U.S. FDA approves ViiV Healthcare’s Tivicay PD, helping close a critical HIV treatment gap for young children

U.S. FDA approves ViiV Healthcare’s Tivicay PD, helping close a critical HIV treatment gap for young children

Approval makes Tivicay PD the first second-generation integrase inhibitor approved for children living with HIV weighing at least 2 kg, including eligible newborns

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced that the U.S. Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir (DTG)), for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor (INSTI)-naïve) weighing at least 2 kg.

Diana F. Clarke, Pharm.D., Assistant Professor of Paediatrics, Boston University School of Medicine and Lead Investigator of the IMPAACT 2023 study, said: “For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs, despite the importance of starting treatment as early as possible. 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. This represents an important advance for the care of newborns, as early treatment with the most effective therapies results in the best possible outcomes.”