1. 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
- Author
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Kondili, Loreta A., GAETA, Giovanni Battista, Ieluzzi, Donatella, Zignego, Anna Linda, Monti, Monica, Gori, Andrea, Soria, Alessandro, Raimondo, Giovanni, Filomia, Roberto, Leo, Alfredo Di, Iannone, Andrea, Massari, Marco, Corsini, Romina, Gulminetti, Roberto, Comini, Alberto Gatti, Toniutto, Pierluigi, Dissegna, Denis, Russo, Francesco Paolo, Zanetto, Alberto, Rumi, Maria Grazia, Brancaccio, Giuseppina, Danieli, Elena, Brunetto, Maurizia Rossana, Weimer, Liliana Elena, Quaranta, Maria Giovanna, Vella, Stefano, Puoti, Massimo, PITER Cohort Study, FEDERICO, Alessandro, Dallio, M, LOGUERCIO, Carmelina, Kondili, L, Gaeta, G, Ieluzzi, D, Zignego, A, Monti, M, Gori, A, Soria, A, Raimondo, G, Filomia, R, Leo, A, Iannone, A, Massari, M, Corsini, R, Gulminetti, R, Comini, A, Toniutto, P, Dissegna, D, Russo, F, Zanetto, A, Rumi, M, Brancaccio, G, Danieli, E, Brunetto, M, Weimer, L, Quaranta, M, Vella, S, Puoti, M, Kondili, Loreta A., Gaeta, Giovanni Battista, Ieluzzi, Donatella, Zignego, Anna Linda, Monti, Monica, Gori, Andrea, Soria, Alessandro, Raimondo, Giovanni, Filomia, Roberto, Leo, Alfredo Di, Iannone, Andrea, Massari, Marco, Corsini, Romina, Gulminetti, Roberto, Comini, Alberto Gatti, Toniutto, Pierluigi, Dissegna, Deni, Russo, Francesco Paolo, Zanetto, Alberto, Rumi, Maria Grazia, Brancaccio, Giuseppina, Danieli, Elena, Brunetto, Maurizia Rossana, Weimer, Liliana Elena, Quaranta, Maria Giovanna, Vella, Stefano, Puoti, Massimo, PITER Cohort, Study, Federico, Alessandro, Dallio, M, and Loguercio, Carmelina
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Genetics and Molecular Biology (all) ,Male ,Cirrhosis ,Disease ,Hepacivirus ,Toxicology ,Biochemistry ,Viral infection ,0302 clinical medicine ,80 and over ,Medicine ,Prospective Studies ,Chronic ,lcsh:Science ,media_common ,Aged, 80 and over ,Liver Diseases ,Drug Interaction ,Italy ,Adult ,Aged ,Antiviral Agents ,Drug Administration Schedule ,Drug Therapy, Combination ,Female ,Hepatitis C, Chronic ,Humans ,Interferons ,Liver Cirrhosis ,Middle Aged ,Risk ,Drug Interactions ,Medicine (all) ,Biochemistry, Genetics and Molecular Biology (all) ,Agricultural and Biological Sciences (all) ,030220 oncology & carcinogenesis ,Interferon ,030211 gastroenterology & hepatology ,Human ,Cohort study ,Drug ,medicine.medical_specialty ,media_common.quotation_subject ,Drug-Drug Interactions ,Gastroenterology and Hepatology ,Microbiology ,03 medical and health sciences ,Drug Therapy ,Pharmacology ,Hepaciviru ,Flaviviruses ,lcsh:R ,Organisms ,Correction ,medicine.disease ,Prospective Studie ,Regimen ,Immunology ,lcsh:Q ,RNA viruses ,lcsh:Medicine ,030204 cardiovascular system & hematology ,medicine.disease_cause ,Cohort Studies ,Liver disease ,Drug Metabolism ,Medicine and Health Sciences ,030212 general & internal medicine ,Prospective cohort study ,Pathology and laboratory medicine ,Multidisciplinary ,HCV DAA ,Hepatitis C virus ,Antiviral therapy ,Medical microbiology ,Hepatitis C ,Real life data ,Research Design ,Combination ,Viruses ,Pathogens ,Research Article ,Liver Cirrhosi ,Biology ,Research and Analysis Methods ,Chronic hepatitis ,Internal medicine ,Pharmacokinetics ,In patient ,Antiviral Agent ,Biology and life sciences ,Toxicity ,business.industry ,Interferon free ,Viral pathogens ,Hepatitis viruses ,Microbial pathogens ,business - Abstract
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.
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- 2018