About emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP

Emtricitabine/tenofovir disoproxil fumarate is indicated in combination with safer sex practices for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg at risk. The following factors may help to identify individuals at risk:

  • Has partner(s) known to be HIV-1 infected, or
  • Engages in sexual activity within a high prevalence area or social network and has additional risk factors for HIV-1 acquisition, such as:
    • Inconsistent or no condom use
    • Diagnosis of sexually transmitted infections
    • Exchange of sex for commodities (such as money, shelter, food, or drugs)
    • Use of illicit drugs, alcohol dependence
    • Incarceration
    • Partner(s) of unknown HIV-1 status with any of the factors listed above

When prescribing emtricitabine/tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis, healthcare providers must:

  • Prescribe emtricitabine/tenofovir disoproxil fumarate as part of a comprehensive prevention strategy because emtricitabine/tenofovir disoproxil fumarate is not always effective in preventing the acquisition of HIV-1 infection
  • Counsel all uninfected individuals to strictly adhere to the recommended emtricitabine/tenofovir disoproxil fumarate daily dosing schedule because the effectiveness of emtricitabine/tenofovir disoproxil fumarate in reducing the risk of acquiring HIV-1 infection was strongly correlated with adherence and measurable drug levels
  • Confirm a negative HIV-1 test immediately prior to initiating emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting HIV-1 PrEP for at least 1 month and reconfirm HIV-1 status or use a test approved or cleared by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
  • Screen for HIV-1 infection at least once every 3 months while taking emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP
  • Be sure to not prescribe emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present

The following points should be also considered when prescribing emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP in adolescents:

  • Use of emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP as part of a comprehensive HIV prevention strategy for adolescents should include consideration of the ability of the individual to understand the importance of adherence to daily dosing, the need for frequent HIV testing, the need for frequent sexually transmitted infection testing, and the continued risk of pregnancy
  • In a clinical study in adolescents, the percentage of subjects with protective levels of drug declined markedly after subjects switched from monthly to quarterly visits suggesting that adolescents may benefit from more frequent visits and counseling

Mechanism of action for HIV-1 pre-exposure prophylaxis

By inhibiting HIV-1 from replicating as it enters the body, emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP helps prevent the virus from establishing permanent infection. Emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP does not replace existing HIV-1 prevention strategies.

The information on this site is intended for audiences
of the United States.

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