| | | | | INDICATION | | DESCOVY® for HIV-1 pre-exposure prophylaxis (PrEP) is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation. | | | | Limitation of Use: DESCOVY FOR PrEP™ is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated. |
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| | | | INDICATION | | DESCOVY® for HIV-1 pre-exposure prophylaxis (PrEP) is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation. | | | | Limitation of Use: The effectiveness of DESCOVY in individuals at risk of HIV-1 from receptive vaginal sex has not been established. |
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| | | | | {{customText[Dear|Hi|Hello|Good morning|Good afternoon|Good evening]}} {{customText[Dr.|Prof.|Mrs.|Ms.|Mr.|]}} {{accFname}} {{accLname}}, | | | | {{customText[I'm pleased to share the news that DESCOVY is now approved for PrEP, giving physicians and appropriate patients at risk a new option for HIV prevention. I know you're always interested in new FDA approvals for medicine that may help your patients, which is why I'm providing some up-to-date information about this new indication.|A new indication for DESCOVY–a new option in PrEP for appropriate patients in your practice.|It was great meeting with you and discussing the approval of DESCOVY FOR PrEP. Gilead Sciences is always working to develop new medical options for patients, and is excited to announce this news.|I just wanted to share some great news: DESCOVY has been approved for PrEP. Please take some time to review the information.]}} | | |
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| | | | | IMPORTANT SAFETY INFORMATION | | | | BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B | | | | • | DESCOVY FOR PrEP must be prescribed only to patients 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 emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for HIV-1 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 patients infected with hepatitis B virus (HBV) who discontinued products containing FTC and/or TDF and may occur with discontinuation of DESCOVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HBV who discontinue DESCOVY. If appropriate, anti-hepatitis B therapy may be warranted | | |
| | | | Please see additional Important Safety Information below or click to view full Prescribing Information for DESCOVY FOR PrEP, including BOXED WARNING. | | | | DISCOVER was the largest PrEP clinical trial, with over 5000 patients1,2 | | | | Randomized, active-controlled, double-blind trial1,3 | | | | | | | At entry and Q12W patients were offered1: | | | | • | Adherence counseling | | | | • | Prevention services (risk-reduction counseling, condoms) | | |
| | | | Primary endpoint analysis (n=5335)1: | | | | HIV incidence/100 PY with a minimum follow-up of 48 weeks and at least 50% of patients having 96 weeks of follow-up. | | | | MSM=men who have sex with men; PY=person-years; Q12W=every 12 weeks; TGW=transgender women (who have sex with men). | | | | Important Safety Information (cont'd) | | | | Contraindication | | | | • | DESCOVY FOR PrEP is contraindicated in patients with unknown or positive HIV status | | |
| | | | Please see additional Important Safety Information below or click to view full Prescribing Information for DESCOVY FOR PrEP, including BOXED WARNING. | | |
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| | | | | New PrEP option. Immediate coverage across major plans. | | |  | | Eligible patients may pay as little as a
$0 co-pay* |
| | | | Eligible patients may pay as little as a $0 co-pay* |
| | | | The co-pay coupon covers up to $7200 per year, with no monthly limit for eligible patients. | | | | * | For eligible, commercially insured patients only.
See full terms and conditions at gileadadvancingaccess.com/hcp.
This is not health insurance. Only accepted at participating pharmacies. |
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| | | | | Important Safety Information (cont'd) | | | | Warnings and precautions | | | | • | Comprehensive management to reduce risks: | | | | | | — | Use DESCOVY FOR PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs) | | | | — | HIV-1 risk factors: Behavioral, biological, or epidemiologic HIV-1 risk factors may include, but are not limited to: condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network | | | | — | Reduce STI risk: Counsel on the use of STI prevention measures (e.g., consistent and correct condom use, knowledge of partner’s HIV-1 viremic status, regular testing for STIs) | | | | — | Reduce potential for drug resistance: Only prescribe DESCOVY FOR PrEP to patients confirmed to be HIV negative immediately prior to initiation, at least every 3 months while taking DESCOVY, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in patients with undetected HIV-1 infection who are taking only DESCOVY because DESCOVY alone is not a complete regimen for treating HIV-1 | | | | — | Some HIV tests may not detect acute HIV infection. Prior to initiating DESCOVY FOR PrEP, ask patients about potential recent exposure events. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the FDA for use in the diagnosis of acute HIV infection | | | | — | If HIV-1 infection is suspected or if symptoms of acute infection are present while taking DESCOVY FOR PrEP, convert the DESCOVY FOR PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the FDA for use in the diagnosis of acute HIV infection | | | | — | Counsel on adherence: Counsel patients to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. Some patients, such as adolescents, may benefit from more frequent visits and counseling |
| | | | • | New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. Do not initiate DESCOVY in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue DESCOVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients (see Dosage and Administration section) | | | | • | Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. 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 |
| | | | Adverse reactions | | | | • | Most common adverse reactions (≥2%) in the DESCOVY FOR PrEP clinical trial were diarrhea, nausea, headache, fatigue, and abdominal pain |
| | | | Drug interactions | | | | • | Prescribing information: Consult the full Prescribing Information for DESCOVY for more information, warnings, and potentially significant drug interactions, including clinical comments | | | | • | Metabolism: Drugs that inhibit P-gp can increase the concentrations of tenofovir alafenamide (TAF), a component of DESCOVY. Drugs that induce P-gp can decrease the concentrations of TAF, which may lead to loss of efficacy | | | | • | Drugs affecting renal function: Coadministration of DESCOVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions | | |
| | | | Dosage and administration | | | | • | Dosage: One tablet taken once daily with or without food | | | | • | HIV screening: Test for HIV-1 infection immediately prior to initiating, at least every 3 months during use, and upon diagnosis of an STI (see Warnings and Precautions section) | | | | • | HBV screening: Test for HBV infection prior to or when initiating DESCOVY | | | | • | Renal impairment and monitoring: Not recommended in patients with creatinine clearance (CrCl) <30 mL/min. Prior to or when initiating DESCOVY, and during use on a clinically appropriate schedule, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus | | |
| | | | For more information about DESCOVY FOR PrEP please see full Prescribing Information including BOXED WARNING. | | | | NSAIDs=nonsteroidal anti-inflammatory drugs. | | | | {{customText[Please let me know if you would like to meet and discuss the new indication for DESCOVY, and I'll set up an office visit.|Learn more about the results of the DISCOVER Trial using the link below, and find out if your patients are appropriate for DESCOVY FOR PrEP today.|I hope our conversation has piqued your interest! Please feel free to reach out if you have any questions about DESCOVY FOR PrEP before we meet again.|If you have any questions about DESCOVY FOR PrEP, I'm always available for a discussion.]}} | | | | | | | {{customText[Best regards,|Sincerely,|Thank you,|Thanks again,]}} | | {{userName}} | | {{userEmailAddress}} | | {{customText(25)}} | | {{customText(25)}} | | | | References: 1. DESCOVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2019. 2. TRUVADA [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2018. 3. US National Library of Medicine. Clinical trials website. Safety and efficacy of emtricitabine and tenofovir alafenamide (F/TAF) fixed-dose combination once daily for pre-exposure prophylaxis in men and transgender women who have sex with men and are at risk of HIV-1 infection (DISCOVER). https://clinicaltrials.gov/ct2/show/study/NCT02842086?term=DISCOVER STUDY: DAILY F/TAF OR F/TDF FOR HIV PREEXPOSURE PROPHYLAXIS&cond=HIV&rank=1. Updated August 19, 2019. Accessed September 18, 2019. | | | | | |
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