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. 2020 Apr;31(4):305-317.
doi: 10.5152/tjg.2020.19197.

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

Bilgehan Aygen  1 , Neşe Demirtürk  2 , Orhan Yıldız  1 , Mustafa Kemal Çelen  3 , İlhami Çelik  4 , Şener Barut  5 , Onur Ural  6 , Ayşe Batırel  7 , Reşit Mıstık  8 , Funda Şimşek  9 , Ali Asan  10 , Gülden Ersöz  11 , Nesrin Türker  12 , Hüseyin Bilgin  13 , Sami Kınıklı  14 , Faruk Karakeçili  15 , Gökmen Zararsız  16 , The Study Group For Viral Hepatitis Of The Turkish Society Of Clinical Microbiology And Infectious Diseases
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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: The Turkey experience experience

Bilgehan Aygen et al. Turk J Gastroenterol. 2020 Apr.

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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Conflict of interest statement

Conflict of Interest: The authors have no conflict of interest to declare.

Figures

Figure 1
Figure 1
Study flowchart.
Figure 2
Figure 2
Efficacy of ombitasvir paritaprevir ritonavir ± dasabuvir ± ribavirin at different time points during treatment and 12 weeks after treatment.
Figure 3
Figure 3
Rates of virological response to ombitasvir paritaprevir ritonavir dasabuvir ribavirin.
See this image and copyright information in PMC

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    Değertekin B, Demir M, Akarca US, Kani HT, Üçbilek E, Yıldırım E, Güzelbulut F, Balkan A, Vatansever S, Danış N, Demircan M, Soylu A, Yaras S, Kartal A, Kefeli A, Gündüz F, Yalçın K, Erarslan E, Aladağ M, Harputluoğlu M, Özakyol A, Temel T, Akarsu M, Sümer H, Akın M, Albayrak B, Sen İ, Alkım H, Uyanıkoğlu A, Irak K, Öztaşkın S, Uğurlu ÇB, Güneş Ş, Gürel S, Nuriyev K, İnci İ, Kaçar S, Dinçer D, Doğanay L, Göktürk HS, Mert A, Coşar AM, Dursun H, Atalay R, Akbulut S, Balkan Y, Koklu H, Şimşek H, Özdoğan O, Çoban M. Değertekin B, et al. Turk J Gastroenterol. 2020 Dec;31(12):883-893. doi: 10.5152/tjg.2020.20696. Turk J Gastroenterol. 2020. PMID: 33626001 Free PMC article.

References

    1. Zare F, Fattahi MR, Sepehrimanesh M, Safarpour AR. Economic burden of hepatitis C virus infection in different stages of disease: A report from Southern Iran. Hepat Mon. 2016;16:e32654. doi: 10.5812/hepatmon.32654. - DOI - PMC - PubMed
    1. Aygen B, Yıldız O, Akhan S, et al. Retreatment of chronic hepatitis C infection with telaprevir: Preliminary results in Turkey. Balkan Med J. 2015;32:266–72. doi: 10.5152/balkanmedj.2015.15366. - DOI - PMC - PubMed
    1. Aygen B, Nemirtürk N, Türker N, et al. Management of chronic hepatitis C virus infection: A consensus report of the Study Group for Viral Hepatitis of the Turkish Society of Clinical Microbiology and Infectious Diseases-2017 Update. Klimik J. 2017;30( Suppl 1):2–36. doi: 10.5152/kd.2017.12. - DOI
    1. Aygen B, Yildiz O, Akhan S, et al. Impact of interleukin 28B genotype on the virological responses in chronic hepatitis C treatment. Gastroenterol Res. 2014;7:123–30. doi: 10.14740/gr629e. - DOI - PMC - PubMed
    1. Taheri S, Aygen B, Korkmaz K, Yildiz O, Zararsiz G, Canatan H. Characterization of the interleukin-28B gene rs12979860 C/T polymorphism in Turkish chronic hepatitis C patients and healthy individuals. Balkan Med J. 2015;32:147–55. doi: 10.5152/balkanmedj.2015.15156. - DOI - PMC - PubMed

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