Virological outcomes of early HIV treatment in infants

The IMPAACT P1115 study, presented at the CROI 2022 conference by Dr Deborah Persaud of Johns Hopkins University School of Medicine, evaluated the response to very early initiation of antiretroviral treatment (ART) in infants born with HIV. 

Recruitment of children to participate in the study began in January 2015 and participants were enrolled at 30 clinical trial centres in 11 countries across Africa, Asia and the Americas.

The Study

460 infants were enrolled into the study, with those participants split between two groups.

• Group one included 440 children who were at higher risk of contracting HIV due to their mother’s unsuppressed viral load. These infants were started on ART within 48 hours of birth. On follow-up testing 34 participants were found to be HIV positive - they continued to participate in the study and receive ART. 
• Group two included 20 infants who started the study at the age of 10 days, they received ART within 48 hours of birth.

Initially, all infants received an ART regimen based on the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine and two nucleoside reverse transcriptase inhibitors (NRTI) abacavir and lamivudine. From either there 10th and 21st days after birth, lopinavir/ritonavir was added to the regimen. Once an undetectable viral load (less than 200 copies/mm3) was achieved the nevirapine was discontinued.

The results

By the age of six months, 75% of children in the first group and 88% in the second group had achieved an undetectable viral load of 200 copies/mm3 or under.

By two years of age, in the children who remained in the study, 33% of the participants in the first group and 57% in the second group had an undetectable viral load. Ten out of twelve children in the first group and all children in the second group lost antibodies to HIV.

Conclusion

Infants with HIV who start ART very early and remain virally suppressed may achieve fewer viral reservoirs by the age of two, and may achieve long lasting HIV remission without the need for ART.

By age two, out of 54 children, 30% had the same characteristics (undetectable HIV, RNA and antibodies) as the Mississippi child. This means that some of these children may be eligible for ART interruption, but the team continues to work on how to do this in a safe and secure way.