From the Department of Epidemiology (K.P., P.L.W., G.R.S.), the Center for Biostatistics in AIDS Research (K.P., Y.H., P.L.W., D.K., D.L.J., S.S.B., G.R.S.), and the Department of Immunology and Infectious Diseases (K.M.P.), Harvard T.H. Chan School of Public Health, the Departments of Pediatrics and Medicine, Massachusetts General Hospital (K.M.P.), and the Department of Medicine, Beth Israel Deaconess Medical Center (R.Z.) - all in Boston; the Departments of Pediatrics (J.J., E.G.C.) and Obstetrics and Gynecology (L.M.Y.), Northwestern University Feinberg School of Medicine, Chicago; the Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ (S.S.); and the Department of Gynecology, University Hospital Zurich, Zurich (L.S.-B.), and Department of Infectious Diseases and Hospital Epidemiology, Children's Hospital of Eastern Switzerland, St. Gallen (C.R.K.) - both in Switzerland.
N Engl J Med. 2022 Sep 1;387(9):799-809. doi: 10.1056/NEJMoa2200600.
BACKGROUND: Data on the effectiveness and safety of dolutegravir-based antiretroviral therapy (ART) for human immunodeficiency virus type 1 (HIV-1) infection in pregnancy as compared with other ART regimens commonly used in the United States and Europe, particularly when initiated before conception, are limited. METHODS: We conducted a study involving pregnancies in persons with HIV-1 infection in the Pediatric HIV/AIDS Cohort Study whose initial ART in pregnancy included dolutegravir, atazanavir-ritonavir, darunavir-ritonavir, oral rilpivirine, raltegravir, or elvitegravir-cobicistat. Viral suppression at delivery and the risks of infants being born preterm, having low birth weight, and being small for gestational age were compared between each non-dolutegravir-based ART regimen and dolutegravir-based ART. Supplementary analyses that included participants in the Swiss Mother and Child HIV Cohort Study were conducted to improve the precision of our results. RESULTS: Of the pregnancies in the study, 120 were in participants who received dolutegravir, 464 in those who received atazanavir-ritonavir, 185 in those who received darunavir-ritonavir, 243 in those who received rilpivirine, 86 in those who received raltegravir, and 159 in those who received elvitegravir-cobicistat. The median age at conception was 29 years; 51% of the pregnancies were in participants who started ART before conception. Viral suppression was present at delivery in 96.7% of the pregnancies in participants who received dolutegravir; corresponding percentages were 84.0% for atazanavir-ritonavir, 89.2% for raltegravir, and 89.8% for elvitegravir-cobicistat (adjusted risk differences vs. dolutegravir, -13.0 percentage points [95% confidence interval {CI}, -17.0 to -6.1], -17.0 percentage points [95% CI, -27.0 to -2.4], and -7.0 percentage points [95% CI, -13.3 to -0.0], respectively). The observed risks of preterm birth were 13.6 to 17.6%. Adjusted risks of infants being born preterm, having low birth weight, or being small for gestational age did not differ substantially between non-dolutegravir-based ART and dolutegravir. Results of supplementary analyses were similar. CONCLUSIONS: Atazanavir-ritonavir and raltegravir were associated with less frequent viral suppression at delivery than dolutegravir. No clear differences in adverse birth outcomes were observed with dolutegravir-based ART as compared with non-dolutegravir-based ART, although samples were small. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others.).
背景：与在美国和欧洲常用的其他抗逆转录病毒治疗（ART）方案相比，针对人免疫缺陷病毒 1（HIV-1）感染孕妇的基于度鲁特韦的抗逆转录病毒治疗（ART）的有效性和安全性的数据有限，特别是在受孕前开始治疗的情况下。
方法：我们开展了一项研究，纳入了儿科 HIV/AIDS 队列研究中 HIV-1 感染孕妇的妊娠情况，这些孕妇在妊娠期间初始 ART 包含度鲁特韦、阿扎那韦-利托那韦、达芦那韦-利托那韦、口服利匹韦林、拉替拉韦或艾维雷韦-考比司他。在每个非度鲁特韦为基础的 ART 方案与度鲁特韦为基础的 ART 之间，比较了分娩时病毒抑制情况以及婴儿早产、低出生体重和小于胎龄儿的风险。为了提高我们研究结果的精确度，进行了包括瑞士母婴 HIV 队列研究参与者的补充分析。
结果：在这项研究的妊娠中，120 例参与者接受了度鲁特韦，464 例接受了阿扎那韦-利托那韦，185 例接受了达芦那韦-利托那韦，243 例接受了利匹韦林，86 例接受了拉替拉韦，159 例接受了艾维雷韦-考比司他。受孕时的中位年龄为 29 岁；51%的妊娠是在受孕前开始接受 ART 的参与者。接受度鲁特韦的参与者中，96.7%的妊娠在分娩时病毒得到抑制；阿扎那韦-利托那韦组相应的百分比为 84.0%，拉替拉韦组为 89.2%，艾维雷韦-考比司他组为 89.8%（与度鲁特韦相比，调整后的风险差异为-13.0 个百分点[95%置信区间{CI}，-17.0 至-6.1]、-17.0 个百分点[95% CI，-27.0 至-2.4]和-7.0 个百分点[95% CI，-13.3 至-0.0]）。观察到的早产风险为 13.6%至 17.6%。与非度鲁特韦为基础的 ART 相比，调整后的婴儿早产、低出生体重或小于胎龄儿的风险在度鲁特韦为基础的 ART 中并没有明显差异。补充分析的结果相似。
结论：与度鲁特韦相比，阿扎那韦-利托那韦和拉替拉韦与分娩时病毒抑制率较低相关。虽然样本量较小，但与非度鲁特韦为基础的 ART 相比，基于度鲁特韦的 ART 并未观察到明显的不良出生结局差异。（由美国国立儿童健康与人类发育研究所及其他机构资助）。
N Engl J Med. 2022-9-1
J Antimicrob Chemother. 2019-5-1
Exp Biol Med (Maywood). 2025-8-13
J Obstet Gynaecol Res. 2025-6
Clin Perinatol. 2024-12
BMJ Open. 2024-9-23
Int J Epidemiol. 2022-2-18
J Acquir Immune Defic Syndr. 2020-7-1
N Engl J Med. 2019-7-22
N Engl J Med. 2018-9-6
Zotero 插件