Prescribing TRUVADA for a PrEP Indication
TRUVADA for a PrEP indication must only be prescribed as part of a comprehensive prevention strategy that includes other prevention measures, such as safer sex practices, because TRUVADA is not always effective in preventing the acquisition of HIV-1. 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)
- Regular testing for other sexually transmitted infections that can facilitate HIV-1 transmission (such as syphilis and gonorrhea)
Uninfected individuals should also be counseled to strictly adhere to the recommended daily dosing schedule. The effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 is strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials. Here are the key steps in prescribing TRUVADA for a PrEP indication. For a complete list of prescribing steps, review the Checklist for Prescribers.
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Important Safety Information
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA, in combination with other antiretrovirals.
- TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and HBV who have discontinued TRUVADA. Therefore, hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
- TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.
Indication and Prescribing Considerations
TRUVADA® for treatment of HIV-1 infection:
TRUVADA (emtricitabine/tenofovir disoproxil fumarate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older.
- Prescribing considerations when initiating TRUVADA for treatment of HIV-1 infection: It is not recommended that TRUVADA be used as a component of a triple nucleoside regimen, nor should it be coadministered with other products containing emtricitabine or tenofovir disoproxil fumarate (tenofovir DF). Use of TRUVADA to treat HIV-1 infection in treatment experienced patients should be guided by laboratory testing and treatment history.
TRUVADA for Pre-exposure Prophylaxis:
TRUVADA is also indicated in combination with safer sex practices for pre-exposure prophylaxis (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.
- Factors which may help identify individuals at high risk for sexually acquired HIV-1 infections include individuals who: (1) has HIV-1 infected partner(s), or (2) engages in sexual activity in a high prevalence area or social network, and have one or more of the following: (a) inconsistent or no condom use, (b) diagnosis of sexually transmitted infections (STIs), (c) exchange of sex for commodities (money, food, shelter or drugs), (d) use of illicit drugs or alcohol dependence, (e) incarceration and/or (f) sexual partners of unknown HIV status.
- 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. Reduction in risk of acquiring HIV-1 is strongly correlated to adherence; therefore, individuals must strictly adhere to their dosing schedule. HIV-1 negative status must be confirmed prior to initiating TRUVADA for PrEP and at least every 3 months thereafter. Delay initiating TRUVADA for PrEP for at least one month until negative HIV-1 status is reconfirmed if signs or symptoms of acute HIV-1 infection are present and if recent exposure is reported (< 1 month). Alternatively, confirm negative HIV status with a test approved by the FDA to aid diagnosis of acute or primary HIV-1 infection.