Forty-eight newborns in South Africa, Thailand, and the United States just helped rewrite the future of HIV care. These tiny pioneers were part of a groundbreaking study that led the U.S. Food and Drug Administration to approve dolutegravir—a powerful HIV drug—for use in full-term newborns from the moment they are born. For decades, babies with HIV had few treatment options tailored to their fragile, fast-changing bodies. Now, thanks to this international effort, doctors have a safer, more effective way to start fighting the virus in the very first days of life.
HIV can pass from mother to child during pregnancy, birth, or breastfeeding. Without treatment, it can quickly take hold in a newborn’s developing immune system. Starting antiretroviral therapy early is critical—but newborns process drugs differently than older children or adults. Their livers and kidneys are still maturing, which affects how they absorb and clear medications. Until now, dolutegravir was only approved for children 4 weeks and older, leaving a dangerous gap in care during the most vulnerable weeks of life.
The study, called IMPAACT 2023, was led by researchers at Boston Medical Center and included key contributions from scientists at the University of California San Diego. It tested how dolutegravir behaves in the bodies of 48 full-term newborns born to mothers with HIV-1. Some babies received a single dose, others multiple doses, all alongside standard HIV prevention treatment. Over 16 weeks, researchers tracked how the drug moved through their systems and whether it caused any side effects. The results were clear: dolutegravir reached effective levels in the babies’ blood—levels known to suppress HIV—and was well tolerated, with no serious safety concerns.
In August 2026, the FDA approved dolutegravir for full-term infants weighing at least 2 kilograms (about 4.4 pounds) from birth up to 4 weeks of age, when used with other antiretroviral drugs. This means more babies can now start on one of the most effective HIV treatments right away, no matter their age at diagnosis. Dolutegravir is already a cornerstone of HIV therapy in older patients because it works quickly, has few side effects, and is less likely to lead to drug resistance.
"For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs, despite the importance of starting treatment as early as possible," said Diana Clarke, Pharm.D., the study’s lead investigator and a pediatric infectious diseases pharmacist at Boston Medical Center. With this approval, a new standard of care is within reach—not just in the U.S., but in countries around the world where this research was conducted and where the need is greatest.