UNITED STATES — A landmark infant study has opened the door to treating HIV in newborns from the day they are born, after the U.S. Food and Drug Administration (FDA) approved the HIV drug dolutegravir for full-term infants weighing at least 2 kilograms, researchers reported in The Lancet HIV in October 2026.
Previously, dolutegravir — a widely used antiretroviral in older children and adults — was approved only for children aged 4 weeks and older. The new approval, announced by the FDA in August 2026 and supported by an international trial of 48 full-term newborns, gives doctors a modern, well-studied treatment option for the youngest patients, a group that has historically had few age-appropriate medicines.
Illustration: A newborn baby in a hospital bassinet, with a nurse gently checking the infant.
What Happened
An international study conducted through the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, including researchers at the University of California San Diego, helped inform the FDA's approval of dolutegravir for the treatment of HIV-1 in newborns from birth, MedicalXpress reported on October 22, 2026. The study, published in The Lancet HIV, identified a dosing regimen that achieves appropriate drug levels in full-term newborns.
The trial, known as IMPAACT 2023, was a phase 1, open-label, multicentre study of 48 full-term newborns exposed to HIV-1. Researchers found that dolutegravir achieved levels in newborns comparable to those observed in older children and adults receiving the medication, and that it was generally well tolerated, with a safety profile similar to that seen in older infants and children. All infants were followed for 16 weeks to assess safety.
The FDA approval, announced on August 25–26, 2026, extends the label for dolutegravir — sold as Tivicay PD tablets for oral suspension by ViiV Healthcare — to treat HIV-1 infection in full-term infants weighing at least 2 kilograms from birth up to four weeks of age, in combination with other antiretroviral medications. Previously the approval began at 4 weeks of age and, for the paediatric indication, at a weight of at least 3 kilograms.
Dolutegravir is a second-generation integrase strand transfer inhibitor, a class of drug that blocks the virus from inserting its genetic material into human cells. According to ViiV Healthcare, the approval makes Tivicay PD the first second-generation integrase inhibitor approved for children weighing at least 2 kilograms, including eligible newborns. The dispersible tablet can be dispersed in water, supporting weight-based dosing in the smallest patients.
Background
Treating HIV in newborns is uniquely difficult. Newborns process medications differently from older children and adults, and their ability to eliminate drugs changes rapidly during the first month of life, said Jeremiah Momper, Pharm.D., Ph.D., first author of the study and a professor at UC San Diego's 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," Momper said.
That rapid change is why dosing cannot simply be scaled down from adult doses. A dose that is safe on day one may behave differently by week three as the infant's liver and kidneys mature. The IMPAACT 2023 study was designed specifically to measure how drug levels evolve in term neonates, rather than extrapolating from older children — and it found a regimen that kept levels in the target range through the newborn period.
The stakes of getting this right are high. Without early diagnosis and treatment, HIV can progress rapidly in infants, and around half of untreated infants with HIV die by age two, according to figures cited by ViiV Healthcare in its approval announcement. Early treatment with the most effective therapies, by contrast, greatly improves health outcomes — which is why paediatric specialists have long argued that newborns should not have to wait weeks for access to the best available drugs.
Dolutegravir itself is already a mainstay of HIV treatment worldwide. It is widely used in older children and adults, has a high barrier to viral resistance, and is a preferred component of many treatment regimens. Extending it to newborns therefore does not introduce an unfamiliar drug to paediatric care — it closes a gap at the very start of life, so that a baby born with HIV can begin on a regimen doctors already know well.
Illustration: Scientists in a medical laboratory studying medicine vials and charts for a paediatric HIV drug trial.
Why It Matters
For newborns, the approval removes a cruel timing problem. A baby diagnosed at birth previously faced a wait before dolutegravir-based therapy could begin, during which doctors had to rely on a smaller set of older options. Diana Clarke, PharmD, lead investigator of the study and a paediatric infectious diseases pharmacist at Boston Medical Center, said newborns living with HIV had for too long had too few treatment options designed and studied for their unique needs, despite the importance of starting treatment as early as possible.
"This represents an important advance for the care of newborns, as early treatment with the most effective therapies can greatly improve health outcomes," Clarke said. The point is not only that a new drug is available, but that it is available with dosing evidence gathered in newborns themselves — the kind of evidence regulators and clinicians need before using a powerful medicine in the first days of life.
The approval also matters for health systems in countries with high HIV burdens. Dolutegravir-based regimens are already the backbone of many national HIV programmes, so adding a newborn formulation that fits into the same treatment family simplifies supply, training and follow-up. A dispersible tablet that can be given in water is practical in clinics without complex preparation, and a regimen that transitions to standard weight-based paediatric dosing at four weeks of age gives clinicians a clear, continuous pathway.
More broadly, the study sets a template for paediatric drug research. Too often, medicines are approved for adults and older children first, and newborn dosing is worked out years later — if at all. The IMPAACT 2023 trial shows that dedicated newborn pharmacokinetic studies can be done safely and can change labels within the same year, a model researchers hope will be repeated for other essential medicines that newborns currently receive without proper dosing data.
What Happens Next
The next step is access. Regulatory approval in the United States does not automatically put the drug into clinics worldwide, and the benefit for newborns in the countries where most babies with HIV are born will depend on national regulators, procurement and inclusion in treatment guidelines. ViiV Healthcare and its partners have framed the approval as part of broader efforts to provide HIV treatment options across the paediatric journey, and advocates will watch for roll-out in low- and middle-income countries.
Clinicians will also need practical guidance: how to identify eligible newborns quickly, how to combine dolutegravir with other antiretrovirals in the first weeks, and how to monitor infants as their drug metabolism changes. The study's 16-week safety follow-up provides a foundation, but real-world use in diverse settings will add evidence on tolerability and outcomes over longer periods.
Researchers are likely to build on the trial in two directions. One is longer-term follow-up of children who start dolutegravir at birth, to confirm that early treatment translates into lasting viral suppression and healthy development. The other is applying the same newborn-study approach to newer HIV medicines, so that the next generation of treatments does not again arrive years late for the youngest patients.
For families, the change is simpler and more personal: a baby born with HIV today can start life on one of the world's most effective HIV medicines, at a dose studied in babies just like them, rather than waiting for an older threshold to pass. That, the study's authors argue, is the real measure of the approval — not a label change, but a first month of life no longer spent waiting.
Illustration: A mother holding her newborn baby at a clinic while a doctor explains a treatment plan.
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FAQ
What is dolutegravir?
Dolutegravir is a second-generation integrase inhibitor, an antiretroviral drug that blocks HIV from inserting its genetic material into human cells. It is widely used to treat HIV in older children and adults.
Who can now receive it from birth?
Under the expanded FDA approval, full-term infants weighing at least 2 kilograms can receive dolutegravir from birth up to four weeks of age, in combination with other antiretroviral medications.
What did the newborn study find?
The IMPAACT 2023 trial studied 48 full-term newborns and found a dosing regimen that achieved drug levels comparable to those in older children and adults. The drug was generally well tolerated over 16 weeks of safety follow-up.
Why is early treatment so important for babies with HIV?
Without early diagnosis and treatment, HIV can progress rapidly in infants, and around half of untreated infants with HIV die by age two, according to figures cited by ViiV Healthcare. Early treatment with effective therapy greatly improves outcomes.
Does the US approval help babies in other countries?
Not automatically. National regulators and treatment programmes elsewhere must adopt the newborn indication, but because dolutegravir is already central to many HIV programmes, advocates hope roll-out will follow.
Sources
- MedicalXpress, "International study helps support FDA approval of HIV drug for newborns," October 22, 2026.
- Momper, J. D., et al., "Pharmacokinetics and safety of dolutegravir in term neonates exposed to HIV-1 (IMPAACT 2023)," The Lancet HIV, 2026.
- ViiV Healthcare, "U.S. FDA approves ViiV Healthcare's Tivicay PD, helping close a critical HIV treatment gap for young children," August 26, 2026.
- News-Medical, "Clinical trial establishes effective HIV dosing regimen for full-term newborns," October 22, 2026.
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