FDA grants priority review to Tivicay PD for neonatal HIV

The FDA has accepted a supplemental new drug application (sNDA) for Tivicay PD (dolutegravir [DTG]; ViiV Healthcare) that would extend its use to newborns from birth, and has granted the application Priority Review with a PDUFA action date of August 25, 2026.¹

If approved, the expanded indication would fill a longstanding gap in age-appropriate antiretroviral therapy (ART) for the youngest patients with HIV, for whom treatment options have historically been more limited than for older children and adults.

"Early HIV treatment can help shape a child's future, yet newborns have historically had the fewest age-appropriate treatment options," said Jean van Wyk, MBChB, MFPM, chief medical officer at ViiV Healthcare. "ViiV Healthcare has a long-standing commitment to changing that and helping ensure children are not left behind in HIV innovation. These regulatory submissions are a key step toward bringing an innovative, INSTI-based treatment to newborns from birth."¹

In a parallel regulatory action, the European Medicines Agency (EMA) has also validated a marketing application for Tivicay covering the neonatal indication, reflecting coordinated global submissions by ViiV Healthcare.¹

Regulatory pathway and supporting data

The sNDA and EMA marketing application are supported by data from the IMPAACT 2023 trial (NCT05590325), a phase 1, multicenter, open-label study evaluating the safety, tolerability, and pharmacokinetics (PK) of DTG in HIV-exposed neonates during the first 4 to 6 weeks of life.² The study enrolled 2 sequential dosing cohorts stratified by maternal DTG use at the time of delivery: neonates who were DTG-naïve (born to mothers not receiving DTG near delivery) and those who were DTG-exposed (born to mothers receiving DTG at delivery).

According to the press release, DTG achieved target PK exposures in term neonates, with no new safety findings observed relative to older pediatric populations.¹ The submissions also incorporated PK modelling that drew on additional pediatric data to inform neonatal dosing. Prior population PK modelling work had identified that neonatal DTG half-life (median approximately 32.8 hours) substantially exceeds that observed in adults (approximately 14 hours), underscoring the importance of age-specific dosing strategies and the complexity of defining optimal regimens for this population.³

Disease burden and urgency of treatment

The public health rationale for neonatal ART initiation is well established and urgent. Without antiretroviral treatment, HIV progresses with particular rapidity in infants: Approximately one-third of untreated HIV-infected newborns die before their first birthday, and approximately 50% die before age 2.⁴ The Children with HIV Early Antiretroviral Therapy (CHER) trial demonstrated that immediate ART initiation in HIV-infected newborns reduced early mortality by 76% compared with deferred treatment,⁴ establishing the scientific basis for treat-from-birth strategies that remain central to current international guidelines.

Despite these findings, access to appropriate neonatal formulations has remained a persistent barrier. Currently, Tivicay PD is approved for pediatric use in patients aged at least 4 weeks and weighing at least 3 kg, leaving a gap in the first month of life during which INSTI-based therapy is not available with this agent.⁵ Lopinavir/ritonavir oral solution has historically been used in this age window but carries tolerability limitations, including risks of cardiac and respiratory adverse events in premature infants and drug interactions.

Drug class and approval history

Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) that binds to the integrase active site and blocks the strand transfer step of retroviral DNA integration into the host genome, an essential step in the HIV replication cycle.¹ Its higher barrier to resistance compared with first-generation INSTIs such as raltegravir and elvitegravir reflects a requirement for multiple resistance-associated substitutions before clinically meaningful loss of activity occurs, a property that has made it a preferred backbone agent in adult and pediatric treatment guidelines globally.

Tivicay (dolutegravir) received initial FDA approval on August 12, 2013, for adults with HIV-1 infection.⁵ The pediatric dispersible tablet formulation, Tivicay PD, received approval in 2020 for use in patients aged at least 4 weeks weighing at least 3 kg, based on PK and safety data from the IMPAACT P1093 trial, a phase 1–2, open-label, multicenter, dose-finding study that established weight-band dosing across pediatric age groups from 4 weeks to 18 years.⁶ Efficacy in pediatric patients was established by extrapolation from adult data, with supporting PK and virologic response data from P1093.

The current sNDA builds on this regulatory foundation by extending the lower age boundary from 4 weeks to birth, representing an incremental but clinically significant expansion of the approved patient population. The submission also aligns with a parallel ViiV effort: in May 2026, the company announced an EMA marketing application and FDA NDA for a dolutegravir/lamivudine (DTG/3TC) fixed-dose combination seeking approval in younger age groups.¹

References

1. FDA accepts and grants Priority Review for sNDA to extend Tivicay PD (dolutegravir) to newborns from birth; EMA validates marketing application. News release. ViiV Healthcare. June 22, 2026. Accessed June 22, 2026. https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2026/june/marketing-application-for-tivicay/

2. International Maternal Pediatric Adolescent AIDS Clinical Trials Network. IMPAACT 2023: a phase I study of the safety, tolerability, and pharmacokinetics of dolutegravir in neonates exposed to HIV-1. ClinicalTrials.gov. NCT05590325. Accessed June 2026. https://clinicaltrials.gov/study/NCT05590325

3. Powis KM, Smeaton L, Hughes MD, et al. Optimizing dolutegravir initiation in neonates using population pharmacokinetic modeling and simulation. Clin Pharmacokinet. 2022;61(1):83-93. doi:10.1007/s40262-021-01062-6

4. Cotton MF, Violari A, Otwombe K, et al; CHER study team. Early time-limited antiretroviral therapy versus deferred therapy in South African infants infected with HIV: results from the children with HIV early antiretroviral (CHER) randomised trial. Lancet. 2013;382(9904):1555-1563. doi:10.1016/S0140-6736(13)61409-9

5. Drugs.com. Tivicay (dolutegravir) FDA approval history. Updated 2026. Accessed June 22, 2026. https://www.drugs.com/history/tivicay.html

6. Aweeka FT, Wiznia A, Nogueira-de-Almeida C, et al; IMPAACT P1093 Study Team. Pharmacokinetics, safety, tolerability, and antiviral activity of dolutegravir dispersible tablets in infants and children with HIV-1 (IMPAACT P1093): results of an open-label, phase 1–2 trial. Lancet HIV. 2022;9(6):e393-e402. doi:10.1016/S2352-3018(22)00044-3