Drug updated on 12/11/2024
Dosage Form | Tablet (oral; emtricitabine/tenofovir alafenamide; 200 mg/25 mg, 120 mg/15 mg) |
Drug Class | HIV 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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Descovy (emtricitabine and tenofovir alafenamide) Prescribing Information. | 2015 | Gilead Sciences, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
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 |