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{{customText[Learn how to identify women with HIV risk factors|More women than you think may be at risk for HIV|Don't let
HIV risk go undetected among women]}}
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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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{{customText[I appreciate you taking the time to meet with me.|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.|I 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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Did you know that 1 in every 5 new HIV diagnoses is in a woman?1
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TRUVADA FOR PrEP is approved to significantly reduce the risk of sexually acquired HIV-1 in individuals at risk,
in combination with safer sex practices.2,3 |
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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 |
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Individuals at risk for sexually acquired HIV‑1 may 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 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 |
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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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For some women, HIV risk factors are out of their control4-7 |
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Where a woman lives—or her
partner's HIV risk factors—can
impact her risk for HIV4-6 |
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HIV risk for many women
can be associated with a
steady male partner7
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Help protect appropriate patients with TRUVADA FOR PrEP, one tablet taken each day.
Approved to significantly reduce the risk of sexually acquired HIV-1 in individuals at risk,
as part of a comprehensive prevention plan. HIV-1–negative status must be confirmed immediately prior to initiating TRUVADA FOR PrEP and at least every 3 months thereafter2,3
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Click here to download the Advancing Access® brochure for information about financial and insurance support for eligible patients.
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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 |
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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, 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 |
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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 |
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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 |
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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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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 |
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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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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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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 |
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Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or
sofosbuvir/velpatasvir/voxilaprevir 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: 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 |
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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 |
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HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during
treatment
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HBV screening: Test for HBV infection prior to or when initiating treatment |
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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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You may only have one chance to have an
open conversation about HIV risk
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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 plan2 |
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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[Feel free to reach out to me if you would like to talk more about women's HIV risk and how TRUVADA FOR PrEP may help appropriate patients.|If you would like additional information about women's HIV risk factors or TRUVADA
FOR PrEP, please contact me.]}}
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{{customText[Best regards,|Sincerely,|Thank you,|Thanks again,]}}
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TRUVADA FOR PrEP has a Risk Evaluation and Mitigation Strategy (REMS). For further information, click here. |
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References: 1. Centers for Disease Control and Prevention. HIV Surveillance Report, 2017;
vol 29. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2017-vol-29.pdf.
Published November 2018. Accessed February 26, 2019. 2. TRUVADA [package insert]. Foster
City, CA: Gilead Sciences, Inc.; 2018. 3. 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. 4. Centers for Disease Control and Prevention. HIV in the United States by region. https://www.cdc.gov/hiv/statistics/overview/geographicdistribution.html.
Updated November 27, 2018. Accessed February 26, 2019. 5. 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 February 26, 2019. 6. Chen YH, Raymond HF, McFarland W, Truong HM.
HIV risk behaviors in heterosexual partnerships: female knowledge and male behavior. AIDS Behav. 2010;14(1):87-91.
7. McMahon JM, Myers JE, Kurth AE, et al. Oral pre-exposure prophylaxis (PrEP) for prevention of
HIV in serodiscordant heterosexual couples in the United States: opportunities and challenges. AIDS Patient Care STDS. 2014;28(9):462-474. |
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