This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fix dose combination (FDC) in patients with acute hepatitis C virus (HCV) infection.
This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with SOF/VEL FDC for 8 weeks in patients with acute HCV infection as measured by the proportion of subjects with sustained viral response (undetectable HCV RNA) 12 weeks after stop of therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
All subjects will receive one film-coated tablet of sofosbuvir/velpatasvir (400/100 mg) orally once daily for 8 weeks.
Zentrum für Infektiologie Prenzlauer Berg
Berlin, Germany
Charité Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Berlin, Germany
Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy
Measured by the portion of subjects with sustained virological response (undetectable HCV RNA)
Time frame: 12 weeks after discontinuation of therapy
Mean HCV RNA viral load at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy
Measured by mean HCV RNA viral load
Time frame: at baseline, after 2 weeks, 4 weeks and 8 weeks of therapy, and 12 weeks after stop of therapy
Proportion of subjects who reached ALT normalization (ALT < ULN) after 8 weeks of therapy and 12 weeks after discontinuation of therapy
Measured by the proportion of subjects who reached ALT normalization (ALT \< ULN)
Time frame: after 8 weeks of therapy, and 12 weeks after discontinuation of therapy
Assessment of frequency and severity of adverse events (AEs)
Collection of all AEs
Time frame: through study completion, an average of 20 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I
Bonn, Germany
Praxis Hohenstaufenring
Cologne, Germany
Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie
Essen, Germany
Klinikum der J.W. Goethe-Universität Frankfurt
Frankfurt, Germany
Allgemeinmedizinische und internistische Praxis
Friedrichshain, Germany
Infektionsmedizinisches Centrum Hamburg (ICH) Study Center
Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik
Hamburg, Germany
Medizinische Hochschule Hannover, Innere Medizin, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
Hanover, Germany
...and 4 more locations