From the Department of Pediatrics, Faculty of Medicine.
Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Pediatr Infect Dis J. 2019 Oct;38(10):1045-1050. doi: 10.1097/INF.0000000000002426.
Combination antiretroviral drug regimens are increasingly preferred for neonatal postexposure prophylaxis (PEP) among HIV-exposed infants with high-risk of transmission. We evaluated the adverse events associated with the use of zidovudine (ZDV)/lamivudine (3TC)/nevirapine (NVP) for neonatal PEP during the first 6 weeks of life.
A prospective cohort of non-breast-fed HIV-exposed infants was conducted at 5 clinical sites in Thailand. Study population included 100 high-risk HIV-exposed infants (maternal HIV RNA > 50 copies/mL prior to delivery or received antiretroviral therapy less than 12 weeks) and 100 low-risk HIV-exposed neonates. High-risk infants received ZDV/3TC/NVP for 6 weeks whereas low-risk HIV-exposed neonates received a 4-week regimen of ZDV. Complete blood count, aspartate transaminase and alanine transaminase were assessed at birth, 1, 2 and 4 months of life.
From October 2015 to November 2017, 200 infants were enrolled, of which 18.5% had low birth weight < 2500 g. The proportion of infants with anemia grade 2 or higher at 1 and 2 months of life between ZDV/3TC/NVP and ZDV prophylaxis was 48.5% vs 32.3% (P=0.02); nevertheless, severe anemia (grade 3) was not significantly different; 9.2% vs 10.2% (P=0.81), respectively. At 1 month old, infants on ZDV/3TC/NVP prophylaxis had significantly higher grade 2 anemia versus infants on ZDV alone (33.0% vs 13.4%; P=0.001); however, no difference was observed at 2 months old. No differences in neutropenia or hepatotoxicity between infant prophylactic regimens were observed.
Triple antiretroviral neonatal PEP with ZDV/3TC/NVP for 6 weeks in high-risk HIV-exposed infants did not significantly increase the risk of short-term toxicity compared with ZDV-monotherapy prophylaxis.
对于具有高传播风险的 HIV 暴露婴儿，联合抗逆转录病毒药物方案越来越多地被用作新生儿接触后预防（PEP）。我们评估了在生命的头 6 周内使用齐多夫定（ZDV）/拉米夫定（3TC）/奈韦拉平（NVP）进行新生儿 PEP 相关的不良事件。
在泰国的 5 个临床地点进行了一项非母乳喂养的 HIV 暴露婴儿的前瞻性队列研究。研究人群包括 100 例高风险 HIV 暴露婴儿（分娩前母亲 HIV RNA>50 拷贝/mL 或接受抗逆转录病毒治疗<12 周）和 100 例低风险 HIV 暴露新生儿。高危婴儿接受 ZDV/3TC/NVP 治疗 6 周，而低危 HIV 暴露新生儿接受 ZDV 4 周治疗。在出生时、1 个月、2 个月和 4 个月时评估全血细胞计数、天冬氨酸转氨酶和丙氨酸转氨酶。
从 2015 年 10 月至 2017 年 11 月，共纳入 200 例婴儿，其中 18.5%的婴儿出生体重<2500g。在 ZDV/3TC/NVP 和 ZDV 预防组中，1 个月和 2 个月时发生 2 级或更高级别贫血的婴儿比例分别为 48.5%和 32.3%（P=0.02）；然而，严重贫血（3 级）并无显著差异，分别为 9.2%和 10.2%（P=0.81）。在 1 个月大时，接受 ZDV/3TC/NVP 预防的婴儿与单独接受 ZDV 的婴儿相比，2 级贫血发生率显著升高（33.0%比 13.4%；P=0.001）；然而，在 2 个月时没有差异。两种婴儿预防方案之间的中性粒细胞减少症或肝毒性无差异。
在高风险 HIV 暴露婴儿中，使用 ZDV/3TC/NVP 进行 6 周的三联抗逆转录病毒新生儿 PEP 与 ZDV 单药预防相比，并未显著增加短期毒性风险。
