Reason for modification |
Overall |
Time period ≤ 11 months |
Time period > 11 months |
Drug Contraindication, IR (95% CI) |
9.5 per 100py (6.5-13.9) |
21 per 100py (12.6-34.8) |
5.4 per 100py (3-9.8) |
TB treatment |
18 |
13 |
5 |
Pregnancy |
9 |
2 |
7 |
Toxicity / Side-effects, IR (95% CI) |
6.3 per 100py (5.2-7.7) |
22.5 per 100py (16.2-31.4) |
4.6 per 100py (3.7-5.9) |
Peripheral neuropathy |
32 |
6 |
26 |
Lipodystrophy / lipoatrophy |
31 |
5 |
26 |
Anaemia |
10 |
9 |
1 |
Hypersensitivity rash |
9 |
4 |
5 |
Hepatitis / raised transaminases |
8 |
2 |
6 |
CNS disturbances |
5 |
3 |
2 |
Lactic acidosis |
3 |
0 |
3 |
Vomiting |
2 |
2 |
0 |
Gynaecomastia |
2 |
2 |
0 |
Myalgia |
2 |
1 |
1 |
Darkening of nails |
1 |
1 |
0 |
Treatment failure, IR (95% CI) |
4.9 per 100py (1.2-19.5) |
10.8 per 100py (1.5-7.7) |
3.2 per 100py (0.4-22.4) |
Treatment failure |
2 |
1 |
1 |
Other reasons, IR (95% CI) |
16.7 per 100py (5.4-52) |
53.5 per 100py (13.3-213.3) |
7.1 per 100py (1-50.2) |
Drug shortage |
2 |
2 |
0 |
Pill load |
1 |
0 |
1 |
Total, IR (95% CI) |
0.9 per 100py (0.7–1) |
4.8 per 1000py (3.7–6.3) |
0.6 per 100py (4.6-7.0) |
Total |
137 |
53 |
84 |
TB–tuberculosis; IR – Incidence rate; 95% CI – 95% Confidence interval; py – person years. Total (n=137): Drug contraindication (n=27, 19.7%); Toxicity (n=105, 77%);
Treatment failure (n=2, 1.5%) and other reasons (n=3, 2.2%). |