FDA Approves Tivicay PD for Infants With HIV

The U.S. Food and Drug Administration (FDA) has approved ViiV Healthcare’s Tivicay PD (dolutegravir) for the treatment of HIV-1 infection in children weighing at least 2 kg.

The medicine is approved for use with other antiretroviral drugs in paediatric patients who are either new to HIV treatment or have received treatment but have not previously used an integrase strand transfer inhibitor (INSTI).

The approval is particularly important for newborns living with HIV, as treatment options for this age group have been limited. Under the new approval, term-born babies weighing at least 2 kg can receive a dolutegravir-based treatment regimen from birth.

HIV can progress quickly in infants if it is not diagnosed and treated early. ViiV Healthcare said that around half of untreated infants with HIV may die by the age of two, highlighting the need for effective and age-appropriate medicines.

Tivicay PD contains dolutegravir, a second-generation INSTI that blocks HIV from integrating its genetic material into human cells. The drug has a higher barrier to resistance than some earlier medicines in the same class.

The FDA decision was supported by results from the National Institutes of Health-funded IMPAACT 2023 study, along with pharmacokinetic modelling using additional paediatric data.

The data showed that dolutegravir reached therapeutic drug levels in term newborns weighing at least 2 kg. Its safety profile was also consistent with what has been seen in older children and adults.

The approval followed an FDA Priority Review for the paediatric population.

ViiV Healthcare said the decision expands treatment options for children with HIV in the United States and addresses an important gap in care for newborns. The company is continuing efforts to make modern HIV treatments available across different stages of childhood.

The approval of Tivicay PD gives healthcare professionals another treatment option for infants and young children with HIV-1 and supports earlier access to dolutegravir-based therapy.