Elena González-Colominas1, María-Carlota Londoño2, Rosa M Morillas3, Xavier Torras4, Sergi Mojal5, Sabela Lens2, Dulce López3, Adolfo Gallego4, Zoe Mariño2, Mercè Ardèvol6, Neus Pagès7, Ricard Solà8, Jose A Carrión8. 1. Pharmacy Department, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain. 2. Liver Unit, Hospital Clínic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain. 3. Department of Hepatology, Hospital Germans Trias i Pujol, CIBERehd, Badalona, Spain. 4. Department of Gastroenterology, Hospital Santa Creu i Sant Pau, CIBERehd, Barcelona, Spain. 5. Biomedical Research Methods Consultant, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain. 6. Pharmacy Department, Hospital Germans Trias i Pujol, Badalona, Spain. 7. Pharmacy Department, Hospital Santa Creu i Sant Pau, Barcelona, Spain. 8. Liver Section, Gastroenterology Department, Hospital del Mar, Universitat Autònoma de Barcelona, IMIM, Barcelona, Spain.
Abstract
BACKGROUND & AIMS: Drug-drug interactions (DDIs) with ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with or without ribavirin (OBV/PTV/r ± DSV ± RBV) are common in clinical trials. Our aim was to analyze the prevalence and management of potential DDIs and adverse events (AEs) related to DDIs in patients with chronic hepatitis C (CHC) receiving OBV/PTV/r ± DSV ± RBV in clinical practice. METHODS: 177 CHC patients started OBV/PTV/r ± DSV ± RBV in 4 Spanish hospitals and were screened for potential DDIs using the University of Liverpool database. Patients were classified according to the most serious potential DDIs at baseline and AEs during therapy. RESULTS: At least one potential DDI was found in 110 (62.1%) patients: 100 (56.5%) had at least one manageable potential DDI and 10 (5.6%) at least one contraindicated. Patients with potential DDIs were receiving a higher number of concomitant drugs (4 vs. 2, P < 0.001). Routine medication was modified at baseline due to potential DDIs in 49 (27.7%) patients. During antiviral treatment, 67 (37.9%) patients presented at least one AE. In 9 (4.5%) patients, a DDI was suspected between OBV/PTV/r ± DSV ± RBV and the concomitant drug, requiring antiviral discontinuation in 4 patients. CONCLUSIONS: Potential DDIs are frequent with OBV/PTV/r ± DSV ± RBV, although a change in baseline medication is made in only one-quarter of patients. More than half of potential DDIs were only followed, and only 5% of patients developed AEs in which the implication of DDIs could not be excluded.
BACKGROUND & AIMS: Drug-drug interactions (DDIs) with ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with or without ribavirin (OBV/PTV/r ± DSV ± RBV) are common in clinical trials. Our aim was to analyze the prevalence and management of potential DDIs and adverse events (AEs) related to DDIs in patients with chronic hepatitis C (CHC) receiving OBV/PTV/r ± DSV ± RBV in clinical practice. METHODS: 177 CHCpatients started OBV/PTV/r ± DSV ± RBV in 4 Spanish hospitals and were screened for potential DDIs using the University of Liverpool database. Patients were classified according to the most serious potential DDIs at baseline and AEs during therapy. RESULTS: At least one potential DDI was found in 110 (62.1%) patients: 100 (56.5%) had at least one manageable potential DDI and 10 (5.6%) at least one contraindicated. Patients with potential DDIs were receiving a higher number of concomitant drugs (4 vs. 2, P < 0.001). Routine medication was modified at baseline due to potential DDIs in 49 (27.7%) patients. During antiviral treatment, 67 (37.9%) patients presented at least one AE. In 9 (4.5%) patients, a DDI was suspected between OBV/PTV/r ± DSV ± RBV and the concomitant drug, requiring antiviral discontinuation in 4 patients. CONCLUSIONS: Potential DDIs are frequent with OBV/PTV/r ± DSV ± RBV, although a change in baseline medication is made in only one-quarter of patients. More than half of potential DDIs were only followed, and only 5% of patients developed AEs in which the implication of DDIs could not be excluded.
Authors: Bilgehan Aygen; Neşe Demirtürk; Orhan Yıldız; Mustafa Kemal Çelen; İlhami Çelik; Şener Barut; Onur Ural; Ayşe Batırel; Reşit Mıstık; Funda Şimşek; Ali Asan; Gülden Ersöz; Nesrin Türker; Hüseyin Bilgin; Sami Kınıklı; Faruk Karakeçili; Gökmen Zararsız; The Study Group For Viral Hepatitis Of The Turkish Society Of Clinical Microbiology And Infectious Diseases Journal: Turk J Gastroenterol Date: 2020-04 Impact factor: 1.852