Updated Results from the Retrospective CREST Study on the Safety and Effectiveness of 8-Week Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis.

Autor: Cornberg M; Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Carl-Neuberg-Straße 1, 30625, Hannover, Germany. cornberg.markus@mh-hannover.de.; Centre for Individualised Infection Medicine (CiiM), Hannover, Germany. cornberg.markus@mh-hannover.de., Hüppe D; Gastroenterologische Gemeinschaftspraxis Herne, Herne, Germany., Sarrazin C; Department of Internal Medicine and Liver Center, St. Josefs-Hospital Wiesbaden and Viral Hepatitis Research Group, Goethe-University Hospital Frankfurt, Frankfurt, Germany., Ahumada A; Liver Unit, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Jorquera Plaza F; Digestive System Service, Complejo Asistencial Universitario de León, IBIOMED and CIBERehd, León, Spain., Mariño Z; Hospital Clínic, IDIBAPS, CIBERehd, Universitat de Barcelona, Barcelona, Spain., Otano JIU; Navarra Institute for Health Research (IdiSNA), Pamplona, Spain.; Department of Gastroenterology, Liver Unit, Complejo Hospitalario de Navarra, Pamplona, Spain., Conway B; Vancouver Infectious Diseases Center, Simon Fraser University, Vancouver, BC, Canada., Myles L; Barrie GI Associates, Barrie, ON, Canada., Ramji A; University of British Columbia, Vancouver, BC, Canada., Abergel A; Département de Médecine Digestive, CHU Estaing, Clermont-Ferrand, France., Asselah T; Department of Hepatology, AP-HP Hôpital Beaujon, Université de Paris, Cité CRI, INSERM UMR 1149, Clichy, France., Larrey D; Service des maladies de l'appareil digestif, Hôpital Saint Eloi and IBR, INSERM, Montpellier, France., Aghemo A; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.; Division of Internal Medicine and Hepatology, Humanitas Research Hospital IRCCS, Rozzano, Italy., Andreoni M; University of Tor Vergata, Rome, Italy., Gasbarrini A; Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Lampertico P; Ospedale Maggiore Policlinico, Policlinico, Division of Gastroenterology and Hepatology, CRC 'AM and A Migliavacca' Centre for Liver Disease, Foundation IRCCS Ca' Granda, Milan, Italy.; University of Milan, Milan, Italy., Persico M; Dipartimento di Medicina Clinica Medica, Epatologica e Lungodegenza, AOU OO. RR. San Giovanni di dio Ruggi e D'Aragona, Salerno, Italy., Villa E; UC Gastroenterologia, Dipartimento di Specialità Mediche, Azienda Ospedaliera Universitaria di Modena, Modena, Italy., Carmiel M; Liver Unit, Galilee Medical Center, Nahariya, Israel.; The Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel., Chodick G; Maccabitech, Maccabi Healthcare Services, Tel-Aviv, Israel.; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel., Weil C; Maccabitech, Maccabi Healthcare Services, Tel-Aviv, Israel., Bhagat A; AbbVie Inc., North Chicago, IL, USA., Bondin M; AbbVie Inc., North Chicago, IL, USA., Butrymowicz I; AbbVie Inc., North Chicago, IL, USA., Song Y; AbbVie Inc., North Chicago, IL, USA., Semizarov D; AbbVie Inc., North Chicago, IL, USA., Sonparote S; AbbVie Inc., North Chicago, IL, USA., Llamas C; AbbVie Inc., North Chicago, IL, USA.
Jazyk: angličtina
Zdroj: Advances in therapy [Adv Ther] 2024 Dec; Vol. 41 (12), pp. 4669-4682. Date of Electronic Publication: 2024 Oct 29.
DOI: 10.1007/s12325-024-02996-6
Abstrakt: Introduction: This brief report presents updated findings from the previously published CREST study evaluating the safety and effectiveness of 8-week glecaprevir/pibrentasvir (GLE/PIB) in treatment-naïve patients with chronic hepatitis C virus (HCV) infection and compensated cirrhosis. The current study includes an additional 51 patients, presents effectiveness data stratified by additional comorbidities and comedications, and offers insights into healthcare resource utilization.
Methods: Analysis of treatment-naïve patients with HCV infection and compensated cirrhosis enrolled in the CREST study, a real-world, observational multicenter study. All enrolled patients were included in the full analysis set (FAS); the modified analysis set (MAS) excluded patients with missing SVR12 data, or who discontinued GLE/PIB for nonvirologic failure. The primary endpoint was sustained virologic response at posttreatment week 12 (SVR12) in the MAS. Safety and healthcare resource utilization were also assessed.
Results: The FAS included 437 patients, and the MAS 375. Overall, the results were consistent with the previously published study, with 98.9% of patients in the MAS achieving SVR12. Patients with comorbidities such as alcoholism, diabetes, and hyperlipidemia achieved SVR12 rates > 94%. High SVR12 rates were also achieved by patients receiving comedications such as anxiolytics, antidepressants, and opioid agonists. Of the 26.8% of patients with an adverse event, 1.1% had a serious adverse event, none of which were deemed related to GLE/PIB. Healthcare resource utilization varied by employment status and history of drug use. Active drug users had more physician and nurse visits than specialist visits compared with former drug users.
Conclusion: This study provides further evidence on the safety and effectiveness of 8-week GLE/PIB, supporting the use of shorter treatment in treatment-naïve patients with Child-Pugh A cirrhosis including subgroups of interest, regardless of comorbidities and comedications observed in this population. The variable healthcare resource utilization in different patient types can help plan and resource linkage to care better, thus supporting HCV elimination efforts.
(© 2024. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.)
Databáze: MEDLINE
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