Skip to main content

Table 1 Summary of the numbers of patients with significant elevations in liver enzyme concentration (≥3 × ULN, ≥5 × ULN and ≥10 × ULN) by treatment arm

From: Liver toxicity associated with tuberculosis chemotherapy in the REMoxTB study

 

Standard arm

(2EHRZ/4HR)

Isoniazid arm

(2MHRZ/2MHR)

Ethambutol arm

(2EMRZ/2MR)

p value

n 1

634

649

634

 

Median peak ALT as × ULN (IQR)

0.83

(0.56–1.35)

0.78

(0.53–1.23)

0.73

(0.51–1.09)

0.0465

0.0006

Median time to peak ALT in arm (days)

28

(14–84)

28

(14–84)

55

(14–84)

0.9725

0.0176

Median time to peak ALT (days) if ≥3 × ULN

28

(14–56)

18

(14–56)

28

(27–56)

0.7555

0.6056

Median time to ALT < 1 × ULN2

(days)

26

(15–42)

28

(19–42)

39

(30–61)

0.5605

0.2706

No with peak ALT ≥ 3 × ULN and < 5 × ULN (%n3)

21

(3.3%)

17

(2.6%)

11

(1.7%)

0.2047

 Bilirubin > 2 × ULN

2

(0.3%)

4

(0.6%)

0

(0.0%)

0.1427

 INR4 >1.5

0

(0.0%)

3

(0.5%)

1

(0.2%)

0.0987

No with peak ALT ≥ 5 × ULN and < 10 × ULN (%n3)

13

(2.0%)

16

(2.4%)

11

(1.7%)

0.6567

 Bilirubin > 2 × ULN

1

(0.2%)

2

(0.3%)

1

(0.2%)

0.7927

 INR4 >1.5

0

(0.0%)

0

(0.0%)

0

(0.0%)

 

No with peak ALT ≥10 × ULN (%n3)

7

(1.1%)

2

(0.3%)

3

(0.5%)

0.1647

 Bilirubin > 2 × ULN

2

(0.3%)

0

(0.0%)

1

(0.2%)

0.3607

 INR4 >1.5

0

(0.0%)

0

(0.0%)

0

(0.0%)

 

No of liver-related withdrawals

11

(1.7%)

7

(1.1%)

4

(0.6%)

0.178

  1. Median days from the start of treatment to reach individual patient peak concentrations and the number of patients withdrawing from treatment for liver-related reasons are reported
  2. ALT alanine aminotransferase, INR international normalised ratio, IQR interquartile range, ULN upper limit of normal
  3. 1 Some patients not included due to missing ALT results
  4. 2 If peak value ≥3 × ULN
  5. 3%n refers to percentage of total patients in the treatment arm
  6. 4 Patients with known anti-coagulant use were excluded from INR numbers
  7. 5 Isoniazid arm against standard therapy
  8. 6 Ethambutol arm against standard therapy
  9. 7 Chi-squared test (Fisher’s exact if any n ≤ 5)