Drug updated on 5/17/2024
| Dosage Form | Tablet (oral; emtricitabine/tenofovir alafenamide; 200 mg/25 mg, 120 mg/15 mg) |
| Drug Class | HIV 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.
Latest News
Summary
- 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 Title | Year | Source |
|---|---|---|
| Descovy (emtricitabine and tenofovir alafenamide) Prescribing Information. | 2022 | Gilead Sciences, Inc., Foster City, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: a pooled analysis from three international phase III randomized trials. | Data not availableSubjects F: null% M: null% | 2023 | HIV Medicine |
| Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. | 5,387Subjects F: 1% M: 99% | 2021 | The Lancet HIV |
| Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. | 5,387Subjects F: 1% M: 99% | 2020 | The Lancet |
Sex Distribution:
Year:
2023
Source:HIV Medicine
Sex Distribution:
F:1%
M:99%
5387Subjects
Year:
2021
Source:The Lancet HIV
Sex Distribution:
F:1%
M:99%
5387Subjects
Year:
2020
Source:The Lancet
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. | 2023 | National Institutes of Health |
| Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. | 2023 | National Institutes of Health |
| Clinical considerations in the selection of preexposure prophylaxis for HIV prevention in Canada. | 2022 | The Canadian Journal of Infectious Diseases & Medical Microbiology |
| European AIDS Clinical Society Guidelines v10.1 October 2020. | 2020 | European AIDS Clinical Society |