TRUVADA for a Pre-exposure Prophylaxis (PrEP) Indication

This is a Risk Evaluation and Mitigation Strategy (REMS) Web site. TRUVADA for a PrEP indication—in combination with safer sex practices—can help reduce the risk of sexually acquired HIV-1 as part of a comprehensive HIV-1 prevention strategy in adults at high risk. TRUVADA for a PrEP indication does not replace existing prophylaxis strategies. Review factors that can help healthcare providers identify individuals at high risk for sexually acquired HIV-1 and important prescribing considerations


Review the online training for prescribers

REMS Information

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.

To make sure TRUVADA for a PrEP indication is prescribed and taken safely, Gilead has worked with the FDA to develop materials for the REMS program to educate and inform healthcare providers and uninfected individuals at high risk for acquiring HIV-1.

Access REMS resources

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TRUVADA® for a Pre-exposure
Prophylaxis (PrEP) Indication

Healthcare Provider Training

Indication

  • TRUVADA (emtricitabine/tenofovir disoproxil fumarate) is 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

Factors to Help Identify Individuals at High Risk

  • Has partner known to be HIV-1 infected, or
  • Engages in sexual activity within a high prevalence area or social network and one or more of the following:
    • 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 or alcohol dependence
    • Incarceration
    • Partner(s) of unknown HIV-1 status with any of the factors listed above

When Prescribing TRUVADA for a PrEP Indication, Healthcare Providers MUST:

  • Prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection
  • Counsel all uninfected individuals to strictly adhere to the recommended daily TRUVADA dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in a subgroup of clinical trials subjects
  • Confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical signs or symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected,
    • delay starting PrEP for at least 1 month and reconfirm HIV-1 status or
    • use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
  • While using TRUVADA for PrEP, HIV-1 screening tests should be repeated at least every 3 months
    • If symptoms consistent with acute HIV-1 infection develop following a potential exposure event, PrEP should be discontinued until negative infection status is confirmed using a test approved by the FDA as an aid in the diagnosis of HIV-1, including acute or primary HIV-1 infection

Boxed Warnings

  • 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 the 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 infection are present unless negative infection status is confirmed

Boxed Warnings (Continued)

  • 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
  • TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 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

Why Use TRUVADA for a PrEP Indication?

  • By inhibiting HIV-1 from replicating as it enters the body, TRUVADA for a PrEP indication works to prevent the virus from establishing permanent infection. However, TRUVADA should not be seen as the first line of defense against HIV-1
  • Because TRUVADA is not always effective in preventing the acquisition of HIV-1, TRUVADA for a PrEP indication must be used in combination with a comprehensive prevention strategy that includes safer sex practices, such as regular and correct condom use, regular HIV testing for themselves (and their sexual partners), and other proven HIV prevention methods to safely and effectively reduce the risk of acquiring HIV-1
    • TRUVADA for a PrEP indication must only be prescribed to uninfected individuals at high risk who are confirmed to be HIV negative
    • Uninfected individuals who are prescribed TRUVADA for a PrEP indication should not miss any doses. Missing doses may increase the risk of acquiring HIV

Key Findings of the TRUVADA for a PrEP Indication Studies: The iPrEx Trial

  • In one clinical trial of TRUVADA for a PrEP indication, TRUVADA was shown to reduce the risk of HIV-1 acquisition by 42% for high risk men who have sex with men who also received comprehensive prevention services, including monthly HIV-1 testing, condom provision, counseling, and management of other sexually transmitted infections
  • In a post-hoc case control study of plasma and intracellular drug levels in about 10% of clinical trial subjects, risk reduction appeared to be the greatest in subjects with detectable intracellular tenofovir. Efficacy was therefore strongly correlated with adherence
  • Because of the intensive risk reduction counseling provided as part of the trial, self-reported risk behavior among the subjects in this clinical trial declined overall during the trial, both in terms of decreases in the number of sexual partners and increases in condom use

Key Findings of the TRUVADA for a PrEP Indication Studies: The Partners PrEP Trial

  • In another clinical trial of TRUVADA for a PrEP indication, TRUVADA was shown to reduce HIV-1 acquisition by 75% in uninfected individuals in stable heterosexual serodiscordant relationships who also received comprehensive prevention services, including monthly HIV testing, evaluation of adherence, assessment of sexual behavior, and safety evaluations
  • In a post-hoc case control study of plasma drug levels in about 10% of study subjects, risk reduction appeared to be the greatest in subjects with detectable plasma tenofovir. Efficacy was therefore strongly correlated with adherence. Risk reduction increased further in subjects with detectable plasma tenofovir

Important Safety Information: Comprehensive Management to Reduce the Risk of Acquiring HIV-1

  • Prescribe TRUVADA for PrEP only 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, knowledge of their HIV-1 status and that of their partner(s), and regular testing for other sexually transmitted infections that can facilitate HIV-1 transmission (such as syphilis and gonorrhea)
    • Inform uninfected individuals about and support their efforts in reducing sexual risk behavior

Important Safety Information: Comprehensive Management to Reduce the Risk of Acquiring HIV-1

  • Prescribe TRUVADA to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-negative
    • HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA, because TRUVADA alone does not constitute a complete regimen for HIV-1 treatment; therefore, care should be taken to minimize drug exposure in HIV-infected individuals
      • Many HIV-1 tests, such as rapid tests, detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. Prior to initiating TRUVADA for a PrEP indication, evaluate seronegative individuals for current or recent signs or symptoms consistent with acute viral infections (e.g., fever, fatigue, myalgia, skin rash, etc.) and ask about potential exposure events (e.g., unprotected, or condom broke during sex with an HIV-1 infected partner) that may have occurred within the last month

Important Safety Information: Comprehensive Management to Reduce the Risk of Acquiring HIV-1

  • Confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical signs or symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected,
    • delay starting PrEP for at least 1 month and reconfirm HIV-1 status or
    • use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
  • While using TRUVADA for a PrEP indication, HIV-1 screening tests should be repeated at least every 3 months
    • If symptoms consistent with acute HIV-1 infection develop following a potential exposure event, PrEP should be discontinued until negative infection status is confirmed using a test approved by the FDA as an aid in the diagnosis of HIV-1, including acute or primary HIV-1 infection

Important Safety Information: Comprehensive Management to Reduce the Risk of Acquiring HIV-1

  • Counsel uninfected individuals to strictly adhere to the recommended daily TRUVADA 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 a subgroup of clinical trials subjects

Important Safety Information: Additional Warnings and Precautions

New Onset or Worsening Renal Impairment

  • Can include acute renal failure and Fanconi syndrome
  • Assess creatinine clearance (CrCl) before prescribing TRUVADA and as clinically appropriate during therapy
  • Routinely monitor CrCl and serum phosphorus in individuals at risk of renal impairment
  • Avoid administering TRUVADA with concurrent or recent use of nephrotoxic drugs
  • Do not use TRUVADA for a PrEP indication in HIV-1 uninfected individuals with a CrCl below 60 mL/min
    • If a decrease in CrCl is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use

Important Safety Information: Additional Warnings and Precautions

Decreases in bone mineral density (BMD)

  • Consider assessment of BMD in individuals with a history of pathologic fracture or other risk factors for osteoporosis or bone loss

Redistribution/accumulation of body fat

  • Observed in patients receiving antiretroviral therapy for treatment of HIV-1

HBV Infection

  • It is recommended that all individuals be tested for the presence of chronic hepatitis B virus (HBV) before initiating TRUVADA
  • HBV-uninfected individuals should be offered vaccination

Important Safety Information: Use of TRUVADA for a PrEP Indication in Specific Populations

Pregnancy

  • TRUVADA has been evaluated in a limited number of women who are pregnant
  • Physicians should assess risk benefit when considering TRUVADA for a PrEP indication in women who are pregnant and at increased risk of HIV-1 infection. Data suggest that there is a potential increased risk of HIV infection during pregnancy*
  • If an uninfected individual becomes pregnant while taking TRUVADA for a PrEP indication, careful consideration should be given to whether the use of TRUVADA should be continued
  • A pregnancy registry is available. Enroll pregnant women taking TRUVADA for a PrEP indication by calling 1-800-258-4263

*Gray RH, et al. Lancet. 2005;366(9492):1182-1188.

Important Safety Information: Use of TRUVADA for a PrEP Indication in Specific Populations

Nursing Mothers

  • Women infected with HIV-1 or taking TRUVADA for a PrEP indication should be instructed not to breast-feed. The components of TRUVADA are excreted in breast milk, and it is not known if these can harm the infant

Pediatrics

  • TRUVADA for a PrEP indication is based on trials in adults

Important Safety Information: Confirming and Regularly Reconfirming Negative HIV Status

  • TRUVADA should be used to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV negative
    • A negative HIV status should be confirmed before prescribing TRUVADA for a PrEP indication
    • Individuals should be regularly tested (at least every 3 months) while taking TRUVADA for a PrEP indication to reconfirm that they are HIV negative
    • If symptoms consistent with acute HIV-1 infection develop following a potential exposure event, PrEP should be discontinued until negative infection status is confirmed using a test approved by the FDA as an aid in the diagnosis of HIV-1, including acute or primary HIV-1 infection
    • It is important to be alert to the signs of potential acute HIV-1 infection when prescribing TRUVADA for a PrEP indication. These include fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and cervical and inguinal adenopathy
    • HIV-1 resistance mutations may emerge in individuals with undetected HIV-1 infection who are taking TRUVADA for a PrEP indication
      • Although TRUVADA is active against HIV-1, TRUVADA alone does not constitute a complete treatment regimen for HIV-1 infection
      • HIV-1–infected patients taking TRUVADA must take it with other antiretroviral agents to fully suppress virus replication and avoid the development of resistance

Important Safety Information: Drug Interactions and Common Adverse Events

Drug Interactions

  • Coadministration with other products
    • Do not use TRUVADA with drugs containing emtricitabine or tenofovir disoproxil fumarate, or with drugs containing lamivudine. Do not administer in combination with HEPSERA® (adefovir dipivoxil)
    • For further details about TRUVADA drug interactions, please see the Full Prescribing Information for TRUVADA

Common Adverse Reactions

  • In HIV-1 uninfected individuals in PrEP trials, adverse reactions that were reported by more than 2% of TRUVADA subjects and more frequently than by placebo subjects were headache, abdominal pain and weight decreased

Additional Educational Materials

  • Agreement Form for Initiating TRUVADA for PrEP of Sexually Acquired HIV-1 Infection
    • Designed for prescribers to use with uninfected individuals to facilitate discussion of appropriate use of TRUVADA for a PrEP indication
    • Form covers safety risks associated with use of TRUVADA for a PrEP indication, the importance of adherence to the recommended daily dosing regimen, regular assessment of HIV-1 test results, and screening for sexually transmitted infections
  • Checklist for Prescribers: Initiation of TRUVADA for PrEP
    • Checklist of key components for prescribers to consider before starting an uninfected individual on TRUVADA for a PrEP indication
    • Checklist items include confirming a negative HIV-1 test result, screening for signs or symptoms of acute HIV infection, counseling on safety risks and importance of adherence, and other components to ensure a comprehensive prevention strategy

Assess Your Knowledge of TRUVADA for a PrEP Indication

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Important Safety Information About TRUVADA for a PrEP Indication

BOXED WARNINGS:

  • TRUVADA for a PrEP indication must only be prescribed to individuals confirmed to be HIV-1 negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with the 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 infection are present unless negative infection status is confirmed
  • 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. 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 HBV-infected patients who discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Contraindications: DO NOT PRESCRIBE TRUVADA for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. TRUVADA should be used in HIV-1 infected patients only in combination with other antiretroviral agents.

Warnings and Precautions Relating to the Use of TRUVADA for a PrEP Indication

  • Comprehensive management strategies to reduce potential risks associated with use of TRUVADA for a PrEP indication:
    • Strategy to reduce uninfected individual’s exposure to HIV-1 infection includes safer sex practices such as consistent and correct use of condoms, an individual knowing their HIV-1 status and that of their partner(s), regular testing for HIV-1 and other sexually transmitted infections, and counseling regarding reducing sexual risk behavior
    • Strategies to reduce potential for drug resistance: TRUVADA must only be used for PrEP 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 TRUVADA, because TRUVADA alone does not constitute a complete regimen for HIV-1 treatment
      • Confirm negative HIV-1 status immediately prior to initiating TRUVADA for PrEP. Do not initiate TRUVADA for PrEP if signs or symptoms of HIV-1 infection are present (e.g., fever, fatigue, mylagia, skin rash, etc.) or if recent exposure (<1 month) is suspected. Alternatively, delay initiating PrEP for at least one month or confirm negative HIV-1 status using a test approved 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 every three (3) months. Discontinue TRUVADA for PrEP if signs or symptoms of acute infection develop after potential exposure event until negative HIV-1 status is confirmed using a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
    • Counsel all uninfected individuals to strictly adhere to their TRUVADA daily dosing schedule because the effectiveness of TRUVADA for PrEP is correlated with adherence as demonstrated by measurable drug levels in clinical trials
  • New or worsening renal impairment: Acute renal impairment including Fanconi syndrome may occur. Assess creatinine clearance (CrCl) before initiating therapy. Routine monitoring of CrCl and serum phosphorus is recommended for patients at risk for renal impairment. Avoid administering TRUVADA with concurrent or recent use of nephrotoxic drugs
    • Do not prescribe TRUVADA for uninfected individuals with a creatinine clearance below 60 mL/min. If a decrease in CrCl is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use
  • HBV Infection: It is recommended that all individuals be tested for the presence of chronic hepatitis B virus (HBV) before initiating TRUVADA. HBV-uninfected individuals should be offered vaccination
  • Decreases in bone mineral density may occur. Consider assessing in individuals with history of bone fractures, osteoporosis, or bone loss
  • Redistribution/accumulation of body fat: observed in patients receiving antiretroviral therapy
  • Immune reconstitution syndrome: has been reported in HIV-1 infected patients treated with combination antiretroviral therapy, including TRUVADA. Autoimmune disorders may occur in the setting of immune reconstitution
  • Coadministration with other products: Do not co-administer with other drugs containing emtricitabine or tenofovir disoproxil fumarate or lamivudine. Do not administer in combination with HEPSERA® (adefovir dipivoxil)

Common Adverse Reactions

Most common adverse reactions (incidence ≥10%) (in combination with efavirenz) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. No new adverse reactions were reported in clinical trials of TRUVADA for PrEP. In HIV-1 uninfected individuals in PrEP trials, adverse reactions that were reported by more than 2% of TRUVADA subjects and more frequently than by placebo subjects were headache, abdominal pain and weight decreased.

Potential drug interactions: Caution should be exercised when administering TRUVADA with didanosine, atazanavir and lopinavir/ritonavir due to the potential for toxicities.

Please see Full Prescribing Information for more information about potential drug interactions.

Use of TRUVADA for PrEP in Specific Populations

  • Pregnancy: There are no adequate and well-controlled trials in pregnant women. TRUVADA should be used during pregnancy only if clearly needed. If an uninfected individual becomes pregnant while taking TRUVADA for a PrEP indication, careful consideration should be given to whether use of TRUVADA should be continued, taking into account the potential increased risk of HIV-1 infection during pregnancy
    • A pregnancy registry is available. Enroll women taking TRUVADA for a PrEP indication by calling 1-800-258-4263
  • Nursing mothers: Women infected with HIV-1 or taking TRUVADA for a PrEP indication should be instructed not to breast-feed. The components of TRUVADA (emtricitabine and tenofovir disoproxil fumarate) are excreted in breast milk and the risk to the infant is not known
  • Pediatrics: The TRUVADA for a PrEP indication is based on studies in adults

Dosage and Administration

  • Adults: Dosage of TRUVADA for PrEP for adults is one tablet once per day orally with or without food
  • Dose Adjustment for Renal Impairment: None. Do not prescribe TRUVADA for uninfected individuals with CrCL below 60 mL/min. If a decrease in CrCl is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use

Indication and Usage for Pre-exposure Prophylaxis

TRUVADA® (emtricitabine/tenofovir disoproxil fumarate), a combination of EMTRIVA® (emtricitabine) and VIREAD® (tenofovir disoproxil fumarate), is 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 that may help identify individuals at high risk include: has partner(s) known to be HIV-1 infected or engages in sexual activity within a high prevalence area or social network and one or more of the following: inconsistent or no condom use, diagnosis of sexually transmitted infections, exchange of sex for commodities (such as money, food, shelter, or drugs), use of illicit drugs or alcohol dependence, incarceration, or partner(s) of unknown HIV-1 status with any of the factors listed above.

The following points must be considered when prescribing TRUVADA for pre-exposure prophylaxis:

  • Prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection
  • Counsel all uninfected individuals to strictly adhere to their TRUVADA daily dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence and measurable drug levels in clinical trials
  • Confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least 1 month and reconfirm HIV-1 status or use a test approved 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 TRUVADA for PrEP
  • Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV-1 infection are present

Please report adverse events to Gilead by calling 1-800-445-3235. Adverse events can also be reported to the FDA through www.fda.gov/medwatch or by calling 1-800-FDA-1088.

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

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