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

Loreta A Kondili, Giovanni Battista Gaeta, Donatella Ieluzzi, Anna Linda Zignego, Monica Monti, Andrea Gori, Alessandro Soria, Giovanni Raimondo, Roberto Filomia, Alfredo Di Leo, Andrea Iannone, Marco Massari, Romina Corsini, Roberto Gulminetti, Alberto Gatti Comini, Pierluigi Toniutto, Denis Dissegna, Francesco Paolo Russo, Alberto Zanetto, Maria Grazia RumiGiuseppina Brancaccio, Elena Danieli, Maurizia Rossana Brunetto, Liliana Elena Weimer, Maria Giovanna Quaranta, Stefano Vella, Massimo Puoti

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)e0172159
JournalPLoS One
Volume12
Issue number2
DOIs
Publication statusPublished - 2017

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Antiviral Agents/adverse effects
  • Drug Administration Schedule
  • Drug Interactions
  • Drug Therapy, Combination
  • Female
  • Hepacivirus
  • Hepatitis C, Chronic/drug therapy
  • Humans
  • Interferons
  • Italy
  • Liver Cirrhosis/chemically induced
  • Male
  • Middle Aged
  • Prospective Studies
  • Risk

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  • Cite this

    Kondili, L. A., Gaeta, G. B., Ieluzzi, D., Zignego, A. L., Monti, M., Gori, A., Soria, A., Raimondo, G., Filomia, R., Di Leo, A., Iannone, A., Massari, M., Corsini, R., Gulminetti, R., Gatti Comini, A., Toniutto, P., Dissegna, D., Russo, F. P., Zanetto, A., ... Puoti, M. (2017). 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. PLoS One, 12(2), e0172159. https://doi.org/10.1371/journal.pone.0172159