Background
Methods
Patients and study design
Outcomes
Assessments
Statistical analyses
Results
Patient disposition and baseline characteristics
Simeprevir 75 mg + TMC647055/ritonavir 450/30 mg | Simeprevir 75 mg + TMC647055/ritonavir 600/50 mg | Simeprevir 75 mg + TMC647055/ ritonavir 450/30 mg + JNJ-56914845 30 mg | Simeprevir 75 mg + TMC647055/ritonavir 450/30 mg + JNJ-56914845 60 mg | ||||
---|---|---|---|---|---|---|---|
Panel 1 | Panel 2 | Panel 3 | Panel 4 | ||||
GT1a/with ribavirin (n = 10) | GT1b/with ribavirin (n = 12) | GT1b/without ribavirin (n = 9) | GT1a/with ribavirin (n = 7) | GT1b/without ribavirin (n = 8) | GT1a/b/other (n = 22)a
| GT1a/b/other (n = 22)b
| |
Caucasian, n (%) | 10 (100) | 12 (100) | 8 (89) | 7 (100) | 6 (75) | 20 (91) | 21 (96) |
Male, n (%) | 8 (80) | 4 (33) | 7 (78) | 7 (100) | 3 (38) | 16 (73) | 17 (77) |
Treatment-naïve, n (%) | 10 (100) | 8 (67) | 8 (89) | 7 (100) | 4 (50) | 20 (91) | 19 (86) |
Prior relapser, n (%) | 0 (0) | 4 (33) | 1 (11) | 0 (0) | 4 (50) | 2 (9) | 3 (14) |
Age, median, years (range) | 46.5 (38–52) | 47.5 (29–62) | 37.0 (18–64) | 44.0 (28–58) | 48.5 (43–66) | 50.5 (24–70) | 48.0 (27–58) |
HCV RNA, median, log10 IU/mL (range) | 6.52 (4.4–7.2) | 6.69 (5.8–7.5) | 5.98 (5.3–7.1) | 6.32 (6.0–7.4) | 6.76 (6.1–7.0) | 6.78 (5.5–7.4) | 6.62 (5.2–7.1) |
METAVIR score, n (%) | |||||||
F0–F2 | 5 (50) | 6 (50) | 6 (67) | 4 (29) | 3 (38) | 7 (32) | 5 (23) |
F3 | 1 (10) | 1 (8) | 1 (11) | 1 (14) | 0 | 2 (9) | 4 (18) |
Missing | 4 (40) | 5 (42) | 2 (22) | 2 (29) | 5 (63) | 13 (59) | 13 (59) |
IL28B genotype, n (%) | |||||||
CC | 5 (50) | 4 (33) | 2 (22) | 0 (0) | 2 (25) | 9 (41) | 6 (27) |
CT | 4 (40) | 6 (50) | 6 (67) | 6 (86) | 5 (63) | 8 (36) | 11 (50) |
TT | 1 (10) | 2 (17) | 1 (11) | 1 (14) | 1 (13) | 5 (23) | 5 (23) |
Virologic response
Virologic resistance testing
Pharmacokinetics
Safety
Simeprevir 75 mg + TMC647055/ritonavir 450/30 mg | Simeprevir 75 mg + TMC647055/ritonavir 600/50 mg | Simeprevir 75 mg + TMC647055/ritonavir 450/30 mg + JNJ-56914845 30 mg | Simeprevir 75 mg + TMC647055/ritonavir 450/30 mg + JNJ-56914845 60 mg | ||||
---|---|---|---|---|---|---|---|
Panel 1 | Panel 2 | Panel 3 | Panel 4 | ||||
GT1a/with ribavirin (n = 10) | GT1b/with ribavirin (n = 12) | GT1b/without ribavirin (n = 9) | GT1a/with ribavirin (n = 7) | GT1b/without ribavirin (n = 8) | GT1a/b/other (n = 22)a
| GT1a/b/other (n = 22)b
| |
Any AE, n (%) | 10 (100) | 12 (100) | 7 (78) | 6 (86) | 6 (75) | 20 (91) | 22 (100) |
Worst Grade 1, n (%) | 6 (60) | 7 (58) | 4 (44) | 5 (71) | 3 (38) | 15 (68) | 15 (68) |
Worst Grade 2, n (%) | 4 (40) | 5 (42) | 3 (33) | 1 (14) | 2 (25) | 5 (23) | 6 (27) |
Worst Grade 3, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (13)c
| 0 (0) | 1 (5)d
|
Worst Grade 4, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Leading to permanent stop of study drugs, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Serious AE, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Death, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |