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
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 ] ..
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 . Eficacia y SeguridadVolver al buscadorRapid review: efficacy and safety of elbasvir / grazoprevir for the treatment of chronic hepatitis C * Año * Áreas de Conocimiento * Tipo Tecnología * Línea de Producción 2017APARATO DIGESTIVO, FARMACIA HOSPITALARIAMEDICAMENTOMEDICAMENTOS. SÍNTESIS EVIDENCIA + Año 2017 + Áreas de Conocimiento APARATO DIGESTIVO, FARMACIA HOSPITALARIA + Tipo Tecnología
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
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
Efficacy and safety of elbasvir/grazoprevir for 12 weeks in people with hepatitis C virus infection aged 35 years or younger compared with older people: a retrospective integrated analysis. In the United States, the number of new cases of hepatitis C virus infection has risen in recent years, driven largely by transmission among young white adults in their 20s and 30s. Herein, we report an integrated analysis of participants with hepatitis C virus infection aged ≤35 years from 12 phase II/III clinical trials of elbasvir/grazoprevir. Treatment-naive and -experienced adults with hepatitis C virus genotype 1 or 4 infection received elbasvir (50 mg/day)/grazoprevir (100 mg/day) for 12 weeks without ribavirin. Analyses were stratified according to participant age (≤35 years vs >35 years
Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study. Hepatitis C virus (HCV) genotype (GT) 4 infection is prevalent in sub-Saharan Africa and the Middle East, particularly in Egypt. This study evaluated the safety and efficacy of elbasvir/grazoprevir administered for 8 and 12 weeks in participants with HCV GT4 infection . In this partially randomized, open-label multicentre study conducted in France (NCT03111108; Protocol MK5172-096), treatment-naive participants with GT4 infection and F0-F2 fibrosis were randomized 2:1 to elbasvir (50 mg)/grazoprevir (100 mg) for 8 or 12 weeks. Treatment-naive participants with F3-F4 fibrosis and all treatment-experienced participants (F0-F4) were assigned to elbasvir/grazoprevir for 12 weeks
Efficacy and safety of elbasvir/grazoprevir in treatment-naive Chinese adults with hepatitis C virus infection: A randomized trial. In China, clinical experience with direct-acting antiviral treatments for hepatitis C virus (HCV) infection is still emerging. C-CORAL is a phase 3, multinational, placebo-controlled, double-blind trial of elbasvir/grazoprevir (EBR/GZR) in participants with HCV
Elbasvir/Grazoprevir for HCV Infection in Russia: A Randomized Trial. Hepatitis C virus (HCV) infection is a major healthcare concern in Russia, where almost 5 million individuals are viremic. Elbasvir/grazoprevir is a fixed-dose combination therapy for the treatment of HCV genotype 1 and genotype 4 infection. The present analysis aimed to assess the safety and efficacy of elbasvir/grazoprevir . Participants in the immediate-treatment group received elbasvir/grazoprevir for 12 weeks, and those in the deferred-treatment group received placebo for 12 weeks, followed by open-label elbasvir/grazoprevir for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12). One hundred and nineteen Russian participants were randomized (immediate-treatment
An open-label, randomized, active control trial of 8 versus 12 weeks of elbasvir/grazoprevir for treatment-naive chronic hepatitis C genotype 1b patients with mild fibrosis (EGALITE): Impact of baseline viral loads and NS5A resistance-associated substitut A 12-week grazoprevir/elbasvir regimen is highly effective against hepatitis C virus genotype 1 (HCV-1) infection. The efficacy of an 8-week
Safety and Efficacy of Elbasvir/Grazoprevir in Asian Participants with Hepatitis C Virus Genotypes 1 and 4 Infection. Estimates suggest that in Asia, more than 31 million individuals have hepatitis C virus infection. The present analysis was conducted to assess the efficacy and safety of elbasvir/grazoprevir in Asian participants enrolled in the elbasvir/grazoprevir phase 2/3 clinical trials . This is an integrated analysis of data from 12 international phase 2/3 clinical trials. Asian participants with chronic hepatitis C virus genotype 1 or 4 infection who received elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks or elbasvir/grazoprevir plus ribavirin for 16 weeks were included in this analysis. The primary end point was sustained virologic response at 12 weeks after completion of therapy (SVR12