The study aimed at evaluating whether current 24 weeks length of combination treatment is appropriate or not for patients with HCV genotype 3 infection.
Patients are randomized to standard length of treatment or to a variable duration: 12 weeks for patients with undetectable HCVRNA at week 4 or 24 or 36 weeks for those with detectable HCV RNA at week 4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
360
B 1 I or II: Experimental variable duration of treatment group according with RVR. In case of RVR present patients will be treated for 12 weeks. Patients without RVR will be treated for 24 (B1I) or 36 (B1II)weeks: different duration of treatment for patients without RVR
Ospedale Civile
Sassari, Sassari, Italy
Ospedale Civile
Canossa, Italy
Ospedale Casarano
Casarano, Italy
IRCCS "De Bellis"
Castellana Grotte, Italy
Sustained virological response (SVR)
The primary measure of efficacy will be HCV RNA not detectable in the serum 24 weeks after the end of therapy (SVR). In addition, virological response at the end of treatment and relapse rates will be calculated for each groups. Two analyses will be performed: 1) intention-to-treat analysis; 2) per-protocol analysis.
Time frame: 6 months after the end of treatment
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Ospedale "Garibaldi"
Catania, Italy
Ospedale "S.Camillo"
Rome, Italy
Università Cattolica Sacro Cuore Roma
Rome, Italy
Ospedale Venosa
Venosa, Italy