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 regularly.1
During treatment, patients must be tested for HIV-1 and pregnancy every 3 months.1,2 Patients should also be tested for sexually transmitted infections and CrCl every 6 months. There may be other tests to consider as well, including an HBV test prior to initiation.1,2
Report adverse events and suspected or confirmed HIV seroconversions by calling Gilead at 1-800-GILEAD-51-800-GILEAD-5.
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