Cohort 1 Treatment-naive | Cohort 2 Ledipasvir/sofosbuvir or sofosbuvir-experienced | Cohort 3 Interferon-experienced | |||||
Ledipasvir/ sofosbuvir 8 weeks (n=43) | Ledipasvir/ sofosbuvir+ ribavirin 8 weeks (n=42) | Ledipasvir/ sofosbuvir 12 weeks (n=43) | Ledipasvir/ sofosbuvir+ribavirin 12 weeks (n=42) | Ledipasvir/ sofosbuvir+ribavirin 12 weeks (n=11) | Ledipasvir/ sofosbuvir 12 weeks (n=36) | Ledipasvir/ sofosbuvir+ribavirin 12 weeks (n=38) | |
Mean age, years (range) | 53 (22–74) | 49 (23–71) | 49 (23–74) | 46 (21–68) | 48 (23–72) | 49 (24–67) | 51 (29–74) |
Male, n (%) | 25 (58) | 22 (52) | 22 (51) | 22 (52) | 8 (73) | 32 (89) | 25 (66) |
Mean BMI, kg/m2 (range) | 30.0 (22.0–50.0) | 31.4 (23.9–45.9) | 30.8 (21.0–45.7) | 29.5 (22.8–39.4) | 33.9 (23.6–50.8) | 29.1 (19.1–42.6) | 28.1 (20.3–37.1) |
Cirrhosis, n (%) | 7 (16) | 7 (17) | 9 (21) | 8 (19) | 3 (27) | 10 (28) | 10 (26) |
IL28B non-CC genotype, n (%) | 31 (72) | 37 (88) | 32 (74) | 33 (79) | 11 (100) | 31 (86) | 30 (79) |
HCV RNA | |||||||
Mean, log10 IU/mL (range) | 6.0 (4.7–7.0) | 5.6 (3.7–6.8) | 5.7 (4.3–7.0) | 5.8 (4.3–7.1) | 6.2 (5.2–7.0) | 5.8 (1.1–7.3) | 5.8 (1.8–7.2) |
≥6 000 000 IU/mL, n (%) | 2 (5) | 0 | 2 (5) | 4 (10) | 3 (27) | 2 (6) | 4 (11) |
Response to prior HCV treatment, n (%) | |||||||
Non-response | NA | NA | NA | NA | 0 | 18 (50) | 21 (55) |
Relapse/breakthrough | NA | NA | NA | NA | 11 (100) | 16 (44) | 17 (45) |
Interferon-intolerant | NA | NA | NA | NA | 0 | 2 (6) | 0 |
BMI, body mass index; HCV, hepatitis C virus; NA, not applicable.