Powis Kathleen M, Lockman Shahin, Ajibola Gbolahan, Hughes Michael D, Bennett Kara, Leidner Jean, Batlang Oganne, Botebele Kerapetse, Moyo Sikhulile, van Widenfelt Erik, Makhema Joseph, Petlo Chipo, Jibril Haruna B, McIntosh Kenneth, Essex Max, Shapiro Roger L
Massachusetts General Hospital, Departments of Medicine and Pediatrics, United States.
Harvard T. H. Chan School of Public Health, Department of Immunology and Infectious Diseases, United States.
South Afr J HIV Med. 2018 Mar 28;19(1):751. doi: 10.4102/sajhivmed.v19i1.751. eCollection 2018.
The World Health Organization HIV guidelines recommend either infant zidovudine (ZDV) or nevirapine (NVP) prophylaxis for the prevention of intrapartum mother-to-child HIV transmission (MTCT) among formula-fed infants. No study has evaluated the comparative efficacy of infant prophylaxis with twice daily ZDV versus once daily NVP in exclusively formula-fed HIV-exposed infants.
Using data from the Mpepu Study, a Botswana-based clinical trial investigating whether prophylactic co-trimoxazole could improve infant survival, retrospective analyses of MTCT events and Division of AIDS (DAIDS) Grade 3 or Grade 4 occurrences of anaemia or neutropenia were performed among infants born full-term (≥ 37 weeks gestation), with a birth weight ≥ 2500 g and who were formula-fed from birth. ZDV infant prophylaxis was used from Mpepu Study inception. A protocol modification mid-way through the study led to the subsequent use of NVP infant prophylaxis.
Among infants qualifying for this secondary retrospective analysis, a total of 695 (52%) infants received ZDV, while 646 (48%) received NVP from birth for at least 25 days but no more than 35 days. Confirmed intrapartum HIV infection occurred in two (0.29%) ZDV recipients and three (0.46%) NVP recipients ( = 0.68). Anaemia occurred in 19 (2.7%) ZDV versus 12 (1.9%) NVP ( = 0.36) recipients. Neutropenia occurred in 28 (4.0%) ZDV versus 21 (3.3%) NVP recipients ( = 0.47).
Both ZDV and NVP resulted in low intrapartum transmission rates and no significant differences in severe infant haematologic toxicity (DAIDS Grade 3 or Grade 4) among formula-fed full-term infants with a birthweight ≥ 2500 g.
世界卫生组织的艾滋病病毒指南推荐，对于人工喂养的婴儿，可采用婴儿齐多夫定（ZDV）或奈韦拉平（NVP）预防措施，以预防分娩期间母婴间的艾滋病病毒传播（MTCT）。尚无研究评估在完全人工喂养的艾滋病病毒暴露婴儿中，每日两次使用ZDV与每日一次使用NVP进行婴儿预防的相对疗效。
利用来自姆佩普研究的数据，该研究是一项在博茨瓦纳进行的临床试验，旨在调查预防性复方新诺明是否能提高婴儿存活率，对足月出生（妊娠≥37周）、出生体重≥2500克且从出生就进行人工喂养的婴儿中的MTCT事件以及艾滋病司（DAIDS）3级或4级贫血或中性粒细胞减少症的发生情况进行回顾性分析。从姆佩普研究开始就使用ZDV进行婴儿预防。研究进行到一半时，方案修改导致随后使用NVP进行婴儿预防。
在符合此次二级回顾性分析条件的婴儿中，共有695名（52%）婴儿接受了ZDV，而646名（48%）婴儿从出生起接受NVP至少25天但不超过35天。2名（0.29%）接受ZDV的婴儿和3名（0.46%）接受NVP的婴儿确诊发生分娩期间的艾滋病病毒感染（P = 0.68）。接受ZDV的婴儿中有19名（2.7%）发生贫血，而接受NVP的婴儿中有12名（1.9%）发生贫血（P = 0.36）。接受ZDV的婴儿中有28名（4.0%）发生中性粒细胞减少症，而接受NVP的婴儿中有21名（3.3%）发生中性粒细胞减少症（P = 0.47）。
对于出生体重≥2500克的足月人工喂养婴儿，ZDV和NVP均导致分娩期间的低传播率，且在严重婴儿血液学毒性（DAIDS 3级或4级）方面无显著差异。
