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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: Turkey experience

Volume 30 · Issue Supplement 1 Publish Date: July 25, 2019
Bilgehan Aygen Neşe Demirtürk Orhan Yıldız Mustafa Kemal Çelen Ilhami Çelik Şener Barut Onur Ural Ayşe Batırel Reşit Mıstık Funda Şimşek Ali Asan Gülden Ersöz Nesrin Türker Hüseyin Bilgin Çiğdem Ataman Hatipoğlu Faruk Karakeçili A A
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Turkish Journal of Gastroenterology

Volume 30 · Issue Supplement 1

Pages: 10-15

History

Published Online: July 25, 2019

Copyright © 2019 Bilgehan Aygen, Neşe Demirtürk, Orhan Yıldız, Mustafa Kemal Çelen, Ilhami Çelik, Şener Barut, Onur Ural, Ayşe Batırel, Reşit Mıstık, Funda Şimşek, Ali Asan, Gülden Ersöz, Nesrin Türker, Hüseyin Bilgin, Çiğdem Ataman Hatipoğlu, Faruk Karakeçili, A A

Bilgehan Aygen
Department of Infectious Diseases and Clinical Microbiology Erciyes University Medical Faculty Kayseri Turkey
Neşe Demirtürk
Department of Infectious Diseases and Clinical Microbiology Afyon Kocatepe University Medical Faculty Afyonkarahisar Turkey
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
Ilhami Çelik
Department of Infectious Diseases and Clinical Microbiology Sağlık Bilimleri University Kayseri Training and Research Hospital Kayseri Turkey
Şener Barut
Department of Infectious Diseases and Clinical Microbiology Gaziosmanpaşa University Medical Faculty Tokat Turkey
Onur Ural
Department of Infectious Diseases and Clinical Microbiology Selçuk University Medical Faculty Konya Turkey
Ayşe Batırel
Department of Infectious Diseases and Clinical Microbiology Sağlık Bilimleri University Kartal Dr. Lütfü Kırdar Training 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
Çiğdem Ataman Hatipoğlu
Department of Infectious Diseases and Clinical Microbiology Ankara Training and Research Hospital Ankara Turkey
Faruk Karakeçili
Department of Infectious Diseases and Clinical Microbiology Erzincan University Medical Faculty Erzincan Turkey
A A
The Study Group for Viral of the Turkish Society of Clinical Microbiology and Infectious Diseases
Aygen, B., Demirtürk, N., Yıldız, O., Çelen, M. K., Çelik, I., Barut, Şener, … A, A. (2019). 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: Turkey experience. Turkish Journal of Gastroenterology, 30(Supplement 1), 10–15. https://doi.org/10.5152/tjg.2019.07
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Abstract

INTRODUCTION: Clinical trials and real-world experiences evaluating ombitasvir/paritaprevir/ritonavir (OMV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) combination therapy have shown excellent rates of sustained virological response (SVR) and good safety profiles in patients with 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. 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. Study patients were treatment-naïve or interferon plus RBV-experienced with or without compensated cirrhosis. Follow-up (FU) ranged from 24 to 36 weeks depending on-treatment duration. Demographic, clinical and virological data were analyzed. Details of clinical and laboratory adverse events (AEs) were recorded. RESULTS: The mean age of the patients was 55.63 and 430 (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%). The HCV RNA level was below 800.000 IU/mL in 442 of the cases. Of all patients, 18 had hepatitis B virus (HBV) co-infection. Sixty-five percent of the patients had an underlying disease. Out of the 862 analysed patients, 57 patients did not return for viral load FU at 12 weeks, 6 patients stopped antiviral therapy because of AEs, 7 patients had virological failure and 1 patient died. Virological rates by per protocol analysis was calculated in the patients. SVR12 rate was 99.1% in all patients. No significant differences were observed in SVR12 according to HCV genotypes (p= 0.410). HCV RNA was undectable at treatment week 4 in 90.9%, at treatment week 8 in 98.5%, and at end of treatment (EOT) in 98.9%. No significant differences were observed in at treatment week 8 and EOT virological response according to HCV genotypes (p= 0.630, p= 0.785, respectively). Rates of rapid virological response (RVR) were significantly higher in the patients infected with HCV genotype 1a or 1b than in the patients infected with genotype 4 (p< 0.001). RVR and SVR12 ratios were significantly higher in non-cirrhotic patients compared to compensated cirrhotic patients (p= 0.004, p=0.016). There was not significant difference in on-treatment or EOT or FU12 weeks responses between treatment-naïve and treatment-experienced patients (p= 0.599, p= 0.166, p= 1000, p=0.431). Rates of AEs and AEs-associated treatment discontinuation were 59.7% and 0.7% in the patients, respectively. HBV reactivation occurred in 13.3% of the patients. CONCLUSION: The present real-life data of Turkey for 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 30 · Issue Supplement 1
Pages 10-15
DOI 10.5152/tjg.2019.07
History
Published Online July 25, 2019
Copyright
Copyright (c) 2019 Bilgehan Aygen, Neşe Demirtürk, Orhan Yıldız, Mustafa Kemal Çelen, Ilhami Çelik, Şener Barut, Onur Ural, Ayşe Batırel, Reşit Mıstık, Funda Şimşek, Ali Asan, Gülden Ersöz, Nesrin Türker, Hüseyin Bilgin, Çiğdem Ataman Hatipoğlu, Faruk Karakeçili, A A
Affiliations
Bilgehan Aygen
Department of Infectious Diseases and Clinical Microbiology Erciyes University Medical Faculty Kayseri Turkey
Neşe Demirtürk
Department of Infectious Diseases and Clinical Microbiology Afyon Kocatepe University Medical Faculty Afyonkarahisar Turkey
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
Ilhami Çelik
Department of Infectious Diseases and Clinical Microbiology Sağlık Bilimleri University Kayseri Training and Research Hospital Kayseri Turkey
Şener Barut
Department of Infectious Diseases and Clinical Microbiology Gaziosmanpaşa University Medical Faculty Tokat Turkey
Onur Ural
Department of Infectious Diseases and Clinical Microbiology Selçuk University Medical Faculty Konya Turkey
Ayşe Batırel
Department of Infectious Diseases and Clinical Microbiology Sağlık Bilimleri University Kartal Dr. Lütfü Kırdar Training 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
Çiğdem Ataman Hatipoğlu
Department of Infectious Diseases and Clinical Microbiology Ankara Training and Research Hospital Ankara Turkey
Faruk Karakeçili
Department of Infectious Diseases and Clinical Microbiology Erzincan University Medical Faculty Erzincan Turkey
A A
The Study Group for Viral of the Turkish Society of Clinical Microbiology and Infectious Diseases
Cite this Article
Aygen, B., Demirtürk, N., Yıldız, O., Çelen, M. K., Çelik, I., Barut, Şener, … A, A. (2019). 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: Turkey experience. Turkish Journal of Gastroenterology, 30(Supplement 1), 10–15. https://doi.org/10.5152/tjg.2019.07
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