TABLE 2.
Rates of virologic response, virologic breakthrough, and relapse by treatment group and fibrosis stagee
| Response | No. positive/total no. (%) by treatment group and fibrosis stagec,d: |
|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TID16Wa |
TID28Wa |
TID40W |
Pooled TIDb |
BID28W |
TID28W-NR |
|||||||||||
| F0–F2 | F3–F4 | F0–F2 | F3–F4 | F0–F2 | F3–F4 | No cirrhosis | Cirrhosis | F0–F2 | F3–F4 | No cirrhosis | Cirrhosis | F0–F2 | F3–F4 | No cirrhosis | Cirrhosis | |
| SVR12 | ||||||||||||||||
| Overall | 40/63 (63) | 8/17 (47) | 31/58 (53) | 16/21 (76) | 30/62 (48) | 10/15 (67) | 124/217 (57) | 11/21 (52) | 40/57 (70) | 14/21 (67) | 48/69 (70) | 6/9 (67) | 14/35 (40) | 4/11 (36) | 17/43 (40) | 1/3 (33) |
| Genotype 1a | 12/27 (44) | 1/7 (14) | 10/25 (40) | 4/6 (67) | 13/29 (45) | 3/5 (60) | 40/93 (43) | 3/7 (43) | 11/25 (44) | 2/5 (40) | 11/26 (42) | 2/4 (50) | 2/16 (13) | 0/2 (0) | 2/18 (11) | 0/0 (0) |
| Genotype 1b | 28/36 (78) | 7/10 (70) | 21/33 (64) | 12/15 (80) | 17/33 (52) | 7/10 (70) | 84/124 (68) | 8/14 (57) | 29/32 (91) | 12/16 (75) | 37/43 (86) | 4/5 (80) | 12/19 (63) | 4/9 (44) | 15/25 (60) | 1/3 (33) |
| Virologic breakthrough | 6/63 (10) | 3/17 (18) | 13/58 (22) | 0/21 (0) | 12/62 (19) | 3/15 (20) | 35/217 (16) | 3/21 (14) | 13/57 (23) | 5/21 (24) | 16/69 (23) | 2/9 (22) | 13/35 (37) | 6/11 (55) | 17/43 (40) | 2/3 (67) |
| Relapse | 9/51 (18) | 1/12 (8) | 1/40 (3) | 0/17 (0) | 1/40 (3) | 0/11 (0) | 12/156 (8) | 1/16 (6) | 0/41 (0) | 0/14 (0) | 0/49 (0) | 0/6 (0) | 2/17 (12) | 0/4 (0) | 2/20 (10) | 0/1 (0) |
Information on the stage of fibrosis was classified as “missing” for two patients (one in the TID16W arm and one in the TID28W arm).
The TID16W, TID28W, and TID40W treatment arms were pooled because of the small number of patients with cirrhosis in these treatment arms.
Fibroscan results were used to determine stage of fibrosis for patients without a liver biopsy result (<F3 = <9.5 kPa, ≥F3 = ≥9.5 kPa).
Cirrhosis was determined by the investigator based on Fibroscan, biopsy, and/or other clinical parameters.
Abbreviations: BID, twice daily; NR, no ribavirin; SVR12, sustained virologic response 12 weeks after completion of treatment; TID, three times daily.