Background There are few real-life data on the potential drug-drug interactions (DDIs) between anti-HCV direct-acting antivirals (DAAs) and the comedications used. Aim To assess the potential DDIs of DAAs in HCV-infected outpatients, according to the severity of liver disease and comedication used in a prospective multicentric study. Methods Data from patients in 15 clinical centers who had started a DAA regimen and were receiving comedications during March 2015 to March 2016 were prospectively evaluated. The DDIs for each regimen and comedication were assigned according to HepC Drug Interactions (www.hep-druginteractions.org). Results Of the 449 patients evaluated, 86 had mild liver disease and 363 had moderate-to-severe disease. The use of a single comedication was more frequent among patients with mild liver disease (p = 0.03), whereas utilization of more than three drugs among those with moderate-to-severe disease (p = 0.05). Of the 142 comedications used in 86 patients with mild disease, 27 (20%) may require dose adjustment/closer monitoring, none was contraindicated. Of the 322 comedications used in 363 patients with moderate-to-severe liver disease, 82 (25%) were classified with potential DDIs that required only monitoring and dose adjustments; 10 (3%) were contraindicated in severe liver disease. In patients with mild liver disease 30% (26/86) used at least one drug with a potential DDI whereas of the 363 patients with moderate-to-severe liver disease, 161 (44%) were at risk for one or more DDI. Conclusions Based on these results, we can estimate that 30-44% of patients undergoing DAA and taking comedications are at risk of a clinically significant DDI. This data indicates the need for increased awareness of potential DDI during DAA therapy, especially in patients with moderate-to-severe liver disease. For several drugs, the recommendation related to the DDI changes from "dose adjustment/closer monitoring" in mild to moderate liver disease, to "the use is contraindicated" in severe liver disease.
Real-life data on potential drug-drug interactions in patients with chronic hepatitis C viral infection undergoing antiviral therapy with interferon-free DAAs in the PITER Cohort Study / L.A. Kondili, G.B. Gaeta, D. Ieluzzi, A.L. Zignego, M. Monti, A. Gori, A. Soria, G. Raimondo, R. Filomia, A.D. Leo, A. Iannone, M. Massari, R. Corsini, R. Gulminetti, A.G. Comini, P. Toniutto, D. Dissegna, F.P. Russo, A. Zanetto, M. Rumi, G. Brancaccio, E. Danieli, M.R. Brunetto, L.E. Weimer, M.G. Quaranta, S. Vella, M. Puoti. - In: PLOS ONE. - ISSN 1932-6203. - 12:2(2017), pp. e0172159.1-e0172159.11.
|Titolo:||Real-life data on potential drug-drug interactions in patients with chronic hepatitis C viral infection undergoing antiviral therapy with interferon-free DAAs in the PITER Cohort Study|
|Parole Chiave:||Adult; Aged; Aged, 80 and over; Antiviral Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Interferons; Italy; Liver Cirrhosis; Male; Middle Aged; Prospective Studies; Risk; Drug Interactions; Biochemistry, Genetics and Molecular Biology (all); Agricultural and Biological Sciences (all)|
|Settore Scientifico Disciplinare:||Settore MED/12 - Gastroenterologia|
|Data di pubblicazione:||2017|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1371/journal.pone.0172159|
|Appare nelle tipologie:||01 - Articolo su periodico|
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