*Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD; †Maternal Adolescent and Child Health, University of the Witwatersrand, South Africa; ‡Fred Hutchinson Cancer Research Center, Seattle, WA; §Department of Pediatrics, Stanford University School of Medicine, Stanford, CA; ‖Department of Obstetrics and Gynecology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe; ¶Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu Natal, Durban, South Africa; #Makerere University, Johns Hopkins University, Research Collaboration, Kampala, Uganda; **Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania; ††Department of Pediatrics, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe; ‡‡Department of Global Health and Population, Harvard University School of Public Health, Boston, MA; §§Family Health International, Research Triangle Park, NC; ‖‖Division of HIV/AIDS, National Institute of Allergy and Infectious Diseases, US National Institutes of Health, Bethesda, MD; and ¶¶Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Rockville, MD.
J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):366-74. doi: 10.1097/QAI.0000000000000052.
HPTN 046 compared the efficacy and safety of infant nevirapine (NVP) among HIV-exposed breastfed infants randomized at 6 weeks to 6 months to t NVP or placebo to prevent postnatal infection: we report final 18-month outcomes.
Randomized, placebo-controlled trial in 4 African countries. Infant diagnostic HIV testing was performed regularly from birth through 18 months. Kaplan-Meier analysis was used to assess 18-month cumulative infant HIV infection, HIV infection/or death, and mortality rates.
Between 6 weeks and 6 months, postnatal HIV infection rates were significantly lower among infants receiving daily NVP from 6 weeks to 6 months 1.1% [95% confidence interval (CI): 0.2% to 1.8%], compared with placebo 2.4% (95% CI: 1.3% to 2.6%), P = 0.049, but not significantly lower thereafter. Eighteen-month postnatal infection rates were low: 2.2% (95% CI: 1.1% to 3.3%) versus 3.1% (95% CI: 1.9% to 4.4%), respectively, P = 0.28. Mortality and HIV infection/death did not differ between arms at any age. Infants of women receiving antiretroviral therapy (ART) for their own health had the lowest 18-month postnatal infection rates (0.5%, 95% CI: 0.0% to 1.1%). However, HIV infection/death rates at 18 months were not significantly different for infants of mothers on ART (3.7%, 95% CI: 1.9% to 5.5%), and infants of mothers with CD4 counts of ≥ 350 cells per cubic millimeter not receiving ART (4.8%, 95% CI: 2.7% to 6.8%; P = 0.46). There were no differences in adverse events between study arms.
This trial demonstrated early but not late differences in postnatal HIV transmission among infants randomized at age 6 weeks to extended NVP or placebo, underscoring the importance of continued prophylaxis throughout breastfeeding.
HPTN 046 比较了在 6 周到 6 个月之间随机分配到婴儿接受奈韦拉平（NVP）或安慰剂以预防产后感染的 HIV 暴露的母乳喂养婴儿的疗效和安全性：我们报告最终的 18 个月结果。
在 4 个非洲国家进行的随机、安慰剂对照试验。婴儿出生后至 18 个月定期进行艾滋病毒诊断检测。采用 Kaplan-Meier 分析评估 18 个月累积婴儿 HIV 感染、HIV 感染/死亡和死亡率。
在 6 周到 6 个月之间，接受 6 周到 6 个月期间每天接受 NVP 的婴儿的产后 HIV 感染率明显低于安慰剂组（1.1%[95%可信区间：0.2%至 1.8%]），P=0.049，但此后并无显著差异。18 个月时的产后感染率较低：分别为 2.2%（95%可信区间：1.1%至 3.3%）和 3.1%（95%可信区间：1.9%至 4.4%），P=0.28。在任何年龄，两组之间的死亡率和 HIV 感染/死亡均无差异。接受抗逆转录病毒治疗（ART）治疗自身健康的妇女的婴儿，18 个月时产后感染率最低（0.5%，95%可信区间：0.0%至 1.1%）。然而，接受 ART 的母亲的婴儿（3.7%，95%可信区间：1.9%至 5.5%）和 CD4 计数≥350 个细胞/立方毫米的母亲未接受 ART 的婴儿（4.8%，95%可信区间：2.7%至 6.8%；P=0.46）的 18 个月 HIV 感染/死亡率并无显著差异。研究组之间的不良事件无差异。
本试验显示，在 6 周龄随机分配至延长 NVP 或安慰剂的婴儿中，产后 HIV 传播的早期而非晚期存在差异，强调了在整个母乳喂养期间持续预防的重要性。
