LONDON, Aug 26, 2026
The U.S. Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir) from ViiV Healthcare for use in combination with other antiretroviral medicines to treat HIV-1 infection in pediatric patients weighing at least 2 kg. The approval includes treatment-naïve and treatment-experienced children who have not previously received an integrase strand transfer inhibitor (INSTI). Importantly, the expanded indication includes eligible newborns born at term and weighing at least 2 kg, providing an additional dolutegravir-based treatment option from birth. ViiV Healthcare, a global specialist HIV company majority owned by GSK with Shionogi as a shareholder, said the decision addresses an important treatment gap for very young children living with HIV.
Tivicay PD Expands Early-Life HIV Treatment Options
The FDA decision expands access to an age-appropriate formulation of dolutegravir, a second-generation integrase inhibitor used as part of combination antiretroviral therapy. The company highlighted the importance of initiating effective treatment as early as possible in infants with HIV, noting that untreated HIV can progress rapidly during infancy. The newly approved dosing regimen allows eligible term newborns weighing at least 2 kg to receive dolutegravir-based therapy starting at birth, potentially broadening treatment choices for clinicians managing pediatric HIV. The approval follows Priority Review for this population and reflects ViiV Healthcare’s continued focus on developing and expanding HIV medicines across the pediatric treatment journey.
IMPAACT 2023 Data Support FDA Approval
The regulatory decision was supported by data from the NIH-funded IMPAACT 2023 study together with pharmacokinetic (PK) modeling that incorporated additional pediatric data. According to ViiV Healthcare, the evidence showed that dolutegravir reached therapeutic drug levels in term neonates while maintaining a safety profile consistent with that established in older pediatric and adult populations. Dolutegravir is described as a second-generation INSTI with a higher barrier to resistance than earlier generations. As an integrase inhibitor, dolutegravir works by binding to the HIV integrase active site and blocking the strand-transfer step required for viral DNA integration, thereby interfering with an essential stage of the HIV replication cycle. The approval therefore represents both a regulatory milestone and an important clinical-development advance in adapting established antiretroviral therapy for use in very young patients.
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Addressing a Critical Pediatric HIV Treatment Gap
The expanded Tivicay PD indication is particularly significant because newborns and young children with HIV require treatment options supported by pediatric-specific clinical and pharmacokinetic evidence. ViiV Healthcare said the availability of a dolutegravir-based regimen for eligible newborns gives families and clinicians greater choice from the beginning of life. The approval also reflects collaboration involving the IMPAACT Network, a global research network focused on improving health outcomes among infants, children, adolescents, pregnant people and postpartum populations affected by HIV and related diseases. The network conducts clinical research evaluating novel and durable HIV treatments and strategies for remission and disease management. For ViiV Healthcare, the FDA authorization strengthens its pediatric HIV portfolio while extending the use of an established antiretroviral mechanism into an important early-life population. Tivicay PD remains a prescription medicine used in combination with other antiretroviral agents, and the new FDA approval specifically covers pediatric patients meeting the stated weight and treatment-history criteria.
Source: ViiV Healthcare press release
