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Background and Aim: The efficacy and safety profiles of elbasvir–grazoprevir (EBR/GZR) has been established in more than 10 clinical trials. However, the characteristics of patients treated in routine clinical practice may differ. The present study was therefore designed to assess the real‐life effectiveness of EBR/GZR therapy in the general population and among subgroups with a high hepatitis C virus (HCV) prevalence in France. Methods: The Zephyr study was designed as a French, multicentre, prospective, observational study on EBR/GZR use and effectiveness in current practice in chronic hepatitis C patients. These results are based on data regarding the adult patients who received at least one dose of EBR/GZR between December 2017 and June 2019 in 67 French hospitals and clinics. Results: Overall, 478 patients were included. The Full Analysis Set corresponded to the 467 patients who met all the inclusion criteria and none of the exclusion criteria. Gender was balanced and the mean age was 55.7 ± 13.3 years. The patients were mainly treatment‐naive (89.5%) and infected with Genotype 1b (70.4%). Among the 75 patients with HCV Gt1a genotype, 56% had HCV RNA ≥ 800,000 IU/ml. F3–F4 fibrosis stage involved 24.2% of our population. Our subgroups were distributed among 110 migrants (23.6%), 58 (15.3%) using opioid agonist treatment, including people who inject drugs, 30 (6.8%) with chronic kidney disease Stages 3–5, 9 (1.9%) with an inherited blood disorder, and 4 (0.9%) coinfected with HIV. The remaining 269 (58.7%) were included in the general population subgroup. Overall, sustained virologic response 12 weeks after the end of treatment reached 98.0% and remained consistent among genotype, HCV RNA values, fibrosis stage, and the subgroup of interest. The rate of Alcohol Use Disorders Identification Test‐Consumption​​​ and Life Habit questionnaire completion was high at each visit, with data suggesting alcohol consumption decrease and an improvement in quality of life. Conclusions: Using real‐world evidence data on a French population representative of HCV patients, we confirmed the results obtained during EBR/GZR development program. [ABSTRACT FROM AUTHOR]

Résumé: La séroprévalence mondiale de l'infection par le virus de l'hépatite D (VHD) est difficile à déterminer puisque le nombre de personnes ayant rencontré ce virus varie entre 12 et 72 millions dans les trois méta-analyses publiées depuis 2020. L'épidémiologie mondiale et l'histoire naturelle de cette hépatite ont changé depuis la généralisation de la vaccination contre l'hépatite B. Dans les pays à revenu élevé, l'infection qui avait presque disparu est réapparue par le biais des flux migratoires provenant des pays de forte endémie. Dans ces régions défavorisées, l'hépatite chronique D (HCD) reste un problème majeur de santé publique avec un risque de progression rapide vers la cirrhose et ses complications. Le regain d'intérêt suscité par l'arrivée de nouveaux traitements efficaces contre le VHD ne doit pas faire oublier la nécessité de recueillir des données épidémiologiques de qualité et de développer des outils diagnostiques adéquats pour une meilleure prise en charge de cette infection sévère qui reste sous-diagnostiquée. The global seroprevalence of hepatitis D virus (HDV) infection is difficult to determine since the number of people who have encountered this virus varies from 12 to 72 million in the 3 meta-analyses published since 2020. The global epidemiology and the natural history of hepatitis D have changed since the generalization of hepatitis B vaccination. In high-income countries the infection, which had almost totally disappeared, reappeared through migratory flows from highly endemic countries. In these disadvantaged regions, chronic hepatitis D (HCD) represents a major public health problem because of the risk of rapid progression to cirrhosis and its complications. The renewed interest raised by the availability of new effective treatments against HDV should not obscure the need to collect quality epidemiological data and to develop adequate diagnostic tools for better management of this severe infection which remains underdiagnosed. [ABSTRACT FROM AUTHOR]

Background and Aim: The efficacy and safety profiles of elbasvir-grazoprevir (EBR/GZR) has been established in more than 10 clinical trials. However, the characteristics of patients treated in routine clinical practice may differ. The present study was therefore designed to assess the real-life effectiveness of EBR/GZR therapy in the general population and among subgroups with a high hepatitis C virus (HCV) prevalence in France., Methods: The Zephyr study was designed as a French, multicentre, prospective, observational study on EBR/GZR use and effectiveness in current practice in chronic hepatitis C patients. These results are based on data regarding the adult patients who received at least one dose of EBR/GZR between December 2017 and June 2019 in 67 French hospitals and clinics., Results: Overall, 478 patients were included. The Full Analysis Set corresponded to the 467 patients who met all the inclusion criteria and none of the exclusion criteria. Gender was balanced and the mean age was 55.7 ± 13.3 years. The patients were mainly treatment-naive (89.5%) and infected with Genotype 1b (70.4%). Among the 75 patients with HCV Gt1a genotype, 56% had HCV RNA ≥ 800,000 IU/ml. F3-F4 fibrosis stage involved 24.2% of our population. Our subgroups were distributed among 110 migrants (23.6%), 58 (15.3%) using opioid agonist treatment, including people who inject drugs, 30 (6.8%) with chronic kidney disease Stages 3-5, 9 (1.9%) with an inherited blood disorder, and 4 (0.9%) coinfected with HIV. The remaining 269 (58.7%) were included in the general population subgroup. Overall, sustained virologic response 12 weeks after the end of treatment reached 98.0% and remained consistent among genotype, HCV RNA values, fibrosis stage, and the subgroup of interest. The rate of Alcohol Use Disorders Identification Test-Consumption​​​ and Life Habit questionnaire completion was high at each visit, with data suggesting alcohol consumption decrease and an improvement in quality of life., Conclusions: Using real-world evidence data on a French population representative of HCV patients, we confirmed the results obtained during EBR/GZR development program., Competing Interests: All the authors reviewed the manuscript and gave their approval for its publication. Jean‐Pierre Bronowicki, Patrick Miailhes, Bertrand Hanslik, Stéphanie Perot, Jérémy Skrzypski, Astrid de Hauteclocque, Axelle Spampinato, Philippe Mariot, Philippe Sogni had full access to all of the data in this study and take complete responsibility for the integrity of the data and the accuracy of the data analysis. Jean‐Pierre Bronowicki reported links of interest with MSD, Gilead, Abbvie; Patrick Miailhes reported links of interest with MSD; Bertrand Hanslik has given some lectures and has participated in the advisory board for MSD; Denis Ouzan reported links of interest with Abbvie and Gilead; Dominique Larrey was invited to participate in the congress and participate as clinicians in registry study for Gilead and Abbvie; Ghassan Riachi was invited to participate in the congress by MSD, Gilead and Abbvie; Régine Truchi has given some lecture and participated in the clinical study for Abbvie, Gilead et Merck; Armand Abergel was invited to participate in the congress and to give some lectures during Post‐University Training session for MSD, Gilead, AbbVie and Ipsen, and has also participated in the advisory board for MSD, Gilead and AbbVie; Xavier Causse reported links of interest with AbbVie, Gilead, Mylan and MYR Pharmaceuticals; Stéphanie Perot and Jérémy Skrzypski worked as contracted CRO staff members for MSD France on the Zephyr Study. Astrid de Hauteclocque, Axelle Spampinato, and Philippe Mariot are employees of MSD France. Philippe Sognia reported links of interest with AbbVie, Galmed, Genfit, Gilead, Intercept Pharma, Janssen, MSD, Novo‐Nordisk, and Roche. Vincent Jouannaud and Dan Pospait reported no conflicts of interest., (© 2022 The Authors. Health Science Reports published by Wiley Periodicals LLC.)