FDA Greenlights Tivicay PD for Pediatric HIV

The US Food and Drug Administration (FDA) has granted approval for Tivicay PD (dolutegravir), a new treatment option for paediatric patients diagnosed with human immunodeficiency virus type 1 (HIV-1). This therapy is indicated for children weighing at least 2kg, who are either initiating treatment or have previous exposure to antiretroviral therapies but have not yet been treated with integrase strand transfer inhibitors (INSTIs).

The approval, which followed a Priority Review by the FDA, is underpinned by findings from the IMPAACT 2023 clinical study. Data from this National Institutes of Health (NIH)-funded research, along with additional paediatric pharmacokinetic modeling, demonstrated that dolutegravir, a second-generation INSTI, achieves therapeutic levels in neonates. The safety profile observed in this age group was consistent with that seen in older children and adults.

This development by ViiV Healthcare, a global HIV specialist company, marks a significant expansion of choices for paediatric HIV care in the US. The company highlighted its commitment to bringing INSTI-based innovations to children and addressing unmet needs in HIV treatment, emphasizing the importance of collaboration within the HIV community to ensure children are not left behind.

Tivicay and Tivicay PD both utilize dolutegravir, an agent designed to inhibit HIV integrase, thereby blocking a crucial stage in the virus's replication cycle. The IMPAACT research network, responsible for the pivotal trial, comprises investigators and partners worldwide, focusing on interventions for HIV and related conditions across diverse populations. The NIH, a key supporter of this research, is the principal federal agency for medical investigation in the United States.