Romanian Society of Pharmaceutical Sciences

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DRUG-DRUG INTERACTION (DDI) TOOLS – USEFUL VERSUS MANDATORY IN THE MANAGEMENT OF DIFFICULT TO TREAT PATIENTS WITH CHRONIC HCV INFECTION

ANCA STREINU-CERCEL1,2, OANA SANDULESCU1,2*, DANIELA MANOLACHE2, MONICA ANDREEA STOICA2, LILIANA LUCIA PREOȚESCU1,2, ADRIAN STREINU-CERCEL1,2

1.“Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
2 .“Prof. Dr. Matei Balș” National Institute for Infectious Diseases, Bucharest, Romania

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The treatment of chronic HCV infection has been redesigned with the advent of direct-acting antivirals which substantially increase the rate of sustained virological response but also entail new challenges – potential drug-drug interactions (DDIs) that may compromise antiviral efficacy or put the patient at risk for toxicity or under-treatment of comorbidities. We collected data on DDIs in the real-life treatment of chronically HCV-infected patients with the 3D regimen containing ombitasvir/paritaprevir/ritonavir plus dasabuvir, in a compassionate study approved by the Romanian National Agency for Medicines and Medical Devices. DDIs were checked with the HEP-Drug Interaction Charts, University of Liverpool (UK). Out of 44 patients, 14 (31.8%) had no comorbidities and 19 (43.2%) had no concomitant medications. After the DDI check, 14 (56%) of the 25 patients on co-medication did not require any intervention apart from close monitoring, 6 (24%) required dose adjustment, in 3 cases (12%) co-medication was changed and in 2 cases (8%) it was stopped during treatment of HCV infection. We identified more advanced baseline liver fibrosis in patients for whom co-medication needed changing (p = 0.001, d = 6.9), and in those who had comorbidities (p = 0.036) or required co-medication (p = 0.001). In conclusion, the 3D regimen displayed a good DDI profile in real-life settings, but close monitoring and accountability of co-medications should be performed by all treating physicians.