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Efficacy of 8- versus 12-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C patients eligible for 8-week regimen in a real-world setting.
Zarebska-Michaluk, Dorota; Piekarska, Anna; Jaroszewicz, Jerzy; Klapaczynski, Jakub; Sitko, Marek; Tudrujek-Zdunek, Magdalena; Tomasiewicz, Krzysztof; Belica-Wdowik, Teresa; Pabjan, Pawel; Lorenc, Beata; Czauz-Andrzejuk, Agnieszka; Tronina, Olga; Krygier, Rafal; Dobracki, Witold; Buczynska, Iwona; Simon, Krzysztof A; Dybowska, Dorota; Halota, Waldemar; Pawlowska, Malgorzata; Citko, Jolanta; Laurans, Lukasz; Mazur, Wlodzimierz; Janczewska, Ewa; Socha, Lukasz; Deron, Zbigniew; Berak, Hanna; Flisiak, Robert.
Afiliación
  • Zarebska-Michaluk D; Department of Infectious Diseases, Voivodeship Hospital and Jan Kochanowski University, Kielce, Poland.
  • Piekarska A; Department of Infectious Diseases and Hepatology, Medical University of Lodz, Lodz, Poland.
  • Jaroszewicz J; Department of Infectious Diseases and Hepatology, Medical University of Silesia in Katowice, Bytom, Poland.
  • Klapaczynski J; Department of Internal Medicine and Hepatology, Central Clinical Hospital of Internal Affairs and Administration, Warsaw, Poland.
  • Sitko M; Department of Infectious and Tropical Diseases, Jagiellonian University Medical College, Krakow, Poland.
  • Tudrujek-Zdunek M; Department of Infectious Diseases, Medical University of Lublin, Lublin, Poland.
  • Tomasiewicz K; Department of Infectious Diseases, Medical University of Lublin, Lublin, Poland.
  • Belica-Wdowik T; Regional Center for Diagnosis and Treatment of Viral Hepatitis and Hepatology, John Paul II Hospital, Krakow, Poland.
  • Pabjan P; Department of Infectious Diseases, Voivodeship Hospital and Jan Kochanowski University, Kielce, Poland.
  • Lorenc B; Department of Infectious Diseases, Pomeranian Center of Infectious Diseases, Medical University of Gdansk, Gdansk, Poland.
  • Czauz-Andrzejuk A; Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.
  • Tronina O; Department of Transplantation Medicine, Nephrology, and Internal Diseases, Medical University of Warsaw, Warsaw, Poland.
  • Krygier R; State University of Applied Sciences, Konin, Poland.
  • Dobracki W; MED-FIX Wroclaw, Poland.
  • Buczynska I; Department of Infectious Diseases and Hepatology, Wroclaw University of Medicine, Wroclaw, Poland.
  • Simon KA; Department of Infectious Diseases and Hepatology, Wroclaw University of Medicine, Wroclaw, Poland.
  • Dybowska D; Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland.
  • Halota W; Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland.
  • Pawlowska M; Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland.
  • Citko J; Medical Practice of Infections, Regional Hospital, Olsztyn, Poland.
  • Laurans L; Outpatient Department, Multidisciplinary Regional Hospital, Gorzow Wielkopolski, Poland.
  • Mazur W; Clinical Department of Infectious Diseases, Specialist Hospital in Chorzow, Medical University of Silesia in Katowice, Poland.
  • Janczewska E; Department of Basic Medical Sciences, School of Public Health in Bytom, Medical University of Silesia in Katowice, Poland.
  • Socha L; Department of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland.
  • Deron Z; Bieganski Regional Specialist Hospital, Lodz, Poland.
  • Berak H; Hospital of Infectious Diseases, Medical University of Warsaw, Warsaw, Poland.
  • Flisiak R; Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.
Arch Med Sci ; 18(6): 1460-1466, 2022.
Article en En | MEDLINE | ID: mdl-36457986
Introduction: Non-cirrhotic treatment-naive hepatitis C patients infected with genotype 1 can be treated with ledipasvir/sofosbuvir (LDV/SOF) for 8 weeks, but in practice this regimen is frequently extended up to 12 weeks at least in part due to insufficient real-world data supporting shortening of treatment. The aim of our study was to compare 8- and 12-week regimens' efficacy in patients eligible for 8-week therapy in a real-world setting. Material and methods: Data of HCV genotype 1 infected patients treated with LDV/SOF between 2015 and 2018 included in the EpiTer-2 database were analyzed with respect to patients' characteristics and length of treatment. Results: Among a total of 1718 patients treated with LDV/SOF, 679 were included in the analysis, 238 (35%) received 8-week regimen, whereas 441 were treated for 12 weeks although they fulfilled the criteria for a shorter course. The majority of patients were infected with genotype 1b (89%) and demonstrated minimal fibrosis (55%). The 12-week regimen was assigned significantly more frequently to patients with comorbidities, concomitant medications and advanced liver fibrosis. The sustained virologic response rate was similar after 8 (98%) and 12 (97%) weeks of therapy according to intent-to-treat analysis and reached 99% in both groups after exclusion of patients lost to follow-up. Conclusions: We confirmed high effectiveness regardless of treatment duration with LDV/SOF in non-cirrhotics infected with HCV genotype 1 eligible for the 8-week regimen according to the current label. This real-world study also demonstrated no need for addition of ribavirin (RBV) in this population and showed that shortening of treatment significantly improves the safety profile of LDV/SOF medication.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Arch Med Sci Año: 2022 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Polonia
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Arch Med Sci Año: 2022 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Polonia