在第二次免疫接种时采取优化策略预防母乳喂养中 HIV 传播：布基纳法索的一项 2 期试验（PREVENIR-PEV）。
An optimized strategy triggered at the 2nd immunization visit to prevent HIV acquisition by breastfeeding: a phase 2 trial in Burkina Faso (PREVENIR-PEV).
机构信息
Pathogenesis and Control of Chronic and Emerging Infections, Montpellier University, INSERM, 60 Rue de Navacelles, Montpellier, EFS, 34394, France.
Infectious Disease Research Programme, Centre MURAZ/National Institute of Public Health, Bobo-Dioulasso, Burkina Faso.
出版信息
BMC Infect Dis. 2024 Sep 20;24(1):1014. doi: 10.1186/s12879-024-09910-z.
BACKGROUND
Mother-to-child transmission of HIV during breastfeeding remains a challenge in low- and middle-income countries (LMIC). A prevention package was initiated during the highly attended 2nd visit of the Expanded Program of Immunisation (EPI-2) to identify the undiagnosed infants living with HIV and reduce the postnatal transmission of infant exposed to HIV.
METHODS
PREVENIR-PEV is a non-randomized phase II clinical trial conducted at two health centres in Bobo Dioulasso (Burkina Faso). The study recruited mothers living with HIV aged 15 years and older with their singleton breastfed infants. During EPI-2 (at 8 weeks) and upon signature of the informed consent, a point-of-care early infant diagnosis (EID) was performed. HIV exposed uninfected (HEU) infants were followed-up until 12 months of age. High risk HEU infants (i.e., whose maternal viral load ≥ 1000 cp/mL at EPI-2 or M6) received an extended postnatal prophylaxis (PNP) with lamivudine until end of follow-up or the end of breastfeeding.
RESULTS
Between 4 December 2019 and 4 December 2020, 118 mothers living with HIV-1 were identified, and 102 eligible mother/infant pairs had their infants tested for HIV EID. Six infants were newly diagnosed with HIV, and 96 HEU infants were followed-up for 10 months. Among the participants followed-up, all mothers were prescribed antiretrovirals. All 18 infants eligible for PNP at either EPI-2 or 6 months (M6) were initiated on lamivudine. No HIV transmission occurred, and no serious adverse events were reported in infants receiving lamivudine.
CONCLUSIONS
The PREVENIR-PEV prevention package integrated into existing care is safe and its implementation is feasible in a LMIC with a low HIV prevalence. More research is needed to target mother/infant pairs not adhering to the intervention proposed in this trial.
TRIAL REGISTRATION
NCT03869944; first registered on 11/03/2019.
背景
在中低收入国家（LMIC），HIV 通过母乳喂养进行母婴传播仍然是一个挑战。在扩大免疫规划（EPI-2）的第二次高参与度访问期间，发起了一项预防方案，以确定感染 HIV 的未被诊断的婴儿，并减少接触 HIV 的婴儿的产后传播。
方法
PREVENIR-PEV 是在布基纳法索博博迪乌拉索的两个卫生中心进行的一项非随机二期临床试验。该研究招募了年龄在 15 岁及以上且正在母乳喂养的 HIV 阳性母亲及其单胎婴儿。在 EPI-2（8 周时）和签署知情同意书后，进行即时婴儿诊断（EID）。未感染 HIV 的 HIV 暴露婴儿（即，EPI-2 时母亲病毒载量≥1000 cp/mL 或 M6 时的高风险 HEU 婴儿）接受拉米夫定的扩展产后预防（PNP），直至随访结束或母乳喂养结束。
结果
在 2019 年 12 月 4 日至 2020 年 12 月 4 日期间，确定了 118 名 HIV-1 阳性母亲，其中 102 名符合条件的母婴对进行了 HIV EID 检测。有 6 名婴儿新诊断出 HIV，96 名 HEU 婴儿接受了 10 个月的随访。在接受随访的参与者中，所有母亲均开具了抗逆转录病毒药物。所有在 EPI-2 或 6 个月（M6）时符合 PNP 条件的 18 名婴儿均开始接受拉米夫定治疗。接受拉米夫定治疗的婴儿均未发生 HIV 传播，也未报告任何严重不良事件。
结论
将 PREVENIR-PEV 预防方案整合到现有护理中是安全的，在 HIV 感染率较低的中低收入国家实施是可行的。需要进一步研究针对不符合本试验提出的干预措施的母婴对。
试验注册
NCT03869944；首次注册于 2019 年 3 月 11 日。
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