A Systematic Review of the Use of Antiretroviral Drugs to Prevent HIV in Neonates and Infants.

BACKGROUND

Preventing the postnatal transmission of HIV remains an unfinished goal globally. Infant antiretroviral (ARV) prophylaxis remains important, particularly when maternal viral suppression is not assured. We conducted a systematic review to identify optimal infant ARV prophylaxis to inform World Health Organization 2025 guidelines.

METHODS

PubMed, Embase, and Global Index Medicus were searched for randomized controlled trials published in 2014-2024 evaluating ARVs given to infants to prevent postnatal HIV transmission. Eligible articles from prior systematic reviews from 1994 to 2014 were also reviewed. Two risk periods were considered: (1) the early postnatal period from delivery to 6 weeks of age, and (2) during breastfeeding from 6 weeks to 12 months. Scenarios were defined as higher risk when the mother was not on ART and lower risk when mothers were on ART.

RESULTS

We screened 1670 studies and reviewed 70 full-text articles. Nine trials (16 279 infants) met eligibility criteria. In 5 studies addressing high-risk scenarios in the early postnatal period, use of 3 drugs for infant prophylaxis for 1 week followed by a single drug through 6 weeks resulted in 0.1% HIV transmission risk; 2 drugs through 6 weeks resulted in 1.5% risk; and 1 drug alone through 6 weeks, 2.5%-8.2% risk. In 6 studies addressing higher-risk scenarios during breastfeeding, single-drug prophylaxis throughout breastfeeding resulted in <1%-1.5% transmission risk at 12 months. No studies evaluated infant prophylaxis in lower-risk early postnatal scenarios. In low-risk breastfeeding scenarios, 6 weeks of infant prophylaxis resulted in <1% risk at 12 months.

CONCLUSION

In higher-risk scenarios, trial data show that infants have the lowest risk of HIV transmission during the early postnatal period when they receive 2 weeks of 3 ARV drugs followed by a single drug through 6 weeks. Afterward, single-drug prophylaxis throughout breastfeeding demonstrates the lowest transmission risk at 12 months.