CLINICAL RESEARCH
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
 
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1
Department of Infectious Diseases, Voivodeship Hospital and Jan Kochanowski University, Kielce, Poland
2
Department of Infectious Diseases and Hepatology, Medical University of Lodz, Lodz, Poland
3
Department of Infectious Diseases and Hepatology, Medical University of Silesia in Katowice, Bytom, Poland
4
Department of Internal Medicine and Hepatology, Central Clinical Hospital of Internal Affairs and Administration, Warsaw, Poland
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Department of Infectious and Tropical Diseases, Jagiellonian University Medical College, Krakow, Poland
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Department of Infectious Diseases, Medical University of Lublin, Lublin, Poland
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Regional Center for Diagnosis and Treatment of Viral Hepatitis and Hepatology, John Paul II Hospital, Krakow, Poland
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Department of Infectious Diseases, Pomeranian Center of Infectious Diseases, Medical University of Gdansk, Gdansk, Poland
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Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland
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Department of Transplantation Medicine, Nephrology, and Internal Diseases, Medical University of Warsaw, Warsaw, Poland
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State University of Applied Sciences, Konin, Poland
12
MED-FIX Wroclaw, Poland
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Department of Infectious Diseases and Hepatology, Wroclaw University of Medicine, Wroclaw Poland
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Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland
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Medical Practice of Infections, Regional Hospital, Olsztyn, Poland
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Outpatient Department, Multidisciplinary Regional Hospital, Gorzow Wielkopolski, Poland
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Clinical Department of Infectious Diseases, Specialist Hospital in Chorzow, Medical University of Silesia in Katowice, Chorzow, Poland
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Department of Basic Medical Sciences, School of Public Health in Bytom, Medical University of Silesia in Katowice, Bytom, Poland
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Department of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland
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Biegański Regional Specialist Hospital, Lodz, Poland
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Hospital of Infectious Diseases, Medical University of Warsaw, Warsaw, Poland
Submission date: 2019-01-23
Final revision date: 2019-05-14
Acceptance date: 2019-06-05
Online publication date: 2019-07-11
 
Arch Med Sci 2022;18(6)
 
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ABSTRACT
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.

eISSN:1896-9151
ISSN:1734-1922