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Treatment of HCV infection in Poland at the beginning of the interferon‐free era—the EpiTer‐2 study
Authors:R. Flisiak  D. Zarębska‐Michaluk  E. Janczewska  A. Staniaszek  A. Gietka  W. Mazur  M. Tudrujek  K. Tomasiewicz  T. Belica‐Wdowik  B. Baka‐Ćwierz  D. Dybowska  W. Halota  B. Lorenc  M. Sitko  A. Garlicki  H. Berak  A. Horban  I. Orłowska  K. Simon  Ł. Socha  M. Wawrzynowicz‐Syczewska  J. Jaroszewicz  Z. Deroń  A. Czauż‐Andrzejuk  J. Citko  R. Krygier  A. Piekarska  Ł. Laurans  W. Dobracki  J. Białkowska  O. Tronina  M. Pawłowska
Affiliation:1. Department of Infectious Diseases and Hepatology, Medical University of Bia?ystok, Bia?ystok, Poland;2. Department of Infectious Diseases, Voivodship Hospital and Jan Kochanowski University, Kielce, Poland;3. Hepatology Outpatient Clinic, ID Clinic, Mys?owice, Poland;4. Department of Internal Medicine and Hepatology, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland;5. Clinical Department of Infectious Diseases, Specialist Hospital in Chorzów, Medical University of Silesia, Katowice, Poland;6. Department of Infectious Diseases and Hepatology, Medical University of Lublin, Lublin, Poland;7. Regional Center for Diagnosis and Treatment of Viral Hepatitis and Hepatology, John Paul II Hospital, Kraków, Poland;8. Department of Infectious Diseases and Hepatology, Faculty of Medicine, Collegium Medicum Bydgoszcz, Nicolaus Copernicus University Toruń, Toruń, Poland;9. Pomeranian Center of Infectious Diseases, Department of Infectious Diseases, Medical University of Gdańsk, Gdańsk, Poland;10. Department of Infectious and Tropical Diseases, Jagiellonian University Collegium Medicum, Kraków, Poland;11. Hospital for Infectious Diseases in Warsaw, Medical University in Warsaw, Warsaw, Poland;12. Department of Infectious Diseases and Hepatology, Wroc?aw Medical University, Warsaw, Poland;13. Department of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland;14. Department of Infectious Diseases, Medical University of Silesia in Katowice, Bytom, Poland;15. Ward of Infectious Diseases and Hepatology, Biegański Regional Specialist Hospital, ?ód?, Poland;16. Medical Practice of Infections, Regional Hospital, Olsztyn, Poland;17. Infectious Diseases and Hepatology Outpatient Clinic NZOZ “Gemini”, ?ychlin, Poland;18. Department of Infectious Diseases and Hepatology, Medical University of ?ód?, ?ód?, Poland;19. Multidisciplinary Regional Hospital in Gorzów Wielkopolski, Gorzów Wielkopolski, Poland;20. MED‐FIX Medical Center, Wroc?aw, Poland;21. Department of Infectious and Liver Diseases, Medical University of ?ód?, ?ód?, Poland;22. Department of Transplantation Medicine, Nephrology, and Internal Diseases, Medical University of Warsaw, Warsaw, Poland
Abstract:The aim of the EpiTer‐2 study was to analyse patient characteristics and their medication for HCV infection in Poland at the beginning of the interferon‐free era. Analysis of data of HCV infected patients treated during the initial period of availability of interferon‐free regimens in Poland, who started therapy after 1 July 2015 and had available an efficacy evaluation report before 30 June 2017 was undertaken. A total of 2879 patients with chronic hepatitis C were entered, including 46% with liver cirrhosis. The most common was genotype 1b (86.8%). The study population was gender balanced, the majority of patients were overweight or obese and 69% presented comorbidities, with the highest prevalence that for hypertension. More than half of patients were retreated due to failure of previous therapy with pegylated interferon and ribavirin. Almost two‐third of patients received current therapy with ombitasvir/paritaprevir/ritonavir±dasabuvir (OPrD) ±ribavirin. Other patients received mostly sofosbuvir‐based regimens including combination with ledipasvir and pegylated interferon and ribavirin for genotype 3‐infected patients. Efficacy of treatment in the whole study population measured as intent‐to‐treat analysis was 95%. The most frequent regimen, administered for patients infected with genotype 1b, was 12 weeks of OPrD, resulting in an SVR rate of 98%. At least one adverse event was reported in 38% of patients, and the death rate was 0.8%. In conclusion, data from the EpiTer‐2 study confirmed the excellent efficacy and safety profile of the real‐world experience with recently introduced therapeutic options for genotype 1 HCV infection, but demonstrated weakness of the current therapeutic programme regarding genotype 3 infections.
Keywords:liver cirrhosis  sustained virologic response  therapy  viral hepatitis C
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