March 1, 2024

Study Confirms Benefit of Early Antiretroviral Therapy for Newborns with HIV

In a study conducted across multiple continents, researchers have found significant evidence that administering antiretroviral therapy (ART) to newborns with HIV within the first days of life can effectively suppress the virus to undetectable levels. The study, co-led by Deborah Persaud, M.D., a physician-scientist and researcher at Johns Hopkins Children’s Center, was sponsored by the National Institutes of Health (NIH) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network. The findings of the study were published in The Lancet HIV.

HIV, or human immunodeficiency virus, attacks the immune system and currently has no cure. However, ART can control the virus and prevent it from progressing to AIDS, the most severe stage of HIV infection. Without ART, there is a significant risk of HIV transmission from pregnant individuals to their children during pregnancy, childbirth, or breastfeeding. However, when pregnant individuals receive ART, the transmission risk decreases to less than 1%. It is estimated that around 1.5 million children worldwide are living with HIV.

The standard treatment for infants with HIV typically starts at around 2 to 3 months of age. This delay is often due to difficulties in testing and obtaining results, particularly in countries where HIV burden is high, and ART drugs are less accessible. Additionally, concerns about side effects, such as anemia, nausea, vomiting, and diarrhea, contribute to the delayed treatment initiation.

The research team, led by Persaud, aimed to replicate the case of the Mississippi baby, who achieved HIV remission after receiving ART within 30 hours of birth. They started infants with HIV on a three-drug oral ART regimen within 48 hours of life. The team enrolled 54 newborns into two groups at sites in 11 countries, primarily in sub-Saharan Africa, but also in Brazil, Thailand, the U.S., and other nations.

One group of 34 infants, whose mothers did not receive ART during pregnancy, started the three-drug regimen shortly after birth. The second group of 20 infants, whose mothers received ART during pregnancy, were initially given a lower dose of one of the drugs but switched to the same regimen as the first group once enrolled in the study. All infants who tested HIV positive at around 14 days old received an additional medicine.

The researchers estimated that infants in the study had a 33-57% chance of achieving and maintaining undetectable levels of HIV in their blood beyond two years of age. At the end of the study period, the majority of participants who maintained virologic suppression tested negative for HIV antibodies, and a significant percentage had no detectable HIV DNA.

The study demonstrates the safety and effectiveness of very early ART in newborns with HIV. Persaud believes that this treatment strategy could lead to longer periods off antiretroviral drugs and reduce the stigma associated with daily medication intake. As the trial continues, the team will explore more effective treatment regimens and evaluate the potential for ART-free remission among infants.

This research highlights the importance of early HIV diagnosis and treatment in infants and suggests that these practices should be a priority in global HIV testing and treatment programs. By initiating ART within hours of birth, healthcare providers can reduce the formation of viral reservoirs that typically allow HIV to persist in the body. Ultimately, early treatment offers hope for better outcomes and improved quality of life for newborns with HIV.

1. Source: Coherent Market Insights, Public sources, Desk research
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