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
Volume 31 · Issue 4
Publish Date: April 15, 2020
Published In
Turkish Journal of Gastroenterology
Volume 31 · Issue 4
Pages: 305-317
History
Published Online: April 15, 2020
This work is licensed under a Creative Commons Attribution 4.0 International License.
Copyright © 2020 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*
Bilgehan Aygen
Department of Infectious Diseases and Clinical Microbiology, Erciyes University School of Medicine, Kayseri, Turkey
Neşe Demirtürk
Departments of Infectious Diseases and Clinical Microbiology, Afyon Kocatepe University School of Medicine, Afyon
Orhan Yıldız
Department of Infectious Diseases and Clinical Microbiology, Erciyes University Medical Faculty, Kayseri, Turkey
Mustafa Kemal Çelen
Department of Infectious Diseases and Clinical Microbiology, Dicle University Medical Faculty, Diyarbakır, Turkey
İlhami Çelik
Department of Infectious Diseases and Clinical Microbiology, Health Sciences University Kayseri Training and Research Hospital, Kayseri, Turkey
Şener Barut
Departments of Clinical Bacteriology and Infectious Disease, Gaziosmanpafla University, School of Medicine, Tokat
Onur Ural
Department of Infectious Diseases and Clinical Microbiology, Selçuk University Medical Faculty, Konya, Turkey
Ayşe Batırel
Department of Infectious Diseases and Clinical Microbiology, Dr. Lütfi Kırdar Kartal Education and Research Hospital, İstanbul, Turkey
Reşit Mıstık
Department of Infectious Diseases and Clinical Microbiology, Uludağ University Medical Faculty, Bursa, Turkey
Funda Şimşek
Department of Infectious Diseases and Clinical Microbiology, Okmeydanı Training and Research Hospital, İstanbul, Turkey
Ali Asan
Department of Infectious Diseases and Clinical Microbiology, Sağlık Bilimleri University Yüksek İhtisas Training and Research Hospital, Bursa, Turkey
Gülden Ersöz
Department of Infectious Diseases and Clinical Microbiology, Mersin University Medical Faculty, Mersin, Turkey
Nesrin Türker
Department of Infectious Diseases and Clinical Microbiology, Katip Çelebi University Atatürk Training and Research Hospital, İzmir, Turkey
Hüseyin Bilgin
Department of Infectious Diseases and Clinical Microbiology, Marmara University Medical Faculty, İstanbul, Turkey
Sami Kınıklı
Ministry of Health Ankara Hospital, Ankara
Faruk Karakeçili
Department of Infectious Diseases and Clinical Microbiology, Erzincan University Medical Faculty, Erzincan, Turkey
Gökmen Zararsız
Department of Biostatistics, Erciyes University School of Medicine, Kayseri, Turkey
Aygen, B., Demirtürk, N., Yıldız, O., Çelen, M. K., Çelik, İlhami, Barut, Şener, … Zararsız, G. (2020). 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. Turkish Journal of Gastroenterology, 31(4), 305–317. https://doi.org/10.5152/tjg.2020.19197
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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.
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Article Info
Published In
Journal
Turkish Journal of Gastroenterology
Volume / Issue
Volume 31 · Issue 4
Pages
305-317
History
Published Online
April 15, 2020
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Copyright
Copyright (c) 2020 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*
Affiliations
Bilgehan Aygen
Department of Infectious Diseases and Clinical Microbiology, Erciyes University School of Medicine, Kayseri, Turkey
Neşe Demirtürk
Departments of Infectious Diseases and Clinical Microbiology, Afyon Kocatepe University School of Medicine, Afyon
Orhan Yıldız
Department of Infectious Diseases and Clinical Microbiology, Erciyes University Medical Faculty, Kayseri, Turkey
Mustafa Kemal Çelen
Department of Infectious Diseases and Clinical Microbiology, Dicle University Medical Faculty, Diyarbakır, Turkey
İlhami Çelik
Department of Infectious Diseases and Clinical Microbiology, Health Sciences University Kayseri Training and Research Hospital, Kayseri, Turkey
Şener Barut
Departments of Clinical Bacteriology and Infectious Disease, Gaziosmanpafla University, School of Medicine, Tokat
Onur Ural
Department of Infectious Diseases and Clinical Microbiology, Selçuk University Medical Faculty, Konya, Turkey
Ayşe Batırel
Department of Infectious Diseases and Clinical Microbiology, Dr. Lütfi Kırdar Kartal Education and Research Hospital, İstanbul, Turkey
Reşit Mıstık
Department of Infectious Diseases and Clinical Microbiology, Uludağ University Medical Faculty, Bursa, Turkey
Funda Şimşek
Department of Infectious Diseases and Clinical Microbiology, Okmeydanı Training and Research Hospital, İstanbul, Turkey
Ali Asan
Department of Infectious Diseases and Clinical Microbiology, Sağlık Bilimleri University Yüksek İhtisas Training and Research Hospital, Bursa, Turkey
Gülden Ersöz
Department of Infectious Diseases and Clinical Microbiology, Mersin University Medical Faculty, Mersin, Turkey
Nesrin Türker
Department of Infectious Diseases and Clinical Microbiology, Katip Çelebi University Atatürk Training and Research Hospital, İzmir, Turkey
Hüseyin Bilgin
Department of Infectious Diseases and Clinical Microbiology, Marmara University Medical Faculty, İstanbul, Turkey
Sami Kınıklı
Ministry of Health Ankara Hospital, Ankara
Faruk Karakeçili
Department of Infectious Diseases and Clinical Microbiology, Erzincan University Medical Faculty, Erzincan, Turkey
Gökmen Zararsız
Department of Biostatistics, Erciyes University School of Medicine, Kayseri, Turkey
Cite this Article
Aygen, B., Demirtürk, N., Yıldız, O., Çelen, M. K., Çelik, İlhami, Barut, Şener, … Zararsız, G. (2020). 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. Turkish Journal of Gastroenterology, 31(4), 305–317. https://doi.org/10.5152/tjg.2020.19197
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