Real-life use of elbasvir/grazoprevir in adults and elderly patients: a prospective evaluation of comedications used in the PITER cohort.


Journal

Antiviral therapy
ISSN: 2040-2058
Titre abrégé: Antivir Ther
Pays: England
ID NLM: 9815705

Informations de publication

Date de publication:
2020
Historique:
accepted: 05 03 2020
pubmed: 4 4 2020
medline: 5 10 2021
entrez: 4 4 2020
Statut: ppublish

Résumé

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. 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. 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. The results of this prospective study support findings that ELB/GZR is effective and safe in most treated patients.

Sections du résumé

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.

Identifiants

pubmed: 32242526
doi: 10.3851/IMP3350
doi:

Substances chimiques

Antiviral Agents 0
Benzofurans 0
Drug Combinations 0
Imidazoles 0
Quinoxalines 0
elbasvir-grazoprevir drug combination 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

73-81

Auteurs

Maria Giovanna Quaranta (MG)

Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.

Stefano Rosato (S)

Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.

Luigina Ferrigno (L)

Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.

Daniela Caterina Amoruso (DC)

Department of Hepatology, Gragnano Hospital, Naples, Italy.

Monica Monti (M)

Center for Systemic Manifestations of Hepatitis Viruses (MaSVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

Paola Di Stefano (P)

Infectious Disease Unit, Spirito Santo General Hospital, Pescara, Italy.

Roberto Filomia (R)

Division of Clinical and Molecular Hepatology, University Hospital of Messina, Messina, Italy.

Elisa Biliotti (E)

Department of Clinical Medicine, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.

Guglielmo Migliorino (G)

Department of Infectious Disease, San Gerardo Hospital, Monza, Italy.

Francesco Paolo Russo (FP)

Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.

Elisabetta Degasperi (E)

Gastroenterology and Hepatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Liliana Chemello (L)

Department of Medicine, University of Padua, Padua, Italy.

Giuseppina Brancaccio (G)

Department of Infectious Disease, Università della Campania Luigi Vanvitelli, Naples, Italy.

Pierluigi Blanc (P)

Infectious Disease Unit, Santa Maria Annunziata Hospital, Florence, Italy.

Marco Cannizzaro (M)

Internal Medicine, Villa Sofia-Cervello Hospital, Palermo, Italy.

Francesco Barbaro (F)

Infectious and Tropical Diseases Unit, Azienda Ospedaliera di Padova, Padua, Italy.

Giulia Morsica (G)

Department of Infectious Diseases, San Raffaele Hospital, Milan, Italy.

Anna Licata (A)

Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy.

Loreta A Kondili (LA)

Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.

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Classifications MeSH