TY - JOUR
T1 - Real-life use of elbasvir/grazoprevir in adults and elderly patients
T2 - A prospective evaluation of comedications used in the PITER cohort
AU - on behalf of PITER Collaborating Group
AU - Quaranta, Maria Giovanna
AU - Rosato, Stefano
AU - Ferrigno, Luigina
AU - Amoruso, Daniela Caterina
AU - Monti, Monica
AU - Di Stefano, Paola
AU - Filomia, Roberto
AU - Biliotti, Elisa
AU - Migliorino, Guglielmo
AU - Russo, Francesco Paolo
AU - Degasperi, Elisabetta
AU - Chemello, Liliana
AU - Brancaccio, Giuseppina
AU - Blanc, Pierluigi
AU - Cannizzaro, Marco
AU - Barbaro, Francesco
AU - Morsica, Giulia
AU - Licata, Anna
AU - Kondili, Loreta A.
N1 - Funding Information:
Authors would like to thank PITER collaborating group and all clinical centres (Additional file 1) which are involved in the study on a voluntary basis. Authors would also like to thank Giampaolo La Terza (Medisoft Informatic Services, Rome, Italy) for database maintenance and implementation. The potential DDIs were assessed and classified based on information available in the HEP Drug Interactions website. This study was funded by Italian Ministry of Health, Grant number RF-2016-02364053.
Publisher Copyright:
© 2020 International Medical Press
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021
Y1 - 2021
N2 - Background: In patients treated for HCV infection, potential drug-drug interactions (DDIs) can occur among direct-acting antiviral drugs (DAAs) and comedications used. The real-life effectiveness and safety of elbasvir/ grazoprevir (ELB/GZR) among co-medicated HCV patients was evaluated. Methods: We prospectively evaluated consecutive patients from 15 clinical centres participating in PITER who were treated with ELB/GZR and had been followed for at least 12 weeks after treatment. Data were prospectively collected on the use of comedications (including discontinuation, dose modification and addition of drugs) and potential DDIs with DAAs. Results: Of the 356 patients with at least 12-week post-treatment follow-up (median age 67, range 50-88 years), 338 (95%) achieved sustained virological response. Of these, 219 (60%) had at least one comorbidity (median 2, range 1-6); information on comedication was available for 212 of them. Of 190 comedications used, 15 (8%) drugs were modified during ELB/GZR therapy, specifically in 9 (4%) patients they were interrupted, in 2 (1%) of whom, the comedication was interrupted before the DAA therapy because of potential DDI (that is, patients treated with carbamazepine); in 12 (6%) patients the comedications were modified in terms of dosage. In 29 (14%) patients, the comedications required monitoring when used with ELB/GZR, as well as with all available DAAs. Of the 190 drugs, 27 (14%) used in 67% of patients were free of DDIs when used with ELB/GZR, whereas they required monitoring if used with other DAA regimens. Conclusions: The results of this prospective study support findings that ELB/GZR is effective and safe in most treated patients.
AB - Background: In patients treated for HCV infection, potential drug-drug interactions (DDIs) can occur among direct-acting antiviral drugs (DAAs) and comedications used. The real-life effectiveness and safety of elbasvir/ grazoprevir (ELB/GZR) among co-medicated HCV patients was evaluated. Methods: We prospectively evaluated consecutive patients from 15 clinical centres participating in PITER who were treated with ELB/GZR and had been followed for at least 12 weeks after treatment. Data were prospectively collected on the use of comedications (including discontinuation, dose modification and addition of drugs) and potential DDIs with DAAs. Results: Of the 356 patients with at least 12-week post-treatment follow-up (median age 67, range 50-88 years), 338 (95%) achieved sustained virological response. Of these, 219 (60%) had at least one comorbidity (median 2, range 1-6); information on comedication was available for 212 of them. Of 190 comedications used, 15 (8%) drugs were modified during ELB/GZR therapy, specifically in 9 (4%) patients they were interrupted, in 2 (1%) of whom, the comedication was interrupted before the DAA therapy because of potential DDI (that is, patients treated with carbamazepine); in 12 (6%) patients the comedications were modified in terms of dosage. In 29 (14%) patients, the comedications required monitoring when used with ELB/GZR, as well as with all available DAAs. Of the 190 drugs, 27 (14%) used in 67% of patients were free of DDIs when used with ELB/GZR, whereas they required monitoring if used with other DAA regimens. Conclusions: The results of this prospective study support findings that ELB/GZR is effective and safe in most treated patients.
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U2 - 10.3851/IMP3350
DO - 10.3851/IMP3350
M3 - Article
C2 - 32242526
AN - SCOPUS:85097967910
VL - 25
SP - 73
EP - 81
JO - Antiviral Therapy
JF - Antiviral Therapy
SN - 1359-6535
IS - 2
ER -