Table 4.
Comparative Incidence of ADRs during the first and subsequent years of antiretroviral treatment at Jos University Teaching Hospital
| ADR type according to Organ/system |
Incident rate per 1000py (95% CI) [number of events] |
Incident rate ratio (95% CI) a versus b |
||
|
| ||||
| Overall | Treatment period ≤1 year (a) |
Treatment period >1 year (b) |
||
| All events | 28.33 (26.92–29.81) [1485] |
42.51 (39.02:46.31) [524] |
23.98 (22.51:25.54) [961] |
1.77 (1.59:1.97) |
|
Metabolic symptoms |
||||
| Lipodystrophy | 14.34 (13.36–15.41) [752] |
3.24 (2.38:4.42) [40] | 17.76 (16.51:19.12) [712] |
0.18 (0.13:0.25) |
| Gynaecomastia | 0.23 (0.13–0.4) [12] | 0.16 (0.04:0.65) [2] |
0.25 (0.13:0.46) [10] |
0.65 (0.07:3.05) |
|
Systemic symptoms |
||||
| Anaemia | 4.87 (4.3–5.5) [255] | 13.79 (11.87:16.03) [170] |
2.12 (1.71:2.62) [85] |
6.5 (4.98:8.54) |
|
Hypersensitivity reaction |
0.15 (0.08–0.31) [8] | 0.57 (0.27:1.19) [7] | 0.02 (0:0.18) [1] | 22.76 (2.92:1025.8) |
| Fever | 0.04 (0.01–0.15) [2] | 0.16 (0.04:0.65) [2] | 0 (0:0) [0] | |
| Headache | 0.04 (0.01–0.15) [2] | 0.08 (0.01:0.58) [1] | 0.02 (0:0.18) [1] | |
|
Skin and appendages |
||||
| Rash and itching | 1.68 (1.37–2.07) [88] | 6.17 (4.92:7.72) [76] | 0.3 (0.17:0.53) [12] | 20.59 (11.13:41.6) |
| SJS | 0.4 (0.26–0.61) [21] | 1.54 (0.98:2.42) [19] | 0.05 (0.01:0.2) [2] | 30.89 (7.45:273.49) |
| Erythema multiforme | 0.86 (0.64–1.15) [45] | 3.24 (2.38:4.42) [40] | 0.12 (0.05:0.3) [5] | 26.01 (10.27:84.45) |
| Exfoliative skin lesions |
0.1 (0.04–0.23) [5] | 0.24 (0.08:0.75) [3] | 0.05 (0.01:0.2) [2] | 4.88 (0.56:58.39) |
| Hyperpigmentation (skin/nail) |
0.25 (0.14–0.43) [13] | 0.57 (0.27:1.19) [7] | 0.15 (0.07:0.33) [6] | 7.59 (1.73:45.47) |
| Photosensitivity | 0.02 (0.00269–0.14) [1] |
0.08 (0.01:0.58) [1] | 0 (0:0) [0] | |
|
Peripheral nervous system |
||||
| Peripheral neuropathy |
2.06 (1.71–2.49) [108] |
5.11 (3.99:6.54) [63] | 1.12 (0.84:1.5) [45] | 4.55 (3.06:6.83) |
|
Central nervous system |
||||
| Nightmares | 0.44 (0.29–0.66) [23] | 0.89 (0.49:1.61) [11] | 0.3 (0.17:0.53) [12] | 2.98 (1.19:7.38) |
| Insomia | 0.38 (0.25–0.59) [20] | 1.14 (0.67:1.92) [14] | 0.15 (0.07:0.33) [6] | 7.59 (2.74:24.09) |
| Anxiety/ restlessness |
0.27 (0.16–0.45) [14] | 0.89 (0.49:1.61) [11] | 0.07 (0.02:0.23) [3] | 11.92 (3.15:66.55) |
| Irrational talk/aggression |
0.25 (0.14–0.43) [13] | 0.81 (0.44:1.51) [10] | 0.07 (0.02:0.23) [3] | 10.84 (2.79:61.29) |
| Somnolence | 0.15 (0.08–0.31) [8] | 0.41 (0.17:0.97) [5] | 0.07 (0.02:0.23) [3] | 5.42 (1.05:34.9) |
| Hallucination | 0.08 (0.03–0.2) [4] | 0.16 (0.04:0.65) [2] | 0.05 (0.01:0.2) [2] | 3.25 (0.24:44.86) |
| Seizures | 0.06 (0.02–0.18) [3] | 0.08 (0.01:0.58) [1] | 0.05 (0.01:0.2) [2] | 1.63 (0.03:31.23) |
| GI symptoms | ||||
| Nausea and vomiting |
0.59 (0.42–0.84) [31] | 1.95 (1.3:2.9) [24] | 0.17 (0.08:0.37) [7] | 11.15 (4.66:30.64) |
| Diarrhoea | 0.48 (0.32–0.71) [25] | 0.24 (0.08:0.75) [3] | 0.55 (0.36:0.83) [22] | 0.44 (0.08:1.48) |
| Abdominal pain | 0.11 (0.05–0.25) [6] | 0.16 (0.04:0.65) [2] | 0.1 (0.04:0.27) [4] | 1.63 (0.15:11.34) |
|
Hepatic symptoms |
||||
| Jaundice | 0.53 (0.37–0.77) [28] | 1.46 (0.92:2.32) [18] | 0.25 (0.13:0.46) [10] | 5.85 (2.56:14.19) |
|
Renal symptoms |
||||
| Oliguria/body swelling |
0.25 (0.14–0.43) [13] | 0.57 (0.27:1.19) [7] | 0.15 (0.07:0.33) [6] | 3.79 (1.09:13.66) |
| Others | ||||
| Muscle cramps | 0.04 (0.01–0.15) [2] | 0.04 (0.01–0.15) [2] | ||
| Bone pain | 0.04 (0.01–0.15) [2] | 0.04 (0.01–0.15) [2] | ||
| Deepening of voice |
0.02 (0.002–0.14) [1] | 0.02 (0.002–0.14) [1] | ||