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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.

  • 1

    Confirm negative HIV-1 status immediately prior to initiating TRUVADA for PrEP.

  • 2

    Prescribe TRUVADA for PrEP as part of a comprehensive prevention strategy.

  • 3

    Counsel individuals on the importance of strict adherence.

  • 4

    Reconfirm negative HIV-1 status at least every 3 months.

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I understand that Gilead Sciences is offering subsidized HIV-1 testing and certain other testing for individuals who may not otherwise have access to testing due to lack of insurance coverage and/or financial hardship and who are being evaluated for TRUVADA for a PrEP indication as part of a comprehensive HIV prevention strategy that includes counseling, safer sex strategies including the use of condoms, and testing before the initiation of TRUVADA for a PrEP indication using a diagnostic test capable of detecting acute HIV-1 infection and HIV-1 antibody testing at least every 3 months while using TRUVADA for a PrEP indication as described in the Prescribing Information.

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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.

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Prescribing TRUVADA for the treatment of HIV-1 infection

TRUVADA is also indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

If you’re initiating therapy with TRUVADA for the treatment of HIV-1 infection, consider the following:

  • It is not recommended that TRUVADA be used as a component of a triple nucleoside regimen
  • TRUVADA should not be coadministered with ATRIPLA®, COMPLERA®, EMTRIVA, STRIBILD®, VIREAD or lamivudine-containing products
  • In treatment experienced patients, the use of TRUVADA should be guided by laboratory testing and treatment history

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.

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

Warnings and Precautions

  • New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir DF. In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, additionally monitor serum phosphorus, urine glucose, and urine protein. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure, some requiring hospitalization and renal replacement therapy, have been reported after initiation of high dose or multiple NSAIDs in patients with risk factors for renal dysfunction; consider alternatives to NSAIDs in these patients. Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function.
    • When used for treating HIV-1 infection: Dosing interval adjustment of TRUVADA and close monitoring of renal function are recommended in all patients with CrCl 30–49 mL/min. No safety or efficacy data are available in patients with renal impairment who received TRUVADA using these dosing guidelines. No data is available regarding the safety or efficacy of dosing adjustment in pediatric patients with renal impairment. TRUVADA should not be administered in patients with CrCl <30 mL/min.
    • When used for PrEP: Do not use TRUVADA for PrEP in uninfected individuals with CrCL <60 mL/min. Re-assess potential risks and benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.
  • Coadministration with other products: Do not coadminister with other drugs containing emtricitabine, tenofovir disoproxil fumarate, lamivudine, or adefovir dipivoxil.
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia, have been seen in patients treated with tenofovir DF. Consider assessment of BMD in adult and pediatric patients with a history of pathologic fracture or risk factors for bone loss. In clinical trials conducted in pediatric subjects aged 2 to <18 years, the total body BMD gain was less in tenofovir DF treated subjects as compared to the control group. In patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms, hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy should be considered.
  • Fat Redistribution: Observed in patients receiving antiretroviral therapy.
  • Immune Reconstitution Syndrome: May necessitate further evaluation and treatment in HIV-1 infected patients. Autoimmune disorders may occur in the setting of immune reconstitution.
  • Early Virologic Failure: May occur in HIV-infected patients on regimens containing only 3 nucleoside reverse transcriptase inhibitors (NRTIs). Monitor carefully and consider treatment modification.
  • 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 adefovir dipvoxil

Warnings and precautions specific to TRUVADA for a PrEP indication

  • Comprehensive management strategies to reduce potential risks associated with use of TRUVADA for a PrEP indication:
    • Strategies to reduce uninfected individual’s exposure to HIV-1 infection include safer sex practices such as consistent and correct use of condoms, an individual knowing their HIV 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 should 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 status immediately prior to initiating TRUVADA for PrEP. Do not initiate TRUVADA for PrEP if signs or symptoms of HIV infection are present (e.g., fever, fatigue, myalgia, skin rash, etc.) and if recent exposure (< 1 month) is suspected. Delay initiating PrEP for 1 month and reconfirm HIV-1 negative status; alternatively, confirm negative HIV-1 status with a test approved by the FDA to aid diagnosis of acute or primary HIV-1 infection.
      • Screen for HIV-1 infection at least every three (3) months. Discontinue TRUVADA for PrEP if symptoms of acute infection develop after a potential HIV-1 exposure event occurs until negative HIV-1 status is confirmed using a test approved by the FDA to aid in the diagnosis of acute or primary HIV-1 infection.

Counsel all uninfected individuals to strictly adhere to their TRUVADA dosing schedule because the effectiveness of TRUVADA for PrEP is correlated with adherence as demonstrated by measurable drug levels in clinical trials.

Adverse reactions

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

Drug Interactions:

  • Didanosine: Coadministration increases didanosine concentrations. Use with caution and monitor for evidence of didanosine toxicity (e.g., pancreatitis, neuropathy). Consider dose reductions or discontinuations of didanosine if warranted.
  • HIV-1 protease inhibitors: Coadministration decreases atazanavir concentrations and increases tenofovir concentrations; use atazanavir given with ritonavir. Coadministration of TRUVADA with atazanavir and ritonavir, darunavir and ritonavir, or lopinavir/ritonavir increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity.
  • Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir.

Use of TRUVADA in specific populations:

  • Pregnancy: There are no adequate and well-controlled trials in pregnant women with TRUVADA. It is not known if TRUVADA may cause fetal harm during pregnancy. In women taking TRUVADA for treatment of HIV-1 infection, TRUVADA should be used during pregnancy only if clearly needed. If uninfected women who become pregnant while taking TRUVADA for PrEP, careful consideration about continuing TRUVADA should be given, taking into account the potential increased risk of HIV-1 infection during pregnancy. A pregnancy registry is available. Enroll women taking TRUVADA by calling 1-800-258-4263
  • Nursing mothers: Women taking TRUVADA for any 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. Breastfeeding by HIV-1 positive women may transmit HIV-1 infection to the infant
  • Pediatrics: TRUVADA for a PrEP indication is based on studies in adults. TRUVADA for treatment of HIV-1 infection should not be prescribed to patients less than 12 years old or weighing less than 35 kg (77 lbs)

Dosage and Administration

Dosage: One tablet once daily taken orally with or without food

  • Renal Impairment:
    • When used for treating HIV-1 infection: Dosing interval adjustment of TRUVADA and close monitoring of renal function are recommended in all patients with CrCl 30–49 mL/min. TRUVADA should not be administered in patients with CrCl <30 mL/min
    • The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment or in pediatric patients with renal impairment; clinical response to treatment and renal function should be closely monitored in these patients
  • When used for PrEP: Do not use TRUVADA for PrEP in uninfected individuals with CrCl <60 mL/min

Please report adverse events to Gilead by calling 1-800-GILEAD-5. Adverse events can also be reported to the FDA through www.fda.gov/medwatch or by calling 1-800-FDA-1088.

Visit the TRUVADA for HIV-1 treatment Web Site at www.TRUVADA.com

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