The U.S. Food and Drug Administration (FDA) has expanded the approval of the antiretroviral medication dolutegravir to treat human immunodeficiency virus (HIV-1) in full-term newborns starting from birth, according to Newswise. Announced in August 2026, the regulatory decision was supported by findings from an international clinical trial that established a safe and effective dosing schedule for infants during their first month of life.
Previously, dolutegravir—a second-generation integrase inhibitor widely prescribed for adults and older pediatric patients—was only cleared for use in children aged four weeks and older. The updated FDA label allows clinicians to prescribe the medication, in combination with other antiretroviral therapies, to full-term infants weighing at least two kilograms (roughly 4.4 pounds) from birth up to four weeks of age. The research backing the decision was conducted through the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, led by investigators at Boston Medical Center alongside researchers from the University of California San Diego, and published in the medical journal The Lancet HIV.
Bridging the Treatment Gap in Neonatal HIV Care
For decades, pediatric infectious disease specialists have faced a narrow selection of approved medications when treating newborns diagnosed with or exposed to HIV-1. While adult antiretroviral therapies have advanced rapidly, adapting those same medications for neonates requires specialized clinical testing. Early intervention is a cornerstone of pediatric HIV care, as initiating effective antiretroviral therapy in the first days of life helps suppress viral replication, protect the developing immune system, and improve long-term health outcomes.
However, newborns cannot simply be given scaled-down adult doses without rigorous testing. During the first four weeks of life, an infant's organs and metabolic pathways undergo rapid physiological changes. The liver enzymes and kidney functions responsible for breaking down and clearing medications from the bloodstream mature day by day, meaning a dose that is too low might fail to control the virus, while a dose that is too high could cause unintended side effects.
"Newborns process medications differently than older children and adults, and their ability to eliminate drugs changes rapidly during the first month of life," said Jeremiah Momper, PharmD, PhD, first author of the study and professor at the UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. "Our study provides important pharmacokinetic and safety data to guide dolutegravir dosing during this critical period of development."
Inside the International IMPAACT 2023 Clinical Trial
To determine whether dolutegravir could be safely administered immediately after birth, researchers launched a Phase I clinical trial known as IMPAACT 2023. The international study took place across clinical research sites in the United States, South Africa, and Thailand, reflecting a collaborative effort to address neonatal HIV care across diverse global healthcare settings.
The research team enrolled 48 full-term newborns born to women living with HIV-1. Alongside standard antiretroviral prophylaxis, the infants were placed into specific study groups to evaluate how their bodies absorbed, distributed, metabolized, and eliminated the medication. Depending on their assigned group, the newborns received either two separate single doses of dolutegravir or repeated doses across the initial weeks of life. Medical teams closely monitored all participating infants for 16 weeks to track their health and evaluate safety outcomes.
The laboratory and clinical assessments revealed that the tailored dosing regimen achieved dolutegravir concentrations in the newborns' bloodstreams comparable to the therapeutic levels seen in older children and adults taking the drug. Furthermore, the medication was generally well tolerated by the neonates, demonstrating a safety profile consistent with prior clinical observations in older infants and pediatric patients.
Why Dolutegravir Access Matters for Newborns
Dolutegravir belongs to a class of antiretroviral drugs called integrase strand transfer inhibitors, which work by blocking an enzyme the HIV virus needs to insert its genetic material into human immune cells. Because of its effectiveness and tolerability, it has become a standard component of HIV treatment guidelines for adults and older children worldwide. Prior to the August 2026 regulatory update, however, clinicians caring for newborns during their first four weeks of life had to rely on a very small pool of older antiretroviral formulations before transitioning infants to dolutegravir once they reached one month of age.
By validating a safe birth-to-four-week dosing schedule, the IMPAACT 2023 study removes that four-week waiting period for full-term infants meeting the weight requirement. Having an approved dosing protocol from day one simplifies care continuity, allowing pediatricians and infectious disease pharmacists to utilize a modern integrase inhibitor right from the maternity ward.
"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, PharmD, lead investigator of the study and a pediatric infectious diseases pharmacist at Boston Medical Center. "This represents an important advance for the care of newborns, as early treatment with the right medications is critical."
What This Means for Families and Clinicians
For parents, caregivers, and pediatric healthcare providers in the United States and around the world, the FDA's expanded label offers a vetted, evidence-based option for managing HIV-1 during the earliest stage of life. Under the updated guidelines, full-term infants weighing at least two kilograms can begin receiving dolutegravir as part of a combination antiretroviral regimen immediately after delivery.
Because newborn medication dosing depends heavily on birth weight, gestational age, and ongoing postnatal development, pediatric specialists and clinical pharmacists will use the pharmacokinetic findings from the IMPAACT 2023 trial to adjust dosing as the infant grows through the first month of life. Families navigating perinatal HIV care should consult directly with their pediatric infectious disease team to understand how combination antiretroviral therapies are selected and monitored during the newborn period.
