Table 4.
Adjusting effects for possible confounders - SVR, HIV-positive patients
| SVR | No SVR | Uni-variate | Multi-variate | Multivariate | |
|---|---|---|---|---|---|
| n = 64 | n = 54 | p-value | p-value | Odds-ratio (95% CI) | |
| Age [years] | 40 (27 - 54) | 41 (27 - 48) | 0.566 | - | - |
| Male sex [%] | 75 | 78 | 0.662 | - | - |
| Transm. risk IVDU [%] | 20 | 30 | 0.709 | - | - |
| HCV GT 1 or 4 [%] | 50 | 76 | 0.002 | 0.001 | 0.2 (0.1 - 0.5) |
| HCVRNA ≥ 5 × 105 IU/ml[%] | 42 | 63 | 0.014 | 0.009 | 0.3 (0.1 - 0.7) |
| ALT [IU/l] | 63 (19 - 190) | 80 (25 - 250) | 0.368 | - | - |
| Weight adapted RBV [%] | 88 | 73 | 0.237 | - | - |
| Tx duration 48 wks [%] | 47 | 27 | 0.309 | - | - |
| Enrollment period [%] | |||||
| 2002 - 2004 | 56 | 67 | 0.253 | - | - |
| 2005 - 2007 | 44 | 32 | |||
| Treatment arm [%] | |||||
| B (no HAART) | 44 | 39 | |||
| C1 (NRTI-cont.) | 33 | 52 | 0.047 | 0.025 | 0.3 (0.1 - 0.9)* |
| C2 (NRTI free) | 23 | 9 | |||
| HIV-RNA [copies/ml, log10] | 1.7 (1.7 - 4.8) | 1.7 (1.7 - 4.8) | 0.372 | - | |
| CD4-cellcount | |||||
| [/μl] | 487 (236 - 1042) | 542 (222 - 831) | 0.828 | - | |
| [%] | 27 (15 - 41) | 26 (12 - 41) | 0.364 | - | |
| Anemia [%] | |||||
| Grade 1/2 | 11 | 11 | 1.000 | . | |
| Grade 3/4 | - | - | |||
| Leucopenia [%] | |||||
| Grade 1/2 | 47 | 41 | 0.578 | - | |
| Grade 3/4 | 9 | 7 | 0.753 | ||
| Thrombocytopenia [%] | |||||
| Grade 1/2 | 47 | 43 | 0.712 | - | |
| Grade 3/4 | 5 | 6 | 1.000 | ||
| Clinical adverse events [%] | |||||
| Grade 1/2 | 67 | 69 | 1.000 | - | |
| Grade 3/4 | 11 | 13 | 0.781 | ||
| Dose reduction PegIFN [%] | 11 | 9 | 1.000 | ||
| Dose reduction RBV [%] | 13 | 20 | 0.215 | - | |
| Treatm. discont. AEs [%] | 5 | 24 | 0.003 | 0.004 | 0.1 (0 - 0.5) |
Data shown as percent of patientsor median (95% range); *treatment arm C1 compared to B and C2 (reference) SVR sustained virological response, IVDU intravenous drug abuse, GT HCV genotype; ALT serum alanine aminotransferase, RBV ribavirin, Tx Treatment, wks weeks, NRTI nucleos(t)ide reverse transcriptase inhibitor, Treatment discont. AEs Treatment discontinuation due to adverse events.