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Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era

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World Journal of Gastroenterology 2023年第13期29卷 2015-2033页

作者： Michał Brzdęk dorota Zarębska-Michaluk Piotr Rzymski Beata Lorenc Adam Kazek Magdalena Tudrujek-Zdunek Justyna Janocha-Litwin Włodzimierz Mazur dorota dybowska Hanna Berak Anna Parfieniuk-Kowerda Jakub Klapaczyński Marek Sitko Barbara Sobala-Szczygieł Anna Piekarska Robert Flisiak Department of Infectious Diseases Jan Kochanowski UniversityKielce 25-317Poland Department of Infectious Diseases Jan Kochanowski UniversotyKielce 25-317Poland Department of Environmental Medicine Poznan University of Medical SciencesPoznań60-806Poland Integrated Science Association Universal Scientific Education and Research NetworkPoznań60-806Poland Pomeranian Center of Infectious Diseases Medical University GdańskGdańsk 80-214Poland ID Clinic Mysłowice 41-400Poland Department of Infectious Diseases Medical University of LublinLublin 20-059Poland Department of Infectious Diseases and Hepatology Medical University WrocławWrocław 50-367Poland Clinical Department of Infectious Diseases Clinical University of Silesia in KatowiceChorzów 41-500Poland Department of Infectious Diseases and Hepatology Faculty of MedicineNicolaus Copernicus UniversityBydgoszcz 85-030Poland Daily Department Hospital for Infectious Diseases in WarsawWarszawa 01-201Poland Department of Infectious Diseases and Hepatology Medical University of BiałystokBiałystok 15-089Poland Department of Internal Medicine and Hepatology Central Clinical Hospital of the Ministry of Internal Affairs and AdministrationWarszawa 00-241Poland Department of Infectious and Tropical Diseases Jagiellonian UniversityKraków 31-088Poland Department of Infectious Diseases Medical University of Silesia in KatowiceBytom 41-902Poland Department of Infectious Diseases and Hepatology Medical University ofŁódźŁódź90-419Poland

BACKGROUND Nearly 290000 patients with chronic hepatitis C die annually from the most severe complications of the *** of them is liver cirrhosis,which occurs in about 20%of patients chronically infected with the hepatitis C virus(HCV).Direct-acting antivirals(DAAs),which replaced interferon(IFN)-based regimens,significantly improved the prognosis of this group of patients,increasing HCV eradication rates and tolerability of *** study is the first to assess changes in patient profile,effectiveness,and safety in the HCV-infected cirrhotic population in the IFN-free *** To document changes in patient characteristics and treatment regimens along with their effectiveness and safety profile over the *** The studied patients were selected from 14801 chronically HCV-infected individuals who started IFN-free therapy between July 2015 and December 2021 in 22 Polish hepatology *** retrospective analysis was conducted in real-world clinical practice based on the EpiTer-2 multicenter *** measure of treatment effectiveness was the percentage of sustained virologic response(SVR)calculated after excluding patients lost to *** data collected during therapy and the 12-wk post-treatment period included information on adverse events,including serious ones,deaths,and treatment *** The studied population(n=3577)was balanced in terms of gender in 2015-2017,while the following years showed the dominance of *** decline in the median age from 63 in 2015-2016 to 61 years in 2021 was accompanied by a decrease in the percentage of patients with comorbidities and ***-experienced patients dominated in 2015-2016,while treatment-naive individuals gained an advantage in 2017 and reached 93.2%in ***(GT)-specific options were more prevalent in treatment in 2015-2018 and were supplanted by pangenotypic combinations in subsequent *** effectiveness of the therapy was comparable regardless of the

关键词： Hepatitis C Liver cirrhosis Direct-acting antivirals Pangenotypic Genotype-specific Epidemiology

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Real-world effectiveness and safety of direct-acting antivirals in hepatitis C virus patients with mental disorders

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World Journal of Gastroenterology 2023年第25期29卷 4085-4098页

作者： dorota dybowska dorota Zarebska-Michaluk Piotr Rzymski Hanna Berak Beata Lorenc Marek Sitko Michal Dybowski Wlodzimierz Mazur Magdalena Tudrujek-Zdunek Justyna Janocha-Litwin Ewa Janczewska Jakub Klapaczynski Anna Parfieniuk-Kowerda Anna Piekarska Barbara Sobala-Szczygiel Krystyna Dobrowolska Malgorzata Pawlowska Robert Flisiak Department of Infectious Diseases and Hepatology Faculty of MedicineNicolaus Copernicus UniversityBydgoszcz 85-030Poland Department of Infectious Diseases and Allergology Jan Kochanowski UniversityKielce 25-317Poland Department of Infectious Diseases Provincial HospitalKielce 25-317Poland Department of Environmental Medicine University of Medical SciencesPoznań60-806Poland Integrated Science Association Universal Scientific Education and Research NetworkPoznań60-806Poland Outpatient Clinic Hospital for Infectious Diseases in WarsawWarsaw 01-201Poland Pomeranian Center of Infectious Diseases Medical UniversityGdańsk 80-214Poland Department of Infectious and Tropical Diseases Jagiellonian UniversityKraków 31-088Poland Utrecht University School of Economics Utrecht UniversityUtrecht 3584 ECNetherlands Clinical Department of Infectious Diseases Medical University of SilesiaChorzów 41-500Poland Department of Infectious Diseases Medical University of LublinLublin 20-059Poland Department of Infectious Diseases and Hepatology Medical University of WrocławWrocław 50-367Poland Department of Basic Medical Sciences Faculty of Public Health in BytomMedical University of SilesiaKatowice 40-007Poland Department of Internal Medicine and Hepatology Central Clinical Hospital of the Ministry of Internal Affairs and AdministrationWarsaw 00-241Poland Department of Infectious Diseases and Hepatology Medical University of BiałystokBiałystok 15-089Poland Department of Infectious Diseases and Hepatology Medical University ofŁódźŁódź91-347Poland Department of Infectious Diseases and Hepatology Medical University of SilesiaBytom 41-902Poland Collegium Medicum Jan Kochanowski UniversityKielce 25-317Poland

BACKGROUND It is estimated that 58 million people worldwide are infected with the hepatitis C virus(HCV).Patients with severe psychiatric disorders could not be treated with previously available interferon-based therapies due to their unfavorable side effect *** has changed with the introduction of direct-acting antivirals(DAA),although their real-life tolerance and effectiveness in patients with different psychiatric disorders remain to be *** To evaluate the effectiveness and safety of DAA in patients with various mental *** This was a retrospective observational study encompassing 14272 patients treated with DAA for chronic hepatitis C in 22 Polish hepatology centers,including 942 individuals diagnosed with a mental disorder(anxiety disorder,bipolar affective disorder,depression,anxiety-depressive disorder,personality disorder,schizophrenia,sleep disorder,substance abuse disorder,and mental illness without a specific diagnosis).The safety and effectiveness of DAA in this group were compared to those in a group without psychiatric illness(n=13330).Antiviral therapy was considered successful if serum ribonucleic acid(RNA)of HCV was undetectable 12 wk after its completion[sustained virologic response(SVR)].Safety data,including the incidence of adverse events(AEs),serious AEs(SAEs),and deaths,and the frequency of treatment modification and discontinuation,were collected during therapy and up to 12 wk after treatment *** entire study population was included in the intent-to-treat(ITT)***-protocol(PP)analysis concerned patients who underwent HCV RNA evaluation 12 wk after completing *** Among patients with mental illness,there was a significantly higher percentage of men,treatmentnaive patients,obese,human immunodeficiency virus and hepatitis B virus-coinfected,patients with cirrhosis,and those infected with genotype 3(GT3)while infection with GT1b was more frequent in the population without psychia

关键词： Hepatitis C Mental disorders Direct-acting antivirals

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Best therapy for the easiest to treat hepatitis C virus genotype 1binfected patients

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World Journal of Gastroenterology 2022年第45期28卷 6380-6396页

作者： dorota Zarębska-Michaluk Michal Brzdęk Jerzy Jaroszewicz Magdalena Tudrujek-Zdunek Beata Lorenc Jakub Klapaczyński Włodzimierz Mazur Adam Kazek Marek Sitko Hanna Berak Justyna Janocha-Litwin dorota dybowska Łukasz Supronowicz Rafal Krygier Jolanta Citko Anna Piekarska Robert Flisiak Department of Infectious Diseases Jan Kochanowski UniversityKielce 25-317Poland Department of Infectious Diseases and Hepatology Medical University of SilesiaKatowice 40-055Poland Department of Infectious Diseases Medical University of LublinLublin 20-059Poland Pomeranian Center of Infectious Diseases Medical University GdańskGdańsk 80-214Poland Department of Internal Medicine and Hepatology Central Clinical Hospital of the Ministry of Internal Affairs and AdministrationWarszawa 00-241Poland Clinical Department of Infectious Diseases Medical University of SilesiaChorzów 41-500Poland ID Clinic Mysłowice 41-400Poland Department of Infectious and Tropical Diseases Jagiellonian UniversityKraków 31-088Poland Hospital for Infectious Diseases Hospital for Infectious DiseasesWarszawa 02-091Poland Department of Infectious Diseases and Hepatology Medical University WrocławWrocław 50-367Poland Department of Infectious Diseases and Hepatology Faculty of MedicineNicolaus Copernicus UniversityBydgoszcz 85-030Poland Department of Infectious Diseases and Hepatology Medical University of BiałystokBiałystok 15-089Poland Infectious Diseases and Hepatology Outpatient Clinic Gemini NZOZŻychlin 62-571Poland Medical Practice of Infections Regional HospitalOlsztyn 10-561Poland Department of Infectious Diseases and Hepatology Medical UniversityŁódźŁódź90-419Poland

BACKGROUND The revolution in treatment of patients with chronic hepatitis C virus(HCV)infection dates back to the introduction of direct-acting antivirals(DAAs).The increase in efficacy was most pronounced in patients infected with genotype(GT)1b,as this was the most poorly responsive population to treatment during the interferon *** To identify the most effective interferon-free therapy for GT1b-infected patients and to determine positive and negative predictors of virological *** This real-world retrospective analysis included patients chronically infected with GT1b HCV whose data were obtained from the multicenter observational EpiTer-2 *** effectiveness was evaluated for each therapeutic regimen as the percentage of sustained virological responses(SVR).Assessment of the safety was based on the evaluation of the course of therapy,the occurrence of adverse events including serious ones,deaths during treatment and in the post 12-wk follow-up *** The studied population consisted of 11385 patients with a mean age of 53±14.8 years and a female predominance(53.4%).The majority of them were treatment-naïve(74.6%)and patients with cirrhosis accounted for 24.3%.Of the DAA regimens used,76.9%were GT-specific with ombitasvir/paritaprevir/ritonavir+dasabuvir±ribavirin being the most used option(32.4%).A total of 10903 patients responded to treatment resulting in a 98.1%in the per-protocol analysis after excluding 273 patients without SVR *** effectiveness of all regimens exceeded 90%and the highest SVR of 98.9%was achieved in patients treated with a combination of glecaprevir/*** regression analyses showed that the virologic response was independently associated with female sex[odds ratio(OR)=1.67],absence of decompensated cirrhosis at baseline(OR=2.42)and higher baseline platelets(OR=1.004 per 1000/μL increase),while the presence of human immunodeficiency virus(HIV)coinfection significantly decreased the odds

关键词： Hepatitis C Genotype 1b Direct-acting antivirals Pangenotypic Genotype-specific Sustained virologic response

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Factors influencing the failure of interferon-free therapy for chronic hepatitis C:Data from the Polish EpiTer-2 cohort study

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World Journal of Gastroenterology 2021年第18期27卷 2177-2192页

作者： Ewa Janczewska Mateusz Franciszek Kołek Beata Lorenc Jakub Klapaczyński Magdalena Tudrujek-Zdunek Marek Sitko Włodzimierz Mazur dorota Zarębska-Michaluk Iwona Buczyńska dorota dybowska Agnieszka Czauż-Andrzejuk Hanna Berak RafałKrygier Jerzy Jaroszewicz Jolanta Citko Anna Piekarska Beata Dobracka Łukasz Socha Zbigniew Deroń Łukasz Laurans Jolanta Białkowska-Warzecha Olga Tronina Brygida Adamek Krzysztof Tomasiewicz Krzysztof Simon Malgorzata Pawłowska Waldemar Halota Robert Flisiak Department of Basic Medical Sciences The School of Health Sciences in BytomMedical University of SilesiaBytom 41-902Poland Department of Animal Physiology Faculty of BiologyUniversity of WarsawWarszawa 02-096Poland Pomeranian Center of Infectious Diseases Medical University GdańskGdańsk 80-214Poland Department of Internal Medicine and Hepatology Central Clinical Hospital of the Ministry of Internal Affairs and AdministrationWarszawa 02-507Poland Department of Infectious Diseases Medical University of LublinLublin 20-081Poland Department of Infectious and Tropical Diseases Jagiellonian UniversityKraków 30-688Poland Clinical Department of Infectious Diseases Medical University of Silesia in KatowiceChorzów 41-500Poland Department of Infectious Diseases Jan Kochanowski University KielceKielce 25-369Poland Department of Infectious Diseases and Hepatology Medical University WrocławWrocław 51-149Poland Department of Infectious Diseases and Hepatology Ludwik Rydygier Collegium Medicum in Bydgoszcz Faculty of Medicine Nicolaus Copernicus University in ToruńBydgoszcz 85-030Poland Department of Infectious Diseases and Hepatology Medical University of BiałystokBiałystok 15-540Poland One-Day Department Hospital for Infectious Diseases in WarsawWarszawa 01-201Poland Outpatient Clinic State University of Applied Sciences in KoninKonin 62-510Poland Department of Infectious Diseases and Hepatology Medical University of Silesia in KatowiceBytom 41-902Poland Department of Medical Practice of Infections Regional HospitalOlsztyn 10-561Poland Department of Infectious Diseases and Hepatology Medical University ofŁódźŁódź90-419Poland MedicalSpec Center Wrocław 53-428Poland Department of Infectious Diseases Hepatology and Liver TransplantationPomeranian Medical UniversitySzczecin 71-455Poland Ward of Infectious Diseases and Hepatology Biegański Regional Specialist HospitalŁódź91-347Poland Infectious and Liver Diseases Clinic Multidisciplinary Regional HospitalGorzów Wielkopolski 66-400Poland Dep

BACKGROUND The introduction of direct-acting antiviral drugs into clinical practice has revolutionized the treatment of chronic hepatitis C,making it highly effective and safe for ***,few researchers have analyzed the factors causing therapy failure in some *** To analyze factors influencing the failure of direct antiviral drugs in the large,multicenter EpiTer-2 cohort in a real-world *** The study cohort consisted of patients with chronic hepatitis C treated at 22 Polish centers from *** collected from the online EpiTer-2 database included the following:hepatitis C virus(HCV)genotype,stage of fibrosis,hematology and liver function parameters,Child-Turcotte-Pugh and Model for End-stage Liver Disease scores,prior antiviral therapy,concomitant diseases,and drugs used in relation to hepatitis B virus(HBV)and/or human immunodeficiency virus(HIV)*** events observed during the treatment and follow-up period were *** standard and machine learning methods were used for statistical *** During analysis,12614 patients with chronic hepatitis C were registered,of which 11938(mean age:52 years)had available sustained virologic response(SVR)data[11629(97%)achieved SVR and 309(3%)did not].Most patients(78.1%)were infected with HCV genotype *** cirrhosis was diagnosed in 2974 patients,while advanced fibrosis(F3)was diagnosed in 1717 *** included patients with features of hepatic failure at baseline[ascites in 142(1.2%)and encephalopathy in 68(0.6%)patients].The most important host factors negatively influencing treatment efficacy were liver cirrhosis,clinical and laboratory features of liver failure,history of hepatocellular carcinoma,and higher body mass *** viral factors,genotype 3 and viral load also exerted an influence on treatment *** statistical analysis revealed that treatment ineffectiveness seemed to be influenced by the male sex,which was not confirmed

关键词： Advanced liver disease Chronic hepatitis C Direct-acting antiviral drugs Sustained virologic response Interferon-free therapy Antiviral therapy

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