Alessio Aghemo1,2, Yves Horsmans3, Stefan Bourgeois4, Mark Bondin5, Michael Gschwantler6, Harald Hofer7, Nasser Semmo8, Francesco Negro9,10, Zhenzhen Zhang5, John Marcinak5, Ella Veitsman11, Rawi Hazzan12, Konstantinos Mimidis13, Ioannis Goulis14, Nuno Marques15, Robert Flisiak16, Wlodzimierz Mazur17, Carlos Roncero18,19, Fiona Marra20, Georges Philippe Pageaux21, Tarik Asselah22, Pietro Lampertico23,24. 1. Department of Biomedical Sciences, Humanitas University, Rozzano, Italy. Alessio.aghemo@hunimed.eu. 2. Division of Internal Medicine and Hepatology, Department of Gastroenterology, Humanitas Research Hospital IRCCS, Via A. Manzoni 56, 20089, Rozzano, Milan, Italy. Alessio.aghemo@hunimed.eu. 3. Cliniques Universitaires Saint-Luc, UCL, Brussels, Belgium. 4. Stuivenberg ZNA, Antwerp, Belgium. 5. AbbVie Inc, North Chicago, IL, USA. 6. Department of Internal Medicine IV, Wilhelminenspital, and Sigmund Freud University, Vienna, Austria. 7. Department of Internal Medicine, Gastroenterology and Hepatology, Klinikum Wels-Grieskirchen, Wels, Austria. 8. Department of BioMedical Research, Hepatology, Inselspital, University of Bern, 3010, Bern, Switzerland. 9. Division of Gastroenterology and Hepatology, University Hospital, Geneva, Switzerland. 10. Division of Clinical Pathology, University Hospital, Geneva, Switzerland. 11. Liver Unit, Rambam Health Care Campus, Haifa, Israel. 12. Emek Medical Center, Afula, Israel. 13. First Department of Internal Medicine, Democritus University of Thrace Medical School, Alexandroupolis, Greece. 14. 4th Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece. 15. Infectious Diseases Service, Hospital Garcia de Orta EPE, Almada, Portugal. 16. Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland. 17. Clinical Department of Infectious Diseases, Medical University of Silesia, Katowice, Poland. 18. Psychiatry Service, University of Salamanca Health Care Complex, Salamanca, Spain. 19. Institute of Biomedicine and School of Medicine, University of Salamanca, Salamanca, Spain. 20. Hepatology Drug Interactions Group, University of Liverpool, Liverpool, UK. 21. Département Hépato-Gastro-Entérologie, Centre Hospitalier Universitaire (CHU) de Montpellier, Montpellier Cedex 5, France. 22. Department of Hepatology, Hopital Beaujon, AP-HP, Paris University and INSERM UMR 1149, Clichy, France. 23. Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Policlinico-Division of Gastroenterology and Hepatology-CRC 'AM and A Migliavacca' Centre for Liver Disease, Milan, Italy. 24. University of Milan, Milan, Italy.
Abstract
INTRODUCTION: Glecaprevir/pibrentasvir is approved for treating chronic hepatitis C virus (HCV) genotypes (GT) 1-6. We evaluated real-world effectiveness, safety, and patient-reported outcomes of glecaprevir/pibrentasvir in underserved patient populations, focusing on persons who use drugs infected with HCV. METHODS: Data were pooled from nine countries (13 November 2017-31 January 2020). Patients had HCV GT1-6, with or without compensated cirrhosis, with or without prior HCV treatment and received glecaprevir/pibrentasvir consistent with local label at their physician's discretion. Patients with prior direct-acting antiviral exposure were excluded from efficacy and quality-of-life analyses. The percentage of patients achieving sustained virologic response at post-treatment week 12 (SVR12) was assessed. Mean changes from baseline to SVR12 visit in 36-Item Short-Form Health Survey mental and physical component summary scores were reported. Safety was assessed in patients receiving at least one dose of glecaprevir/pibrentasvir. RESULTS: Of 2036 patients, 1701 (83.5%) received 8-week glecaprevir/pibrentasvir. In 1684 patients with sufficient follow-up, SVR12 rates were 98.0% (1651/1684) overall, 98.1% (1432/1459) in 8-week treated patients, 97.0% (519/535) in persons who use drugs, and greater than 95% across subgroups. Mean changes from baseline in mental and physical component summary scores were 3.7 and 2.4, respectively. One glecaprevir/pibrentasvir-related serious adverse event was reported; six glecaprevir/pibrentasvir-related adverse events led to discontinuation. CONCLUSIONS: Glecaprevir/pibrentasvir was highly effective, well tolerated, and improved quality of life in HCV-infected persons who use drugs and other underserved patients. TRIAL REGISTRATION: These multinational post-marketing observational studies are registered with ClinicalTrials.gov, number NCT03303599.
INTRODUCTION:Glecaprevir/pibrentasvir is approved for treating chronic hepatitis C virus (HCV) genotypes (GT) 1-6. We evaluated real-world effectiveness, safety, and patient-reported outcomes of glecaprevir/pibrentasvir in underserved patient populations, focusing on persons who use drugs infected with HCV. METHODS: Data were pooled from nine countries (13 November 2017-31 January 2020). Patients had HCV GT1-6, with or without compensated cirrhosis, with or without prior HCV treatment and received glecaprevir/pibrentasvir consistent with local label at their physician's discretion. Patients with prior direct-acting antiviral exposure were excluded from efficacy and quality-of-life analyses. The percentage of patients achieving sustained virologic response at post-treatment week 12 (SVR12) was assessed. Mean changes from baseline to SVR12 visit in 36-Item Short-Form Health Survey mental and physical component summary scores were reported. Safety was assessed in patients receiving at least one dose of glecaprevir/pibrentasvir. RESULTS: Of 2036 patients, 1701 (83.5%) received 8-week glecaprevir/pibrentasvir. In 1684 patients with sufficient follow-up, SVR12 rates were 98.0% (1651/1684) overall, 98.1% (1432/1459) in 8-week treated patients, 97.0% (519/535) in persons who use drugs, and greater than 95% across subgroups. Mean changes from baseline in mental and physical component summary scores were 3.7 and 2.4, respectively. One glecaprevir/pibrentasvir-related serious adverse event was reported; six glecaprevir/pibrentasvir-related adverse events led to discontinuation. CONCLUSIONS:Glecaprevir/pibrentasvir was highly effective, well tolerated, and improved quality of life in HCV-infectedpersons who use drugs and other underserved patients. TRIAL REGISTRATION: These multinational post-marketing observational studies are registered with ClinicalTrials.gov, number NCT03303599.
Entities:
Keywords:
Alcohol use disorder; Health-related quality of life; Hepatitis C; Illicit drugs; Psychiatric disorders
Authors: Jeffrey V Lazarus; Kelly Safreed-Harmon; Mark R Thursz; John F Dillon; Manal H El-Sayed; Ahmed M Elsharkawy; Angelos Hatzakis; Michel Jadoul; Tullio Prestileo; Homie Razavi; Jürgen K Rockstroh; Stefan Z Wiktor; Massimo Colombo Journal: Semin Liver Dis Date: 2018-07-09 Impact factor: 6.115
Authors: Natasha K Martin; Peter Vickerman; Jason Grebely; Margaret Hellard; Sharon J Hutchinson; Viviane D Lima; Graham R Foster; John F Dillon; David J Goldberg; Gregory J Dore; Matthew Hickman Journal: Hepatology Date: 2013-08-26 Impact factor: 17.425