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1. Identify those at risk for HIV by taking a sexual history
2. How many of your patients could benefit from HIV prevention?
3. Learn which questions to ask and what to look for during 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 adults at high 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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1. I appreciate you taking the time to meet.
2. I look forward to our discussion.
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4. It was great meeting with you.
5. I am so glad we could connect.
6. Hope we can speak again soon.
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There are 1.1 million individuals estimated to be at elevated 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 in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults at high risk. |
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| Individuals at high risk for sexually acquired HIV-1 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 one or more of the following risk factors: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities, use of illicit drugs or alcohol dependence, incarceration, and/or sexual partners of unknown HIV status with any of these risk factors
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| Prescribing considerations: |
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TRUVADA FOR PrEP must only be prescribed as part of a comprehensive prevention strategy because it is not always effective in preventing HIV-1 infection
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Individuals must strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence
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HIV-negative status must be confirmed immediately prior to initiation and at least every 3 months thereafter. 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 approved by the FDA to aid in the diagnosis of acute HIV-1 infection
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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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TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and its safety and efficacy have not been established in patients with HBV. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HBV and HIV-1 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 patients who are at high 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, including how to assess cues to take a patient's sexual history, taking a patient's 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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Do not use TRUVADA FOR PrEP in individuals with unknown or positive HIV status
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| Warnings and precautions |
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New onset or worsening renal impairment: Acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). Do not use TRUVADA FOR PrEP in individuals with estimated creatinine clearance (CrCl) <60 mL/min. In all patients, assess CrCl prior to initiating and during therapy; reassess potential risks and benefits of use if a decrease in CrCl is observed. 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. 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
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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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Antiviral products: Do not coadminister with other antiviral products containing emtricitabine, tenofovir alafenamide, TDF, lamivudine, or adefovir dipivoxil
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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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| Warnings and precautions: risk reduction strategies |
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Reduce HIV-1 exposure: TRUVADA FOR PrEP is not always effective in preventing HIV-1 infection. 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. 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, delay initiating (≥1 month) or discontinue use if current or recent symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash). Prior to initiating or continuing use, reconfirm HIV-negative status with a test approved by the FDA for the diagnosis of acute HIV infection
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Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence
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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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Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir or velpatasvir/sofosbuvir 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 Category B: There are no adequate and well-controlled trials in pregnant women. Use during pregnancy only if clearly needed. In 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. An Antiretroviral Pregnancy Registry has been established
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Lactation: Emtricitabine and tenofovir have been detected in human milk. Mothers taking TRUVADA FOR PrEP should be instructed not to breastfeed because the potential for adverse reactions in nursing infants is not known and to avoid HIV-1 transmission to the infant if HIV-1 infection is acquired
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| Dosage and administration |
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Adult dosage: One tablet once daily with or without food
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Renal impairment: Do not use in individuals with CrCl <60 mL/min
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Testing prior to initiation: Test for HIV-1 and HBV infection
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For more information about TRUVADA FOR PrEP, please see full Prescribing Information, including BOXED WARNING.
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1. Please let me know if you would like any additional materials about TRUVADA FOR PrEP before we meet.
2. I look forward to reviewing this information in more detail and answering any questions you may have.
3. I can answer any questions you may have when we speak.
4. Please reach out to me if you have any questions. I would be happy to discuss further.
5. I look forward to our next meeting.
6. If you would like additional materials about TRUVADA FOR PrEP, please do not hesitate to contact me.
7. Feel free to contact me if you would like to set up a meeting to learn more.
8. Please reach out for more information on TRUVADA FOR PrEP.
9. Hope to connect with you soon.
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1. Best regards,
2. Sincerely,
3. Thank you,
4. Thanks again,
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212-555-1212
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| TRUVADA FOR PrEP has a Risk Evaluation and Mitigation Strategy (REMS). For further information, visit www.truvadapreprems.com |
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| PEP=post-exposure prophylaxis; STI=sexually transmitted infection. |
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| References: 1. TRUVADA [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017. 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, 2015; vol. 27. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2015-vol-27.pdf. Published November 2016. Accessed October 9, 2017. 4. Nehl EJ, Klein H, Sterk CE, Elifson KW. Prediction of HIV sexual risk behaviors among disadvantaged African American adults using a syndemic conceptual framework. AIDS Behav. 2016;20(2):449-460. 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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