FDA Expands Tivicay PD Use to Newborns, Strengthening ViiV’s Pediatric HIV Strategy

The FDA has approved Tivicay PD (dolutegravir) tablets for oral suspension for the treatment of HIV infection in newborns from birth to 4 weeks of age weighing at least 2 kg, in combination with other antiretroviral therapies. This expands the previous indication, which covered adults and children older than 4 weeks and weighing at least 3 kg.

The approval is supported by data from the IMPAACT 2023 study and pharmacokinetic modeling. In the study, 48 HIV-exposed newborns received Tivicay PD from birth for up to six weeks alongside standard antiretroviral treatment. Drug exposure levels were consistent with those associated with efficacy in adults, and the safety profile aligned with that seen in older pediatric and adult populations.

ViiV Healthcare highlighted the approval as an important step toward addressing a significant unmet need in pediatric HIV care and emphasized that Tivicay PD is the first second-generation integrase inhibitor approved for children weighing at least 2 kg, including eligible newborns. The company also reiterated its commitment to ensuring that children living with HIV have access to effective treatment options.

From a competitive intelligence perspective, the approval follows the FDA’s acceptance of ViiV’s supplemental NDA in June and reinforces the company’s efforts to expand the dolutegravir (DTG) franchise across the pediatric treatment continuum. The decision strengthens ViiV’s positioning of DTG as a preferred option for managing HIV in young children, including cases of mother-to-child transmission, and sets a positive precedent for the ongoing expansion of Dovato (DTG/3TC) into younger pediatric populations.

Despite this development, BIKTARVY remains strongly positioned as a DHHS Preferred single-tablet regimen for treatment-naïve children aged ≥2 years and weighing ≥14 kg.