Aghemo, Alessio; Horsmans, Yves; Bourgeois, Stefan; Bondin, Mark; Gschwantler, Michael; Hofer, Harald; Semmo, Nasser; Negro, Francesco; Zhang, Zhenzhen; Marcinak, John; Veitsman, Ella; Hazzan, Rawi; Mimidis, Konstantinos; Goulis, Ioannis; Marques, Nuno; Flisiak, Robert; Mazur, Wlodzimierz; Roncero, Carlos; Marra, Fiona; Pageaux, Georges Philippe; ... (2021). Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir. Infectious diseases and therapy, 10(4), pp. 2203-2222. Springer 10.1007/s40121-021-00455-1
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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.
Item Type: |
Journal Article (Original Article) |
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Division/Institute: |
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Hepatologie 04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Hepatologie 04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Hepatology |
UniBE Contributor: |
Semmo, Nasser |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
2193-8229 |
Publisher: |
Springer |
Language: |
English |
Submitter: |
Rahel Fuhrer |
Date Deposited: |
06 Jul 2021 14:15 |
Last Modified: |
05 Dec 2022 15:51 |
Publisher DOI: |
10.1007/s40121-021-00455-1 |
PubMed ID: |
34125405 |
Uncontrolled Keywords: |
Alcohol use disorder Health-related quality of life Hepatitis C Illicit drugs Psychiatric disorders |
BORIS DOI: |
10.48350/157350 |
URI: |
https://boris.unibe.ch/id/eprint/157350 |
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