Dorota Zarębska-Michaluk1, Jerzy Jaroszewicz2, Paweł Pabjan1, Tadeusz W Łapiński3, Włodzimierz Mazur4, Rafał Krygier5, Dorota Dybowska6, Waldemar Halota6, Małgorzata Pawłowska6, Ewa Janczewska7, Iwona Buczyńska8, Krzysztof Simon8, Beata Dobracka9, Jolanta Citko10, Łukasz Laurans11,12, Magdalena Tudrujek-Zdunek13, Krzysztof Tomasiewicz13, Anna Piekarska14, Marek Sitko15, Jolanta Białkowska-Warzecha16, Jakub Klapaczyński17, Barbara Sobala-Szczygieł2, Andrzej Horban18, Hanna Berak18, Zbigniew Deroń19, Beata Lorenc20, Łukasz Socha21, Olga Tronina12, Robert Flisiak3. 1. Department of Infectious Diseases, Voivodeship Hospital, 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 of Białystok, Białystok, Poland. 4. Clinical Department of Infectious Diseases, Infective Hepatology and Acquired Immunodeficiences, Medical University of Silesia, Chorzów, Poland. 5. Outpatients Hepatology Department, State University of Applied Sciences, Konin, Poland. 6. Department of Infectious Diseases and Hepatology, Ludwik Rydygier Collegium Medicum, Bydgoszcz Faculty of Medicine, Nicolaus Copernicus University, Toruń, Poland. 7. School of Public Health in Bytom, Department of Basic Medical Sciences; ID Clinic, Hepatology Outpatient Department, Medical University of Silesia, Bytom, Poland. 8. Department of Infectious Diseases and Hepatology, Medical University Wrocław, Wrocław, Poland. 9. Outpatient Department, MED.-FIX, Wrocław, Poland. 10. Medical Practice of Infections, Regional Hospital, Olsztyn, Poland. 11. Department of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland. 12. Department of Transplantation Medicine, Nephrology, and Internal Diseases, Medical University of Warsaw, Warszawa, Poland. 13. Department of Infectious Diseases, Medical University of Lublin, Lublin, Poland. 14. Department of Infectious Diseases and Hepatology, Medical University of Łódź, Łódź, Poland. 15. Department of Infectious and Tropical Diseases, Jagiellonian University, Kraków, Poland. 16. Department of Infectious and Liver Diseases, Medical University Łódź, Łódź, Poland. 17. Department of Internal Medicine and Hepatology, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland. 18. Outpatient Clinic, Hospital for Infectious Diseases, Warsaw, Poland. 19. Ward of Infectious Diseases and Hepatology, Biegański Regional Specialist Hospital, Łódź, Poland. 20. Pomeranian Center of Infectious Diseases, Medical University Gdańsk, Gdańsk, Poland. 21. Outpatient Department, Multidisciplinary Regional Hospital, Gorzów Wielkopolski, Poland.
Abstract
BACKGROUND AND AIMS: The revolution of the antiviral treatment of hepatitis C virus (HCV) infection resulting in higher effectiveness came with the introduction of direct-acting antivirals with pangenotypic regimens as a final touch. Among them, the combination of glecaprevir (GLE) and pibrentasvir (PIB) provides the opportunity for shortening therapy to 8 weeks in the majority of patients. Because of still insufficient evaluation of this regimen in the real-world experience, our study aimed to assess the efficacy and safety of 8-week GLE/PIB in chronic hepatitis C patients depending on liver fibrosis and genotype (GT). METHODS: The analysis included patients who received GLE/PIB for 8 weeks selected from the EpiTer-2 database, large retrospective national real-world study evaluating antiviral treatment in 12 584 individuals in 22 Polish hepatology centers. RESULTS: A total of 1034 patients with female predominance (52%) were enrolled in the analysis. The majority of them were treatment naïve (94%), presented liver fibrosis (F) of F0-F3 (92%), with the most common GT1b, followed by GT3. The overall sustained virologic response after exclusion of nonvirologic failures was achieved in 95.8% and 98%, respectively (P = 0.19). In multivariate logistic regression HCV GT-3 (beta = 0.07, P = 0.02) and HIV infection (beta = -0.14, P < 0.001) were independent predictors of nonresponse. CONCLUSIONS: We demonstrated high effectiveness of 8-week GLE/PIB treatment in a non-GT3 population irrespective of liver fibrosis stage. Comparable efficacy was achieved in non-cirrhotic patients regardless of the genotype, including GT3 HCV.
BACKGROUND AND AIMS: The revolution of the antiviral treatment of hepatitis C virus (HCV) infection resulting in higher effectiveness came with the introduction of direct-acting antivirals with pangenotypic regimens as a final touch. Among them, the combination of glecaprevir (GLE) and pibrentasvir (PIB) provides the opportunity for shortening therapy to 8 weeks in the majority of patients. Because of still insufficient evaluation of this regimen in the real-world experience, our study aimed to assess the efficacy and safety of 8-week GLE/PIB in chronic hepatitis C patients depending on liver fibrosis and genotype (GT). METHODS: The analysis included patients who received GLE/PIB for 8 weeks selected from the EpiTer-2 database, large retrospective national real-world study evaluating antiviral treatment in 12 584 individuals in 22 Polish hepatology centers. RESULTS: A total of 1034 patients with female predominance (52%) were enrolled in the analysis. The majority of them were treatment naïve (94%), presented liver fibrosis (F) of F0-F3 (92%), with the most common GT1b, followed by GT3. The overall sustained virologic response after exclusion of nonvirologic failures was achieved in 95.8% and 98%, respectively (P = 0.19). In multivariate logistic regression HCV GT-3 (beta = 0.07, P = 0.02) and HIV infection (beta = -0.14, P < 0.001) were independent predictors of nonresponse. CONCLUSIONS: We demonstrated high effectiveness of 8-week GLE/PIB treatment in a non-GT3 population irrespective of liver fibrosis stage. Comparable efficacy was achieved in non-cirrhotic patients regardless of the genotype, including GT3 HCV.
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