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Identify those at risk for HIV by taking a sexual history
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TRUVADA FOR PrEP is the only medication approved to significantly reduce the risk of sexually acquired HIV-1 in individuals at risk, in combination with safer sex practices.1,2
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Help protect your patients from HIV with TRUVADA FOR PrEP, one tablet taken each day—as part of a comprehensive prevention plan.1
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HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA FOR PrEP and at least every 3 months thereafter.
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| Dear Dr. John Doe, |
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I appreciate you taking the time to meet.
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There are 1.1 million individuals estimated to be at risk for sexually acquired HIV in the U.S. and approximately 40,000 diagnoses annually.3,4 HIV risk and diagnosis varies by age, ethnicity, sexual orientation, and gender throughout the U.S.3
Now you can help protect your patients from sexually acquired HIV with TRUVADA FOR PrEP in combination with safer sex practices.
Consider these important steps to proactively identify patients at risk for HIV, and plan ahead: |
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Assessing cues to take a sexual history
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Taking a sexual history
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Developing a prevention plan
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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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| 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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| Please click to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING. |
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| For individuals in your practice... |
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CONSIDER THREE STEPS TO PROACTIVELY IDENTIFY PATIENTS AT RISK FOR HIV AND PLAN AHEAD |
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ASSESS CUES TO TAKE A SEXUAL HISTORY |
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Clinical, sexual, and circumstantial cues represent opportunities to take an in-depth sexual history. Certain clinical cues may indicate increased likelihood of condomless sex, such as5,6:
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An STI diagnosis or test |
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Recent PEP usage |
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A request for an HIV test, or |
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Inquiry about PrEP |
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TAKE A SEXUAL HISTORY |
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When evaluating those who may be at risk for HIV-1, it is important to create a more comfortable environment. Remind your patients that sexual health is a part of overall health, and that conversations about sexual health are standard protocol. Ask non-judgmental questions, such as7:
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Do you have sex with men, women, or both? |
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How do you protect yourself and your partners during sex? |
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DEVELOP A PREVENTION PLAN |
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If you determine a patient is sexually active and at risk for HIV, provide them with counseling and education on comprehensive HIV prevention options, routine screening for HIV and other STIs, and consider TRUVADA FOR PrEP in combination with safer sex practices for individuals who are at risk, HIV-negative, and eligible.7 |
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| Proactive Patient Identification |
| A brochure providing information on how to proactively identify patients at risk of HIV and plan ahead. This includes assessing cues to take a patient's sexual history, taking a sexual history, and developing an HIV prevention plan. |
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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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| 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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| 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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For more information about TRUVADA FOR PrEP, please see full Prescribing Information, including BOXED WARNING.
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Please let me know if you would like any 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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| TRUVADA FOR PrEP has a Risk Evaluation and Mitigation Strategy (REMS). For further information, click here |
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| PEP=post-exposure prophylaxis. |
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| References: 1. TRUVADA [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2018. 2. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399-410. 3. 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 17, 2018. 4. Smith DK, Van Handel M, Wolitski RJ, et al. Vital signs: estimated percentages and numbers of adults with indications for preexposure prophylaxis to prevent HIV acquisition–United States, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(46):1291-1295. 5. Feinstein BA, Johnson BA, Parsons JT, Mustanski B. Reactions to testing HIV negative: measurement and associations with sexual risk behaviour among young MSM who recently tested HIV negative. AIDS Behav. 2017;21(5):1467-1477. 6. Golub SA, Rosenthal L, Cohen DE, Mayer KH. Determinants of high-risk sexual behavior during post-exposure prophylaxis to prevent HIV infection. AIDS Behav. 2008;12(6):852-859. 7. Makadon HJ, Goldhammer H. Taking a sexual history and creating affirming environments for lesbian, gay, bisexual, and transgender people. J Miss State Med Assoc. 2015;56(12):358-362. |
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