Elbasvir/grazoprevir (Zepatier) - for the treatment of genotype 1 or 4 chronic hepatitis C (CHC) in paediatric patients Final Appraisal Recommendation Advice number: 1222 – July 2022 Elbasvir/grazoprevir (Zepatier®) 50 mg/100 mg film coated tablets Submission by Merck Sharp & Dohme (UK) Limited Recommendation of the All Wales Medicines Strategy Group Elbasvir/grazoprevir (Zepatier® ) is recommended as an option for use within NHS Wales for the treatment of genotype 1 or 4 chronic hepatitis C (CHC) in paediatric patients 12 years of age and older who weigh at least 30 kg. Additional note(s): • See NICE guidance for elbasvir/grazoprevir (Zepatier®) for the treatment of genotype 1 or 4 chronic hepatitis C in adults (TA413, originally published October 2016). In reaching the above
Elbasvir/grazoprevir (chronic hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Elbasvir/Grazoprevir (chronische Hepatitis C bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11 February 2022). Please note : This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A21-143 Elbasvir/grazoprevir (chronic hepatitis C in adolescents) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A21
Elbasvir/Grazoprevir (chronische Hepatitis C) - Nutzenbewertung gemäß § 35a SGB V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Elbasvir/Grazoprevir (chronische Hepatitis C) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 10 March 2017). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A16-75 Elbasvir/grazoprevir (chronic hepatitis C) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A16-75 Version 1.0 Elbasvir/grazoprevir (chronic hepatitis C) 10 March 2017 Institute for Quality and Efficiency
ZEPATIER - Elbasvir and grazoprevir Search Page - Drug and Health Product Register * Skip to main content * Skip to "About this site"Language selection * FrançaisGovernment of CanadaSearch and menus * Search and menusSearchSearch websiteSearchTopics menu * Jobs * Immigration * Travel * Business * Benefits * Health * Taxes * More servicesYou are here: 1. HomeSummary Basis of Decision - - Health
Elbasvir/grazoprevir (chronic hepatitis C): Benefit assessment according to õ35a Social Code Book V Elbasvir/Grazoprevir (chronische Hepatitis C): Nutzenbewertung gemäß § 35a SGB V; Dossierbewertung; Auftrag A16-75 [Elbasvir/grazoprevir (chronic hepatitis C): Benefit assessment according to §35a Social Code Book V ] ..
Zepatier (elbasvir and grazoprevir) - To treat patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients Zepatier (elbasvir/grazoprevir) tablet * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco Products * Home * Drugs * Drug Approvals and Databases * Drugs@FDAZepatier (elbasvir/grazoprevir) tablet * Share * Tweet * Linkedin * Pin it * More sharing options * Linkedin * Pin it * Email * Print Zepatier
Grazoprevir/Elbasvir Treatment in Liver or Kidney Transplant Recipients with Genotype 1b Hepatitis C Virus Infection. More options regarding the choice of direct-acting antivirals (DAAs) are helpful for avoiding individual limitations in treating hepatitis C virus (HCV) infection. We aimed to assess the efficacy and tolerability of grazoprevir (GZR)/elbasvir (EBR) treatment in genotype-1b (GT-1b
Sustainable and equivalent improvements in symptoms and functional well-being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial. The PRIORITIZE trial (clinicaltrials.gov: NCT02786537) was the first comparative effectiveness study to directly compare ledipasvir/sofosbuvir (LDV/SOF ) and elbasvir/grazoprevir (EBR/GZR) for the treatment of chronic hepatitis C virus (HCV). A secondary aim of this study was to compare LDV/SOF and EBR/GZR on sustainable changes in several HCV-associated symptoms and functional well-being in patients who achieved sustained virological response (SVR). PRIORITIZE, a randomized controlled trial conducted between 2016 and 2020, evaluated change in six PROMIS®
Rapid review: efficacy and safety of elbasvir / grazoprevir for the treatment of chronic hepatitis C Grazoprevir/elbasvir en el tratamiento de la Hepatitis C crónica. Eficacia y Seguridad | Servicio de Evaluación de Tecnologías Sanitarias de Andalucía (AETSA) TwitterRssServicio de Evaluación de Tecnologías Sanitarias de Andalucía (AETSA)La misión del Servicio de Evaluación de Tecnologías * Conócenos * Quienes somos * Qué hacemos * Cómo lo hacemos * Contacto * Producción * Trabajos en marcha * Producción científica * Trabajo en red * Red de agencias del SNS (RedETS). * EUnetHTA-JA3 * Euroscan * INAHTA * Actividades * Formación * Colabora con nosotros * Noticias * Eventos Grazoprevir/elbasvir en el tratamiento de la Hepatitis C crónica
Elbasvir/grazoprevir is effective and tolerable for the treatment of HCV GT1-infected patients: A real world multicenter observatory study in Taiwan. Treatment of hepatitis C virus (HCV) by elbasvir/grazoprevir (EBR/GZR) was found to be efficacious and well tolerated in clinical trials. This study aimed to evaluate the effectiveness and tolerability of EBR/GZR in the treatment of HCV genotype 1
Grazoprevir An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM Levels and EffectsSummary of Use during LactationGrazoprevir has not been studied in nursing mothers being treated for hepatitis C infection. Because it is greater than 98.9% bound to maternal plasma proteins, amounts in breastmilk are likely to be very low. Some sources recommend against breastfeeding when grazoprevir is used with ribavirin.Hepatitis C is not transmitted through breastmilk
Phase 3, Multicenter Open-Label study to investigate the efficacy of elbasvir and grazoprevir fixed-dose combination for 8 weeks in treatment-naïve, HCV GT1b-infected patients, with non-severe fibrosis. Genotype 1b is the most common HCV genotype worldwide, accounting for the largest proportion of infections in Europe, Russia, Latin America and Asia. Reducing treatment duration can improve adherence, reduce drug exposure and cost. Accordingly, we evaluated the efficacy of 8 weeks fixed-dose combination of grazoprevir-elbasvir in treatment-naïve patients, with non-severe fibrosis. HCV mono-infected and treatment naïve patients with non-severe fibrosis (Fibroscan <9.5 kPa and Fibrotest < 0.59) were enrolled in a study which included 117 patients. Genotyping by sequencing identified five
Real-world experience of elbasvir/grazoprevir in Taiwan: This study was focused on liver and renal adverse effects. Elbasvir/grazoprevir with or without ribavirin has excellent efficacy and safety for the treatment of hepatitis C virus (HCV) genotype 1 and 4 patients. The real-world experience has been reported but the detailed analysis of liver and renal adverse effects is lacking. This study evaluated the real-world experience relating to the effectiveness and liver/renal safety of elbasvir/grazoprevir in HCV genotype 1 patients with compensated liver disease. In the four medical centres of Chang Gung Medical System, 350 HCV genotype 1 patients with compensated liver disease who were treated with elbasvir/grazoprevir were enrolled. Clinical characteristics and laboratory data were collected
Efficacy of elbasvir/grazoprevir therapy in HCV genotype-1 with or without HIV infection: role of HCV core antigen monitoring and improvement of liver stiffness and steatosis. The combination of elbasvir and grazoprevir (EBR/GZR) has been approved for treating HCV infection. This study aimed to evaluate the efficacy of EBR/GZR in terms of sustained virological response (SVR) and improvement
Real-life use of elbasvir/grazoprevir in adults and elderly patients: a prospective evaluation of comedications used in the PITER cohort. In patients treated for HCV infection, potential drug-drug interactions (DDIs) can occur among direct-acting antiviral drugs (DAAs) and comedications used. The real-life effectiveness and safety of elbasvir/grazoprevir (ELB/GZR) among co-medicated HCV patients
Pharmacokinetic similarity demonstrated after crushing of the elbasvir/grazoprevir fixed-dose combination tablet for HCV infection. Finding a suitable treatment for HCV patients with swallowing disorders is still a major challenge. In practice, direct-acting antivirals are crushed without knowledge of adequate absorption. Crushing can alter drug exposure, possibly leading to treatment failure , development of resistance or toxicity. Currently, there is no information about crushing of the fixed-dose combination tablet of elbasvir/grazoprevir; therefore, crushing of this tablet is not recommended. To investigate the influence of crushing on the pharmacokinetics of the elbasvir/grazoprevir fixed-dose combination tablet. We conducted an open-label, two-period, randomized, cross-over, Phase I, single