Table 2. Crude and adjusted hazard ratios of nephrotoxicity and death by creatinine clearance level at tenofovir initiation among patients at Themba Lethu Clinic, Johannesburg, South Africa (n=890).
| Nephrotoxicity§ | |||||
|---|---|---|---|---|---|
| Creatinine clearance (ml/min) ‡ |
Nephrotoxicity (n) |
Person Time (years) |
Rate/100 person-years |
Crude HR (95% CI) |
Adjusted HR¥ (95% CI) |
| Normal (≥90) | 4 | 985.2 | 0.4 | 1.0 | 1.0 |
| Mild (60-89.9) | 11 | 442.7 | 2.5 | 6.1 (1.9-19.2) | 4.8 (1.5-15.2) |
| Moderate (30-59.9) | 6 | 56.2 | 10.7 | 27.5 (7.5-101.2) | 15.0 (3.4-66.5) |
|
| |||||
|
Nephrotoxicity§ amongst ART-naïve patients initiated onto tenofovir
| |||||
| Normal (≥90) | 1 | 139.3 | 0.7 | 1.0 | 1.0 |
| Mild (60-89.9) | 4 | 101.9 | 3.9 | 5.8 (0.6-53.5) | 4.4 (0.4-45.8) |
| Moderate (30-59.9) | 3 | 25.3 | 11.9 | 18.0 (1.7-187.8) | 14.3 (1.4-149.5) |
|
| |||||
|
Nephrotoxicity§ amongst ART patients switched onto tenofovir
| |||||
| Normal (≥90) | 3 | 845.9 | 0.4 | 1.0 | 1.0 |
| Mild (60-89.9) | 7 | 340.9 | 2.1 | 5.6 (1.5-21.9) | 5.3 (1.4-19.8) |
| Moderate (30-59.9) | 3 | 30.9 | 9.7 | 28.0 (5.5-141.7) | 24.5 (3.2-188.2) |
|
| |||||
|
Death€
| |||||
| Normal (≥90) | 30 | 988.9 | 3.0 | 1.0 | 1.0 |
| Mild (60-89.9) | 25 | 453.8 | 5.5 | 2.0 (1.1-3.6) | 1.2 (0.7-2.3) |
| Moderate (30-59.9) | 14 | 64.0 | 21.9 | 7.8 (3.8-15.9) | 3.2 (1.3-7.8) |
|
| |||||
|
Death€ amongst ART-naïve patients initiated onto tenofovir
| |||||
| Normal (≥90) | 10 | 139.5 | 7.2 | 1.0 | 1.0 |
| Mild (60-89.9) | 10 | 101.9 | 9.4 | 1.7 (0.6-4.6) | 1.2 (0.4-3.4) |
| Moderate (30-59.9) | 7 | 29.1 | 24.0 | 3.9 (1.2-12.9) | 1.6 (0.4-6.6) |
|
| |||||
|
Death€ amongst ART patients switched onto tenofovir
| |||||
| Normal (≥90) | 20 | 849.4 | 2.4 | 1.0 | 1.0 |
| Mild (60-89.9) | 15 | 346.9 | 4.3 | 1.9 (0.9-3.9) | 1.2 (0.6-2.7) |
| Moderate (30-59.9) | 7 | 34.9 | 20.1 | 9.1 (3.7-22.4) | 5.2 (1.6-17.0) |
§
Nephrotoxicity was defined decline in kidney function from baseline (acute or chronic) that is secondary to a toxin (including drugs)
‡
Creatinine clearance was categorized according to the U.S. National Kidney Foundation’s Kidney Disease Outcome Quality Initiative (K/DOQI)
¥
Hazard ratios (HR) are from a marginal structural Cox hazard models adjusted for WHO stage III/IV, gender, age, CD4 count, BMI, ART-naive and haemoglobin at tenofovir initiation and current viral load status
€
Death obtained from South African National Vital Registration Infrastructure Initiative
CI, confidence interval