HIV-negative | HIV-positive | |||
---|---|---|---|---|
No HAART | NRTI-containing | NRTI-free | ||
Arm A | Arm B | Arm C1 | Arm C2 | |
n = 50 | n = 49 | n = 49 | n = 20 | |
Elevations serum ALT [%] | ||||
Grade 1/2** | 64 | 61 | 78 | 90 |
Grade 3/4 | - | 10 | 6 | 5 |
Anemia [%] | ||||
Grade 1/2** | 10 | 2 | 22 | 5 |
Grade 3/4 | - | - | - | - |
Maximum Hb loss [g/dl] | 3.1 (1.1 - 5.1) | 3.0 (0.6 - 5.3) | 2.9 (0.8 - 5.7) | 3.3 (0.8 - 4.4) |
Leucopenia [%] | ||||
Grade 1/2** | 40 | 25 | 69 | 55 |
Grade 3/4* | 0 | 4 | 12 | 10 |
Thrombocytopenia [%] | ||||
Grade 1/2 | 44 | 35 | 51 | 55 |
Grade 3/4 | 4 | - | 10 | 5 |
Clinical adverse events [%] | ||||
Grade 1/2 | 70 | 63 | 63 | 90 |
Grade 3/4 | 12 | 18 | 8 | 5 |
Dose reduction PegIFN [%]†* | 22 | 8 | 14 | 5 |
% of total dose received | 84 | 87 | 81 | 88 |
Dose reduction RBV [%]† | 28 | 8 | 25 | 15 |
% of total dose received | 86 | 81 | 79 | 90 |
Treatment discont. AEs [%] | 8 | 18 | 8 | 10 |