From the Guidelines
Emtricitabine/Tenofovir is a highly effective HIV prevention medication.
Key Points
- The fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) has been shown to decrease HIV-1 acquisition among various populations, including men who have sex with men (MSM), serodiscordant heterosexual couples, and heterosexual adults 1.
- The medication is most effective when taken daily, with detection of tenofovir in plasma associated with a reduction in HIV acquisition by approximately 90% among MSM and heterosexual adults 1.
- The US Food and Drug Administration (FDA) approved daily oral FTC/TDF for HIV prevention in 2013, and the CDC has issued guidance for its use 1.
- The recommended dosage is one tablet containing 300mg of tenofovir disoproxil fumarate and 200mg of emtricitabine, taken orally daily 1.
- Emtricitabine/Tenofovir is not recommended for individuals with osteopenia or osteoporosis, or a creatinine clearance rate of less than 60 mL/min 1.
Important Considerations
- Medication adherence is a key determinant of PrEP efficacy, with daily use associated with an estimated 99% reduction in HIV risk 1.
- HIV testing, preferably with a combination antigen-antibody assay, is recommended prior to initiation of PrEP, as well as regular follow-up intervals of no longer than every 3 months 1.
- Emtricitabine/Tenofovir can be used concurrently with hormonal contraception or IUDs, with no evidence of drug interactions demonstrated in studies 1.
From the FDA Drug Label
Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase.
The combination of Emtricitabine and Tenofovir is used as an antiretroviral treatment, with Emtricitabine being a synthetic nucleoside analog of cytidine and Tenofovir being converted to an acyclic nucleoside phosphonate analog of adenosine 5'-monophosphate.
- The combination is available in a film-coated tablet containing 200 mg of FTC and 300 mg of TDF.
- Both FTC and Tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase 2.
From the Research
Emtricitabine/Tenofovir Overview
- Emtricitabine/Tenofovir is a combination of two antiretroviral medications used for HIV pre-exposure prophylaxis (PrEP) 3, 4, 5, 6, 7
- The combination has been shown to be effective in reducing the risk of HIV transmission in individuals at high risk of acquiring the virus 4, 5, 6, 7
Efficacy and Safety
- Studies have demonstrated that Emtricitabine/Tenofovir is effective in preventing HIV transmission, with a significant reduction in HIV incidence compared to placebo 4, 5, 6, 7
- The combination has been shown to be safe and well-tolerated, with a low number of adverse events leading to discontinuation of the study drug 5, 7
- Emtricitabine and tenofovir alafenamide has been shown to have improved renal and bone safety compared to emtricitabine and tenofovir disoproxil fumarate 5, 7
Comparison to Other Regimens
- Emtricitabine/Tenofovir has been compared to other regimens, including tenofovir disoproxil fumarate alone, and has been shown to be non-inferior in terms of efficacy 6, 7
- Emtricitabine and tenofovir alafenamide has been shown to be superior to emtricitabine and tenofovir disoproxil fumarate in terms of bone mineral density and renal biomarker safety endpoints 5, 7
Real-World Implementation
- The implementation of Emtricitabine/Tenofovir as PrEP in real-world settings has been evaluated, with studies highlighting the importance of patient and provider acceptance, as well as patient adherence and retention in care 3
- Concerns regarding the use of PrEP in healthy individuals, including medication adverse effects and risk compensation, have been noted 3, 4