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Dear healthcare provider,
We are inspired by your commitment to protect individuals who are at high risk of acquiring HIV. To support you in your ongoing HIV prevention efforts, Gilead is launching new initiatives to broaden awareness of TRUVADA FOR PrEP™—the only medication approved to significantly reduce the risk of sexually acquired HIV‑1 as part of a comprehensive prevention plan.1,2
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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) |
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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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This Is The Day
A new HIV prevention initiative for TRUVADA FOR PrEP
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We are proud to introduce a new initiative, "This is the Day," to inform healthcare providers about TRUVADA FOR PrEP. The content provides a view into different moments when a patient's future could change, and highlights the role you can play to help proactively protect your appropriate patients from sexually acquired HIV‑1 infection with TRUVADA FOR PrEP in combination with safer sex practices.
A key part of the "This is the Day" initiative is the newly launched website, TRUVADA.com/hcp, which contains the following comprehensive resources:
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HIV diagnosis rates and risk
in the U.S. |
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Proactive identification of at‑risk individuals |
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Guidelines recommendations for TRUVADA FOR PrEP |
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Safety, efficacy results and clinical trial information |
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Important prescribing factors and considerations |
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Access and financial support information |
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Please see below to access links to these important topics
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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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Use these links to access helpful information on the new TRUVADA FOR PrEP website:
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We look forward to sharing more resources to help you proactively prevent sexually acquired HIV‑1 with TRUVADA FOR PrEP in at-risk patients as part of a comprehensive HIV prevention plan.
The TRUVADA FOR PrEP team at GILEAD
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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. 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. |
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