ViiV Healthcare wins US approval for HIV treatment in newborn babies as the FDA authorizes Tivicay PD for infants weighing at least 2 kg, including eligible newborns from birth.
Regulatory clearance expands pediatric options
The agency’s decision lets clinicians combine the new formulation with other antiretrovirals for children who have not yet received integrase strand transfer inhibitors. It marks the first time a second‑generation INSTI is cleared for this weight class.
According to the filing, the drug works by blocking an enzyme the virus needs to insert its genetic material into human cells. The company notes the medication has a higher barrier to resistance than earlier members of its class.
Study results underpin the approval
Data came from the NIH‑funded International Maternal Paediatric Adolescent AIDS Clinical Trials (IMPAACT 2023) study and pharmacokinetic modelling that used pediatric information. The trial showed therapeutic levels were reached in term neonates and safety matched that seen in older patients.
“Today’s approval of Tivicay PD expands the options available for paediatric HIV care, giving families and clinicians in the US greater choice from the very beginning of life,” said Jean van Wyk, chief medical officer at ViiV Healthcare.
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She added, “For ViiV Healthcare, it reflects our commitment to bringing INSTI‑based innovation to children and addressing persistent gaps in HIV care.”
Lead investigator Diana F Clarke, an assistant professor at Boston University School of Medicine, emphasized the need for newborn‑specific regimens. “For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs,” she said. “With the approval of a Tivicay PD dosing regimen, babies born at term and weighing at least 2 kg will now have access to dolutegravir‑based therapy starting at birth.”
The study also highlighted that around half of untreated children with HIV die by age two, showing the urgency of early intervention. Researchers noted that early treatment with the most effective therapies yields the best possible outcomes.
Families can start therapy within hours.
In practice, this could simplify hospital protocols and reduce the need for multiple drug switches as infants grow.
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From a practical standpoint, the new dosing schedule may lessen the logistical burden on clinics that previously relied on off‑label use or compounded preparations. Parents could receive a single, ready‑to‑administer product, which may improve adherence during the critical first weeks of life.
The approval also aligns with broader public‑health goals to lower pediatric HIV mortality. By providing a regimen that is both potent and tolerable, clinicians can aim for viral suppression earlier, potentially decreasing the long‑term health costs associated with disease progression.
Health‑care providers are advised to follow the prescribing information released alongside the clearance, which details weight‑based dosing and monitoring recommendations. The guidance also outlines contraindications and potential drug‑interaction considerations.
Regulators based their decision on a combination of clinical trial outcomes and modeled projections, indicating confidence in the safety profile for this vulnerable population. The agency’s review process included input from independent pediatric experts.
For more details on the study design, see the NIH website. The FDA’s full approval notice is available on its official portal here.
