Summary

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• Descovy (emtricitabine and tenofovir alafenamide) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. It is also indicated in combination with other antiretroviral agents, except protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg. Additionally, Descovy is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must have a negative HIV-1 test immediately prior to initiating Descovy for HIV-1 PrEP.
• This summary is based on the review of three randomized controlled trial(s). ^[1-3]
• Virologically suppressed Asian people living with HIV: At week 48, the proportion of participants with plasma HIV-1 RNA ≥50 copies/ml was 0% for those on B/F/TAF compared to 1.4% for those on baseline regimens. Virological suppression rates were 100% for B/F/TAF and 95.9% for the baseline regimen (p = 0.2485). No treatment-emergent resistance was observed.
• High-risk adult cisgender men and transgender women: After 96 weeks, the incidence of HIV infection was 0.16 per 100 person-years for emtricitabine and tenofovir alafenamide, compared to 0.30 per 100 person-years for emtricitabine and tenofovir disoproxil fumarate (IRR 0.54 [95% CI 0.23-1.26]), maintaining non-inferiority.
• High-risk adult cisgender men and transgender women: At 48 weeks, the incidence of HIV infection was 0.16 per 100 person-years for emtricitabine and tenofovir alafenamide, versus 0.34 per 100 person-years for emtricitabine and tenofovir disoproxil fumarate (IRR 0.47 [95% CI 0.19-1.15]), with non-inferiority established.
• Drug-related adverse events (AEs) occurred in three participants in each arm; none were serious, and no participants discontinued due to AEs. There were no significant differences in estimated glomerular filtration rate, body weight, and most lipid parameters; however, there was a significant decrease in tubular proteinuria in those switching from tenofovir disoproxil fumarate-containing regimens to B/F/TAF (p < 0.01).
• Emtricitabine and tenofovir alafenamide were associated with improved bone mineral density and renal safety biomarkers, with more weight gain observed (median weight gain 1.7 kg vs. 0.5 kg, p < 0.0001). A low number of participants reported AEs leading to discontinuation (1% for emtricitabine and tenofovir alafenamide vs. 2% for emtricitabine and tenofovir disoproxil fumarate).
• There is no population types or subgroups information available in the reviewed studies.