Table 3.
Treatment modifications and selected adverse events under therapy
| 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 |
* Statistically significant difference comparing arm A with arms B and C (HIV-positive vs. HIV-negative)
** Statistically significant difference comparing arm B versus C1 versus C2
†Percent of patients who were dose reduced for pegylated interferon (PegIFN) or ribavirin (RBV) and respective percent of the cumulative dose received.
Data shown as percent of patients or median (95% range)
NRTI nucleos(t)ide reverse transcriptase inhibitor, ALT serum alanine aminotransferase, Treatment discont. AEs Treatment discontinuation due to adverse events.