ViiV Healthcare has received US FDA approval for Tivicay PD (dolutegravir) for children with HIV-1 weighing at least 2kg, including eligible newborns.

FDA approval expands paediatric HIV treatment

The approval covers treatment-naïve or treatment-experienced paediatric patients who have not previously received an integrase strand transfer inhibitor (INSTI), and allows Tivicay PD to be used in combination with other antiretroviral medicines.

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

The decision follows Priority Review by the FDA and is supported by data from the National Institutes of Health-funded IMPAACT 2023 study, alongside pharmacokinetic modelling incorporating additional paediatric data.

The data showed that dolutegravir reached therapeutic drug levels in term neonates, with a safety profile consistent with that established in older children and adults.

Diana Clarke, assistant professor of paediatrics at 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.”

Earlier HIV treatment for newborns

HIV can progress rapidly in infants who do not receive early diagnosis and treatment, with the company citing evidence that around half of untreated infants with HIV die by the age of two.

The availability of an age-appropriate formulation for children weighing as little as 2kg is therefore significant for early paediatric HIV treatment, particularly for newborns who require antiretroviral therapy from birth.

Dolutegravir is a second-generation INSTI with a higher barrier to resistance than earlier generations of the drug class. Tivicay PD is supplied as tablets for oral suspension, providing a formulation suitable for young children who may not be able to take conventional tablets.

Jean van Wyk, chief medical officer at ViiV Healthcare, said the approval gives US families and clinicians more options for paediatric HIV treatment from the beginning of life.

“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,” van Wyk said.

Expanding dolutegravir access in paediatric HIV

The FDA decision extends the use of dolutegravir across an important part of the paediatric HIV treatment pathway.

ViiV Healthcare said the approval reflects its focus on developing INSTI-based treatment options for children and addressing gaps in paediatric HIV care.

The company is majority owned by GSK, with Shionogi as a shareholder.

The approval applies specifically to paediatric patients weighing at least 2kg who are INSTI-naïve. Tivicay and Tivicay PD remain indicated for use in combination with other antiretroviral agents for HIV-1 treatment.

The FDA approval adds a treatment option for some of the youngest children living with HIV and enables eligible term newborns weighing at least 2kg to begin dolutegravir-based therapy from birth.