Liver - Original Article

Real-life experience of ledipasvir and sofosbuvir single-tablet regimen among chronic hepatitis C patients in Turkey

Volume 31 · Issue 3 Publish Date: March 15, 2020
Tansu Yamazhan İlker Turan Galip Ersöz Fulya Günşar Hüsnü Pullukçu Nilay Danış Nalan G. Ünal Rukiye Vardar Nevin Oruç Fatih Tekin Meltem Taşbakan Oğuz R. Sipahi Ulus S. Akarca
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Turkish Journal of Gastroenterology

Volume 31 · Issue 3

Pages: 239-245

History

Published Online: March 15, 2020

Copyright © 2020 Tansu Yamazhan, İlker Turan, Galip Ersöz, Fulya Günşar, Hüsnü Pullukçu, Nilay Danış, Nalan G. Ünal, Rukiye Vardar, Nevin Oruç, Fatih Tekin, Meltem Taşbakan, Oğuz R. Sipahi, Ulus S. Akarca

Tansu Yamazhan
Turkish Association for the Study of the Liver, İstanbul, Turkey; Viral Hepatitis Society, Ankara, Turkey
İlker Turan
Department of Gastroenterology, Ege University School of Medicine, İzmir, Turkey
Galip Ersöz
Department of Gastroenterology, Ege University School of Medicine, İzmir, Turkey
Fulya Günşar
Departments of Gastroenterology, Ege University School of Medicine, İzmir
Hüsnü Pullukçu
Department of Infectious Disease, Ege University, İzmir, Turkey
Nilay Danış
Department of Gastroenterology, Ege University School of Medicine, İzmir, Turkey
Nalan G. Ünal
Department of Gastroenterology, Ege University, İzmir, Turkey
Rukiye Vardar
Department of Gastroenterology, Ege University Faculty of Medicine, İzmir, Turkey
Nevin Oruç
Department of Gastroenterology, Ege University Faculty of Medicine, İzmir, Turkey
Fatih Tekin
Department of Gastroenterology, Ege University School of Medicine, İzmir, Turkey
Meltem Taşbakan
Liver Transplantation Department of Organ Transplantation and Research Center, Ege University School of Medicine, İzmir, Turkey
Oğuz R. Sipahi
Department of Infectious Disease, Ege University, İzmir, Turkey
Ulus S. Akarca
Ege Universitesi Tıp Fakültesi Gastroenteroloji Bilim Dalı
Yamazhan, T., Turan, İlker, Ersöz, G., Günşar, F., Pullukçu, H., Danış, N., … Akarca, U. S. (2020). Real-life experience of ledipasvir and sofosbuvir single-tablet regimen among chronic hepatitis C patients in Turkey. Turkish Journal of Gastroenterology, 31(3), 239–245. https://doi.org/10.5152/tjg.2020.19076
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Abstract

Background/Aims: Ledipasvir (LDV) and sofosbuvir (SOF) as single-tablet regimen (STR) has been approved for treatment of chronic HCV infection (CHC) for treatment-naïve or experienced cirrhotic or non-cirrhotic patients. Our aim was to analyse the effectiveness and safety of 12-24 weeks treatment of LDV/SOF (90mg/400 mg)±ribavirin in a real-life setting in Turkey. Materials and Methods: Between May-Dec 2016, 104 treatment-naïve or experienced adult patients with CHC and with or without cirrhosis (including decompensated cirrhosis) were included in this observational study. Patients were administered LDV/SOF STR± ribavirin once daily for 12 -24 weeks. SVR12 rates and effects of the baseline characteristics on SVR12 rates were assessed. Results: Out of 104 enrolled patients (61.5% female, mean age 62.0 years); 60.6% were cirrhotic, 76.0% previously used peg-IFN, 94.2% had GT1. At the end of the treatment, 77.8% (77/99, no data for 21 patients) had undetectable HCV-RNA and 98.9% (94/95) had SVR12. In the baseline characteristics subgroups, the SVR12 rates varied between 94.4% and 100%, and none of the baseline characteristics had a significant effect on the SVR12 rates. During the study, 6 (5.8%) patients died and none of the deaths was suspected to be related to the LDV/SOF. No treatment-emergent adverse event was reported. Conclusion: In conclusion, LDV/SOF±ribavirin yielded very high SVR12 rates, without any safety or tolerability concern in Turkey. The effectiveness of the LDV/SOF treatment was not affected by the patient demographics or medical characteristics such as fibrosis level, cirrhosis status, previous treatment status, HCV-RNA level or HCV genotype.

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Article Info
Published In
Journal Turkish Journal of Gastroenterology
Volume / Issue Volume 31 · Issue 3
Pages 239-245
DOI 10.5152/tjg.2020.19076
History
Published Online March 15, 2020
Copyright
Copyright (c) 2020 Tansu Yamazhan, İlker Turan, Galip Ersöz, Fulya Günşar, Hüsnü Pullukçu, Nilay Danış, Nalan G. Ünal, Rukiye Vardar, Nevin Oruç, Fatih Tekin, Meltem Taşbakan, Oğuz R. Sipahi, Ulus S. Akarca
Affiliations
Tansu Yamazhan
Turkish Association for the Study of the Liver, İstanbul, Turkey; Viral Hepatitis Society, Ankara, Turkey
İlker Turan
Department of Gastroenterology, Ege University School of Medicine, İzmir, Turkey
Galip Ersöz
Department of Gastroenterology, Ege University School of Medicine, İzmir, Turkey
Fulya Günşar
Departments of Gastroenterology, Ege University School of Medicine, İzmir
Hüsnü Pullukçu
Department of Infectious Disease, Ege University, İzmir, Turkey
Nilay Danış
Department of Gastroenterology, Ege University School of Medicine, İzmir, Turkey
Nalan G. Ünal
Department of Gastroenterology, Ege University, İzmir, Turkey
Rukiye Vardar
Department of Gastroenterology, Ege University Faculty of Medicine, İzmir, Turkey
Nevin Oruç
Department of Gastroenterology, Ege University Faculty of Medicine, İzmir, Turkey
Fatih Tekin
Department of Gastroenterology, Ege University School of Medicine, İzmir, Turkey
Meltem Taşbakan
Liver Transplantation Department of Organ Transplantation and Research Center, Ege University School of Medicine, İzmir, Turkey
Oğuz R. Sipahi
Department of Infectious Disease, Ege University, İzmir, Turkey
Ulus S. Akarca
Ege Universitesi Tıp Fakültesi Gastroenteroloji Bilim Dalı
Cite this Article
Yamazhan, T., Turan, İlker, Ersöz, G., Günşar, F., Pullukçu, H., Danış, N., … Akarca, U. S. (2020). Real-life experience of ledipasvir and sofosbuvir single-tablet regimen among chronic hepatitis C patients in Turkey. Turkish Journal of Gastroenterology, 31(3), 239–245. https://doi.org/10.5152/tjg.2020.19076
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