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Find out how you can help protect your patients who are at risk for HIV
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IMPORTANT SAFETY
INFORMATION |
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TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed |
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Severe acute exacerbations of hepatitis B have been reported in HBV-infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted |
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Dear Dr. John Doe,
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I appreciate you taking the time to meet.
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In preparation for our meeting, I am sending you some important information about TRUVADA FOR PrEP.
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| TRUVADA FOR PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV-negative status must be confirmed immediately prior to initiation |
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If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiation for at least 1 month until HIV-negative status is reconfirmed. Alternatively, confirm HIV-negative status with a test cleared by the FDA to aid in the diagnosis of acute HIV-1 infection |
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| Individuals at risk for sexually acquired HIV-1 may include those: |
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With HIV-1 infected partner(s), or |
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Who engage in sexual activity in a high prevalence area or social network and have additional risk factors, such as: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities, use of illicit drugs or alcohol dependence, incarceration, or sexual partners of unknown HIV status with any of these risk factors |
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| Did you know >100 people are diagnosed with HIV in the U.S. each day, on average?1 |
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| HIV and STI testing are important opportunities to assess an individual's risk of sexually acquired HIV infection. You can help reduce that risk by prescribing TRUVADA FOR PrEP to eligible HIV‑negative individuals at risk of HIV as part of a comprehensive prevention strategy that includes counseling on safer sex practices.2 |
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| Please see below for additional Important Safety Information for TRUVADA FOR PrEP. |
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CLINICAL MANAGEMENT CHECKLIST
FOR INDIVIDUALS AT RISK OF HIV‑1 |
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PRIOR TO INITIATION OF TRUVADA FOR PrEP
Steps for patients you determined are appropriate candidates for TRUVADA FOR PrEP2,3 |
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Screen for HIV-1 to confirm HIV-negative status |
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Confirm HIV-negative status with a test approved by the FDA to aid diagnosis of acute or primary HIV-1 infection |
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Ensure no symptoms of acute HIV infection are present if recent exposures are suspected <1 month |
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Assess renal function |
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Determine serum creatinine, estimated CrCl ≥60 mL/min, urine glucose and protein levels. In chronic kidney disease, assess serum phosphorus |
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Test for HBV at or prior to initiation; consider vaccination if HBV uninfected |
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Test for pregnancy, if applicable |
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Counsel on the risks and benefits of using TRUVADA FOR PrEP during pregnancy, taking into account the increased risk of HIV‑1 infection during pregnancy |
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An Antiretroviral Pregnancy Registry is available. Enroll women taking TRUVADA FOR PrEP by calling 1‑800‑258‑4263 |
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If appropriate, consider prescribing TRUVADA (emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg) FOR PrEP, 1 tablet PO daily, max 90-day supply |
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Counsel on importance of adherence since efficacy is strongly correlated with adherence, as well as using TRUVADA FOR PrEP as part of a comprehensive prevention plan |
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It is recommended that one-time HCV testing be performed for sexually active persons about to start PrEP for HIV |
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IMPORTANT SAFETY INFORMATION (cont'd) |
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| Contraindications |
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TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status |
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CONTINUING PATIENTS/FOLLOW-UP VISITS
For appropriate patients continuing on TRUVADA FOR PrEP2-4
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Screen for HIV-1 to confirm HIV-negative status every 3 months, and upon diagnosis of an STI |
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Use an FDA-approved test to confirm HIV-negative status |
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Drug-resistant HIV-1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV-1 infection |
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Screen for STIs routinely (3-site testing) |
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Not all STIs are symptomatic so test all sites of exposure, including the urethra, pharynx, and rectum, regardless of condom use |
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Monitor renal function to ensure CrCl ≥60 mL/min |
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Reassess potential risks and benefits of using TRUVADA FOR PrEP if a decrease in CrCl is observed during use |
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In patients at risk for renal dysfunction, continue renal monitoring |
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Counsel on importance of adherence and using TRUVADA FOR PrEP as part of a comprehensive prevention plan |
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Re-assess HIV risk at each visit
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If appropriate, consider continuing TRUVADA (emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg) FOR PrEP, 1 tablet PO daily, max 90-day supply |
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Consider screening HIV-negative MSM taking TRUVADA FOR PrEP annually for HCV or more frequently, if warranted |
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HELP ELIGIBLE PATIENTS AFFORD TRUVADA FOR PrEP WITH ADVANCING ACCESS®
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Advancing Access is committed to helping eligible patients afford their Gilead medication whether they are insured, uninsured, or underinsured
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Live case specialists available to provide access support to patients, including:
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Individual coverage and benefits investigation and prior authorization information |
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Information regarding understanding additional insurance and financial resources, including co-pay coupon cards*, independent co-pay foundations, and the Medication Assistance Program |
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Terms and conditions apply and can be found at www.gileadadvancingaccess.com/copay-coupon-card Not all patients will be eligible. |
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| Co-pay coupon support for TRUVADA now covers up to $7200 (previously $4800) in co-pays per year with no monthly limit. |
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| Enroll patients at: |
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OR  1-800-226-2056 |
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| IMPORTANT SAFETY INFORMATION (cont'd) |
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| Warnings and precautions: Comprehensive risk reduction strategies |
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Reduce HIV-1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV-1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other STIs, and counseling on reducing sexual risk behaviors |
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Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV-1 |
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HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection |
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If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed |
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Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling |
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| Additional Resources for You and Your Patients |
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Sexual Health Questionnaire
A form for your patients to provide information about their sexual health and get the conversation started. Understanding your patients' sexual health will better inform discussions about how your patients can protect themselves from STIs, including HIV.
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TRUVADA FOR PrEP Patient Brochure
A brochure for patients providing important information about TRUVADA FOR PrEP. This includes efficacy, safety, and financial support information, as well as safer sex practices, who may be at risk for HIV, how to discuss sexual health with a healthcare provider, and more.
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Advancing Access Brochure
A brochure providing information for your patients to help ensure they have access to the medication you prescribe. This includes help with financial support for eligible patients and addressing potential insurance and coverage issues.
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| IMPORTANT SAFETY INFORMATION |
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| BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B |
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TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV‑negative status is confirmed |
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Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted |
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| Contraindications |
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TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status |
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| Warnings and precautions: Comprehensive risk reduction strategies |
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Reduce HIV-1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV-1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other STIs, and counseling on reducing sexual risk behaviors |
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Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV-1 |
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HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection |
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If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed |
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Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling |
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| Warnings and precautions |
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New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section |
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Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss |
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Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations |
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Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions |
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| Please see below for additional Important Safety Information for TRUVADA FOR PrEP. |
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| IMPORTANT SAFETY INFORMATION (cont'd) |
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| Warnings and precautions |
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New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section
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Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss |
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Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations |
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Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions |
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| IMPORTANT SAFETY INFORMATION (cont'd) |
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| Adverse reactions |
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Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss |
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| Drug interactions |
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Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments |
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Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions |
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Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir |
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| Pregnancy and lactation |
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Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection
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Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown
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| Dosage and administration |
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Dosage: One tablet once daily with or without food |
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HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment |
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HBV screening: Test for HBV infection prior to or when initiating treatment |
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Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus |
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Please click to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING.
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Please let me know if you would like additional materials about TRUVADA FOR PrEP before we meet.
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| Best regards, |
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Gilead Gilead US
veeva@harrisonandstar.com
O: 212-555-1212
M: 917-555-1213
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Learn more at www.TRUVADA.com/hcp
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Get helpful HIV prevention resources for you and your patients at
www.HIVPreventionResources.com
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TRUVADA FOR PrEP has a Risk Evaluation and Mitigation Strategy (REMS). For further information, click here
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References: 1. Centers for Disease Control and Prevention. HIV Surveillance Report, 2016; vol 28. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2016-vol-28.pdf. Published November 2017. Accessed July 20, 2018. 2. TRUVADA [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2018. 3. The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. https://www.hcvguidelines.org/sites/default/files/full-guidance-pdf/HCVGuidance_May_24_2018b.pdf. Updated May 24, 2018. Accessed August 21, 2018. 4. Marcus JL, Bernstein KT, Kohn RP, Liska S, Philip SS. Infections missed by urethral-only screening for chlamydia or gonorrhea detection among men who have sex with men. Sex Transm Dis. 2011;38(10):922-924.
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