The FDA has approved ViiV Healthcare’s Tivicay PD for children with HIV-1 weighing at least 2 kg, including eligible newborns.

FDA expands paediatric HIV treatment

The US Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir) for use with other antiretroviral medicines in paediatric patients with HIV-1 who weigh at least 2kg.

The approval covers treatment-naïve and treatment-experienced children who have not previously received an integrase strand transfer inhibitor (INSTI).

Tivicay PD is the first second-generation INSTI approved in the US for children living with HIV who weigh at least 2 kg, according to ViiV Healthcare.

The approval expands the use of dolutegravir-based treatment to younger children, including eligible newborns, providing an age-appropriate formulation for patients who meet the approved criteria.

Diana F Clarke, assistant professor of paediatrics at Boston University School of Medicine and lead investigator of the IMPAACT 2023 study, said: “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.”

Approval supported by IMPAACT data

The FDA decision was supported by data from the NIH-funded IMPAACT 2023 study and pharmacokinetic modelling incorporating additional paediatric data.

The data showed that dolutegravir reached therapeutic drug concentrations in term neonates weighing at least 2 kg. The safety findings were consistent with the established safety profile of dolutegravir in older paediatric patients and adults, according to ViiV Healthcare.

Dolutegravir is a second-generation INSTI that blocks HIV integrase, an enzyme the virus uses to insert its genetic material into human cells. INSTIs form part of combination antiretroviral treatment for HIV.

The IMPAACT 2023 study was designed to evaluate dolutegravir dosing and pharmacokinetics in infants and young children, supporting the development of dosing recommendations for this population.

The FDA granted Priority Review for the application.

Jean van Wyk, 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.”

Earlier treatment for children with HIV

HIV can progress rapidly in infants and young children without effective treatment, making access to appropriate antiretroviral medicines an important part of paediatric HIV care.

The new indication provides a treatment option for children who meet the FDA-approved criteria from a younger age than previous formulations and dosing regimens allowed.

The approval also adds to the use of dolutegravir across the paediatric HIV treatment pathway. ViiV Healthcare said the company is continuing to develop treatment options intended for children at different stages of HIV care.

Clarke said: “This represents an important advance for the care of newborns, as early treatment with the most effective therapies results in the best possible outcomes.”

The FDA approval applies to Tivicay PD used in combination with other antiretroviral agents and does not represent approval of dolutegravir as a standalone treatment for HIV-1.

The decision follows regulatory review of clinical pharmacokinetic data and modelling intended to establish an appropriate dosing regimen for the youngest patients.