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Extended HIV prophylaxis effective in infants for up to 50 weeks of breastfeeding

Twelve months of antiretroviral drug treatment was highly effective at preventing transmission of HIV-1 from infected women to their breastfeeding infants, according to recently published data in the Lancet.

“Our study showed that two infant [pre-exposure prophylaxis (PrEP)] regimens, using lopinavir-ritonavir or lamivudine, were equally well-tolerated and effective to reduce postnatal HIV-1 transmission incidence to lower than 1.5%,” the researchers wrote.  

Researchers conducted a randomized controlled trial of infants in four African countries to compare the efficacy of infant prophylaxis with the drug treatments lamivudine or lopinavir-ritonavir over a 12-month period. Overall, 615 infants whose mothers were not eligible for antiretroviral therapy were randomly assigned to lopinavir-ritonavir and 621 were assigned to lamivudine.

Results demonstrated that HIV infection rates did not differ between the two drugs regimens (HR = 0.9; 95% CI, 0.35-2.34), with eight infections in the lopinavir–ritonavir group and nine in the lamivudine group. Of these infections, almost half occurred after 6 months of breastfeeding.

Additionally, no significant difference in adverse events was seen between the two cohorts.

“Infant PrEP proved an effective and safe alternative to prevent postnatal HIV-1 transmission for mothers who are not ready or prepared to embark on long-term [antiretroviral therapy]. In addition, adding infant PrEP in breastfed babies whose mothers are taking [antiretroviral therapy] is a strategy that should be assessed…This finding justifies the extension of infant PrEP until the end of HIV-1 exposure and the need to inform mothers about the persistent risk of transmission throughout breastfeeding to adherence fatigue,” the researchers concluded.

In an accompanying editorial, Hoosen Coovadia, MD, professor, Maternal Adolescent and Child Health, School of Public Health, University of the Witwatersrand, Durban, South Africa and Dhayendre Moodley, PhD, Center for the AIDS Programme of Research in South Africa, noted that the importance of the study findings, which show that infant PrEP reduces the risk of HIV transmission during breastfeeding beyond the length of time that has been previously studied.

“Given the opportunities for infant PrEP in optimizing prevention of breastfeeding transmission, and faced with the challenges of maternal [antiretroviral therapy] use, further research is now needed to evaluate the feasibility, cost-effectiveness, and safety of multipronged prevention of mother-to-child transmission programme to eliminate mother-to-child transmission of HIV while promoting a long duration of breastfeeding and equally maintain maternal and child survival,” Coovadia and Moodley conclude. – by Casey Hower

Disclosures: The researchers report no relevant financial disclosures.