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.

Autor:	Zarębska-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., Klapaczyński 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., Czauż-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., Buczyńska 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., Pawłowska 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 Ł; 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 Ł; Department of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland., Deroń Z; Biegański 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.
Jazyk:	angličtina
Zdroj:	Archives of medical science : AMS [Arch Med Sci] 2019 Jul 11; Vol. 18 (6), pp. 1460-1466. Date of Electronic Publication: 2019 Jul 11 (Print Publication: 2022).
DOI:	10.5114/aoms.2019.86569
Abstrakt:	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. Competing Interests: The authors declare no conflict of interest. (Copyright: © 2019 Termedia & Banach.)
Databáze:	MEDLINE
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