1. Real-world efficacy, safety, and clinical outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin combination therapy in patients with hepatitis C virus genotype 1 or 4 infection: The Turkey experience experience.
- Author
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Aygen B, Demirtürk N, Yıldız O, Çelen MK, Çelik İ, Barut Ş, Ural O, Batırel A, Mıstık R, Şimşek F, Asan A, Ersöz G, Türker N, Bilgin H, Kınıklı S, Karakeçili F, Zararsız G, and Turkish Society Of Clinical Microbiology And Infectious Diseases TSGFVHOT
- Subjects
- Adult, Aged, Aged, 80 and over, Anilides administration & dosage, Cyclopropanes administration & dosage, Databases, Factual, Drug Therapy, Combination, Female, Genotype, Humans, Lactams, Macrocyclic administration & dosage, Male, Middle Aged, Proline administration & dosage, Proline analogs & derivatives, Ritonavir administration & dosage, Sustained Virologic Response, Turkey, Uracil administration & dosage, Valine administration & dosage, Young Adult, 2-Naphthylamine administration & dosage, Antiviral Agents administration & dosage, Hepacivirus genetics, Hepatitis C, Chronic drug therapy, Ribavirin administration & dosage, Sulfonamides administration & dosage, Uracil analogs & derivatives
- Abstract
Background/aims: mbitasvir/paritaprevir/ritonavir (OMV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) combination has demonstrated excellent rates of sustained virologic response (SVR) and a very good safety profile in patients with the chronic hepatitis C virus (HCV) genotype 1 or 4 infections. We aimed to investigate the effectiveness and safety of OMV/PTV/r ± DSV ± RBV combination regimen in a real-world clinical practice., Materials and Methods: Data from HCV genotype 1 and 4 patients treated with OMV/PTV/r ± DSV ± RBV (n=862) in 34 centers across Turkey between April 1, 2017 and August 31, 2018 were recorded in a large national database. Demographic, clinical, and virologic data were analyzed., Results: The mean age of the patients was 55.63, and 430 patients (49.9%) were male. The majority had HCV genotype 1b infection (77.3%), and 66.2% were treatment-naïve. Non-cirrhosis was present at baseline in 789 patients (91.5%). SVR12 rate was 99.1% in all patients. Seven patients had virologic failure. No significant differences were observed in SVR12 according to HCV genotypes. HCV RNA was undetectable at treatment week 4 in 90.9%, at treatment week 8 in 98.5%, and at the end of treatment (EOT) in 98.9%. SVR12 ratio was significantly higher in the non-cirrhotic patients compared to that in the compensated cirrhotic patients. Rates of adverse events (AEs) in the patients was 59.7%., Conclusion: The present real-life data of Turkey for the OBV/PTV/r ± DSV ± RBV treatment of patients with HCV genotype 1b, 1a, or 4 infection from 862 patients demonstrated high efficacy and a safety profile.
- Published
- 2020
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