Table A.3.
Univariable analyses of risk factors for treatment-limiting hepatotoxicity in the PREVENT TB study
| All hepatotoxicity*
|
Symptomatic hepatotoxicity*
|
|||
|---|---|---|---|---|
| RR (95%CI)† | P value† | RR (95%CI)† | P value† | |
| Demographic factors | ||||
| Age, per year increase | 1.03 (1.01–1.04) | <0.0001 | 1.03 (1.01–1.04) | 0.002 |
| Female sex | 2.11 (1.33–3.34) | 0.002 | 2.71 (1.51–4.88) | 0.009 |
| Race | 0.07 | 0.04 | ||
| White | 1.00 (reference) | 1.00 (reference) | ||
| Black | 0.54 (0.30–0.98) | 0.44 (0.21–0.94) | ||
| Asian | 0.50 (0.21–1.15) | 0.22 (0.05–0.92) | ||
| Other | 1.37 (0.59–3.16) | 0.92 (0.28–2.95) | ||
| Ethnicity | 0.04 | 0.09 | ||
| Hispanic | 1.00 (reference) | 1.00 (reference) | ||
| Non-Hispanic | 1.51 (0.94–2.42) | 1.66 (0.92–3.00) | ||
| Not applicable (not US or Canada) | 0.20 (0.03–1.50) | |||
| Health factors | ||||
| BMI, per kg/m2 increase | 0.97 (0.93–1.01) | 0.10 | 0.97 (0.93–1.02) | 0.24 |
| HIV status | 0.77 | 0.96 | ||
| Non-infected | 1.00 (reference) | 1.00 (reference) | ||
| Infected | 1.10 (0.27–4.51) | 0.90 (0.12–6.63) | ||
| Unknown | 0.86 (0.54–1.34) | 1.07 (0.62–1.85) | ||
| History of chronic liver disease | 4.68 (2.69–8.15) | <0.0001 | 4.67 (2.36–9.22) | <0.0001 |
| Elevated baseline AST | 5.10 (3.10–8.39) | <0.0001 | 2.94 (1.44–6.03) | 0.003 |
| Social factors | ||||
| Homeless >6 months | 1.07 (0.47–2.46) | 0.87 | 1.34 (0.54–3.37) | 0.52 |
| Unemployed >12 months | 1.17 (0.60–2.26) | 0.65 | 1.22 (0.54–2.68) | 0.63 |
| Correctional institute >1 month | 1.69 (0.78–3.64) | 0.18 | 1.04 (0.33–3.32) | 0.95 |
| Current or past alcohol use | 0.006 | 0.03 | ||
| None | 1.00 (reference) | 1.00 (reference) | ||
| Use | 1.26 (0.77–2.05) | 0.93 (0.52–1.70) | ||
| Abuse | 2.86 (1.49–5.48) | 2.53 (1.17–5.47) | ||
| Current or past IDU | 3.73 (1.94–7.16) | <0.0001 | 4.56 (2.17–9.58) | <0.0001 |
| Current cigarette smoker | 1.38 (0.87–2.20) | 0.17 | 1.28 (0.72–2.27) | 0.39 |
| TB treatment factors | ||||
| Indication for TLTBI‡ | 0.55 | 0.23 | ||
| Close contact | 1.00 (reference) | 1.00 (reference) | ||
| Recent converter | 1.31 (0.81–2.10) | 1.60 (0.91–2.82) | ||
| Fibrosis on chest X-ray | 1.11 (0.27–4.54) | 1.79 (0.43–7.41) | ||
| Treatment with 9H | 4.42 (2.52–7.75) | <0.0001 | 4.51 (2.27–8.97) | <0.0001 |
Hepatotoxicity was defined as serum AST >3 × ULN with symptoms of nausea, vomiting, jaundice or fatigue or AST >5 × ULN regardless of symptoms.
P values are from the Wald χ2 test. RRs are estimated through log-binomial regression.
Subjects were counted only once in the order presented. The total number of HIV-infected persons who were enrolled is listed separately in this table.
RR =risk ratio; CI =confidence interval; BMI =body mass index; HIV =human immunodeficiency virus; AST =aspartate aminotransferase; IDU =injection drug user; TLTBI =treatment for latent tuberculous infection; 9H =9 months of self-administered daily isoniazid at 5–15 mg/kg rounded to the nearest 50 mg, with a maximum dose of 300 mg; ULN = upper limit of normal.