The indication for the HIV-1 treatment Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF) has been expanded to include children and adolescents aged 6 years and older.

Gilead Sciences Korea announced on the 23rd that its Biktarvy has been approved by the Ministry of Food and Drug Safety for the treatment of HIV-1 infection in children or adolescents 6 years of age and older.

The approval allows Biktarvy’s use in adults and pediatric patients aged 6 years and older weighing 25 kg or more who are antiretroviral treatment-naïve or who have achieved stable viral suppression (HIV-1 RNA <50 copies/mL) for at least 3 months without failure of an existing antiretroviral treatment regimen and who do not have known resistance-related substitutions of individual components of B/F/TAF.

This makes Biktarvy the first second-generation integrase strand transfer Inhibitor (InSTI) in Korea to be approved for use in all age groups of children, adolescents, and adults aged 6 years and above.

The MFDS’s approval was based on the results of a single-arm, open-label, multi-cohort Phase 2/3 study in 100 pediatric and adolescent HIV-infected patients aged 6 to 18 years. 

The study evaluated the efficacy and safety of Biktarvy for 48 weeks in two cohorts: pediatric infected patients 6 to 12 years of age weighing 25 kg or more (n=50) and adolescent infected patients 12 to 18 years of age weighing 35 kg or more (n=50). 

Results showed that both cohorts achieved 100% virological suppression (HIV-1 RNA <50 copies/mL) at week 24 of treatment with Biktarvy and 98% continued to achieve and maintain undetectable viral load at week 48.

No Biktarvy-related resistance occurred during the 48-week treatment period, and median treatment adherence was high at 99%, indicating good tolerability.

“‘We are pleased to be able to expand the indication for Biktarvy to treat not only adults but pediatric and adolescent infections, who are often more immunocompromised, and enable faster viral suppression with Biktarvy,” said Sunhee Kwon, BU Director of the HIV Business Unit at Gilead Sciences Korea.

“With Biktarvy’s well-tolerated safety profile, we expect children and adolescents living with HIV to remain stable on treatment and maintain healthy lives,” said Kwon. We are committed to ensuring people in various clinical situations can fully benefit from Biktarvy and receive safe and effective treatment from the moment they are first diagnosed."