Emtricitabine and tenofovir alafenamide

(Descovy®)

Emtricitabine and tenofovir alafenamide

Drug updated on 12/11/2024

Dosage FormTablet (oral; emtricitabine/tenofovir alafenamide; 200 mg/25 mg, 120 mg/15 mg)
Drug ClassHIV nucleoside analog reverse transcriptase inhibitors (HIV NRTI)
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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  • This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
  • Tenofovir-based therapies for human immunodeficiency virus (HIV) prevention and treatment are associated with common neuropsychiatric adverse events (NPAEs), including headache, dizziness, insomnia, and depression. Tenofovir alafenamide specifically showed a higher risk of headache in HIV studies (odds ratio (OR) 1.24, cnfidence interval (CI) 1.01-1.52).
  • Oral pre-exposure prophylaxis (PrEP) was effective in HIV prevention for men who have sex with men (MSM), serodiscordant couples, and people who inject drugs (PWID), but not effective in heterosexual populations. The effectiveness of PrEP was closely associated with adherence levels.
  • In comparison to tenofovir disoproxil fumarate-emtricitabine, long-acting cabotegravir (CAB-LA) was more effective in preventing HIV (relative risk (RR) 0.21, CI 0.07-0.61) and showed sustained virological suppression when combined with rilpivirine (RPV-LA) over extended periods.
  • In ART (antiretroviral therapy)-naive people with HIV, dolutegravir plus lamivudine (DTG+3TC) demonstrated similar efficacy but fewer serious adverse events compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir/abacavir/lamivudine (DTG/ABC/3TC).
  • Neuropsychiatric adverse events (NPAEs) associated with tenofovir-based therapies included headache, dizziness, insomnia, and depression, with an increased risk of dizziness noted (OR 1.32; CI 1.09-1.59; P = 0.004). A higher risk of headache was observed with tenofovir alafenamide in HIV studies (OR 1.24; CI 1.01-1.52; P = 0.04).
  • Safety outcomes from long-acting cabotegravir (CAB-LA) and rilpivirine (RPV-LA) showed comparable safety profiles to placebo, though CAB-LA+RPV-LA was associated with more mild to moderate injection site reactions.
  • DTG+3TC resulted in fewer serious adverse events compared to BIC/FTC/TAF and DTG/ABC/3TC).
  • The population types studied included treatment-naive adults using tenofovir-based therapies, pregnant women in Africa assessed for adverse perinatal outcomes related to PrEP, and people living with HIV evaluated for long-acting antiretrovirals (ARVs) and daily oral drug regimens. Findings indicated that tenofovir-based therapies commonly led to neuropsychiatric adverse events such as headache, dizziness, insomnia, and depression, and that oral PrEP was not associated with adverse perinatal outcomes like preterm birth or low birth weight.

Product Monograph / Prescribing Information

Document TitleYearSource
Descovy (emtricitabine and tenofovir alafenamide) Prescribing Information.2015Gilead Sciences, Inc., Foster City, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Neuropsychiatric adverse events in tenofovir disoproxil fumarate- and tenofovir alafenamide-based HIV therapy and prophylaxis: a systematic review and meta-analysis2024Polish Archives of Internal Medicine
Perinatal outcomes associated with pre-exposure prophylaxis for HIV prevention during pregnancy: a systematic review and meta-analysis2024Eclinicalmedicine
Safety and Efficacy of Long-Acting Injectable Agents for HIV-1: Systematic Review and Meta-Analysis2023Jmir Public Health and Surveillance
Antivirals for prevention of hepatitis B virus mother-to-child transmission in human immunodeficiency virus positive pregnant women co-infected with hepatitis B virus2023The Cochrane Database of Systematic Reviews
An indirect comparison of 144-week efficacy, safety, and tolerability of dolutegravir plus lamivudine and second-generation integrase inhibitor-based, 3-drug, single-tablet regimens in therapy-naive people with HIV-12023Aids Research and Therapy
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 trials2023Hiv Medicine
Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature2023Expert Review of Anti-infective Therapy
Oral pre-exposure prophylaxis (PrEP) to prevent HIV: a systematic review and meta-analysis of clinical effectiveness, safety, adherence and risk compensation in all populations2022Bmj Open
Pharmacokinetic Outcomes of the Interactions of Antiretroviral Agents with Food and Supplements: A Systematic Review and Meta-Analysis2022Nutrients
The effectiveness of tenofovir-based pre-exposure prophylaxis for prevention of HIV acquisition among sub-Saharan African women at high risk: a systematic review2021The Pan African Medical Journal

Clinical Practice Guidelines