Treatment duration | SOF plus RBV for 12 weeks (N=283) | SOF plus RBV for 16 weeks (N=38) | Total population (N=321) | ||||||
---|---|---|---|---|---|---|---|---|---|
Overall SVR12 rate (EP)* | 250/283 (88.3%) | 33/38 (86.8%) | 283/321 (88.2%) | ||||||
Overall SVR12 rate (PP)† | 250/271 (92.3%) | 33/36 (91.7%) | 283/307 (92.2%) | ||||||
Non-cirrhotic | Cirrhotic | Non-cirrhotic | Cirrhotic | ||||||
SVR12 rate by cirrhosis status (EP) | 91.0% (201/221) | 79.0% (49/62) | 92.9% (13/14) | 83.3% (20/24) | |||||
SVR12 rate by cirrhosis status (PP) | 93.9% (201/214) | 86.0% (49/57) | 100% (13/13) | 87.0% (20/23) | |||||
Treatment naïve | Treatment exp. | Treatment naïve | Treatment exp. | Treatment naïve | Treatment exp. | Treatment naïve | Treatment exp. | ||
SVR12 rate by cirrhosis status and prior treatment experience (EP)* | 91.9% (159/173) | 87.5% (42/48) | 71.9% (23/32) | 86.7% (26/30) | 90.9% (10/11) | 100% (3/3) | 100% (7/7) | 76.5% (13/17) | |
SVR12 rate (PP) by cirrhosis status and prior treatment experience† | 95.8% (159/166) | 87.5% (42/48) | 76.7% (23/30) | 96.3% (26/27) | 100% (10/10) | 100% (3/3) | 100% (7/7) | 81.3% (13/16) | 92.2% (283/307) |
Virological failure | |||||||||
Breakthrough | – | – | 1 | 1 | – | – | – | – | 2 |
Relapse | 7 | 5 | 6 | – | – | – | – | 3 | 21 |
Non-response | – | 1 | – | – | – | – | – | – | 1 |
Non-virological failure‡ | 7 | – | 2 | 3 | 1 | – | – | 1 | 14 |
*Evaluable population (EP): patients who completed treatment excluding those lost to on-treatment follow-up or who withdrew consent and have virological outcome or are confirmed by site to be lost to post-treatment follow-up (counted as non-virological treatment failures).
†Per protocol (PP) population patients who completed treatment early due to virological failure or completed treatment and have virological outcome.
‡Lost to post-treatment follow-up (n=14).
SVR12, sustained virological response 12 weeks after therapy.