| | | | 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. | |  |
| | | 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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| | | | | {{customText[Dear|Hi|Hello|Good morning|Good afternoon|Good evening]}} {{customText[Dr.|Prof.|Mrs.|Ms.|Mr.|]}} {{accFname}} {{accLname}}, | | | | {{customText[Now that DESCOVY FOR PrEP is available, I am sending you an overview of key data for renal and bone markers that I would love to discuss in person.|It was great meeting with you and discussing DESCOVY FOR PrEP. As a follow-up, I wanted to send key data for renal and bone markers from the pivotal trial. Please see below.|Are you interested in giving your patients another option for PrEP? I wanted to share some renal and bone data about DESCOVY FOR PrEP from the DISCOVER clinical trial below.]}} | | |
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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. | | | | Nearly all patients remained HIV-free with DESCOVY FOR PrEP1 | | | | DESCOVY FOR PrEP was noninferior to TRUVADA® | | | | • | HIV incidence rate of 0.16/100 PY vs 0.34/100 PY (IRR=0.47; CI: 0.19-1.15) | | | | • | 99.7% of patients remained HIV-free at primary analysis* with DESCOVY (n=2670) vs 99.4% of patients with TRUVADA (n=2665) | | | | • | For the subset of patients (17%) using TRUVADA at baseline: | | | | | – | 100% of patients who switched to DESCOVY FOR PrEP (n=459) remained HIV-free vs 99.8% of those who continued using TRUVADA (n=438)2 | | |
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| | | | Common adverse reactions were similar through primary analysis1* | | | | The most common adverse reactions in patients who received DESCOVY (n=2694) and TRUVADA (n=2693) (incidence ≥2%, all grades) were diarrhea 5% and 6%, nausea 4% and 5%, headache 2% and 2%, fatigue 2% and 3%, and abdominal pain 2% and 3%, respectively. | | | | * | When 100% of patients reached Week 48 and ≥50% reached Week 96. |
| | | | The DISCOVER Trial Design1,3 | | | | The efficacy and safety of DESCOVY to reduce the risk of acquiring HIV-1 infection were evaluated in the randomized, double-blind DISCOVER Trial comparing DESCOVY (n=2670 for efficacy; n=2694 for safety) with TRUVADA (n=2665 for efficacy; n=2693 for safety). HIV-seronegative men and transgender women who have sex with men, who were at risk of HIV-1 infection and reported condomless anal sex with ≥2 partners in the prior 12 weeks, or who had syphilis or rectal gonorrhea or chlamydia in the prior 24 weeks, were randomized 1:1 to receive once-daily, blinded, active tablets of DESCOVY or TRUVADA with matching placebos. The primary endpoint was the incidence of documented HIV-1 infection per 100 PY (primary analysis occurred with a minimum follow-up of 48 weeks and at least 50% of patients having 96 weeks of follow-up). | | | | Switch subset1 | | | | In the study population, a subset of 17% of patients (n=905) were using TRUVADA at baseline. Of these patients, 465 were randomized to DESCOVY and 440 were randomized to continue using TRUVADA. | | | | Less impact on markers of renal function1,2 | | | | | | There was a 4.1-mL/min difference between DESCOVY FOR PrEP
(+1.8 mL/min) and TRUVADA (-2.3 mL/min) in eGFRCG at Week 48. | | | | | | | The long-term clinical significance of changes in eGFR is not known. | | | | Lower serum creatinine levels were also seen with DESCOVY FOR PrEP at Week 48 | | | | • | Mean serum creatinine decreased 0.01 mg/dL with DESCOVY FOR PrEP vs a 0.01-mg/dL increase with TRUVADA from baseline1 | | |
| | | | Important Safety Information (cont'd) | | | | Warnings and precautions | | | | • | 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) | | |
| | | | Please see additional Important Safety Information below or click to view full Prescribing Information for DESCOVY FOR PrEP, including BOXED WARNING. | | | | Switching to DESCOVY FOR PrEP resulted in increased eGFR vs TRUVADA1,2 | | | | | | There was a 4.5-mL/min difference between DESCOVY FOR PrEP
(+3.9 mL/min) and TRUVADA (-0.6 mL/min) in eGFRCG at Week 48. | | | | | | | Significantly less impact on BMD1,3 | | | | Mean % change in lumbar spine and hip BMD at Week 48 |  | |
| | | | The long-term clinical significance of changes in BMD is not known. | | | | • | At Week 48, BMD declines of ≥5% at the lumbar spine and ≥7% at the total hip were experienced by 4% and 1% of patients, respectively, in both treatment arms1 | | | | • | Analysis of these parameters was conducted in a subset of the study population (n=383)1,3 | | | | • | BMD was assessed at baseline and Week 48 by dual-energy X-ray absorptiometry (DXA) scans1 | | | | • | DESCOVY FOR PrEP had less impact on BMD compared with TRUVADA.1 Increases in BMD observed in DISCOVER patients may be consistent with innate bone development | | |
| | | | Many of the patients in the DISCOVER Trial were under 30, an age at which many people still experience bone growth.3-5 | | | | Important Safety Information (cont'd) | | | | Contraindication | | | | • | DESCOVY FOR PrEP is contraindicated in patients with unknown or positive HIV status | | |
| | | | 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 |
| | | | 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 card covers up to $7200 per year for DESCOVY, 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) | | | | 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. | | | | BMD=bone mineral density; eGFRCG=estimated glomerular filtration rate (Cockcroft-Gault); NSAIDs=nonsteroidal anti-inflammatory drugs; PY=person-years; Q1, Q3=first quartile, third quartile. | | | | {{customText[Please let me know if you would like to meet and discuss the safety data for DESCOVY FOR PrEP, and I'll set up an office visit.|Learn more about the DISCOVER Trial using the link below, and find out if your patients are appropriate for DESCOVY FOR PrEP today.|I hope our conversation sparked 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, feel free to contact me to set up a meeting to learn more.]}} | | | | {{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. Data on file. Gilead Sciences, Inc. 3. Hare B, Coll P, Ruane P, et al. The phase 3 DISCOVER study: daily F/TAF or F/TDF for HIV preexposure prophylaxis. Presented at: The annual Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2019; Seattle, WA. Abstract 104. 4. Walsh JS, Henry YM, Fatayerji D, Eastell R. Lumbar spine peak bone mass and bone turnover in men and women: a longitudinal study. Osteoporos Int. 2009;20(3):355-362. 5. Weaver CM, Gordon CM, Janz KF. The National Osteoporosis Foundation's position statement on peak bone mass development and lifestyle factors: a systematic review and implementation recommendations. Osteoporos Int. 2016;27(4):1281-1386. | | | | | |
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