Dorota Zarębska-Michaluk1, Jerzy Jaroszewicz2, Iwona Buczyńska3, Krzysztof Simon3, Beata Lorenc4, Magdalena Tudrujek-Zdunek5, Krzysztof Tomasiewicz5, Marek Sitko6, Aleksander Garlicki6, Ewa Janczewska7, Dorota Dybowska8, Waldemar Halota8, Małgorzata Pawłowska8, Paweł Pabjan1, Włodzimierz Mazur9, Agnieszka Czauż-Andrzejuk10, Hanna Berak11, Andrzej Horban11, Łukasz Socha12, Jakub Klapaczyński13, Anna Piekarska14, Maria Blaszkowska2, Teresa Belica-Wdowik15, Beata Dobracka16, Olga Tronina17, Zbigniew Deroń18, Jolanta Białkowska-Warzecha19, Łukasz Laurans12,20, Robert Flisiak10. 1. Department of Infectious Diseases, Jan Kochanowski University, Kielce, Poland. 2. Department of Infectious Diseases and Hepatology, Medical University of Silesia, Katowice, Poland. 3. Department of Infectious Diseases and Hepatology, Medical University Wrocła, Wrocław, Poland. 4. Pomeranian Center of Infectious Diseases, Medical University Gdańsk, Gdańsk, Poland. 5. Department of Infectious Diseases, Medical University of Lublin, Lublin, Poland. 6. Department of Infectious and Tropical Diseases, Jagiellonian University, Kraków, Poland. 7. Department of Basic Medical Sciences, ID Clinic, Hepatology Outpatient Department, School of Public Health in Bytom, Medical University of Silesia, Bytom, Poland. 8. Department of Infectious Diseases and Hepatology, Ludwik Rydygier Collegium Medicum in Bydgoszcz Faculty of Medicine, Nicolaus Copernicus University, Toruń, Poland. 9. Clinical Department of Infectious Diseases, Medical University of Silesia, Katowice, Poland. 10. Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland. 11. Hospital for Infectious Diseases in Warsaw, Warsaw, Poland. 12. Department of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland. 13. Department of Internal Medicine and Hepatology, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland. 14. Department of Infectious Diseases and Hepatology, Medical University of Łódź, Łódź, Poland. 15. Regional Center for Diagnosis and Treatment of Viral Hepatitis and Hepatology, Kraków, Poland. 16. MED.-FIX, Wrocław, Poland. 17. Department of Transplantation Medicine, Nephrology, and Internal Diseases, Medical University of Warsaw, Warszawa, Poland. 18. Ward of Infectious Diseases and Hepatology, Biegański Regional Specialist Hospital, Łódź, Poland. 19. Department of Infectious and Liver Diseases, Medical University of Łódź, Łódź, Poland. 20. Multidisciplinary Regional Hospital, Gorzów Wielkopolski, Poland.
Abstract
BACKGROUND AND AIM: Grazoprevir/elbasvir (GZR/EBR) was approved for the treatment of chronic hepatitis C virus (HCV) genotype 1 and 4 infected patients with or without compensated liver cirrhosis. The aim of this study was to assess GZR/EBR regimen in the real-world experience, particularly in previously "difficult-to-treat" patients with chronic kidney diseases, human immunodeficiency virus-coinfected, cirrhotics, and treatment-experienced. METHODS: The analysis included patients treated with GZR/EBR selected from 10 152 individuals from the EpiTer-2 database, large national real-world study evaluating antiviral treatment in 22 Polish hepatology centers between 2015 and 2018. Data were completed retrospectively and submitted online. RESULTS: A total of 1615 patients who started GZR/EBR therapy in 2017 and 2018 with a female predominance (54%) and median age of 54 years were analyzed. The majority were infected with GT1b (89%) and treatment naïve (81%). Liver cirrhosis was diagnosed in 19%, and 70% of patients had comorbidities, of which chronic renal disease was present in 7% and HIV-coinfection in 4%. Overall, a sustained virologic response (SVR) was achieved by 95% according to intent-to-treat (ITT) and 98% after exclusion of lost to follow up (modified ITT). No differences were found in cure rate between all included patients and subpopulations previously considered as difficult-to-treat. Majority of patients completed the treatment course as scheduled, adverse events were mostly mild and did not lead to therapy discontinuation. CONCLUSIONS: GZR/EBR treatment carried-out in patients infected with HCV genotype 1 and 4 demonstrated good tolerability and an excellent SVR rate with no effectiveness reduction in so called difficult-to-treat populations.
BACKGROUND AND AIM: Grazoprevir/elbasvir (GZR/EBR) was approved for the treatment of chronic hepatitis C virus (HCV) genotype 1 and 4 infected patients with or without compensated liver cirrhosis. The aim of this study was to assess GZR/EBR regimen in the real-world experience, particularly in previously "difficult-to-treat" patients with chronic kidney diseases, human immunodeficiency virus-coinfected, cirrhotics, and treatment-experienced. METHODS: The analysis included patients treated with GZR/EBR selected from 10 152 individuals from the EpiTer-2 database, large national real-world study evaluating antiviral treatment in 22 Polish hepatology centers between 2015 and 2018. Data were completed retrospectively and submitted online. RESULTS: A total of 1615 patients who started GZR/EBR therapy in 2017 and 2018 with a female predominance (54%) and median age of 54 years were analyzed. The majority were infected with GT1b (89%) and treatment naïve (81%). Liver cirrhosis was diagnosed in 19%, and 70% of patients had comorbidities, of which chronic renal disease was present in 7% and HIV-coinfection in 4%. Overall, a sustained virologic response (SVR) was achieved by 95% according to intent-to-treat (ITT) and 98% after exclusion of lost to follow up (modified ITT). No differences were found in cure rate between all included patients and subpopulations previously considered as difficult-to-treat. Majority of patients completed the treatment course as scheduled, adverse events were mostly mild and did not lead to therapy discontinuation. CONCLUSIONS: GZR/EBR treatment carried-out in patients infected with HCV genotype 1 and 4 demonstrated good tolerability and an excellent SVR rate with no effectiveness reduction in so called difficult-to-treat populations.
Authors: Paweł Pabjan; Michał Brzdęk; Magdalena Chrapek; Kacper Dziedzic; Krystyna Dobrowolska; Katarzyna Paluch; Anna Garbat; Piotr Błoniarczyk; Katarzyna Reczko; Piotr Stępień; Dorota Zarębska-Michaluk Journal: Viruses Date: 2022-01-06 Impact factor: 5.048
Authors: Dorota Zarębska-Michaluk; Jerzy Jaroszewicz; Anna Parfieniuk-Kowerda; Małgorzata Pawłowska; Ewa Janczewska; Hanna Berak; Justyna Janocha-Litwin; Jakub Klapaczyński; Krzysztof Tomasiewicz; Anna Piekarska; Rafał Krygier; Jolanta Citko; Olga Tronina; Krystyna Dobrowolska; Robert Flisiak Journal: J Clin Med Date: 2022-01-13 Impact factor: 4.241