Published In
Turkish Journal of Gastroenterology
Volume 30 · Issue Supplement 1
Pages: 106-107
History
Published Online: July 25, 2019
Copyright © 2019 Yeşim Taşova, Tansu Yamazhan, Şaban Esen, Nefise Çuvalcı Öztoprak, Yusuf Önlen, Nagehan Didem Sarı, İlknur Esen Yıldız, Dilara İnan, Esra Zerdali, Rahmet Güner, Şener Barut, Hayat Kumbasar Karaosmanoğlu, Sibel Kaya, Nevin İnce, İlyas Dökmetaş, Fehmi Tabak, Hepcturkey Study Group
Yeşim Taşova
Cukurova University Medical Faculty Infectious Diseases Adana Turkey
Tansu Yamazhan
Ege University Medical Faculty Infectious Diseases İzmir Turkey
Şaban Esen
19 Mayıs University Medical Faculty Infectious Diseases Samsun Turkey
Nefise Çuvalcı Öztoprak
Antalya Training and Research Hospital Infectious Diseases Antalya Turkey
Yusuf Önlen
Mustafa Kemal University Medical Faculty Infectious Diseases Hatay Turkey
Nagehan Didem Sarı
Istanbul Training and Research Hospital Infectious Diseases İstanbul Turkey
İlknur Esen Yıldız
RTE University Medical Faculty Infectious Diseases Rize Turkey
Dilara İnan
Akdeniz University Medical Faculty Infectious Diseases Antalya Turkey
Esra Zerdali
Haseki Training and Research Hospital Infectious Diseases İstanbul Turkey
Rahmet Güner
Yıldırım Beyazıt University Faculty of Medicine Infectious Diseases Department Ankara Turkey
Şener Barut
Gaziosmanpaşa University Infectious Diseases Department Tokat Turkey
Hayat Kumbasar Karaosmanoğlu
Bakırköy Sadi Konuk Training and Research Hospital Infectious Diseases Department İstanbul Turkey
Sibel Kaya
Istanbul University Cerrahpasa Medical Faculty İstanbul Turkey
Nevin İnce
Düzce Üniversity Düzce Turkey
İlyas Dökmetaş
Şişli Hamideye Etfal Training and Research Hospital Infectious Diseases İstanbul Turkey
Fehmi Tabak
Istanbul University Cerrahpasa Medical Faculty İstanbul Turkey
Hepcturkey Study Group
Istanbul University Cerrahpasa Medical Faculty İstanbul Turkey
Taşova, Y., Yamazhan, T., Esen, Şaban, Çuvalcı Öztoprak, N., Önlen, Y., Sarı, N. D., … Group, H. S. (2019). Efficiency and safety of direct-acting antiviral in cirrhotic hepatitis C infection patients: Real-life data from Turkey. Turkish Journal of Gastroenterology, 30(Supplement 1), 106–107. https://doi.org/10.5152/tjg.2019.69
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Abstract
INTRODUCTION: Anti-HCV treatment in cirrhotic patients was less effective than in noncirrhotic patients in pre-direct-acting antiviral (DAA) era. In cirrhotics, a significant increase in the incidence of liver-related events, including mortality, is likely in the following years. The development and approval of several DAAs in recent years has revolutionized antiviral therapy especially for cirrhotic patients. Two societies in Turkey created an online database and collect data of patients with chronic hepatitis C (CHC) patients using in Turkey. We aimed to evaluate effectiveness and safety of DAA in cirrhotic CHC patients.
METHODS: 37 centers from Turkey recorded 1807 patients to the database. The centers well represented the country. Patients >18 years with CHC under DAAs were enrolled in this non-interventional observational study. Demographics, clinical information, DAAs used, efficiency and safety information were recorded Efficiency and safety results are given for the patients with 12 weeks after end of treatment (SVR12) data. The study was approved by ethics committee and registered to clinicaltrials.gov.
RESULTS: Among the 1807 patients; 238 (13%) were cirrhotic. Of those, 118 (49.6%) were male and mean age was 64.7±10.7 years. Among cirrhotics, 206 (86.5%) were compensated (Child-Pugh A) and 32 were (13.5%) decompensated (Child-Pugh B-C). The most common HCV genotype was G1: 215 (90.3%; among G1 93% G1b, 7% G1a), followed by G2 (9, 3.8%), G3 (9, 3.8%), G4 (3, 1.3%), G5 (1, 0.4%). Previous treatment information was available for 228 patients: 111 out of the patients (49%) were treatment-experienced (64, 58% relapser and 47, 42% non-responder): 89% had used peginterferon/ribavirin, 8% peginterferon/ribavirin+boceprevir and 4% peginterferon/ribavirin+telaprevir. Baseline viral load was 4.11 x106 copies/mL. Baseline laboratory studies were ALT 50 IU/L, AST 51 IU/L, albumin 3.9 g/dL, and prothrombin time 13.5 sec. DAAs given to the patients are shown in Table 1. Viral responses at treatment week 4, at the end of treatment and at SVR12 were 85% (147/173), 100% (188/188), and 98% (150/153) respectively (Figure 1). Laboratory studies at SVR 12 were ALT 23 IU/L, AST 28 IU/L, albumin 4.18 g/dL, and prothrombin time 12.7 sec. DAAs were generally well tolerated. On treatment; 53 patients (22.3%) experienced 88 adverse events: asthenia (9%), pruritus (8%), nausea (5%), insomnia (4%), headache (3%), herpes labialis activation (2%), anemia (15), and miscellaneous (5%).
CONCLUSION: Real-life data show that HCV treatment with DAA is highly efficacious and safe in cirrhotic patients as well. Being decompensated or decompensated, treatment-naïve or previously treated (relapse or non-responder) do not seem to affect the response rate.
*This study was supported by Gilead Sciences, was not involved to the content of the study/publication; no involvement to the decision to submit for publication.
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Article Info
Published In
Journal
Turkish Journal of Gastroenterology
Volume / Issue
Volume 30 · Issue Supplement 1
Pages
106-107
History
Published Online
July 25, 2019
Copyright
Copyright (c) 2019 Yeşim Taşova, Tansu Yamazhan, Şaban Esen, Nefise Çuvalcı Öztoprak, Yusuf Önlen, Nagehan Didem Sarı, İlknur Esen Yıldız, Dilara İnan, Esra Zerdali, Rahmet Güner, Şener Barut, Hayat Kumbasar Karaosmanoğlu, Sibel Kaya, Nevin İnce, İlyas Dökmetaş, Fehmi Tabak, Hepcturkey Study Group
Affiliations
Yeşim Taşova
Cukurova University Medical Faculty Infectious Diseases Adana Turkey
Tansu Yamazhan
Ege University Medical Faculty Infectious Diseases İzmir Turkey
Şaban Esen
19 Mayıs University Medical Faculty Infectious Diseases Samsun Turkey
Nefise Çuvalcı Öztoprak
Antalya Training and Research Hospital Infectious Diseases Antalya Turkey
Yusuf Önlen
Mustafa Kemal University Medical Faculty Infectious Diseases Hatay Turkey
Nagehan Didem Sarı
Istanbul Training and Research Hospital Infectious Diseases İstanbul Turkey
İlknur Esen Yıldız
RTE University Medical Faculty Infectious Diseases Rize Turkey
Dilara İnan
Akdeniz University Medical Faculty Infectious Diseases Antalya Turkey
Esra Zerdali
Haseki Training and Research Hospital Infectious Diseases İstanbul Turkey
Rahmet Güner
Yıldırım Beyazıt University Faculty of Medicine Infectious Diseases Department Ankara Turkey
Şener Barut
Gaziosmanpaşa University Infectious Diseases Department Tokat Turkey
Hayat Kumbasar Karaosmanoğlu
Bakırköy Sadi Konuk Training and Research Hospital Infectious Diseases Department İstanbul Turkey
Sibel Kaya
Istanbul University Cerrahpasa Medical Faculty İstanbul Turkey
Nevin İnce
Düzce Üniversity Düzce Turkey
İlyas Dökmetaş
Şişli Hamideye Etfal Training and Research Hospital Infectious Diseases İstanbul Turkey
Fehmi Tabak
Istanbul University Cerrahpasa Medical Faculty İstanbul Turkey
Hepcturkey Study Group
Istanbul University Cerrahpasa Medical Faculty İstanbul Turkey
Cite this Article
Taşova, Y., Yamazhan, T., Esen, Şaban, Çuvalcı Öztoprak, N., Önlen, Y., Sarı, N. D., … Group, H. S. (2019). Efficiency and safety of direct-acting antiviral in cirrhotic hepatitis C infection patients: Real-life data from Turkey. Turkish Journal of Gastroenterology, 30(Supplement 1), 106–107. https://doi.org/10.5152/tjg.2019.69
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