Author information
1Liver Unit, Fondazione "Casa Sollievo Della Sofferenza" IRCCS, 71013 San Giovanni Rotondo, Italy.
2Department of Oncology and Onco-Hematology, University of Milan, 20122 Milan, Italy.
3Hepatology and Liver Transplantation Unit, Azienda Ospedaliero Universitaria, 33100 Udine, Italy.
4Department of Translational Medicine (DiMeT), Università del Piemonte Orientale, 28100 Novara, Italy.
5Department of Mental Health and Public Medicine-Infectious Diseases Unit, University of Campania Luigi Vanvitelli, 81100 Caserta, Italy.
6Department of Medical Sciences, University of Turin, 10124 Turin, Italy.
7Gilead Sciences, Medical Affairs Italy, 202124 Milan, Italy.
8Gilead Sciences, Global Medical Affairs, Stockley Park, London UB11 1BD, UK.
9CliCon S.r.l. Health, Economics & Outcomes Research, 40137 Bologna, Italy.
10Gastroenterology and Transplant Hepatology, Papa Giovanni XXIII Hospital, 24127 Bergamo, Italy.
Abstract
This Italian observational real-world study aims to assess in chronic hepatitis C virus (HCV) patients treated with pangenotypic direct acting agents (pDAAs) glecaprevir/pibrentasvir (GLE/PIB) or sofosbuvir/velpatasvir (SOF/VEL) the potential drug-drug interactions (DDIs) with concomitant medications prescribed, with a focus on cardiovascular and system nervous (CNS) co-medications. Data were collected from administrative databases covering 6.9 million health-assisted individuals. All patients prescribed SOF/VEL or GLE/PIB between 11/2017 and 12/2018 were included. Patients were analyzed while on DAA. DDIs were identified according to the Liverpool University tool. Overall, 3181 HCV patients were included: 1619 in the GLE/PIB cohort and 1562 in the SOF/VEL cohort. SOF/VEL patients were generally older than GLE/PIB ones (mean age 58.4 vs. 53.1, p < 0.001) and had more cardiovascular and CNS comorbidities (58% vs. 42%, p < 0.001 and 33% vs. 28%, p = 0.002, respectively). Contraindications due to DDIs in the GLE/PIB cohort affected 9.3% and 3.2% of patients before and on DAA, respectively, while the percentages in the SOF/VEL cohort were 3.2% before and 0.4% after pDAAs initiation. Among GLE/PIB patients, 2.7% had cardiovascular drugs (all statins) contraindicated while on DAA. The potential DDIs between cardiovascular drugs and SOF/VEL were mainly with statins (5%). SOF/VEL was prescribed in patients with older age and with more cardiovascular and CNS comorbidities. Despite this, a proportion of contraindicated drugs lower than that of GLE/PIB was registered.