Table A.1.
Demographic and clinical characteristics of adults enrolled in PREVENT TB and the nested case-control study
| PREVENT TB
|
Case-control study
|
|||||
|---|---|---|---|---|---|---|
| Hepatotoxicity* (n = 77)†
n (%) |
Symptomatic hepatotoxicity* (n = 52) n (%) |
Asymptomatic hepatotoxicity* (n = 24) n (%) |
No hepatotoxicity* (n = 6785) n (%) |
Cases (n = 49) n (%) |
Controls (n = 243) n (%) |
|
| Demographic factors | ||||||
| Age, years, median [IQR] | 44 [34–52] | 44 [33–52] | 47 [37–50] | 37 [28–48] | 44 [33–52] | 46 [32–53] |
| Female sex | 49 (64) | 36 (69) | 12 (50) | 3065 (45) | 33 (67) | 107 (44) |
| Race | ||||||
| White | 52 (68) | 39 (75) | 13 (54) | 3799 (56) | 35 (67) | 121 (60) |
| Black | 13 (17) | 8 (15) | 5 (21) | 1780 (26) | 10 (20) | 76 (31) |
| Asian/Pacific Islander | 6 (7.8) | 2 (3.9) | 4 (17) | 887 (13) | 4 (8.2) | 32 (13) |
| North American Indian | 2 (2.6) | 1 (1.9) | 0 (0) | 109 (1.6) | 0 (0) | 7 (2.9) |
| Other | 4 (5.2) | 2 (3.9) | 2 (8.3) | 210 (3.1) | 2 (4.1) | 7 (2.9) |
| Ethnicity | ||||||
| Hispanic | 25 (32) | 16 (31) | 9 (37) | 2666 (39) | 11 (22) | 62 (25) |
| Non-Hispanic | 51 (66) | 36 (69) | 14 (58) | 3591 (53) | 37 (76) | 144 (59) |
| Not applicable (not in the United States or Canada) | 1 (1.3) | 0 (0) | 1 (4.2) | 528 (7.8) | 1 (2.0) | 37 (15) |
| Health factors | ||||||
| BMI, kg/m2, median [IQR] | 26 [23–28] | 26 [23–28] | 25 [23–28] | 27 [24–31] | 26 [23–30] | 28 [24–31] |
| HIV status | ||||||
| Non-infected | 41 (53) | 25 (48) | 15 (63) | 3366 (50) | 31 (63) | 132 (54) |
| Infected | 2 (2.6) | 1 (1.9) | 1 (4.2) | 149 (2.2) | 2 (4.1) | 9 (3.7) |
| Unknown | 34 (44) | 26 (50) | 8 (33) | 3270 (48) | 16 (33) | 102 (42) |
| History of chronic liver disease | 15 (19) | 10 (19) | 5 (21) | 322 (4.8) | 11 (20) | 16 (6.6) |
| Elevated baseline AST | 21/72 (29) | 9/48 (19) | 12/23 (52) | 369/5151 (7.2) | 11/46 (24) | 15/168 (8.9) |
| Hepatitis serology results‡ | ||||||
| Hepatitis B virus co-infection | — | — | — | — | 0 (0) | 3 (1.2) |
| Hepatitis C virus co-infection | — | — | — | — | 12 (24) | 23 (9.5) |
| Self-reported social factors | ||||||
| Homeless >6 months | 6 (7.8) | 5 (9.6) | 1 (4.2) | 495 (7.3) | 4 (8.2) | 24 (9.9) |
| Unemployed >12 months | 10 (13) | 7 (13) | 3 (13) | 769 (11) | 7 (14) | 25 (10) |
| Correctional institute >1 month | 7 (9.1) | 3 (5.8) | 4 (17) | 377 (5.6) | 3 (6.1) | 18 (7.4) |
| Current or past alcohol use | ||||||
| None | 28 (36) | 22 (42) | 6 (25) | 3107/6777 (46) | 17 (35) | 119 (49) |
| Use | 36 (47) | 21 (40) | 14 (58) | 3147/6777 (47) | 24 (49) | 110 (45) |
| Abuse | 13 (17) | 9 (17) | 4 (17) | 469/6777 (6.9) | 8 (16) | 14 (5.8) |
| Current or past IDU | 10 (13) | 8 (15) | 2 (8.3) | 254/6776 (3.8) | 5 (10) | 15 (6.2) |
| Current cigarette smoker | 28 (36) | 18 (35) | 10 (42) | 1977 (29) | 19 (39) | 89 (35) |
| Anti-tuberculosis treatment factors | ||||||
| Indication for TLTBI§ | ||||||
| Close contact | 50 (65) | 31 (60) | 19 (79) | 4711 (69) | 29 (59) | 181 (74) |
| Recent converter | 25 (32) | 19 (37) | 5 (21) | 1798 (27) | 18 (37) | 50 (21) |
| HIV-infected | 0 (0) | 0 (0) | — | 107 (1.6) | 0 (0) | 8 (3.3) |
| Fibrosis on chest X-ray | 2 (2.6) | 2 (3.9) | — | 169 (2.5) | 2 (4.1) | 4 (1.7) |
| 9H | 62 (81) | 42 (81) | 19 (80) | 3353 (48) | 41 (84) | 95 (39) |
Hepatotoxicity was defined as serum AST >3 × ULN with symptoms of nausea, vomiting, jaundice or fatigue, or AST >5 × ULN regardless of symptoms.
Symptoms were not assessed for one participant.
Hepatitis B and C serological and NAT tests were performed systematically only for participants in the nested case-control study.
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.
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; NAT = nucleic acid testing.