| | | | 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'm excited to share the efficacy and safety data from the pivotal trial. I would love to set aside some time to discuss the results in greater detail.|It was great meeting with you to discuss DESCOVY FOR PrEP. I’m following up to make sure you know all about the efficacy and safety results of the DISCOVER Trial. The pivotal trial shows why it may be the right PrEP option for appropriate patients.|I have some information that may be relevant to your practice. I would like to share some efficacy and safety highlights from the DISCOVER Trial about DESCOVY FOR PrEP. The data helps show why this new option is available.]}} | | |
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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) | | |
| | | | | | | • | Primary analysis: when 100% of patients reached Week 48 and ≥50% reached Week 961 | | |
| | | | Treatment outcomes were similar across subgroups of age, race, gender identity, and baseline TRUVADA use.1 | | | | The DISCOVER Trial design1,2 | | | | 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 subset | | | | 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. | | | | Few seroconversions were observed1 | | | | | | | Observed efficacy in switch subset1,3 | | | | | | | • | Patients who switched: Patients who were using TRUVADA at baseline and randomized to DESCOVY FOR PrEP1,3 | | |
| | | | • | Patients who continued: Patients using TRUVADA at baseline who continued using the drug1,3 | | |
| | | | Common adverse reactions were similar through primary analysis1 | | | | The most common adverse reactions in patients using 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. | | | | Few discontinuations due to adverse events through primary analysis1 | | | | The proportion of patients who discontinued treatment with DESCOVY or TRUVADA was 1% and 2%, respectively. | | |
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| | | | | 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, 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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| | | | | NSAIDs=nonsteroidal anti-inflammatory drugs; PY=person-years. | | | | 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 | | |
| | | | Please click to view full Prescribing Information for DESCOVY FOR PrEP, including BOXED WARNING. | | | | {{customText[Please let me know if you would like to meet to discuss the DESCOVY FOR PrEP clinical trial results, and I'll set up a meeting.|Follow the link below for more on the results of the DISCOVER Trial, and find out if your patients are appropriate for DESCOVY FOR PrEP.|If you have any more questions, please let me know and we can set up another meeting.|If you have any questions about this data and DESCOVY FOR PrEP, I'm always available to meet to discuss.]}} | | | | {{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. 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. 3. Data on file. Gilead Sciences, Inc. | | | | | |
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