Table 3.
Characteristics of patients with and without early upper gastrointestinal adverse events on TDF-FTC-ZDV (n=71)
| Upper gastrointestinal adverse event within first month of treatment | |||
|---|---|---|---|
| No (n=13) | Yes (n=58) | P | |
| Female, n (%) | 13 (100%) | 56 (97%) | 1.00 |
| Age (years), median (IQR) | 31 (29–34) | 32 (29–37) | 0.78 |
| WHO clinical stage, n (%) | 0.44 | ||
| Stage 1 | 12 (92%) | 47 (81%) | |
| Stage 2 or 3 | 1 (8%) | 11 (19%) | |
| Body mass index (kg/m2), median (IQR) | 22.5 (21.4–24.2) | 24.4 (21.1–26.4) | 0.13 |
| CD4 count (cells/mm3), median (IQR) | 426 (357–444) | 378 (291–446) | 0.27 |
| HIV serotype, n (%) | 0.57 | ||
| HIV-1 only | 13 (100%) | 53 (91%) | |
| Dual | – | 5 (9%) | |
| Cotrimoxazole started before ART, n (%) | 4 (31%) | 37 (64%) | 0.06 |
| Time on Cotrimoxazole (months), median (IQR) | 7.0 (0.3–20.6) | 9.4 (2.4–36.7) | 0.38 |
| Positive serum HBs antigen, n (%) | – | 9 (16%) | 0.19 |
| Haemoglobin (g/l), median (IQR) | 98 (90–102) | 108 (101–115) | 0.01 |
| Creatinine clearance (ml/min) | 0.99 | ||
| <60 | 1 (8%) | 6 (11%) | |
| ≥60 | 12 (92%) | 51 (89%) | |
| Serum transaminases >1.25×ULN, n (%) | – | 1 (2%) | 0.99 |
| Zidovudine pill manufacturer, n (%) | 0.79 | ||
| ZDV 300 mg Ranbaxy or Aurobindo | 5 | 24 | |
| ZDV 300 mg Cipla | 6 | 21 | |
| ZDV 250 mg GSK | 2 | 13 | |
ULN: upper limit of normal; ZDV: zidovudine; CTX: cotrimoxazole;
n: number; %: percentage; IQR: interquartile range; ULN: upper limit of normal; ml/min: millilitres per minute; g/l: grams per litre; kg/m2: kilos per square metre; mm3: cubic millimetre: HBs antigen: hepatitis B surface antigen.