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Find out how you can help protect your patients who are at risk for HIV
Important factors to consider to help prevent HIV in those at risk
Help protect your at-risk patients from HIV
An HIV prevention option you can implement in your practice
HIV prevention clinical management checklist
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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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| {{customText[Dear |Hello |Hi |Good morning |Good afternoon |Good evening ]}}{{customText[Dr. |Mr. |Mrs. |Ms. |Prof. |]}} {{accFname}} {{accLname}}, |
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I appreciate you taking the time to meet.
I look forward to our discussion.
I am looking forward to connecting with you.
It was great meeting with you.
I am so glad we could connect.
Hope we can speak again soon.
I hope we can schedule a meeting soon.
Sorry I missed you.
I hope to connect with you in the near future.
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In preparation for our meeting, I am sending you some important information about TRUVADA FOR PrEP.
To help continue our conversation, I am sending some additional information about TRUVADA FOR PrEP.
As a follow up, I wanted to share some additional information with you.
Thank you for taking the time to speak with me about TRUVADA FOR PrEP. Here is some additional information for you to review.
In addition to the content in this email, I have attached more detailed information that you may find useful when implementing HIV prevention.
I have included some information about TRUVADA FOR PrEP that could be relevant to your clinical practice.
Please contact me to schedule a lunch for yourself or your team to learn more about TRUVADA FOR PrEP.
In addition to the content in this email, I have attached more detailed information about implementing TRUVADA FOR PrEP in your practice.
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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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| Did you know as recently as 2016, an average of 100 people in the U.S. were diagnosed with HIV every day?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 high risk for HIV as part of a comprehensive prevention strategy that includes counseling on safer sex practices.2 |
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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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| 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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| Please see below for additional Important Safety Information for TRUVADA FOR PrEP. |
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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 HIGH RISK OF HIV‑1
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INITIAL/BASELINE VISIT
Steps for patients you determined are appropriate candidates for TRUVADA FOR PrEP
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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 and ensure that CrCl ≥60 mL/min
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Test for hepatitis B; 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, one tablet once 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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| 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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CONTINUING PATIENTS/FOLLOW-UP VISITS
For appropriate patients continuing on TRUVADA FOR PrEP
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Screen for HIV-1 to confirm HIV-negative status every 3 months
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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 that 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, periodically monitor serum phosphorus, urine glucose, and urine protein
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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, one tablet once daily, max 90-day supply |
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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 $4800 (previously $3600) 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 |
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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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| 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 high 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 you and your patients to help ensure patients 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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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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| 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 high 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 you and your patients to help ensure patients 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 (cont'd) |
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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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| 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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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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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.
I look forward to reviewing this information in more detail and answering questions you may have.
I can answer any 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 materials 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.
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{{customText[Best regards,|Sincerely,|Thank you,|Thanks again,]}}
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{{userName}}
{{userEmailAddress}}
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, visit www.truvadapreprems.com
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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 February 27, 2018. 2. TRUVADA [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017.
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©2018 Gilead Sciences, Inc. 333 Lakeside Drive, Foster City, CA 94404
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All rights reserved. TVDP0292 05/18
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