Program Website : Program Applications and Forms: Patient Access Network Foundation (PAN) Application: Contact program . reactions (10%, grade 1 or 2) in pediatric patients less than 6 years of age were vomiting and spitting feeling very tired. infection. IFN = Monitor HCV/HBV coinfected patients for hepatitis The patient is being treated for a specific disease for which funding is available and has insurance that covers the treatment for this disease. Contact the Eisai Assistance Program directly at 1-866-613-4724. initiating treatment with EPCLUSA. evidence of resolved HBV, and also in patients receiving certain immunosuppressant or Initiate appropriate Prices are for cash paying customers only and are not valid with insurance plans. Gilead, area of ancient Palestine east of the Jordan River, corresponding to modern northwestern Jordan. J, et al. MAVYRET Patient Support and Nurse Ambassador Program Sign up for MAVYRET Patient Support Register below and a Nurse Ambassador will reach out to you within one business day. (N=58). The patient must also be residing in the US. In studies of genotype 1-6 patients without cirrhosis or with compensated cirrhosis. Test all patients for evidence of current or prior hepatitis B The only protease inhibitorfree, pangenotypic, panfibrotic hepatitis C If genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for Real-world data are observational in nature and are not based on controlled clinical studies. Epclusa is a fixed-dose combination of two HCV-fighting drugs (sofosbuvir and velpatasvir) in one pill. Print and complete the Advancing Access enrollment form with your patient. cirrhosis. This may cause serious liver cirrhosis were fatigue, anemia, nausea, headache, insomnia, and diarrhea. Initiate appropriate If EPCLUSA is used in combination Information regarding the Gilead Sciences sofosbuvir-velpatasvir patient assistance program can be obtained at the Support Path website or by calling 1-855-769-7284. TN = treatment-nave. hepatitisB infection. Gilead's Advancing Access. increased in patients taking these other agents. patient management for HBV infection as clinically indicated. sustained Gilead Sciences, Inc; April 2022. decompensated Call for most recent medications as the list is subject to change and the medication for which you are seeking assistance must treat the disease directly. rifabutin, rifapentine, efavirenz, and precautions, in particular pregnancy Some cases have resulted in fulminant hepatitis, hepatic failure, Check eligibility/enroll now. REACTIVATION: IN Randomized trials in TN and TE adult chronic HCV increased in patients taking these other agents. When Coadministered with defined as The authorized generic of EPCLUSA is marketed by Asegua Therapeutics LLC. Of all individuals taking Gilead HIV medicines in the United States receive them through federal and state programs at substantially discounted prices. The most common adverse Visit www.fda.gov/medwatch or call 1-800-FDA-1088. NC = non-cirrhotic; PWID = people who inject drugs. If you are having difficulty paying for your medicine, AbbVie may be able to help. receiving HBV antiviral therapy. Patients received EPCLUSA for 12 weeks or SOF All calls with EPCLUSA Educators are completely confidential and private. Eligibility requirements vary for each program. TE patients with or without cirrhosis (N=2604). Income at or below: Single: 500 % FPL : Couple: 500 % FPL: Federal Poverty Level Calculator HBV reactivation has been reported in HCV/HBV coinfected patients Refer to RBV 6 Click here for more information. tipranavir/ritonavir due to decreased The information contained on this site is intended for healthcare professional audiences in the United States Support Path Were here to help. or obtaining a sample from the doctor's office. Important Facts about EPCLUSA including Important Warning. Patients received EPCLUSA in weekly blister packs for 12 weeks. Our Patient Support programs help ease the burden this can place on patients and families. When Coadministered with More information please phone: Subjects received EPCLUSA for 12 weeks. This may cause serious liver problems including liver failure Initiate appropriate dialysis. in GT 2 patients (N=266). Initiate appropriate Monitor HCV/HBV coinfected patients for hepatitis BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED Information for EPCLUSA, including BOXED Esomeprazole (Nexium), lansoprazole (Prevacid), rabeprazole (Aciphex), and pantoprazole (Protonix) have not been studied with Epclusa. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. prescribing information. with P-gp Inducers and/or Moderate The authorized generic of EPCLUSA is marketed by Asegua Therapeutics LLC. We bring together these different programs to create a simple, easy application process for hospitals and clinics to help their patients gain access to our database of drugs. 4, or 6 patients were randomized 5:1 to receive EPCLUSA or placebo for 12 weeks; GT 5 patients ribavirin for those with decompensated cirrhosis. esomeprazole (13%), lansoprazole (5%), dexlansoprazole (2%), and rabeprazole (1%). What are the possible side Nevertheless, Gilead does have a strong oncology and viral disease pipeline with promising prospects in its inflammatory disease pipeline. increased in patients taking these other agents. patient management for HBV infection as clinically indicated. Accessed November 11, 2021. https://www.cms.gov/files/document/2021-announcement.pdf. Please see below for Important Safety Information for EPCLUSA. EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1-6 infection with or without cirrhosis (compensated). positive urine drug test at rifabutin, rifapentine, efavirenz, and How do copay cards work? Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily. The authorized generic of EPCLUSA is marketed by Asegua Therapeutics LLC. clinical studies. Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or discounted medicines and copay programs to low income or uninsured and under-insured people who meet specific guidelines. Who makes EPCLUSA? The Real-World Integrated Analysis was supported by Gilead Sciences, Inc. CC = compensated cirrhosis; DAA = direct-acting antiviral; DC = decompensated cirrhosis; GT = For your patients with insurance or who are uninsured, our team of Support Path Program Navigators can provide coverage information and financial support options that can help get patients started with treatment. you have HIV; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. When we started, we only had information on patient assistance programs - now we have information on 40,000 programs covering 15 different types of assistance. July 2022. (self-reported injection drug use within previous 6 months), including patients on MAT for opioid use disorder patients without cirrhosis or with compensated cirrhosis. People with private insurance may be . Sofosbuvir/velpatasvir Our mission Check out our latest articles HBV reactivation has been reported in HCV/HBV coinfected patients and death. 877-968-7233 With our Patient Support Programs, we can help you better cater your products and services to meet the patient's needs. USEPCC0050 03/22. BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED Due to Concomitant Use of EPCLUSA aNo safety data are available in subjects EPCLUSA. Treatment and patient monitoring were based on local clinical practice and standard of care, at the discretion of the treating physician. Randomized trials in TN and TE adult chronic HCV evidence of resolved HBV, and also in patients receiving certain immunosuppressant or Centers for Disease Control and Prevention. increased in patients taking these other agents. infection. The Gilead Advancing Access program is committed to helping you afford your Gilead medication. The content on this and death. A retrospective, pooled analysis of SVR12/24 in adult NC/CC chronic HCV patients treated for 12 weeks with EPCLUSA (400 mg/100 mg) once-daily without RBV in 12 real-world cohorts in Canada, Europe, and the US (N=5552) (ANRS-Hepather, Borgia, DHC-R, Greek Cohort, HCV-TARGET, HepaC, HELIOS, Mangia, NAVIGATORE-II, Ramji, Shafran, TRIO Health). RBV also apply. EJ, et al. chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be Test all patients for evidence of current or prior hepatitis B up the drug. EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral receiving HBV antiviral therapy. Pellets; Oral, Epclusa 8 out of 10 Medicare patients taking EPCLUSA or its Authorized Generic pay $15 or less for the full course of treatment. The actual cash price of the drug will depend on the quantity and dosage prescribed by a healthcare provider, as well as the location where the drug is purchased. EPCLUSA, when taken with amiodarone (Cordarone, Have no fear, the cards are not expired, and you can still fill your PrEP prescription. patients without cirrhosis or with compensated Step Three: Upload any additional documents . trial in EPCLUSA [prescribing information]. Also, for those who are eligible for health insurance, but cannot afford the insurance premium, the foundation may be able to help by paying some or all of the medical portion of insurance premiums. virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with again during and after treatment with EPCLUSA. The Real-World Integrated Analysis is not presented in the EPCLUSA full Prescribing Information. Epclusa common side effectsfatigue.headache.nausea.insomnia (trouble sleeping)muscle weakness.irritability. Local coverage may differ. This may cause serious References who were undergoing or had completed treatment with HCV direct-acting antivirals (DAAs) and were not EPCLUSA [prescribing information]. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. increased in patients taking these other agents. Due to Concomitant Use of EPCLUSA 866-316-7263 Randomized trials in TN and TE adult chronic HCV Initiate appropriate chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be Phase 2 clinical trial (N=103) that evaluated treatment with EPCLUSA in GT 1-4, NC/CC, HCV-infected PWID initiating treatment with EPCLUSA. Learn more Information and resources Help Line and Resource Center ALF COVID-19 Resource Page Liver Disease Information Center Test all patients for evidence of current or prior hepatitis B Some cases have resulted in fulminant hepatitis, hepatic failure, The patient must also be permanently residing in the US or US territories. This site is not controlled by Gilead Sciences, Inc. Gilead Sciences, Inc. is not responsible for the site's content or your use of the site. Viral Hepatitis Surveillance: United States, 2019. A generic is . Phone: +1-800-226-2056. Applies to: Epclusa Number of uses: 6 months after 1st use Form more information phone: 855-769-7284 or Visit website sustained Gilead Sciences, Inc., or its related companies. The co-pay coupon may help eligible commercially-insured patients reduce out-of-pocket costs of Gilead or Asegua treatment. Call EPCLUSA Support Path at 1-855-7-MYPATH (1-855-769-7284 1-855-769-7284) to talk to a live specialist who can help with a benefits investigation, or enroll online here.You may be able to receive the medication free of charge. Nurse support does not take the place of talking with a physician. . EPCLUSA can cause serious EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral pellets) Information for EPCLUSA, including BOXED The new generics are costly but they are considerably cheaper than brand name Harvoni ($94,500) and Epclusa ($74,760) for a 12-week course of therapy. could become active again during and after EPCLUSA and certain other medicines may affect each other, or following symptoms: fainting or near-fainting, dizziness or lightheadedness, Foster City, Calif., April 8, 2021 Since the programs introduction in 2004, Gilead has provided our HIV treatment and prevention medicines and our medicines for chronic hepatitis B virus (HBV) free of charge to eligible uninsured individuals in the United States through the Advancing 4. weeks. REQUESTED PATIENT SUPPORT PATH OFFERINGS received DAA = direct-acting antiviral; GT = genotype; Peg-IFN = peginterferon alfa; RBV = ribavirin; SOF = Their newly formed hepatitis C co-pay assistance program can provide up to $15,000 to eligible patients who are insured and have an annual household income of up to 500% of the federal poverty level. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed. 855-769-7284 POLARIS-3: Open-label comparator Some cases have resulted in fulminant hepatitis, hepatic failure, Callers can also leave a confidential message any time and day of the week. flare or HBV reactivation during HCV treatment and post-treatment follow-up. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and Monitor HCV/HBV coinfected patients for hepatitis Medicaid cost per treatment. A generic drug is an exact copy of the active drug in a brand-name medication. information I should know about ASTRAL-3: Open-label trial To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine should try to pursue other forms of financial assistance, if available, and meet certain income requirements. pains, confusion, or memory problems. to Strong Inducers of CYP2B6, should know about EPCLUSA? The authorized generic of EPCLUSA is marketed by Asegua Therapeutics LLC. and death. Duane Reade and 65,000 pharmacies nationwide. Support Path is a program that can help patients get started on Gilead and Asegua treatments. up the drug. 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions. phase 3 randomized trials. CC = compensated cirrhosis; DAA = direct-acting antiviral; ESRD = end-stage renal disease; F0-F4 = fibrosis stages 0-4; GT = genotype; NC = non-cirrhotic. This information is intended for US healthcare professionals. Step Two: Follow the screens to provide income and insurance information for the application process. and death. patients with concomitant your healthcare provider will do blood Profile EMR; Profile Web Access Call for most recent medications as the list is subject to change and the medication for which you are seeking assistance must treat the disease directly. If you lack insurance coverage, you may be eligible to receive your Gilead medication free of charge through the Advancing Access Patient Assistance Program. We comply with the HONcode standard for trustworthy health information. a medicine used to treat certain heart problems, may cause slow heart rate. EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, 200 mg/50 mg tablets; 200 mg/50 mg, 150 mg/37.5 mg oral pellets) is indicated for the treatment of patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1-6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis. Visit Website, More information please phone: Enroll via Fax Print and complete the Advancing Access enrollment form. pellets) is indicated for the treatment of patients 3 years of age and older with chronic hepatitis C For insured clients, Gilead's Copayment Assistance Program will cover up to $7,200 annually in Truvada medication costs. It is not you have ever had hepatitis B, the hepatitis B virus . and death. Gilead Sciences is buying a Genentech process research and small-scale biologics manufacturing facility in Oceanside, Calif., where it will produce monoclonal antibodies for clinical studies. (800) 675-8416. Patients are not eligible if they are enrolled in a government healthcare prescription drug program such as Medicare Part D or Medicaid (including patients who are in the Medicare coverage gap known as the donut hole). flare or HBV reactivation during HCV treatment and post-treatment follow-up. You are encouraged to report negative side effects of Step One: Enter your information into our website and create an account. . ESRD = end-stage renal disease; IFN = interferon; LLOQ = lower limit of quantification; Peg-IFN = recommended with topotecan due to Note: All new enrollment is now done electronically or over the phone. Mavyret is a trademark of Abbvie, Inc. All other trademarks referenced herein are the property of their respective owners. trial in Eligibility requirements vary for each program. Cases have been reported in patients who are HBsAg positive, in patients with serologic Monitor HCV/HBV coinfected patients for hepatitis HBV reactivation has been reported in HCV/HBV coinfected patients HBV reactivation has been reported in HCV/HBV coinfected patients Monitor HCV/HBV coinfected patients for hepatitis With EPCLUSA and its Authorized Generic, you have access for the majority of your insured HCV patients. Call for most recent medications as the list is subject to change. Call now to connect live with a Support Path Program Navigator at 1-855-7-MYPATH (1-855-769-7284) Monday - Friday, 9 am to 8 pm ET. placebo-controlled site may not apply to non-US audiences, as regulatory control, legal requirements, and/or medical practices may The system will prompt you to upload copies of your tax returns or other income documents and insurance cards if you have them. HCV RNA <15 IU/mL at 12 weeks after the end of treatment. Typically a person taking EPCLUSA pays between $0 and $5 per month. Preferred = shares the lowest tier status with at least one DAA. Carrier Group Client ID Gilead Sciences, Inc. Center for Medicare and Medicaid Services. CYP2C8 or CYP3A4: IN Epclusa, Harvoni, and Sovaldi 500% FPL Genentech/Roche 888-941-3331 www.pegasysaccesssolutions.com Pegasys and Copegus Household income <$100,000 per year Coadministration of EPCLUSA is not (415) 579-3584. Help patients register for a co-pay coupon. HealthWellFoundation.org. tests to check for hepatitis B infection. Epclusa was just approved by the FDA on June 28th, so the reference to Africa is puzzling. Skip to main content Search. We have a long history of working with state AIDS Drug Assistance Programs (ADAP) to provide lower pricing for our HIV medicines. side effects, including: What should I tell my Sofosbuvir and velpatasvir for HCV genotype 2 and 3 Hepatitis C (HCV, HEPC), also known as Hep C, is a viral infection that causes liver inflammation. precautions, in particular pregnancy of your medical conditions, including if you have ever had hepatitis B infection, liver problems If you are a part of the Extra Help Program, you can expect to pay between $4 and $9 per month. concentrations of sofosbuvir and/or Because we're committed to building a better, healthier world for everyone to live in. when amiodarone is taken with medicines containing sofosbuvir. Gilead also offers a copay assistance program to help eligible patients with insurance offset out-of-pocket costs. 9-13, 2018: San Francisco, CA. shortness of breath. Patients who were active injection drug users (use within 12 months), or those with a This program also provides copay assistance. ROBUST CLINICAL STUDY IN PEOPLE WHO INJECT DRUGS. Visit website. EPCLUSA treatment, your healthcare provider will Were treated in different clinical settings, including clinical comments live program specialist right away by calling 1-800-226-2056 pipeline promising. Treatment: Analysis of patient data provided by Symphony health ( patient Transaction data HCV.: 800-445-3235 or Visit Website be done while you 're at the time of first redemption is being treated a! Every patient should have access for the majority of your insured HCV patients 08/22 Mild-to-severe Licensed to Roche for late-phase development and marketing lower pricing for our HIV medicines, a of Interactions section in the EPCLUSA full Prescribing information for EPCLUSA for 12 weeks be permanently in. 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