Giving antiretroviral therapy (ART) to newborns with HIV within 48 hours of life — rather than within weeks or months — can safely suppress amounts of HIV in the blood to undetectable levels, revealed a study of more than 50 babies in 11 countries in Africa, Asia, North America and South America.
The study, published in Lancet HIV, showed that children given ART within 48 hours exhibit biomarkers by 2 years of age that may make them eligible to test for medication-free remission.
“Moving away from reliance on daily antiretroviral therapy (ART) to control HIV would be a huge improvement to the quality of life of these children,” said Ellen Chadwick, Professor of Pediatrics at Northwestern University Feinberg School of Medicine.
The study included a three-drug ART regimen initiated within 48 hours of life, with the fourth drug added within 2-4 weeks. This is very early treatment compared to the standard of care where three-drug ART may not begin until 2- 3 months of age.
The team enrolled 54 newborns into two groups in 11 countries — Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania, Thailand, Uganda, the US, Zambia and Zimbabwe — between January 2015 and December 2017.
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One group of 34 infants (23 females and 11 males, whose mothers had HIV and were not on ART during pregnancy) were started on a three-drug oral ART regimen of azidothymidine (AZT) or abacavir, lamivudine (3TC) and nevirapine within two days of life. All of the drugs had previously been shown to help prevent HIV transfer to newborns.
The second group of 20 infants (10 females and 10 males, whose mothers had HIV and were on ART during pregnancy) were started on the same three-drug regimen but with a lower dose of nevirapine shortly after birth. They were then switched to the same study regimen as the first group by ten days of age once enrolled in the study.
A fourth medicine, lopinavir-ritonavir, was also added to the regimen for all babies who were HIV positive after being about 14 days old. Both groups were on ART through the infants’ first two years of life during this phase of the study.
Researchers estimated that infants had a 33 per cent chance (group 1) or 57 per cent chance (group 2) of reaching and maintaining undetectable plasma levels of HIV in the blood beyond the age of two years.
At age two years, among the participants who remained with virologic suppression, 83 per cent in group 1 and 100 per cent in group 2 tested negative for HIV antibodies, and 64 per cent in group 1 and 71 per cent in group 2 had no detectable HIV DNA.
Among the 54 infants who received very early ART, 19 per cent met all of the study’s criteria for becoming eligible to stop treatment in later phases of the ongoing trial.
“Another benefit of smaller viral reservoirs might be that newer treatments such as long-acting antibody therapies or therapeutic vaccines could potentially be used instead of daily ART,” Chadwick added.
“Our results show a higher percentage of children might be eligible to interrupt therapy than we expected, and the next step is to stop ART and see how many children actually achieve remission.”
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