Emtricitabine and tenofovir alafenamide

(Descovy®)

Emtricitabine and tenofovir alafenamide

Drug updated on 5/17/2024

Dosage FormTablet (oral; emtricitabine/tenofovir alafenamide; 200 mg/25 mg, 120 mg/15 mg)
Drug ClassHIV nucleoside analog reverse transcriptase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg.
  • Indicated in combination with other antiretroviral agents other than 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.
  • 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.

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Summary
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  • Emtricitabine and tenofovir alafenamide (Descovy) is approved 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 approved for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex.
  • Three randomized controlled studies focused on safety and effectiveness comparisons with other drugs, considering populations and subgroups where specified.
  • The first study demonstrated comparable effectiveness between those switched to a B/F/TAF (bictegravir, emtricitabine, tenofovir alafenamide) regimen versus those who remained on their baseline regimen among Asian people living with HIV. Similar safety profiles were observed across both groups; however, a significant benefit was noted in reduced tubular proteinuria in the B/F/TAF group.
  • In the DISCOVER study aimed at preventing HIV infections among adult cisgender men and transgender women who have sex with men, emtricitabine/tenofovir alafenamide showed non-inferior efficacy compared to emtricitabine/tenofovir disoproxil fumarate. There was a better safety profile indicated by improved bone mineral density and renal safety biomarkers, though the median weight gain was slightly higher in the emtricitabine/tenofovir alafenamide group.
  • A phase 3 study revealed the non-inferiority of Descovy compared to its counterpart for PrEP of HIV infection, demonstrating similar low rates of new infections while providing more favorable outcomes regarding bone mineral density and renal safety biomarkers, suggesting a superior long-term use safety profile, especially in a prevention context.
  • The studies collectively highlight Descovy's effectiveness across different populations, including virologically suppressed individuals with HIV as well as high-risk adult cisgender men and transgender women, indicating broad preventive utility across various demographic profiles.

Product Monograph / Prescribing Information

Document TitleYearSource
Descovy (emtricitabine and tenofovir alafenamide) Prescribing Information.2022Gilead Sciences, Inc., Foster City, CA

Randomized Controlled Trials

Clinical Practice Guidelines