal cleft lip and palate. No infants in either group had birth defects. In the TAF group, the hepatitis B e antigen seroconversion rate was 20.7% at postpartum month 6, infants had normal growth parameters, and no infants were positive for HBsAg at 7 months. The TDF group had comparable safety and effectiveness profiles.
CONCLUSIONS: TAF administered throughout or beginning in early pregnancy is generally safe and effective for pregnant women with active CHB and their infants.

First Authors:
Qing-Lei Zeng,Hong-Xu Zhang,Ji-Yuan Zhang,Shuo Huang,Wei-Zhe Li,Guang-Ming Li

Correspondence Authors:
Qing-Lei Zeng,Zujiang Yu,Fu-Sheng Wang

All Authors:
Qing-Lei Zeng,Hong-Xu Zhang,Ji-Yuan Zhang,Shuo Huang,Wei-Zhe Li,Guang-Ming Li,Ya-Jie Pan,Ying-Hua Feng,Zhi-Qin Li,Guo-Fan Zhang,Jiang-Hai Xu,Wan-Bao Lin,Guang-Hua Xu,Na Liu,Guo-Qiang Zhang,Guo-Tao Li,Wei Li,Yan-Li Zeng,Ning Song,Meng Wang,Da-Wei Zhang,Zhi-Min Chen,Guang-Lin Cui,Juan Li,Jun Lv,Yan-Min Liu,Hong-Xia Liang,Chang-Yu Sun,Yi-Hua Zhou,Zujiang Yu,Fu-Sheng Wang

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