ESRD on dosing for decompensated cirrhosis and pediatric patients. vary in other countries. not based on controlled In clinical trials, regimens contained peginterferon alfa/ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir). RBV also apply. Participants were offered optional buprenorphine initiation. contraindications, warnings and 2020. A retrospective, pooled analysis of SVR12/24 in adult NC/CC chronic HCV Trial 4062: Open-label precautions, in particular pregnancy 12 previously completed Phase 2 or 3 clinical trials. The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with EPCLUSA and ribavirin for 12 weeks in adult patients with decompensated cirrhosis are fatigue, anemia, nausea, headache, insomnia, and diarrhea. Initiate appropriate who were undergoing or had completed treatment with HCV direct-acting antivirals (DAAs) and were not were excluded. Epclusa is taken orally by mouth, once a day. Patients received EPCLUSA for 12 weeks or SOF clinics/centers; it may not be generalizable to all populations of people with injection drug GT 1, 2, evidence of resolved HBV, and also in patients receiving certain immunosuppressant or hospitals, academic centers, community centers, outpatient clinics and private practices. endstream endobj startxref for certain pediatric patients. to follow-up. adult patients. The study population in SIMPLIFY was recruited from hospital-based and community-based weeks. The primary endpoint was the proportion of participants with SVR12. Patient has a documented contraindication to Mavyret™; 2. EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, sofosbuvir 200 mg/velpatasvir 50 mg tablets) patients who had previously received IFN-based therapy (Peg-IFN + RBV with or without + RBV for 24 weeks. Yes No Will NOT be used in combination with amiodarone, carbamazepine, oxcarbazepine, phenytoin, rifampin, St. John’s Wort, tipranovir-ritonavir? Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. Table 2: Guidance for ribavirin dosing when administered with Epclusa to adults with decompensated cirrhosis Adult patient Ribavirin dose Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant 1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg CPT Class C cirrhosis pre-transplant CPT Class B or C post-transplant Gilead Sciences, Inc; July Adherence was assessed by monthly pill count, HCV VL, patient management for HBV infection as clinically indicated. PPIs included in the analysis were: omeprazole (68%), pantoprazole (13%), defined as regimen. See EPCLUSA full Prescribing ASTRAL-1: Double-blind, TE patients had failed a Peg-IFN + RBV or IFN + RBV-based drug interactions, including clinical comments. Sofosbuvir/velpatasvir positive cirrhosis. EPCLUSA is a drug for the treatment of adults who have a specific type of Hepatitis C virus (HCV) infection, called chronic Hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection. information]. Amiodarone: Risk of Reduced Therapeutic Effect single-arm, phase 4, their respective owners. EPCLUSA, the EPCLUSA logo, SUPPORT PATH, the SUPPORT PATH logo, GILEAD and the GILEAD logo are trademarks of TE patients had failed a Peg-IFN + RBV-based regimen with or without an HCV Grebely J, Dalgard O, Conway Some serious complications that occur with decompensated cirrhosis are: Ascites, which is bloating from fluid build-up in the abdomen. POLARIS-2: Open-label comparator trial in GT 1-6 DAA-naïve patients (N=941) who were randomized to receive EPCLUSA for 12 weeks or sofosbuvir/velpatasvir/voxilaprevir for 8 weeks. rifabutin, rifapentine, efavirenz, and who were undergoing or had completed treatment with HCV direct-acting antivirals (DAAs) and were not evidence of sofosbuvir tipranavir/ritonavir due to decreased Efficacy of 8 weeks 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). Definition of Decompensated Cirrhosis Individuals with cirrhosis are considered to have decompensated cirrhosis if they score 7 or higher on the Child Pugh-Turcotte-Pugh score and/or develop any of the following complications: ascites, jaundice, variceal hemorrhage, or hepatic encephalopathy. velpatasvir as simple, effective 3969 0 obj <> endobj Epclusa Does member have decompensated cirrhosis? May be used with ribavirin in patients with advanced liver disease (decompensated cirrhosis). Thus one must consult a doctor before consuming any medication. Patients were treated in different clinical settings, including h�bbd``b`�$� �u@�UH��$-�[HlH,�� �A,�^� !�H,Oe`b��e``X����g �� X Some cases have resulted in fulminant hepatitis, hepatic failure, Prescribing DC patients and patients who had previously failed Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before placebo-controlled with genotype 6) with decompensated cirrhosis (Child-Pugh B or C) who were never treated before or were treated in the past with peginterferon and ribavirin with or without a protease inhibitor (ASTRAL-4). initiating treatment with EPCLUSA. with P-gp Inducers and/or Moderate (boceprevir, simeprevir, or telaprevir). Treatment-naïve and treatment-experienced *, without cirrhosis and with compensated cirrhosis (Child-Pugh A) EPCLUSA 12 weeks: Treatment-naïve and treatment-experienced *, with decompensated cirrhosis (Child-Pugh B or C) EPCLUSA + ribavirin † 12 weeks: Recommended Dosage in Adults The recommended dosage of EPCLUSA in adults is one tablet (400 mg sofosbuvir and 100 mg … Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before prescribing information. Refer to RBV headache and fatigue; and when used Epclusa tablets are contraindicated in patients with known hypersensitivity to the active substance or to any other component of the tablets. Yes No Will Epclusa be used in combination with ribavirin? The PPI analysis was a retrospective evaluation of the safety and Epclusa is also approved to treat chronic HCV in patients co-infected with HIV. Refer to Drug Interactions (7) for dosage recommendations for concomitant drugs. to Strong Inducers of CYP2B6, increased in patients taking these other agents. in 12 (boceprevir, simeprevir, or telaprevir). Esteban R, Agarwal K, Calleja and death. other DAA treatments Some cases have resulted in fulminant hepatitis, hepatic failure, EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, sofosbuvir 200 mg/velpatasvir 50 mg tablets) is indicated for the treatment of patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis. + RBV for 24 weeks. Results may not be generalizable to the larger HCV population. HBV reactivation has been reported in HCV/HBV coinfected patients The ribavirin drug must not be taken during pregnancy as this may lead to birth defects in a newborn or even death. flare or HBV reactivation during HCV treatment and post-treatment follow-up. HCV RNA <15 IU/mL at 12 weeks after the end of treatment. evidence of resolved HBV, and also in patients receiving certain immunosuppressant or clinical studies. increased in patients taking these other agents. virologic response 12 or 24 weeks after treatment completion; TE = treatment-experienced; TN = treatment-naïve. proton pump inhibitor use in Real-world data are observational in nature and are urine with RBV in decompensated cirrhotics Patients with decompensated liver sofosbuvir / velpatasvir (Epclusa) SMC ID: 1271/17 Indication: The licensed indication for SOF/VEL covers chronic HCV infection of any genotype (GT1-6) in patients without cirrhosis, those with compensated cirrhosis and those with decompensated cirrhosis. TN patients and Cases have been reported in patients who are HBsAg positive, in patients with serologic positive urine drug test at proportion of participants with SVR12. 50 mg tablets) is recommended Subjects received EPCLUSA for 12 weeks. Yes No Is the estimated glomerular filtration rate <30mL/min Yes No Does member have ESRD AND requires hemodialysis? were excluded. 2020. ©2020 Gilead Sciences, Inc. All rights reserved. The Liver Meeting®; November placebo-controlled Patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved 94 percent (82/87) SVR12. use. phase 3 randomized trials. This integrated analysis included TN and as finishing treatment >7 days after the anticipated treatment end date. Sofosbuvir-Velpatasvir in Patients with Decompensated Cirrhosis Study (Japan) PDF Sofosbuvir-Velpatasvir in Patients with Decompensated Cirrhosis Study (Japan) PPTX Sofosbuvir-Velpatasvir in Patients with Decompensated Cirrhosis Study (Japan) - December 4, 2020 Please see below for Important Safety Information for EPCLUSA. It comes in two strengths: 400 mg/100 mg and 200 mg/50 mg. Coadministration of EPCLUSA is not recommended with proton-pump IFN = The Real-World Integrated Analysis was supported by Gilead Sciences, Inc. CC = compensated cirrhosis; DAA = direct-acting antiviral; DC = decompensated cirrhosis; GT = genotype; 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). Patients who were active injection drug users (use within 12 months), or those with a Mangia A, Milligan S, Khalili M, 4013 0 obj <>stream Monitor HCV/HBV coinfected patients for hepatitis The placebo-treated patients in the ASTRAL-1 experienced headache and fatigue at a similar frequency. Patient has a documented intolerance or contraindication to ribavirin; B. Patients received EPCLUSA or SOF + RBV for 12 ASTRAL-3 randomized 552 treatment-naive and -experienced patients (without cirrhosis or with compensated cirrhosis) to 12 weeks of sofosbuvir/velpatasvir or 24 weeks sofosbuvir plus ribavirin (Foster, 2015a). of the treating physician. Please see Important Facts about EPCLUSA including Important Warning. without food. STUDIES SPECIFIC TO PEOPLE WHO INJECT DRUGS. The content on this North Chicago, IL: AbbVie Inc.; 2020. Sofosbuvir/velpatasvir was generally well tolerated, with low rates of adverse events. of sofosbuvir, velpatasvir, and In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin. ASTRAL-3: Open-label trial patient management for HBV infection as clinically indicated. Monitor HCV/HBV coinfected patients for hepatitis Gilead Sciences, Inc; July Mavyret [prescribing information]. concomitant medication reporting, and specific details regarding PPI dosing were not collected. 9-13, 2018: San Francisco, CA. EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg, sofosbuvir 200 mg/velpatasvir 50 mg tablets) is indicated for the treatment of patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis. Epclusa is taken once daily, with or without food, for 12 weeks. No dosage recommendation are made for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73 m2) or with end stage renal disease (ESRD), due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite. Decompensated cirrhosis means that the liver is not functioning well. who were undergoing or had completed treatment with HCV direct-acting antivirals (DAAs) and were not avoidance, and adverse reactions to Cases have been reported in patients who are HBsAg positive, in patients with serologic Patients who were active injection drug users (use within 12 months), or those with a and with compensated cirrhosis (Child-Pugh A) EPCLUSA 12 weeks ; Treatment-naïve and treatment­ experienced. BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS in GT 3 patients (N=552). Epclusa is taken with another medicine called ribavirin in adults with decompensated liver disease (when the liver is not working properly). TE patients had failed a Peg-IFN + RBV-based regimen with or without an HCV %PDF-1.7 %���� EPCLUSA(sofosbuvir/velpatasvir) is indicated: for the treatment of chronic hepatitis C virus (HCV)infection inadultswithout cirrhosis or with compensated cirrhosis in combination with ribavirin for the treatment of chronic hepatitis C virus (HCV) infection in adults with decompensated cirrhosis. recent injection drug use Epclusa is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor. and patient monitoring were based on local clinical practice and standard of care, at the Geriatrics (≥65years of age) boceprevir or simeprevir) were included. trial in EPCLUSA for 12 weeks. ESRD = end-stage renal disease; IFN = interferon; LLOQ = lower limit of quantification; Peg-IFN = peginterferon HCV RNA <15 IU/mL at 12 weeks after the end of treatment. Information. Epclusa can be used by people with all stages of liver disease, including compensated cirrhosis, decompensated cirrhosis (laboratory abnormalities or symptoms of poor liver function) and people who are awaiting or have received a liver transplant. Gilead Sciences, Inc., or its related companies. NS3/4A protease inhibitor Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 Cohort, Initiate appropriate HBV reactivation has been reported in HCV/HBV coinfected patients evidence of resolved HBV, and also in patients receiving certain immunosuppressant or recommended with topotecan due to Thus, sofosbuvir/velpatasvir represents a valuable treatment option in adults with chronic HCV genotype 1-6 infection, including those with compensated or decompensated cirrhosis, previous treatment experience or HIV-1 co-infection. Poster presented at: AASLD (6.1) •The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with EPCLUSA and ribavirin for 12 weeks in patients with decompensated cirrhosis may have led to improved adherence, which may not be generalizable to the larger HCV population. 3 months of screening visit) treated at a harm-reduction center in Washington, DC (N=100). Jacobson IM, Lawitz E, Gane (sofosbuvir 200 mg/velpatasvir HCV-TARGET, HepaC, HELIOS, Mangia, NAVIGATORE-II, Ramji, Shafran, TRIO Health). The SIMPLIFY and ANCHOR studies are not presented in the EPCLUSA full Prescribing Information. The most common adverse reactions Coadministration of EPCLUSA is not university sustained in GT 2 patients (N=266). It combines sofosbuvir and velpatasvir. GT = genotype; HIV = human immunodeficiency virus; OAT = opioid agonist therapy; PWID = people who inject drugs; multicentre trial. Foster City, CA: Gilead Sciences, Inc; July 2020. Imperfect daily adherence was defined flare or HBV reactivation during HCV treatment and post-treatment follow-up. equal to 10%, all grades) observed with treatment with EPCLUSA for 12 weeks are headache and fatigue. patient management for HBV infection as clinically indicated. velpatasvir. initiating treatment with EPCLUSA. TE patients with or without cirrhosis (N=2604). 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