| {{customText[Dear|Hello|Hi|Good morning|Good afternoon|Good evening]}} {{customText[Dr.|Mr.|Mrs.|Ms.|Prof.|]}} {{accFname}} {{accLname}}, |
| |
| Don’t miss an opportunity to identify HIV risk when discussing STIs |
| |
| 25% of patients newly diagnosed with HIV had an STI within the 6 months prior to their diagnosis.3 So if a patient asks about STI testing—or has recently tested positive for an STI—that could be an indication that they are at an increased risk for HIV.4 Don’t let this crucial opportunity to have a conversation about HIV prevention strategies pass by. |
| |
| Below you will find some suggestions and helpful resources for having conversations with your patients and identifying whether they are an appropriate candidate for TRUVADA FOR PrEP. |
| |
| TRUVADA FOR PrEP does not prevent other STIs. |
| |
| IMPORTANT SAFETY INFORMATION |
| |
| 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 |
| |
| • | 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 |
|
| |
| See additional Important Safety Information below. |
| |
| INDICATION |
| |
| 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 |
| |
| • | 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 |
|
| |
| Please see additional Important Safety Information below or click to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING. |
| |
| |
| |
| ~82% OF PATIENTS AT RISK FOR HIV ARE NOT CURRENTLY PRESCRIBED TRUVADA FOR PrEP. YOU CAN HELP CLOSE THE PREVENTION GAP5 |
| |
| |
| |
| Talk openly with your patients about their STI history and HIV risk with these questions1,4,6: |
| |
 | | | • | Have you or your partner(s) ever had an STI? | | | | • | When was the last time you were screened for STIs? | | | | • | How do you protect yourself and your partner(s) during sex? | | |
| | | |  | | | • | Did you know that having certain STIs may mean that you are at higher risk for HIV? | | | | • | Have you heard about TRUVADA FOR PrEP, a once-daily pill that can help prevent HIV when used in combination with safer sex practices? | | |
| | | |
| | | | • | Have you or your partner(s) ever had an STI? | | | | • | When was the last time you were screened for STIs? | | | | • | How do you protect yourself and your partner(s) during sex? | | |
| | | | | | | • | Did you know that having certain STIs may mean that you are at higher risk for HIV? | | | | • | Have you heard about TRUVADA FOR PrEP, a once-daily pill that can help prevent HIV when used in combination with safer sex practices? | | |
| | |
|
| CDC guidelines recommend considering TRUVADA FOR PrEP in HIV-negative individuals with recent bacterial STIs who are determined to be at risk for HIV7 |
| |
| IMPORTANT SAFETY INFORMATION (cont’d) |
| |
| Contraindications |
| |
| • | TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status |
|
| |
| Please see additional Important Safety Information below or click to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING. |
| |
| Take a closer look |
| |
| Below are links to two helpful resources: one to help you identify patients who may be at risk of HIV infection, and another that explains Advancing Access®, a program that helps eligible patients access their TRUVADA FOR PrEP. |
| |
 | | | TRUVADA FOR PrEP Overview | | | | The TRUVADA FOR PrEP Overview provides information about identifying patient risk factors for HIV, as well as clinical trial efficacy and safety, and real-world study results for TRUVADA FOR PrEP. |
|
|
| |
|
| |
| IMPORTANT SAFETY INFORMATION (cont’d) |
| |
| Warnings and precautions: Comprehensive risk reduction strategies |
| |
| • | 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 |
|
| |
| 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 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 | | |
| | | | Adverse reactions | | | | • | Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss | | |
| | | | Drug interactions | | | | • | 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 | | |
| | | | Pregnancy and lactation | | | | • | 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 | | |
| | | | Dosage and administration | | | | • | 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 | | |
| | |
|
| |
| For more information about TRUVADA FOR PrEP, please see full Prescribing Information, including BOXED WARNING. |
| |
| {{customText[Please let me know if you would like any additional information about TRUVADA FOR PrEP before we meet.|I look forward to reviewing this information in more detail and answering questions you may have.|I can answer questions you may have when we speak.|Please reach out to me if you have any questions. I would be happy to discuss further.|I look forward to our next meeting.|If you would like additional information about TRUVADA FOR PrEP, please do not hesitate to contact me.|Feel free to contact me if you would like to set up a meeting to learn more.|Please reach out for more information on TRUVADA FOR PrEP.|Hope to connect with you soon.]}} |
| |
| {{customText[Best regards,|Sincerely,|Thank you,|Thanks again,]}} |
| |
| {{userName}} |
| |
| {{userEmailAddress}} |
| |
| {{customText(25)}} |
| |
| {{customText(25)}} |
| |
|
| |
 | |
| |
|
| |
|
| |
TRUVADA FOR PrEP has a Risk Evaluation and Mitigation Strategy (REMS).
Learn more |
| |
| 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. 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. 4. 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 May 14, 2019. 5. Data on file. Gilead Sciences, Inc. 2019. 6. 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 May 14, 2019. 7. Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2017: A Clinical Practice Guideline. http://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf. Published March 2018. Accessed May 14, 2019. |
|
| |
 | |
