In a new study conducted by Professor Philippe Van de Perre, INSERM, Montpellier, France, and colleagues has revealed that feeding babies with up to 12 months of liquid formula HIV drugs, while breastfeeding with their HIV-positive mothers, is effective in protecting the babies from infection. The study covered four countries in Africa; it included the 6-12 month period after birth which was not covered in previous research and the results of the study were published in The Lancet'.
Even though breastfeeding has been recommended for up to 12 months after birth, there was a lack of assessment for strategies to prevent postnatal mother-to-child transmission of HIV-1 in Africa. In fact, strategy like directly protecting infants through prophylaxis with special child formulations of HIV drugs was never assessed past 6 months of breastfeeding. This new study 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.
Four sites in Burkina Faso, South Africa, Uganda, and Zambia were chosen for a randomized controlled trial in children born to HIV-infected mothers. As per the guidelines that existed when the trial took place (CD4 count >350 cells per ?L), these mothers were yet eligible for antiretroviral therapy.
As a part of the study, HIV-negative breastfed infants aged 7 days were randomly selected to receive either lopinavir-ritonavir or lamivudine (pediatric liquid formulations, twice a day) up to 1 week after complete cessation of breastfeeding or at the final visit at week 50. Participants and study physicians were not made aware of the treatment allocation.
During the period of November, 2009, and May, 2012, 1273 infants were enrolled and 1236 were analysed. Of the 615 assigned to lopinavir-ritonavir, 8 were diagnosed with HIV infection and of 621 assigned to lamivudine, 9 were found to be infected. Analysis showed that infection rates did not differ between the two drug regimens.
The authors were of the opinion that about half of the postnatal HIV-1 infections in both groups occurred after 6 months of breastfeeding, even though HIV exposure was much reduced during this period as many women stopping breastfeeding before 50 weeks. This finding justifies the extension of infant pre-exposure prophylaxis (PrEP) until the end of HIV exposure.
Also, on further analysis of the data it was found that most of the HIV infections in the babies in both groups happened not because of the failure of the drug to protect the baby, but because of lack of adherence to the study drug. The authors also added that there is an need for more research for more palatable oral pediatric formulations and long-acting injectable drugs. The data suggest that rates of HIV infection when the drug was taken fell to 0·2% for the lopinavir-ritonavir group and 0·8% in the lamivudine group, respectively.
It was concluded by the authors that infant PrEP is an effective and safe alternative to prevent postnatal HIV-1 transmission for mothers who are not ready or prepared to embark on long-term ART. They also added that the strategy of adding infant PrEP in breastfed babies whose mothers are taking ART need to be assessed. The crux of the matter is that at population level, in countries where universal maternal ART cannot be implemented as recommended by WHO, infant PrEP with either lopinavir-ritonavir, lamivudine, or nevirapine for the whole duration of breastfeeding is definitely recommended
To sum up, the data in this study reveals that infant ART prophylaxis substantially decreases the breastfeeding risk of transmitting HIV, works at a scale greater than previously studied, and is effective and safe.
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