| TRUVADA FOR PrEP is approved to significantly reduce the risk of sexually acquired HIV-1 in individuals at risk.1,2 |
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| Talk to them about one-tablet, once-daily TRUVADA FOR PrEP 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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| {{customText[Dear|Hello|Hi|Good morning|Good afternoon|Good evening]}} {{customText[Dr.|Mr.|Mrs.|Prof.|]}} {{accFname}} {{accLname}}, |
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| STIs are on the rise. In 2017, STI diagnoses in the US exceeded the 2016 record by more than 200,000, reaching a high of ~2.3 million new cases of syphilis, gonorrhea, and chlamydia combined. And the risk of HIV is often higher in places or sexual networks where STIs are more prevalent. Given the rise in STIs, how many of your patients are at risk of HIV?3-6 |
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| INDICATION |
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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 | | | | Individuals at risk for sexually acquired HIV-1 may include those: | | | | • | With HIV-1 infected partner(s), or | | | | • | 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 | | | | • | 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 see additional Important Safety Information below or click to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING. |
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| STIs can be a red flag for HIV risk7 |
| 51% of people newly diagnosed with HIV had an STI history that included syphilis, gonorrhea, or chlamydia in a real-world study (n=214).8 |
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| • | Among men with syphilis, ~20% became HIV positive within 10 years9 | | | | • | Among women with a history of gonorrhea, there was a 6x increased risk of HIV diagnoses10 | | | | • | Among MSM with a history of rectal gonorrhea or chlamydia, 1 in 15 became HIV positive within 1 year11 |
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| | 25% of individuals newly diagnosed with HIV had an STI within the 6 months prior to their diagnosis in a real-world study (SF Cohort [N=1311])8 | | | |
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| TRUVADA FOR PrEP does not prevent other STIs. |
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| Be the catalyst—start an open conversation with your patients about STIs and HIV risk |
| Here are some questions to help you get the conversation started7,12: |
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| • | Have you or your partner(s) ever had an STI? | | | | • | When was the last time you were screened for STls? | | | | • | How do you protect yourself and your partner(s) during sex? | | | | • | Did you know that having certain STls may mean that you are at higher risk for HIV? |
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| Talk to patients at risk about their prevention options, including TRUVADA FOR PrEP. |
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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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| Eligible patients may pay as little as a |
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 | 0 | | CO-PAY | * |
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| The co-pay coupon covers up to $7,200 per year with no monthly limit for eligible patients |
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| Enroll patients at: |
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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 | | | | • | 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 | | | | | • | 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 | | | | • | 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 |
| | | | • | 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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| Please see additional Important Safety Information below or click to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING. |
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| With STIs on the rise, your patients may be at risk of HIV. This is because the behaviors that result in an STI can also increase the risk of HIV, including sex without a condom, sex with partner(s) of unknown HIV status, and sex under the influence of drugs or alcohol. Help close the prevention gap and talk to your patients at risk about TRUVADA FOR PrEP today.3,4,7,13 |
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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 | | | | • | 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 | | | | • | 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 | | | | • | 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 | | | | • | Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions | | | | • | 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 | | | | • | 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 | | | | • | HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment | | | | • | HBV screening: Test for HBV infection prior to or when initiating treatment | | | | • | 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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| {{customText[Please let me know if you would like any additional materials about TRUVADA FOR PrEP before we meet.|I look forward to reviewing this information in more detail and answering questions you may have.|If you would like additional information about TRUVADA FOR PrEP, please contact me.|If you have any questions, please do not hesitate to reach out. I would be happy to provide additional information or set up a meeting.|Feel free to reach out if you would like to have a more in-depth conversation about TRUVADA FOR PrEP.|Hope to connect with you soon.]}} |
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TRUVADA FOR PrEP has a Risk Evaluation and Mitigation Strategy (REMS).
Learn more |
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| MSM=men who have sex with men. |
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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. New CDC analysis shows steep and sustained increases in STDs in recent years [press release]. Atlanta, GA: Centers for Disease Control and Prevention; August 28, 2018. https://www.cdc.gov/media/releases/2018/p0828-increases-in-stds.html. Accessed April 24, 2019. 4. Centers for Disease Control and Prevention. Reported STDs in the United States, 2017. https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/std-trends-508.pdf. Published September 2018. Accessed April 24, 2019. 5. Centers for Disease Control and Prevention. NCHHSTP AtlasPlus. https://www.cdc.gov/nchhstp/atlas/index.htm. Updated August 30, 2017. Accessed May 14, 2019. 6. Centers for Disease Control and Prevention. Lifetime risk of HIV diagnosis in the United States. https://www.justfacts.com/document/lifetime_risk_hiv.pdf. Published February 2016. Accessed May 14, 2019. 7. Centers for Disease Control and Prevention. STDs and HIV. https://www.cdc.gov/std/hiv/stdfact-std-hiv-detailed.htm. Updated September 26, 2017. Accessed April 24, 2019. 8. Truong HM, Pipkin S, O’Keefe KJ, et al. Recent infection, sexually transmitted infections, and transmission clusters frequently observed among persons newly diagnosed with HIV in San Francisco. J Acquir Immune Defic Syndr. 2015;69(5):606-609. 9. Peterman TA, Newman DR, Maddox L, Schmitt K, Shiver S. High risk for HIV following syphilis diagnosis among men in Florida, 2000-2011. Public Health Rep. 2014;129(2):164-169. 10. Peterman TA, Newman DR, Maddox L, Schmitt K, Shiver S. Risk for HIV following a diagnosis of syphilis, gonorrhoea or chlamydia: 328,456 women in Florida, 2000-2011. Int J STD AIDS. 2015;26(2):113-119. 11. Pathela P, Braunstein SL, Blank S, Schillinger JA. HIV incidence among men with and those without sexually transmitted rectal infections: estimates from matching against an HIV case registry. Clin Infect Dis. 2013;57(8):1203-1209. 12. Centers for Disease Control and Prevention. A guide to taking a sexual history. CDC publication: 99-8445. https://www.cdc.gov/std/treatment/sexualhistory.pdf. Accessed April 24, 2019. 13. Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2017 Update: A Clinical Practice Guideline. http://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Published March 2018. Accessed April 28, 2019. |
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