Table 2.
Univariate odds ratios for having hepatotoxicity in the isoniazid preventive therapy arm within 24 weeks of follow up in the REMEMBER trial (N=426)
| Hepatotoxicity | Odds Ratio | 95% CI | P-value | ||
|---|---|---|---|---|---|
| Yes n=31 |
No n=395 |
||||
| Cd4 cell count (cells per µL) | |||||
| <25 | 16 (6%) | 241 (94%) | 1 | ||
| 25–50 | 15 (9%) | 154 (91%) | 1.5 | 0.7–3.1 | 0.31 |
| HIV-1 RNA (copies per mL) * | |||||
| <100,000 | 9 (7%) | 122 (93%) | 1 | ||
| 100,000–500,000 | 13 (7%) | 178 (93%) | 1.0 | 0.4–2.4 | 0.98 |
| >500,000 | 9 (9%) | 93 (91%) | 1.3 | 0.5–3.4 | 0.58 |
| Karnofsky Score | |||||
| 80–100 | 24 (7%) | 347 (94%) | 1 | ||
| 0–70 | 7 (13%) | 48 (87%) | 2.1 | 0.9–5.2 | 0.10 |
| Body mass index (kg/m2) | |||||
| ≥18.5 | 26 (9%) | 272 (91%) | 1 | ||
| <18.5 | 5 (4%) | 123 (96%) | 0.4 | 0.2–1.1 | 0.09 |
| Hospital admission within 30 days prior to study entry | |||||
| No | 28 (7%) | 375 (93%) | 1 | ||
| Yes | 3 (13%) | 20 (87%) | 2.0 | 0.6–7.2 | 0.28 |
| Age (years) | |||||
| ≤35 | 19 (9%) | 203 (91%) | 1 | ||
| >35 | 12 (6%) | 192 (94%) | 0.7 | 0.3–1.4 | 0.29 |
| Sex | |||||
| Male | 16 (7%) | 210 (93%) | 1 | ||
| Female | 15 (8%) | 185 (93%) | 1.1 | 0.5–2.2 | 0.87 |
| Hepatitis B surface antigen† | |||||
| Negative | 23 (6%) | 361 (94%) | 1 | ||
| Positive | 7 (27%) | 19 (73%) | 5.8 | 2.2–15.2 | <0.001 |
| Anemia | |||||
| No anemia | 7 (7%) | 98 (93%) | 1 | ||
| Anemia | 24 (8%) | 297 (93%) | 1.1 | 0.5–2.7 | 0.80 |
| Pretreatment AST/ALT‡ | |||||
| Normal | 15 (5%) | 312 (95%) | 1 | ||
| Raised | 16 (16%) | 83 (84%) | 4.0 | 1.9–8.4 | <0.001 |
| APRI score§ | |||||
| <=1.5 | 29 (7%) | 383 (93%) | 1 | ||
| >1.5 | 1 (8%) | 11 (92%) | 1.2 | 0.1–6.6 | 0.86 |
| Alcohol intake | |||||
| Never | 17 (8%) | 197 (92%) | 1 | ||
| Takes alcohol | 4 (12%) | 29 (88%) | 1.6 | 0.5–5.1 | 0.4 |
| No answer | 10 (6) | 169 (94%) | 0.7 | 0.3–1.5 | 0.36 |
*
2 results were not obtained
†
16 results were not obtained
‡
Raised pretreatment AST/ALT defined as AST and/or ALT elevations at ≥1.25× ULN and <2.5×ULN at study entry.
§
2 values were missing