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Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir
Sponsor: ANRS, Emerging Infectious Diseases
Summary
The primary objective of this study is to estimate, in HCV genotype 1 or 4-infected patients who failed a prior DAA bitherapy with Sofosbuvir, the efficacy of a treatment with Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in the two treatment groups and compare the rate of sustained virological response (SVR) 12 weeks after 16 or 24 weeks of this treatment. SVR12 is defined as HCV RNA \< LLOQ (either TD\[u\] or TND).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2016-01
Completion Date
2017-04
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
Grazoprevir/Elbasvir
Sofosbuvir
Ribavirin
Locations (13)
ASSELAH Tarik
Clichy, France
Christophe HEZODE
Créteil, France
LEROY Vincent
Grenoble, France
ZOULIM Fabien
Lyon, France
BOURLIERE Marc
Marseille, France
LARREY Dominique
Montpellier, France
TRAN Albert
Nice, France
SERFATY Lawrence
Paris, France
POL Stanislas
Paris, France
JEZEQUEL Caroline
Rennes, France
ALRIC Laurent
Toulouse, France
METIVIER Sophie
Toulouse, France
SAMUEL Didier
Villejuif, France