Maria Giovanna Quaranta1, Stefano Rosato1, Luigina Ferrigno1, Daniela Caterina Amoruso2, Monica Monti3, Paola Di Stefano4, Roberto Filomia5, Elisa Biliotti6, Guglielmo Migliorino7, Francesco Paolo Russo8, Elisabetta Degasperi9, Liliana Chemello10, Giuseppina Brancaccio11, Pierluigi Blanc12, Marco Cannizzaro13, Francesco Barbaro14, Giulia Morsica15, Anna Licata16, Loreta A Kondili1. 1. Center for Global Health, Istituto Superiore di Sanità, Rome, Italy. 2. Department of Hepatology, Gragnano Hospital, Naples, Italy. 3. Center for Systemic Manifestations of Hepatitis Viruses (MaSVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. 4. Infectious Disease Unit, Spirito Santo General Hospital, Pescara, Italy. 5. Division of Clinical and Molecular Hepatology, University Hospital of Messina, Messina, Italy. 6. Department of Clinical Medicine, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy. 7. Department of Infectious Disease, San Gerardo Hospital, Monza, Italy. 8. Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy. 9. Gastroenterology and Hepatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. 10. Department of Medicine, University of Padua, Padua, Italy. 11. Department of Infectious Disease, Università della Campania Luigi Vanvitelli, Naples, Italy. 12. Infectious Disease Unit, Santa Maria Annunziata Hospital, Florence, Italy. 13. Internal Medicine, Villa Sofia-Cervello Hospital, Palermo, Italy. 14. Infectious and Tropical Diseases Unit, Azienda Ospedaliera di Padova, Padua, Italy. 15. Department of Infectious Diseases, San Raffaele Hospital, Milan, Italy. 16. Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy.
Abstract
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.
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.
Authors: Anna Licata; Maria Giovanna Minissale; Lydia Giannitrapani; Filippo A Montalto; Clelia Lombardo; Luigi Mirarchi; Simona Amodeo; Maurizio Soresi; Giuseppe Montalto Journal: Intern Emerg Med Date: 2021-04-28 Impact factor: 3.397