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

• DOI: 10.1007/s40121-021-00455-1
• Publication Date: 2021-06-14T11:03:01Z
• Authors: Alessio Aghemo; Yves Horsmans; Stefan Bourgeois; Mark Bondin; Michael Gschwantler; Harald Hofer; Nasser Semmo; Francesco Negro; Zhenzhen Zhang; John Marcinak; Ella Veitsman; Rawi Hazzan; Konstantinos Mimidis; Ioannis Goulis; Nuno Marques; Robert Flisiak; Wlodzimierz Mazur; Carlos Roncero; Fiona Marra; Georges Philippe ...; Tarik Asselah; Pietro Lampertico
• Keywords: Discontinuation; Hepatitis C

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.Data were pooled from nine countries (13 November 2017-31 January 2020). Patients had HCV GT1-6, or without compensated cirrhosis, prior treatment received consistent local label at their physician's discretion. direct-acting antiviral exposure excluded efficacy quality-of-life analyses. The percentage patients achieving sustained virologic response post-treatment week 12 (SVR12) was assessed. Mean changes baseline to SVR12 visit 36-Item Short-Form Health Survey mental physical component summary scores reported. Safety assessed receiving least one dose glecaprevir/pibrentasvir.Of 2036 patients, 1701 (83.5%) 8-week glecaprevir/pibrentasvir. In 1684 sufficient follow-up, rates 98.0% (1651/1684) overall, 98.1% (1432/1459) treated 97.0% (519/535) drugs, greater than 95% across subgroups. 3.7 2.4, respectively. One glecaprevir/pibrentasvir-related serious adverse event reported; six events led discontinuation.Glecaprevir/pibrentasvir highly effective, well tolerated, improved quality life HCV-infected other patients.These multinational post-marketing observational studies are registered ClinicalTrials.gov, number NCT03303599.