Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir.

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. (In Press). Infectious diseases and therapy 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)

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:

06 Jul 2021 14:15

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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