Turkish Journal of Gastroenterology
Liver - Original Article

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

1.

Department of Infectious Diseases and Clinical Microbiology, Erciyes University School of Medicine, Kayseri, Turkey

2.

Department of Infectious Diseases and Clinical Microbiology, Afyon Kocatepe University School of Medicine, Afyonkarahisar, Turkey

3.

Department of Infectious Diseases and Clinical Microbiology, Dicle University School of Medicine, Diyarbakır, Turkey

4.

Department of Infectious Diseases and Clinical Microbiology, Sağlık Bilimleri University Kayseri Training and Research Hospital, Kayseri, Turkey

5.

Department of Infectious Diseases and Clinical Microbiology, Gaziosmanpaşa University School of Medicine, Tokat, Turkey

6.

Department of Infectious Diseases and Clinical Microbiology, Selçuk University School of Medicine, Konya, Turkey

7.

Department of Infectious Diseases and Clinical Microbiology, Sağlık Bilimleri University Kartal Dr. Lütfü Kırdar Training and Research Hospital, İstanbul, Turkey

8.

Department of Infectious Diseases and Clinical Microbiology, Uludağ University School of Medicine, Bursa, Turkey

9.

Department of Infectious Diseases and Clinical Microbiology, Okmeydanı Training and Research Hospital, İstanbul, Turkey

10.

Department of Infectious Diseases and Clinical Microbiology, Sağlık Bilimleri University Yüksek İhtisas Training and Research Hospital, Bursa, Turkey

11.

Department of Infectious Diseases and Clinical Microbiology, Mersin University School of Medicine, Mersin, Turkey

12.

Department of Infectious Diseases and Clinical Microbiology, Katip Çelebi University Atatürk Training and Research Hospital, İzmir, Turkey

13.

Department of Infectious Diseases and Clinical Microbiology, Marmara University School of Medicine, İstanbul, Turkey

14.

Department of Infectious Diseases and Clinical Microbiology, Ankara Training and Research Hospital, Ankara, Turkey

15.

Department of Infectious Diseases and Clinical Microbiology, Erzincan University School of Medicine, Erzincan, Turkey

16.

Department of Biostatistics, Erciyes University School of Medicine, Kayseri, Turkey

Turk J Gastroenterol 2020; 31: 305-317
DOI: 10.5152/tjg.2020.19197
Read: 117 Downloads: 67 Published: 07 May 2020

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.

Cite this article as: Aygen B, Demirtürk N, Yıldız O, et al. 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. Turk J Gastroenterol 2020; 31(4): 305-17.

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