Table 3. Characteristics at randomisation.
| Total (N=202) | VUS duration
(N=100) |
Fixed duration
(N=102) |
Ribavirin
(N=100) |
No ribavirin
(N=102) |
|
|---|---|---|---|---|---|
| Randomised under first protocol (VUS1) | 136 (67%) | 68 (68%) | 68 (67%) | 68 (68%) | 68 (67%) |
| Age (years) | 45.5 (37.5, 53.0) | 45.2 (38.8, 51.6) | 46.3 (36.6, 54.1) | 46.1 (36.7,
52.4) |
44.8 (37.7,
54.1) |
| Female at birth | 62 (31%) | 28 (28%) | 34 (33%) | 34 (34%) | 28 (27%) |
| BMI (kg/m 2) | 24.9 (22.2, 27.2) | 24.9 (22.6,
26.7) |
24.9 (21.8, 27.7) | 23.7 (21.7,
26.5) |
25.8 (23.3,
27.6) |
| White ethnicity | 176 (87%) | 89 (89%) | 87 (85%) | 89 (89%) | 87 (85%) |
| Weight (kg) | 74.0 (66.0, 84.6) | 73.0 (65.9,
84.1) |
76.1 (66.0, 85.9) | 69.9 (63.8,
82.3) |
78.9 (68.5,
86.8) |
| Screening HCV viral load (IU/ml) | 711423 (218776,1995262) | 790664
(214388, 1917731) |
687916 (220000,
2381846) |
700272
(169717, 2071064) |
750523
(275000, 1949844) |
| Enrolment HCV viral load (IU/ml) n=199 | 741946 (249097,1872136) | 801000
(251188, 1500000) |
(614047 (248000,
2238721) |
657858
(178842, 1500000) |
801000
(385595, 2200000) |
| HCV genotype/subgenotype: 1a | 166 (82%) | 82 (82%) | 84 (82%) | 84 (84%) | 82 (80%) |
| 1b | 34 (17%) | 17 (17%) | 17 (17%) | 16 (16%) | 18 (18%) |
| 4 | 2 (1%) | 1 (1%) | 1 (1%) | 0 | 2 (2%) |
| HIV coinfected | 68 (34%) | 32 (32%) | 36 (35%) | 35 (35%) | 33 (32%) |
| Fibroscan result (kPa) | 4.9 (4.2, 5.8) | 5.0 (4.3, 5.9) | 4.8 (4.1, 5.5) | 4.8 (4.4,
5.8) |
4.9 (4.1, 5.9) |
| Haemoglobin (g/dl) | 14.7 (14.0, 15.6) | 14.8 (14.1, 15.6) | 14.7 (13.8, 15.6) | 14.7 (13.8 ,
15.6) |
14.8 (14.0,
15.7) |
| ALT (IU/ml) | 52 (34, 87) | 50 (34, 90) | 54 (34, 87) | 51 (35, 89) | 54 (31, 87) |
| AST (IU/l) n=189 | 38 (30, 57) | 38 (29, 57) | 38 (31, 58) | 39 (31, 55) | 38 (29, 58) |
| ALP (IU/l) | 72 (59, 91) | 71 (59, 87) | 75 (59, 94) | 76 (61, 95) | 69 (58, 85) |
| eGFR (ml/min) | 109 (93, 131) | 109 (94, 126) | 109 (92, 138) | 107 (92,
126) |
110 (93, 133) |
| Total bilirubin (umol/l) | 9 ( 6, 12) | 8 (6, 11) | 9 (6, 12) | 9 (6, 12) | 9 (6, 12) |
| IL28b genotype *: CC | 60 (30%) | 32 (32%) | 28 (27%) | 29 (29%) | 31 (30%) |
| CT | 106 (52%) | 51 (51%) | 55 (54%) | 56 (56%) | 50 (49%) |
| TT | 27 (13%) | 14 (14%) | 13 (13%) | 11 (11%) | 16 (16%) |
| No result | 9 (4%) | 3 (3%) | 6 (6%) | 4 (4%) | 5 (5%) |
| Previously unsuccessfully treated with
interferon and/or ribavirin |
24 (12%) | 12 (12%) | 12 (12%) | 11 (11%) | 13 (13%) |
| Ever spontaneously cleared and re-
infected |
6 (3%) | 4 (4%) | 2 (2%) | 2 (2%) | 4 (4%) |
| Ever successfully treated with interferon
and/or ribavirin and re-infected |
10 (5%) | 5 (5%) | 5 (5%) | 5 (5%) | 5 (5%) |
| Current/recent alcoholism/alcohol abuse | 13 (6%) | 5 (5%) | 8 (8%) | 7 (7%) | 6 (6%) |
| Current/recent illicit substance abuse | 64 (32%) | 31 (31%) | 33 (32%) | 28 (28%) | 26 (25%) |
| Treated with paritaprevir\ombitasvir\
dasabuvir |
198 (98%) | 98 (98%) | 100 (98%) | 100 (100%) | 98 (96%) |
| Treated with paritaprevir\ombitasvir | 2 (1%) | 1 (1%) | 1 (1%) | 0 | 2 (2%) |
| Treated with glecaprevir\pibrentasvir | 2 (1%) | 1 (1%) | 1 (1%) | 0 | 2 (2%) |
* Result from whole genome sequencing or from Epistem point of care test if genotyping result not available.
Note: showing n (%) for categorical factors, or median (IQR) for continuous factors. Missing data indicated by denominators in the row label. As an indicator of imbalance, P>0.05 for all comparisons of baseline characteristics between groups other than BMI (p<0.001), weight (p=0.003) and ALP (p=0.04) between ribavirin and no ribavirin groups.