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U.S. FDA APPROVES ViiV HEALTHCARE'S TIVICAY PD, HELPING CLOSE A CRITICAL HIV TREATMENT GAP FOR YOUNG CHILDREN
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Approval makes Tivicay PD the first second-generation integrase inhibitor approved for children living with HIV weighing at least 2 kg, including eligible newborns
London, 26 August 2026 - 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."
Without early diagnosis and treatment, HIV can progress rapidly in infants, with around 50% of untreated infants with HIV dying by age two.1 The urgent need for effective treatment options underscores the importance of broadening access to modern, age-appropriate HIV medicines for this vulnerable group, and this expanded indication builds on ViiV Healthcare's broader efforts to provide HIV treatment options across the paediatric treatment journey.
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: "Today's approval of Tivicay PD expands the options available for paediatric HIV care, giving families and clinicians in the U.S. greater choice from the very beginning of life. For ViiV Healthcare, it reflects our commitment to bringing INSTI-based innovation to children and addressing persistent gaps in HIV care. This progress has been made possible through vital collaboration with the HIV community, united by a shared focus on ensuring children living with HIV are not left behind."
The FDA approval follows Priority Review for this population and is supported by data from the National Institutes of Health (NIH)-funded IMPAACT 2023 study and pharmacokinetic (PK) modelling incorporating additional paediatric data. These data showed that DTG, a second-generation INSTI with a higher barrier to resistance than previous generations, reached therapeutic drug levels in term neonates with a safety profile consistent with that established in older paediatric and adult populations.
Please consult the full Prescribing Information here.
About IMPAACT
The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is a global collaboration of investigators, institutions, community representatives, and other partners with a mission to improve health outcomes in infancy, childhood, adolescence, pregnancy, and postpartum among those who are impacted by or living with HIV, tuberculosis, and other related complications through the conduct of high-quality clinical trials. www.impaactnetwork.org.
Download the PDF here
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