Gilead’s Biktarvy received EC approval for the treatment of HIV in paediatric populations

Gilead Sciences (Gilead) has announced that the European Commission (EC) has authorised a new low-dose tablet dosage form of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and an extension of its indication to treat HIV infection in virologically suppressed children aged at least two years and weighing at least 14kg.

The authorisation is the first paediatric approval for Biktarvy in the EU and applies to all 27 member states, as well as Norway, Iceland and Liechtenstein.

The EC’s decision is based on an open-label study, which found Biktarvy to be effective and generally well-tolerated through 24 weeks in virologically suppressed adolescents and children with HIV.

In study 1474, treatment outcomes with Biktarvy were evaluated in adolescents between the ages of 12 to less than 18 years weighing at least 35kg (treatment cohort 1), in children between the ages of six to less than 12 years weighing at least 25kg (treatment cohort 2), as well as in children at least two years of age and weighing at least 14kg to less than 25kg (treatment cohort 3).

After switching to Biktarvy, 98% of participants in both cohorts 1 and 2 remained suppressed at week 48. A similar result was seen in treatment cohort 3, with 91% of participants remaining virologically suppressed at week 24 after switching to Biktarvy.

The company reported that no new adverse reactions were observed in paediatric patients aged two years and older living with HIV-1 as compared to those observed in adults.

Each day in 2021 around 850 children became infected with HIV and approximately 301 died from AIDS-related causes, mainly due to inadequate access to HIV care and treatment services, Gilead said, with the gap in treatment coverage between children and adults reportedly increasing.

“The EC’s approval is a significant milestone to address what is sadly an important unmet need, namely children with HIV requiring new treatment options,” said Jared Baeten, vice president, HIV clinical development, Gilead.

He continued: “Additional therapy choices help to ensure children can access care and expand their HIV treatment options, which helps advance the collective efforts to overcome the HIV epidemic. Through the Gilead Global Pediatric Center of Excellence, we are committed to applying our decades of antiviral expertise to drive innovation in paediatric HIV research.”