FDA Approves Dose Modification for Children With HIV
Genvoya is now indicated to treat adult and pediatric patients weighing ≥25kg compared to the previous ≥35kg requirement.
The Food and Drug Administration (FDA) has approved labeling changes for Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide; Gilead) to include new safety and efficacy data from Study 106 (Cohort 2) involving HIV-1 positive, virologically-suppressed children aged 6 to <12 years weighing ≥25kg.
Genvoya is currently indicated to treat HIV-1 infection in patients who are antiretroviral treatment-naive or to replace a current antiretroviral regimen in virologically-suppressed (HIV-1 RNA <50 copies/mL) patients on a stable antiretroviral regimen for ≥6 months with no history of treatment failure or no known substitutions associated with resistance to any components of Genvoya.
Based on this new data, Genvoya is now indicated to treat adult and pediatric patients weighing ≥25kg compared to the previous ≥35kg requirement. The recommended dose in patients weighing ≥25kg with creatinine clearance ≥30mL/min is 1 tablet once daily with food.
The adverse reactions section has been updated with Week 24 safety data in 23 pediatric patients from Cohort 2 who weighed ≥25kg. The cohort included patients aged 6 to <12 years who were switched from their antiretroviral regimen to Genvoya. In these virologically-suppressed children, mean bone mineral density (BMD) increased +2.9% at the lumbar spine and +1.7% for the total body less head. The data also showed a decrease from baseline in CD4+ cell count at Week 24 but all patients maintained counts >400 cells/mm3.
Genvoya is available as 150mg/150mg/200mg/10mg strength fixed-dose tablets in 30-count bottles.
Genvoya® [package insert]. Foster City, California: Gilead; 2015