The Food and Drug Administration (FDA) has approved updated labeling for Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide; Gilead) to include treatment of both adult and pediatric patients weighing at least 25kg with HIV-1 who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Previously, the combination therapy had only been approved for adults.
Biktarvy combines bictegravir, an integrase strand transfer inhibitor, and emtricitabine and tenofovir alafenamide, 2 nucleoside reverse transcriptase inhibitors (NRTIs). The pediatric approval was based on data from an open label, single arm trial that evaluated the efficacy, safety, and pharmacokinetics of Biktarvy in virologically suppressed children (6 to <12 years old; n=50) and adolescents (12 to <18 years old; n=50).
Results showed that after switching to Biktarvy, 100% of patients 6 to <12 years of age and 98% of patients 12 to <18 years of age remained virologically suppressed (HIV-1 RNA <50 copies/mL). Adverse reactions were reported in 10% of pediatric patients, the majority (85%) of which were Grade 1. The safety profile was found to be similar to that observed in adult patients.
The safety and effectiveness of Biktarvy in pediatric patients weighing <25kg have not been established.
Biktarvy is available as 50mg/200mg/25mg fixed-dose tablets in 30-count bottles.
For more information visit biktarvy.com.