Drug updated on 9/4/2024
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.
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Summary
- 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.
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 |