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Glecaprevir/pibrentasvir (chronic hepatitis C in children) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Glecaprevir/Pibrentasvir (chronische Hepatitis C bei Kindern) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 September 2021). 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. A21-88 Glecaprevir/pibrentasvir (chronic hepatitis C in children) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A21-88 Version 1.0
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Glecaprevir/pibrentasvir (chronic hepatitis C in adolescents) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Glecaprevir/Pibrentasvir ( chronische Hepatitis C bei Jugendlichen) – Nutzenbewertung gemäß § 35a SGB V ( Version 1.0; Status: 11 July 2019 ). 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. A19-33 Glecaprevir/pibrentasvir (chronic hepatitis C in adolescents) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A19-33 Version 1.0 Glecaprevir
Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study. Glecaprevir/pibrentasvir (G/P) has demonstrated high rates (>95%) of sustained virologic response at posttreatment Week 12 (SVR12) in treatment-naïve (TN) patients with hepatitis C virus (HCV) infection and compensated cirrhosis (CC). Here, in a key real-world subset
Glecaprevir/pibrentasvir (chronic hepatitis C) ? Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Glecaprevir/Pibrentasvir (chronische Hepatitis C) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 25 October 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. 17-34 Glecaprevir/Pibrentasvir (chronic hepatitis C) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment 17-34 Version 1.0 Glecaprevir/Pibrentasvir ( chronic hepatitis C) 25 October 2017
Effectiveness and safety of glecaprevir/pibrentasvir for 8 weeks in the treatment of patients with acute hepatitis C: A single-arm retrospective study. No direct-acting antiviral is currently approved for acute HCV infection, delaying treatment. We investigated the effectiveness and safety of 8-week glecaprevir/pibrentasvir (G/P) in patients with acute HCV infection. This noninterventional
Real-life effectiveness of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients previously treated with sofosbuvir/velpatasvir or glecaprevir/pibrentasvir. Sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) is the recommended rescue therapy for patients with chronic hepatitis C infection who fail direct-acting antivirals (DAAs). Data are limited on the effectiveness of this treatment after the current first-line therapies. Our aim was to analyse the effectiveness and safety of SOF/VEL/VOX among patients failing sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE/PIB). Retrospective multicentre study (26 Spanish hospitals), including chronic hepatitis C patients unsuccessfully treated with SOF/VEL or GLE/PIB, and retreated with SOF/VEL/VOX ± ribavirin for 12 weeks
Bioequivalence and Safety of Generic Glecaprevir/Pibrentasvir Compared to a Branded Product: A Randomized, Crossover Study in Healthy Volunteers. This was an open-label, randomized, single-dose, 2-period, crossover clinical trial with an adaptive design to evaluate the bioequivalence and comparative pharmacokinetics of generic glecaprevir/pibrentasvir versus the brand name product in healthy -dosing. Plasma concentrations of glecaprevir and pibrentasvir were determined using a validated high-performance liquid chromatography-tandem mass spectrometry method. The geometric mean ratios of the test to the reference formulation for maximum plasma concentration (C) and area under the concentration-time curve from drug administration to the last measurable concentration (AUC) fell within
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Glecaprevir/pibrentasvir (Maviret) - chronic hepatitis C virus (HCV) infection in adolescents Published 11 November 2019 1 Product update SMC2214 glecaprevir/pibrentasvir 100mg/40mg film-coated tablets (Maviret®) AbbVie Ltd 04 October 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following an abbreviated submission glecaprevir/pibrentasvir (Maviret®) is accepted for use within NHSScotland. Indication under review: treatment of chronic hepatitis C virus (HCV) infection in adolescents aged 12 to <18 years. SMC has previously accepted glecaprevir/pibrentasvir
Glecaprevir and pibrentasvir (Mavyret) - To treat adults with chronic hepatitis C virus Drug Approval Package: MAVYRET (glecaprevir and pibrentasvir) * 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@FDADrug Approval Package: MAVYRET (glecaprevir and pibrentasvir) * Share * Tweet * Linkedin * Pin it * More sharing options * Linkedin * Pin it * Email * Print Company: AbbVie
Glecaprevir-pibrentasvir for 4 weeks among people with recent HCV infection: The TARGET3D study. Short duration treatment may aid HCV elimination among key populations. This study evaluated the efficacy of glecaprevir-pibrentasvir for 4 weeks among people with recent HCV infection. In this single-arm multicentre international trial, adults with recent HCV (duration of infection <12 months ) received glecaprevir-pibrentasvir 300 mg-120 mg daily for 4 weeks. Primary infection was defined as a first positive anti-HCV antibody and/or HCV RNA measurement within 6 months of enrolment and either acute clinical hepatitis within 12 months (symptomatic illness or alanine aminotransferase >10x the upper limit of normal) or antibody seroconversion within 18 months. Reinfection was defined as new
Response to glecaprevir/pibrentasvir in HIV/HCV-coinfected patients in clinical practice. HIV infection has been associated with lower rates of sustained viral response (SVR) with direct-acting antivirals (DAAs). There are few data on glecaprevir/pibrentasvir (G/P) in HIV/HCV coinfection outside clinical trials. The HEPAVIR-DAA cohort, which recruits HIV/HCV-coinfected patients (NCT02057003
[Glecaprevir/pibrentasvir (chronic hepatitis C) - benefit assessment according to õ 35a Social Code Book V] Glecaprevir/Pibrentasvir (chronische hepatitis C): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-34 [Glecaprevir/pibrentasvir (chronic hepatitis C) – benefit assessment according to § 35a Social Code Book V ] ..
Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older. It is estimated that approximately 50% of patients with hepatitis C virus (HCV) infection in Japan are currently over 75 years old. However, patients aged ≥ 75 years are typically underrepresented in clinical trials of direct-acting antivirals. This study aimed to evaluate the efficacy and safety of glecaprevir and pibrentasvir (G/P) treatment in Japanese patients with HCV infection aged ≥ 75 years. This multicenter, retrospective study included 271 Japanese patients with HCV infection from 12 centers in Miyazaki Prefecture, Japan. Demographic, clinical, virological, and adverse events (AEs) data obtained during and after G/P treatment were collected from medical
Safety and efficacy of glecaprevir and pibrentasvir in north Tohoku Japanese patients with genotype 1/2 hepatitis C virus infection. To assess the efficacy and safety of treatment with glecaprevir/pibrentasvir in Japanese patients with genotype (GT) 1/2 hepatitis C virus (HCV) infection in a real-world clinical setting. A total of 230 patients from 12 centers in northern Tohoku Japan with chronic hepatitis (CH) or compensated liver cirrhosis (LC) and GT1/2 HCV infection were treated with glecaprevir/pibrentasvir and followed up for 12 weeks after treatment completion. Those patients were evaluated by dividing them into the following three groups: CH GT1/2 HCV-infected, direct-acting antiviral agents (DAA)-naive patients received 8 weeks of treatment (8-week initial treatment group