Table 2. Adverse events according to the latent tuberculosis infection treatment regimens.
| Variable | 9H (n = 43) | 3HR (n = 81) | 4R (n = 13) | P valuea | ||
|---|---|---|---|---|---|---|
| Adverse events, n (%) | 25 (58.1) | 37 (45.7) | 3 (23.1) | 0.26 | ||
| Number of adverse events, n (%) | ||||||
| 0 | 18 (41.9) | 43 (53.1) | 11 (84.6) | 0.26 | ||
| 1 | 17 (39.5) | 33 (40.7) | 2 (15.4) | 1.00 | ||
| 2 | 7 (16.3) | 3 (3.7) | 0 | 0.32 | ||
| 3 | 1 (2.3) | 1 (1.2) | 0 | 1.00 | ||
| Grade of adverse eventsb, n (%) | ||||||
| 1 | 14 (32.6) | 29 (35.8) | 1 (7.7) | 0.70 | ||
| 2 | 10 (23.3) | 7 (8.6) | 0 | 0.03 | ||
| 3 | 2 (4.7) | 1 (1.2) | 1 (7.7) | 0.28 | ||
| 4 | 0 | 1 (1.2) | 0 | 1.00 | ||
| Hepatotoxicity, n (%) | 17 (39.5) | 14 (17.3) | 0 | 0.009 | ||
| Hepatotoxicity (≥grade 2) | 8 (18.6) | 3 (3.7) | 0 | 0.02 | ||
| Time to hepatotoxicity, median (IQR) | 102 (96–105) | 20 (15–89) | NA | <0.001 | ||
| Major adverse eventsc, n (%) | 7 (16.3) | 1 (1.2) | 1 (7.7) | 0.02 | ||
| Hepatotoxicity | ||||||
| ALT elevation more than 3 times the ULN in the presence of hepatitis symptoms | 4 (9.3) | 0 | 0 | 0.12 | ||
| ALT elevation more than 5 times the ULN in the absence of symptoms | 3 (7.0) | 0 | 0 | 0.05 | ||
| Anaphylaxis, n (%) | 0 | 0 | 1 (7.7) | NA | ||
| Thrombocytopenia, n (%) | 0 | 1 (1.2)d | 0 | 1.00 | ||
Data are presented as number of healthcare workers (%), unless otherwise specified.
aP value for comparison between the 9-month isoniazid and 3-month isoniazid/rifampin.
bGrade 1, Mild: asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2, Moderate: minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3, Severe or medically significant but not immediately life-threatening: hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to adverse events.
cMajor adverse event was defined as one wherein a patient had any adverse event ≥ grade 3, which caused an interruption in latent tuberculosis infection treatment.
dAt day 85 of 3HR treatment, a decreased platelet count below 5,000 mm3 was identified.
9H, 9-month isoniazid; 3HR, 3-month isoniazid/rifampin; 4R, 4-month rifampin; IQR, interquartile range; NA, not applicable; ALT, alanine aminotransferase; ULN, upper limit of normal.