1. Efficacy and Tolerability of Ombitasvir/Paritaprevir/Ritonavir in HCV Genotype 1-infected Elderly Japanese Patients.
- Author
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Uojima H, Kobayashi S, Hidaka H, Kinbara T, Fujikawa T, Nakayama T, Yamanoue H, Kanemaru T, Hashimotoh T, Hyun Sung J, Kako M, and Koizumi W
- Subjects
- Administration, Oral, Adult, Age Factors, Aged, Aged, 80 and over, Antiviral Agents administration & dosage, Cyclopropanes, Cytochrome P-450 CYP3A Inhibitors administration & dosage, Dose-Response Relationship, Drug, Drug Therapy, Combination, Female, Follow-Up Studies, Genotype, Hepatitis C, Chronic epidemiology, Hepatitis C, Chronic virology, Humans, Japan epidemiology, Lactams, Macrocyclic, Male, Middle Aged, Morbidity trends, Proline analogs & derivatives, Prospective Studies, Risk Factors, Sulfonamides, Valine, Anilides administration & dosage, Carbamates administration & dosage, DNA, Viral genetics, Drug Tolerance, Hepacivirus genetics, Hepatitis C, Chronic drug therapy, Macrocyclic Compounds administration & dosage, Ritonavir administration & dosage
- Abstract
Introduction and Aim: We assessed the characteristics of virological response to a combination treatment of ombitasvir, paritaprevir, and ritonavir in hepatitis C virus genotype 1-infected elderly Japanese patients., Material and Methods: This multicenter prospective study was conducted at six locations in Japan. Seventy patients with chronic hepatitis C virus genotype 1b infection were orally administered ombitasvir/paritaprevir/ritonavir once daily for 12 weeks. The primary endpoint was the proportion of elderly patients with sustained virological response (SVR) 12 weeks after the completion of treatment. Adverse events were also recorded to evaluate drug safety and tolerability during the trial period. SVR in elderly patients (age > 65; 94% [47 / 50]) was lower than that in younger patients (100% [20 / 20])., Results: No significant differences in SVR 12 weeks after the completion of treatment were observed between the age groups (P = 0.153). Adverse events were observed in 16 patients (23.3%). Multivariate analysis confirmed that the change or discontinuation of concomitant drugs owing to drug interactions was independent of risk factors for adverse events associated with this drug combination (P = 0.015; odds ratio, 15.9; 95% confidence interval, 1.79 - 148). Ombitasvir/paritaprevir/ritonavir combination treatment was highly effective in elderly patients., Conclusion: Tolerability should be monitored in older patients for whom concomitant medications are discontinued or changed because of drug interactions., (Copyright © 2019 Fundación Clínica Médica Sur, A.C. Published by Elsevier España, S.L.U. All rights reserved.)
- Published
- 2019
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