Comprehensive Management

Use emtricitabine/tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis only as part of a comprehensive prevention strategy that includes other prevention measures, such as safer sex practices, because emtricitabine/tenofovir disoproxil fumarate is not always effective in preventing the acquisition of HIV-1 infection.

  • Counsel uninfected individuals about safer sex practices that include consistent and correct use of condoms, limiting the number of sexual partners, knowledge of their HIV-1 status and that of their partner(s), the importance of virologic suppression in their partner(s) with HIV-1 and regular testing for other sexually transmitted infections that can facilitate HIV-1 transmission (such as syphilis, chlamydia, and gonorrhea)
  • Inform uninfected individuals about and support their efforts in reducing sexual risk behavior

Use emtricitabine/tenofovir disoproxil fumarate to reduce the risk of acquiring HIV-1 infection only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only emtricitabine/tenofovir disoproxil fumarate, because emtricitabine/tenofovir disoproxil fumarate alone does not constitute a complete treatment regimen for HIV-1 treatment; therefore, care should be taken to minimize drug exposure in HIV-1 infected individuals.

  • Evaluate for signs or symptoms of acute HIV-1 infection prior to prescribing and while taking emtricitabine/tenofovir disoproxil fumarate
  • You must confirm a negative HIV-1 test immediately prior to prescribing 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 emtricitabine/tenofovir disoproxil fumarate for at least 1 month and reconfirm HIV-1 negative 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. Some individuals, such as adolescents, may benefit from more frequent visits and counseling
  • If a screening test indicates possible infection, or symptoms consistent with acute HIV-1 infection develop following a potential exposure event, convert the HIV-1 PrEP regimen to an HIV treatment regimen until negative infection status is confirmed using a test approved or cleared by the FDA as an aid in the diagnosis of HIV-1, including acute or primary HIV-1 infection

Counsel uninfected individuals to strictly adhere to the recommended emtricitabine/tenofovir disoproxil fumarate daily dosing schedule. The effectiveness of emtricitabine/tenofovir disoproxil fumarate in reducing the risk of acquiring HIV-1 infection is strongly correlated with adherence and measurable drug levels.

It's important to remember that emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status. Emtricitabine/tenofovir disoproxil fumarate should only be used in HIV-1 infected patients in combination with other antiretroviral agents.

Access tools that can help you manage and counsel individuals on the correct and safe use of emtricitabine/tenofovir disoproxil fumarate for HIV-1 PrEP.

Checklist for Prescribers

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