Biktarvy can now be used to treat HIV infection in children over 6 and adolescents
Gilead Sciences Korea said that the U.S. Food and Drug Administration has approved an expanded indication for its Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Tablets for treating HIV infection in children aged 6 years and older and adolescents.
The approval allows Biktarvy to be used in adults and pediatric patients aged six years and older and weighing at least 25 kilograms with stable viral suppression (HIV-1 RNA <50 copies/mL) for at least three months without antiretroviral therapy (ART) experience or failure of prior antiretroviral therapy regimens and without known resistance-related substitutions of individual components of the drug.
That makes Biktarvy the first treatment in the second-generation Integrase Strand Transfer Inhibitors (InSTI) class available for children 6 years and older, adolescent, and adult age groups.
The indication expansion is based on the results of a single-arm, open-label, multi-cohort phase 2/3 clinical trial in 100 pediatric and adolescent HIV-infected patients aged 6 to 18. The study evaluated the efficacy and safety of Biktarvy over 48 weeks in two cohorts: pediatric-infected patients aged 6 to 12 and weighing at least 25 kg (n=50) and adolescent-infected patients aged 12 to 18 years and weighing at least 35 kg (n=50).
Clinical results showed that both cohorts achieved 100 percent viral suppression (HIV-1 RNA <50 copies/mL) at week 24 of treatment with Biktarvy and achieved and maintained undetectable viral load at week 48 at 98 percent.
No Biktarvy-related resistance occurred during the 48-week treatment period, and median treatment adherence was high at 99 percent, indicating good tolerability.
“We are pleased to expand the indication for Biktarvy to include infected adults, children, and adolescents who are more relatively immunocompromised and can achieve viral suppression with Biktarvy more quickly,” said Kwon Sun-hee, director of Gilead Sciences Korea’s HIV Business Unit. “With Biktarvy's favorable tolerability profile, we expect that infected children and adolescents will be able to remain on treatment and maintain a healthy life.”
Kwon added that Gilead Sciences Korea is committed to ensuring that people in various clinical situations can fully benefit from Biktarvy and receive safe, effective treatment from the moment they are first diagnosed and on an ongoing basis.
Biktarvy is an HIV treatment that combines three drugs in one, making it easy to take once a day with or without meals, according to the company. It also has a relatively low potential for drug interactions and a high barrier to resistance. Biktarvy is licensed as a complete regimen for treating HIV infection and should not be co-administered with other antiretroviral agents.
In the most recent HIV treatment guidelines from the U.S. Department of Health and Human Services (DHHS) and the International Antiviral Society-USA (IAS-USA), Biktarvy is one of the recommended initial antiretroviral treatment options for most people living with HIV, with the highest level of evidence. It is also recommended for people who need rapid treatment before genotypic drug resistance testing results are available, according to Gilead Sciences Korea.