Table 1.
Descriptive data on liver transaminases by treatment group
| AST levels | ||||
|---|---|---|---|---|
| Baseline | Week 4 | Week 8 | Week 12 | |
|
HaRT-A + XR-NTX
(N=74/54/48/53) |
||||
| Enzyme value (median, IQR) | 30.5 | 29.5 | 31 | 30 |
| <1x ULN (n, %) | 49 (66.2%) |
37 (68.5%) |
36 (75%) |
32 (60.4%) |
| 1–3x ULN (n, %) | 23 (31.1%) |
15 (27.8%) |
8 (16.7%) |
17 32.1% |
| >3x ULN (n, %) | 2 (2.7%) |
2 (3.7%) |
4 (8.3%) |
4 (7.6%) |
|
HaRT-A + placebo
(N= 77/54/47/48) |
||||
| Enzyme value (median, IQR) | 35 | 31.5 | 40 | 39.5 |
| <1x ULN (n,%) | 43 (55.8%) |
30 (55.6%) |
23 (48.9%) |
22 (45.8%) |
| 1–3x ULN (n, %) | 26 (33.8%) |
18 (33.3%) |
20 (42.6%) |
20 (41.7%) |
| >3x ULN (n, %) | 8 (10.4%) |
6 (11.1%) |
4 (8.5%) |
6 (12.5%) |
| ALT levels | ||||
| Baseline | Week 4 | Week 8 | Week 12 | |
|
HaRT-A + XR-NTX
(N=74/54/48/53) |
||||
| Enzyme value (median, IQR) | 24 | 23 | 25 | 22 |
| <1x ULN (n, %) | 64 (86.5%) |
51 (94.4%) |
44 (91.7%) |
45 (84.9%) |
| 1–3x ULN (n, %) | 8 (10.8%) |
2 (3.7%) |
4 (8.3%) |
6 (11.3%) |
| >3x ULN (n, %) | 2 (2.7%) |
1 (1.9%) |
0 (0%) |
2 (3.8%) |
|
HaRT-A + placebo
(N= 77/54/47/48) |
||||
| Enzyme value (median, IQR) | 26 | 27.5 | 32 | 29 |
| <1x ULN (n,%) | 55 (71.4%) |
43 (79.6%) |
40 (85.1%) |
34 (70.8%) |
| 1–3x ULN (n, %) | 19 (24.7%) |
10 (18.5%) |
6 (12.8%) |
12 (25%) |
| >3x ULN (n, %) | 3 (3.9%) |
1 (1.9%) |
1 (2.1%) |
2 (4.2%) |
| GGT levels | ||||
| Baseline | Week 4 | Week 8 | Week 12 | |
|
HaRT-A + XR-NTX
(N=74/54/48/53) |
||||
| Enzyme value (median, IQR) | 38.5 | 28 | 27.5 | 32 |
| <1x ULN (n, %) | 48 (64.9%) |
37 (68.5%) |
33 (68.8%) |
33 (62.3%) |
| 1–3x ULN (n, %) | 18 (24.3%) |
12 (22.2%) |
10 (20.8%) |
14 (26.4%) |
| >3x ULN (n, %) | 8 (10.8%) |
5 (9.3%) |
5 (10.4%) |
6 (11.3%) |
|
HaRT-A + placebo
(N= 77/54/47/48) |
||||
| Enzyme value (median, IQR) | 38 | 37 | 36 | 56.5 |
| <1x ULN (n,%) | 47 (61%) |
34 (63%) |
27 (57.5%) |
23 (47.9%) |
| 1–3x ULN (n, %) | 16 (20.8%) |
10 (18.5%) |
9 (19.2%) |
14 (29.2%) |
| >3x ULN (n, %) | 14 (18.2%) |
10 (18.5%) |
11 (23.4%) |
11 (22.9%) |
ALT: alanine aminotransferase. AST: aspartate aminotransferase. GGT: gamma glutamyl-transferase. HaRT-A: behavioral harm reduction treatment sessions. IQR: interquartile range.
XR-NTX: extended-release naltrexone.