December 13, 2023
3 min read
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Key takeaways:
- Very early ART initiation can lead to sustained viral suppression in infants with HIV.
- The study identified infants eligible to stop ART to see if they experience treatment-free remission.
Newborns with HIV who receive very early ART can achieve sustained virological suppression, a study found. Researchers said the results provide a jumping-off point to identify infants who may later achieve treatment-free remission.
“In 2013, we reported on a case of ART-free remission in a toddler diagnosed with HIV-1 that was acquired in utero that we believed was due to the very early start of a triple antiretroviral drug regimen that was initiated at 30 hours of life,” Deborah Persaud, MD, director of the Eudowood Division of Pediatric Infectious Diseases at Johns Hopkins Children’s Center, told Healio, referring to the case of the Mississippi baby.
“This child experienced 27 months of ART-free remission where the HIV did not return for 27 months after her ART treatment regimen was withdrawn at 18 months of age,” Persaud said. “The discovery that very early neonatal ART treatment may have been the therapy that led to the ART-free remission resulted in the development of a clinical trial in newborns around the world.”
From Jan 23, 2015, to Dec. 14, 2017, Persaud and colleagues conducted the ongoing phase 1/2 proof-of-concept IMPAACT P1115 trial, which enrolled 460 infants at least 34 weeks’ gestational age from 30 research clinics in Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania, Thailand, Uganda, United States, Zambia and Zimbabwe.
The researchers assigned infants into two cohorts: 440 infants at high risk for in-utero HIV with untreated maternal HIV, and 20 infants at high risk for in-utero HIV who received pre-emptive triple ART prophylaxis outside of the study.
Infants in the first cohort received three-drug nevirapine-based ART, and those in the second cohort received three-drug nevirapine-based prophylaxis in addition to three-drug nevirapine-based ART following HIV diagnosis by age 10 days.
“We set out to test whether treating newborns who acquired HIV in utero very early — within 48 hours of life — would lead to sustained virologic suppression on neonatal ART and to marked decrease in the amount of HIV-infected cells lingering on ART,” Persaud said.
A total of 54 infants — 34 from the first cohort and 20 from the second — had confirmed in-utero HIV-1 and received ART.
Among 18 total participants who maintained virological control through week 108, seven of 11 (64%) in the first cohort and five of seven (71%) in the second cohort had not detectable HIV DNA, Persaud and colleagues reported.
Among the 54 infants who received very earl ART, 19% overall — six infants in the first cohort and four in the second — had undetectable HIV DNA and HIV antibodies, “making them eligible to consider stopping the study ART regimen to see if they have experienced ART-free remission, in which the virus doesn’t return within the usual 2 to 4 weeks of stopping ART,” Persaud said.
In the study, Persaud and colleagues wrote: “Sustained virological control is the first step in eligibility criteria for analytical treatment interruption, offering hope of achieving low reservoir size, with HIV-1 DNA not detected in peripheral blood cells in early infancy.”
Persaud said future research can examine whether immunotherapies such as vaccines and broadly neutralizing antibodies can lead to ART-free remission in children.
“It is very important to not only test pregnant people for HIV to first be able to prevent infection, but in the few cases of breakthrough infection to be able to test very early and start triple therapy in the first few days of life,” Persaud said.
The goal, Persaud said, is getting to “undetectable viral loads, stay[ing] undetectable and keep[ing] children on their treatment regimen until we know how to get to ART-free remission where therapy can be stopped.”
“We are far from that goal, but these proof-of-concept clinical trials help us understand how to curtail these reservoirs and keep them at very low levels to help get to ART-free remission,” Persaud said. “ART is lifesaving for children but we need better therapies to help with the challenge of adherence and long-term toxicities.”
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Sources/Disclosures
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Source:
Persaud D, et al. The Lancet HIV. 2023;doi:10.1016/S2352-3018(23)00236-9.
Disclosures:
Persaud reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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