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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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
...and 3 more locations
rate of the Sustained Virological Response 12 weeks after the end of the therapy (SVR12), i.e. at W28 or W36 for treatment duration of 16 weeks and 24 weeks respectively.
The primary endpoint is the rate of the Sustained Virological Response defined as HCV RNA \< LLOQ (either TD\[u\] or TND) 12 weeks after the end of the therapy associating Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin (SVR12), i.e. at W28 or W36 for treatment duration of 16 weeks and 24 weeks respectively.
Time frame: Week 28 (W28) or Week 36 (W36)
SVR rate 4 weeks after the end of treatment (i.e. at week 20 or week 28 for treatment duration of 16 weeks and 24 weeks respectively) and 24 weeks after the end of treatment (i.e. at week 40 or week 48).
Time frame: Week 20 (W20) or Week 28 (W28), and W40 or W48
HCV viral load assessment
Time frame: from Day 0 (D0) to Week 40 (W40) or Week 48 (W48)
Assessment of HCV subtypic distribution at baseline
Time frame: Pre-inclusion
Numbers and proportions of patients presenting variants of resistance (RAV) at baseline
The numbers and proportions of patients presenting variants of resistance (RAV) and their characteristics will be studied
Time frame: Pre-inclusion
Assessment of liver fibrosis by Hepatic impulse elastometry (Fibroscan®), or biological parameters (FibroMeter® or Fibrotest®)
Time frame: Pre-inclusion, Week 40 or Week 48
For cirrhotic patients, description of the risk of cirrhosis evolution (decompensation, hepatocarcinoma)
Cirrhosis evaluation (Child-Pugh)
Time frame: Pre-inclusion, Day 0 (D0), Week 16 (W16), W20, W24, W28, W36, W40 or W48
For cirrhotic patients, description of the risk of cirrhosis evolution (decompensation, hepatocarcinoma)
Cirrhosis evaluation (MELD score)
Time frame: Pre-inclusion, Day 0 (D0), Week 16 (W16), W20, W24, W28, W36, W40 or W48
Clinical and biological adverse events occurring during the treatment and until 24 weeks after the end of the treatment
Time frame: from Day 0(D0) to Week 40 (W40) or W48
Numbers and proportions of patients who interrupted the treatments of the study
Time frame: from Day 0 (D0) to Week 40 (W40) or W48
Patient's reported outcomes evaluation with questionnaires
Evaluation of patient's quality of life
Time frame: Day 0 (D0), Week 4 (W4), W16, W28, W40 or D0, W4, W16, W24, W36, W48 (24 weeks treatment-arm))
Patient's reported outcomes evaluation with questionnaires
Evaluation of perceived symptoms (ANRS questionnaire)
Time frame: Day 0 (D0), Week 4 (W4), W16, W28, W40 or D0, W4, W16, W24, W36, W48 (24 weeks treatment-arm))
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.