Table 1.
Participant characteristics at baseline, overall and by INH-related toxicity during IPT.
| Overall | Any Grade 3+ INH-related toxicity | Any Grade 2 INH-related toxicity (among those without Grade 3+) | |||
| (n = 301) | No (n = 276) | Yes (n = 25) | No (n = 216) | Yes (n = 60) | |
| N (%) or median [IQR] | N (%) or median [IQR] | N (%) or median [IQR] | N (%) or median [IQR] | N (%) or median [IQR] | |
| Sex | |||||
| Female | 154 (51.2) | 140 (90.9) | 14 (9.1) | 121 (86.4) | 19 (13.6) |
| Male | 147 (48.8) | 136 (92.5) | 11 (7.5) | 95 (69.9) | 41 (30.2) |
| Age (median [IQR]) | 40 [33–47] | 40 [34–47] | 43 [31–47] | 40 [34–49] | 41 [35–45] |
| BMI | |||||
| Low (<18.5) | 31 (10.3) | 26 (83.9) | 5 (16.1) | 22 (84.6) | 4 (15.4) |
| Middle (18.5 to <25) | 185 (61.5) | 171 (92.4) | 14 (7.6) | 127 (74.3) | 44 (25.7) |
| High (≥25) | 85 (28.2) | 79 (92.9) | 6 (7.1) | 67 (84.8) | 12 (15.2) |
| Alcohol use | |||||
| Any self-reported alcohol use at screening | |||||
| No | 101 (33.6) | 88 (87.1) | 13 (12.9) | 75 (85.2) | 13 (14.8) |
| Yes | 200 (66.5) | 188 (94.0) | 12 (6.0) | 141 (75.0) | 47 (25.0) |
| Self-report at baseline (AUDIT-C)a | |||||
| None | 100 (33.2) | 87 (87.0) | 13 (13.0) | 74 (85.1) | 13 (14.9) |
| Low | 85 (28.2) | 80 (94.1) | 5 (5.9) | 66 (82.5) | 14 (17.5) |
| Medium | 66 (21.9) | 63 (95.5) | 3 (4.6) | 50 (79.4) | 13 (20.6) |
| High/very high | 50 (16.6) | 46 (92.0) | 4 (8.0) | 26 (56.5) | 20 (43.5) |
| PEth (median [IQR]) | 14.0 [1.0–181.0] | 15.5 [1.0–187.5] | 1.0 [1.0–147.0] | 5.0 [1.0–133.0] | 99.5 [1.0–459.5] |
| PEth at baselineb | |||||
| None | 140 (46.5) | 125 (89.3) | 15 (10.7) | 108 (86.4) | 17 (13.6) |
| Low | 44 (14.6) | 43 (97.7) | 1 (2.3) | 33 (76.7) | 10 (23.3) |
| Medium | 45 (15.0) | 41 (91.1) | 4 (8.9) | 33 (80.5) | 8 (19.5) |
| High/very high | 72 (23.9) | 67 (93.1) | 5 (6.9) | 42 (62.7) | 25 (37.3) |
| Self-report /PEth combinedc | |||||
| None | 86 (28.6) | 75 (87.2) | 11 (12.8) | 65 (86.7) | 10 (13.3) |
| Low | 66 (21.9) | 62 (93.9) | 4 (6.1) | 52 (83.9) | 10 (16.1) |
| Medium | 56 (18.6) | 53 (94.6) | 3 (5.4) | 47 (88.7) | 6 (11.3) |
| High/very high | 93 (30.9) | 86 (92.5) | 7 (7.5) | 52 (60.5) | 34 (39.5) |
| Health status | |||||
| Self-reported health status | |||||
| Good/fair/poor | 162 (53.8) | 147 (90.7) | 15 (9.3) | 115 (78.2) | 32 (21.8) |
| Excellent/very good | 139 (46.2) | 129 (92.8) | 10 (7.2) | 101 (78.3) | 28 (21.7) |
| Fib-4 score (median [IQR]) | 0.96 [0.71–1.30] | 0.97 [0.71–1.33] | 0.85 [0.68–1.16] | 0.93 [0.70–1.26] | 1.08 [0.73–1.46] |
| Liver injury due to alcohol use (AST/ALT ratio ≥2) | |||||
| No | 286 (95.0) | 263 (92.0) | 23 (8.0) | 207 (78.7) | 56 (21.3) |
| Yes | 15 (5.0) | 13 (86.7) | 2 (13.3) | 9 (69.2) | 4 (30.8) |
| Liver injury (ALT >1.25× ULN) | |||||
| No | 219 (72.8) | 200 (91.3) | 19 (8.7) | 159 (79.5) | 41 (20.5) |
| Yes | 82 (27.2) | 76 (92.7) | 6 (7.3) | 57 (75.0) | 19 (25.0) |
| Virally suppressed | |||||
| No | 23 (7.9) | 22 (95.7) | 1 (4.4) | 19 (86.4) | 3 (13.6) |
| Yes | 269 (92.1) | 246 (91.5) | 23 (8.6) | 190 (77.2) | 56 (22.8) |
| CD4+ cell count (median [IQR]) | 673 [506–866] | 676 [509–870] | 606 [459–746] | 692 [526–887] | 631 [447–854.5] |
| Hepatitis B status | |||||
| Negative | 296 (98.3) | 271 (91.6) | 25 (8.5) | 4 (80.0) | 1 (20.0) |
| Positive | 5 (1.7) | 5 (100.0) | 0 (0.0) | 212 (78.2) | 59 (21.8) |
| ART regimen | |||||
| Dolutegravir | 55 (18.3) | 51 (92.7) | 4 (7.3) | 40 (78.4) | 11 (21.6) |
| Efavirenz-based | 232 (77.1) | 211 (91.0) | 21 (9.1) | 164 (77.7) | 47 (22.3) |
| PI-based | 14 (4.7) | 14 (100.0) | 0 (0.0) | 12 (85.7) | 2 (14.3) |
| ART adherence (self-reported) | |||||
| Good/fair/poor/very poor | 56 (18.6) | 54 (96.4) | 2 (3.6) | 48 (88.9) | 6 (11.1) |
| Excellent/very good | 245 (81.4) | 222 (90.6) | 23 (9.4) | 168 (75.7) | 54 (24.3) |
| Years since ART initiation (median [IQR]) (n = 283) | 5.1 [3.3–7.6] | 5.1 [3.2–7.7] | 5.4 [3.6–7.4] | 5.1 [3.2–8.1] | 5.1 [3.4–6.6] |
a
Self-report categories: None: AUDIT-C = 0; Low: AUDIT-C 1-2 for women and 1–3 for men; Medium: AUDIT-C 3–5 for women and 4--5 for men; High/very high: AUDIT-C ≥6.
b
PEth categories: None: PEth <8 ng/ml; Low: PEth 8–<50 ng/ml; Medium: PEth 50–200 ng/ml, High: PEth ≥200 ng/ml.
c
Self-report/PEth combined categories assigns the higher of the self-report and PEth categories.