The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Tivicay PD (dolutegravir), for use with other antiretroviral agents in paediatric patients with human immunodeficiency virus type 1 (HIV-1) who weigh at least 2kg.

The therapy is indicated for children who are either new to treatment or have prior experience with antiretroviral therapies but have not been treated with integrase strand transfer inhibitors (INSTIs).

ViiV Healthcare is a global HIV specialist company, majority owned by GSK, with Shionogi as a shareholder.

Tivicay PD’s approval follows a Priority Review by the FDA.

The decision is backed by data from the International Maternal Paediatric Adolescent AIDS Clinical Trials (IMPAACT) 2023 clinical study, funded by the National Institutes of Health (NIH), as well as additional paediatric pharmacokinetic modelling.

The studies indicated that dolutegravir, described as a second-generation INSTI, reached therapeutic levels in term neonates and demonstrated a safety profile similar to that of older children and adults taking the drug.

ViiV Healthcare chief medical officer Jean van Wyk said: “Today’s approval of Tivicay PD expands the options available for paediatric HIV care, giving families and clinicians in the US 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.”

Tivicay and Tivicay PD both contain dolutegravir, which is designed to inhibit HIV integrase and block a critical step in the virus’ replication cycle.

IMPAACT, the clinical research network behind the pivotal trial, brings together investigators and partners worldwide.

It studies interventions for HIV and related conditions across different populations.

The NIH, which supported the research, is the primary US federal agency for medical investigation and part of the Department of Health and Human Services.

In February 2025, the European Commission authorised the use of ViiV Healthcare’s Vocabria (cabotegravir long-acting injections) plus Rekambys (rilpivirine long-acting injections) from Johnson & Johnson for treating adolescents with HIV-1.