TRUVADA for Pre-Exposure Prophylaxis (PrEP)
TRUVADA is indicated in combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples.
- Uninfected individuals at high risk for sexually acquired HIV-1 infections include:
- individuals with HIV-1 infected partner(s)
- individuals who engage in sexual activity in a high prevalence area or social network and have one or more of the following: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities (money, food, shelter, drugs), use of illicit drugs or alcohol dependence, incarceration, and/or sexual partners of unknown HIV status with any of the above risk factors.
- Prescribing considerations before initiating TRUVADA for PrEP:
- TRUVADA for PrEP must only be prescribed as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection.
- Uninfected individuals must strictly adhere to their dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 is strongly correlated with adherence.
- HIV-1 negative status must be confirmed prior to initiating TRUVADA for PrEP and at least every 3 months thereafter.
- If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiating TRUVADA for PrEP for at least 1 month until negative HIV-1 status is reconfirmed.
- Alternatively, negative HIV-1 status can be confirmed with a test approved by the FDA to aid diagnosis of acute or primary HIV-1 infection.
This website is intended to provide information on how TRUVADA for PrEP can be prescribed and used safely and effectively as part of a comprehensive HIV-1 prevention strategy for adults at high risk for sexually acquired HIV-1 infection.1
Prescribe only to HIV-1 negative adult patients.1
TRUVADA for PrEP must only be prescribed to individuals confirmed to be HIV-1 negative immediately prior to initiating treatment. Test patients for HIV-1 before initiating TRUVADA for PrEP and at least every 3 months during use.1
Drug resistant HIV-1 variants have been identified with the use of TRUVADA for PrEP following undetected acute HIV-1 infection.1
If symptoms of acute HIV-1 infection are present, do not initiate TRUVADA for PrEP unless patients have been confirmed to be HIV negative.1
TRUVADA for PrEP is a once-daily treatment.1
Uninfected individuals must strictly adhere to their dosing schedule to reduce their risk of sexually acquired HIV-1. The efficacy of TRUVADA is strongly correlated with adherence as demonstrated by measurable drug levels in two clinical trials.1
Monitor your patients at least every 3 months.1
Patients must be tested regularly for HIV-1 and other
sexually transmitted infections. There may be other tests you
will want to consider.1
Report adverse events and suspected or confirmed HIV seroconversions by calling Gilead at 1-800-GILEAD-51-800-GILEAD-5.
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