An observational, prospective, multicenter study on the utilization and effectiveness of elbasvir-grazoprevir treatment association for chronic hepatitis C in France (ZEPHYR study).

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.

Informations de copyright

© 2022 The Authors. Health Science Reports published by Wiley Periodicals LLC.

Déclaration de conflit d'intérêts

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.