Summary

This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

• Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya.
• This summary is based on the review of three randomized controlled trial(s). ^[1-3]
• Virologic Suppression in Participants with Resistance Mutations: Participants with M184V/I mutations switching to E/C/F/TAF maintained a 100% virologic suppression rate (HIV-1 RNA < 50 copies per milliliter) at weeks 12, 24, and 48, with only one participant showing HIV-1 RNA ≥ 50 copies per milliliter at week 12, which was resolved by confirmatory testing.
• Efficacy in Asian Participants: In ART-naive Asian participants, 93% achieved virologic suppression with TAF versus 88% with TDF at week 144. In ART-experienced participants who switched regimens, 95% maintained virologic suppression on TAF versus 86% on TDF at week 96. Additionally, 91% of those with mild-moderate renal impairment maintained virologic suppression at week 144.
• Effect on Bone Mineral Density in Older Participants: Older participants (≥ 60 years) switching from TDF to E/C/F/TAF showed significant improvements in bone mineral density at week 48, with a 2.24% increase in spine bone mineral density and a 1.33% increase in hip bone mineral density, compared to decreases in the TDF group (-0.10% and -0.73%, respectively).
• Drug-related adverse events (AEs) were reported in 15.6% of participants with resistance mutations, with Grade 3-4 AEs or serious AEs occurring in 9.4% and 7.8% of participants, respectively, but were not drug-related.
• In older participants (≥ 60 years), 20% of those in the E/C/F/TAF group reported AEs considered related to treatment, with no treatment-related serious AEs observed. Similar proportions of AEs led to treatment discontinuation in both groups (4% for E/C/F/TAF vs 2% for TDF).
• Population Types and Subgroups: Virologically suppressed adults with M184V/I mutations, Asian participants (ART-naive and ART-experienced), and older participants (≥ 60 years) were the primary subgroups studied, showing high virologic suppression rates across groups, minimal drug-related adverse events, no significant renal adverse events in Asians, and improved bone mineral density in older adults on E/C/F/TAF.