Breastfeeding babies protected against HIV infection from their HIV-positive mothers with 12 months of liquid antiretroviral drug treatment
A study from four countries in Africa, published in The Lancet, shows that providing babies with up to 12 months of liquid formula HIV drugs, while breastfeeding with their HIV-positive mothers, is highly effective at protecting them from infection, including in the 6-12 month period after birth which has not been analysed in previous research. The study is by Professor Philippe Van de Perre, INSERM, Montpellier, France, and colleagues.
Strategies to prevent postnatal mother-to-child transmission of HIV-1 in Africa, including directly protecting infants through prophylaxis with special child formulations of HIV drugs, have never been assessed past six months of breastfeeding, despite breastfeeding being recommended up to 12 months after birth. In this new study, the authors aimed to compare the efficacy and safety of infant prophylaxis with two drug regimens (lamivudine or lopinavir-ritonavir) to prevent postnatal HIV-1 transmission during up to 50 weeks of breastfeeding.
They did a randomised controlled trial in four sites in Burkina Faso, South Africa, Uganda, and Zambia in children born to HIV-infected mothers who were not yet eligible for antiretroviral therapy under the guidelines that existed when the trial took place (CD4 count >350 cells per μL–however, today, WHO advises that all people diagnosed with HIV immediately begin treatment, regardless of CD4 count).
In the study, HIV-negative breastfed infants aged 7 days were randomised to receive either lopinavir-ritonavir or lamivudine (paediatric liquid formulations, twice a day) up to 1 week after complete cessation of breastfeeding or at the final visit at week 50. Treatment allocation was hidden from participants and study physicians, and the primary outcome was infant HIV-1 infection between age 7 days and 50 weeks, in the modified intention-to-treat population (meaning all babies in the study who attended at least one follow-up visit).
Between November, 2009, and May, 2012, 1273 infants were enrolled and 1236 were analysed; 615 assigned to lopinavir-ritonavir and 621 assigned to lamivudine. A total of 17 HIV infections were diagnosed in the study period (eight in the lopinavir-ritonavir group and nine in the lamivudine group), resulting in cumulative rates of HIV-1 infection of 1·4 per cent and 1·5 per cent, respectively, and meaning that infection rates did not differ between the two drug regimens. Clinical and biological severe adverse events did not differ between groups.
The authors say: “Crucially, about half of the postnatal HIV-1 infections in both g