Emtricitabine/tenofovir disoproxil tablets

Emtricitabine/Tenofovir Disoproxil 200 mg/245 mg Film-coated Tablets. Summary of Product Characteristics (Branded & generic products). 3

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Pre-exposure prophylaxis (PrEP): 

Emtricitabine/tenofovir disoproxil is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk. 

Scottish Medicines Consortium  Emtricitabine/tenofovir disoproxil is accepted for use within NHS Scotland 
Route  Oral
Frequency  Oral – daily, TTSS or ‘Ts & Ss’, or event-based 2:1:1 or 2:7 dosing*
Indicative cost  Usually lowest cost PrEP option (when supplied through secondary care /sexual health services.  Primary care supplies/prescribing via community pharmacy may be considerably more expensive).

*See BASHH BHIVA Guideline on the use of HIV pre-exposure prophylaxis (PrEP) 20252 for details of and rationale for dosing options

Suitability considerations

Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate plus emtricitabine has been proven to be a highly effective means of HIV prevention in randomised clinical trials (RCTs), with reported efficacy in preventing HIV infection of up to 92% (among patients with a detectable drug concentration) in iPrEx4, 86% in PROUD5  and 86% in IPERGAY6,7. PrEP efficacy is strongly associated with adherence. The open label extension of the iPrEx study showed no HIV seroconversions in those taking ≥4 pills per week8. 

RCTs have shown good safety data (including renal safety data) for daily and on-demand oral TDF-FTC as PrEP. Where renal function has been affected, TDF-FTC was associated with mild, non-progressive and reversible reductions in creatinine clearance (CrCl)2. 

TD/FTC became available through the NHS in Scotland in July 2017 and is approved for all populations at risk of HIV.

Good practice points

  • Counsel all individuals who would benefit from a reduction in HIV risk about the availability of PrEP. 
  • Behaviour, reporting and understanding of risk change over time. Therefore, consideration of risk and benefit over time is as important as at the time of initiation. 
  • PrEP should be prescribed for people in whom it is suitable as soon as HIV risk is identified as benefit is immediate and toxicity is uncommon and delayed. 
  • Individuals with risk factors or who have chronic renal disease should be advised of the possibility of reduced renal function and the required frequency of renal monitoring. 

References

2. BHIVA/BASHH (2025). Guideline on the use of HIV Pre exposure prophalyxis. Available from: https://www.bashh.org/resources/5/guidelines_hiv_preexposure_prophylaxis_2025_updated_guideline

3. Emtricitabine/Tenofovir Disoproxil 200 mg/245 mg Film-coated Tablets. Summary of Product Characteristics. Available from: 

Truvada film-coated tablets - Summary of Product Characteristics (SmPC) - (emc) | 3890  

Emtricitabine/Tenofovir disoproxil Dr. Reddy's 200 mg/245 mg Film-Coated Tablets - Summary of Product Characteristics (SmPC) - (emc) | 8608 

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets - Summary of Product Characteristics (SmPC) - (emc) | 8989 

4. Grant RM,  Lama JR, Anderson PL et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010; 363:2587-2599. Available from: https://nhs.primo.exlibrisgroup.com/permalink/44NHSS_INST/nf660i/cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3079639 

5. McCormack S, Dunn DT, Desai M et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial.  Lancet. 2016; 387:53-60. Available from: https://nhs.primo.exlibrisgroup.com/permalink/44NHSS_INST/nf660i/cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4700047

6. Molina J-M,  Capitant C, Spire B et al. On-demand preexposure prophylaxis in men at high risk for HIV-1 infection. N Engl J Med. 2015; 373:2237-2246. Available from: https://nhs.primo.exlibrisgroup.com/permalink/44NHSS_INST/nf660i/cdi_hal_primary_oai_HAL_halshs_01429281v1

7. Molina J-M, Charreau I, Spire B et al. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV. 2017; 4:e402-e410. Available from: https://pubmed.ncbi.nlm.nih.gov/28747274/

8. Grant RM, Anderson PL, McMahan V, et al. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis 2014; 14:820–9. Available from: https://nhs.primo.exlibrisgroup.com/permalink/44NHSS_INST/nf660i/cdi_proquest_miscellaneous_1558521935