LONDON — ViiV Healthcare said the U.S. Food and Drug Administration has approved Tivicay PD (dolutegravir) for use with other antiretroviral medicines to treat HIV-1 in pediatric patients weighing at least 2 kilograms, including eligible newborns.
The approval makes Tivicay PD the first second-generation integrase strand transfer inhibitor approved for children with HIV weighing at least 2 kilograms. It is indicated for patients who are treatment-naïve or treatment-experienced but have not previously received an integrase strand transfer inhibitor.
“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,” said Diana F. Clarke, Pharm.D., Assistant Professor of Pediatrics at Boston University School of Medicine and Lead Investigator of the IMPAACT 2023 study. “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.”
Clarke said early treatment with effective therapies can improve outcomes for newborns living with HIV.
Without early diagnosis and treatment, HIV can progress rapidly in infants. ViiV Healthcare said about half of untreated infants with HIV die by age two, underscoring the need for age-appropriate treatment options.
“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,” said Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare. “For ViiV Healthcare, it reflects our commitment to bringing INSTI-based innovation to children and addressing persistent gaps in HIV care.”
The FDA approval followed a Priority Review and was supported by data from the National Institutes of Health-funded IMPAACT 2023 study and pharmacokinetic modeling that incorporated additional pediatric data.
The data showed that dolutegravir reached therapeutic drug levels in term newborns and had a safety profile consistent with findings in older pediatric and adult patients, according to the company.
Tivicay and Tivicay PD contain dolutegravir, an integrase strand transfer inhibitor used with other antiretroviral medicines to treat HIV. The drug works by blocking HIV integrase, an enzyme needed for the virus to integrate its genetic material and replicate.
