Table 4 Adverse events observed in patients treated with generic abacavir/lamivudine and efavirenz in comparison to adverse events reported in published clinical trials evaluating the same branded drugs
Adverse event in studies with regimen abacavir/lamivudine/efavirenz | Current study, N = 42 | CLASS Study [20] N = 97 (96 weeks) | CNA30024 Study [21], N = 324 | ESS30009 Study [22], N = 169 |
|---|---|---|---|---|
Skin rash, n (%) | 6 (14.3) | 7 (7.2) | 21 (6.5) | 16 (9.6) |
Dizziness, n (%) | 7 (16.7) | No reported | 18 (5.6) | 9 (5.4) |
Drowsiness, n (%) | 5 (11.9) | No reported | No reported | No reported |
Depressive disorder, n (%) | 3 (7.1) | No reported | 20 (6.2) | 8 (4.8) |
Sleep disorder (insomnia), n (%) | 3 (7.1) | 8 (8.2) | 20 (6.2) | 10 (5.9) |
Dreams, n (%) | 2 (4.8) | 6 (6.2) | 15 (4.6) | No reported |
Anxiety, n (%) | 1 (2.4) | No reported | No reported | 4 (2.4) |
Tingling/Numbness (Sensation of heat) | 3 (7. 1) | No reported | No reported | No reported |
Dyspepsia or abdominal pain, n (%) | 3 (7.1) | No reported | 12 (3.7) | No reported |
Nausea, n (%) | 1 (2.4) | 4 (4.1) | 22 (6.8) | No reported |
Anorexia | 1 (2.4) | No reported | No reported | No reported |
Fatigue/weakness, n (%) | 1 (2.4) | 1 (2.4) | No reported | 7 (4.2) |
Increased cardiovascular risk - leading to study drug discontinuation | 1 (2.4) | No reported | No reported | No reported |
Vomiting, n (%) | 0 (0.0) | No reported | 7 (2.2) | No reported |
Suspected hypersensitivity to abacavir or other drug, n (%) | 0 (0.0) | 8 (8.2) | 28 (8.6) | 17 (10.1) |
Headache, n (%) | 0 (0.0) | No reported | 19 (5.9) | 10 (5.9) |
Ear, nose, and throat (ENT) Infections, n (%) | 0 (0.0) | No reported | 29 (9.0) | 11 (6.6) |
Upper respiratory tract infection, n (%) | 0 (0.0) | No reported | 13 (4.0) | 9 (5.4) |
Diarrhea, n (%) | 0 (0.0) | 1 (1.0) | 22 (6.8) | 6 (3.6) |
Viral respiratory infection, n (%) | 0 (0.0) | No reported | 21 (6.5) | No reported |
Musculoskeletal pain, n (%) | 0 (0.0) | No reported | 21 (6.5) | No reported |
Hypertriglyceridemia, n (% among 33 finished the study) | 8 (24.2) | 9 (9.3) | 18 (5.6) | No reported |
Increased Creatinine phosphokinase, n (%) | No assessed | No reported | No reported | 19 (11.4) |
Increased liver function test results, n (%) | 0 (0.0) | No reported | 13 (4.0) | 14 (8.4 %) |
Anemia, n (%) | 0 (0.0) | No reported | 7 (2.2) | No reported |