Table 5.
Post-hoc analysis treatment arm C1 with regard to SVR
| SVR | No SVR | p-value | |
|---|---|---|---|
| n = 21 | n = 28 | ||
| Age [years] | 41 (31 - 47) | 42 (27 - 47) | 0.732 |
| Male sex [%] | 81 | 71 | 0.733 |
| Transmission risk IVDU [%] | 19 | 29 | 0.844 |
| HCV genotype 1 or 4 [%] | 43 | 79 | 0.007 |
| HCV-RNA [IU/ml, log10] | |||
| HCV-RNA ≥ 500 000 IU/ml [%] | 5.1 (4 - 6) | 5.7 (4.7 - 7.2) | 0.001 |
| 24 | 54 | 0.019 | |
| ALT [IU/l] | 72 (31 - 206) | 71 (27 - 243) | 0.949 |
| Weight adapted RBV, GT 1/4 infections only [%] | 100 | 68 | 0.141 |
| Tx duration 48 wks, GT 2/3 infections only [%] | 42 | 20 | 0.600 |
| Enrollment period 2002 - 2004 [%] | 52 | 57 | 0.771 |
| HAART [%] | |||
| 3 × NRTI | 10 | 14 | 0.688 |
| AZT | 24 | 39 | 0.359 |
| d4T | 19 | 18 | 1.000 |
| ABC | 19 | 39 | 0.210 |
| TDF | 52 | 43 | 0.572 |
| HIV-RNA > Lod [%] | 4 | 14 | 0.369 |
| CD4-cellcount [/μl] | 470 (268 - 685) | 524 (222 - 781) | 0.521 |
| Elevations serum ALT [%] | |||
| Grade 1/2 | 76 | 79 | 1.000 |
| Grade 3/4 | - | 11 | 0.250 |
| Anemia [%] | |||
| Grade 1/2 | 24 | 21 | 1.000 |
| Grade 3/4 | - | - | - |
| Leucopenia [%] | |||
| Grade 1/2 | 57 | 61 | 1.000 |
| Grade 3/4 | 14 | 11 | 1.000 |
| Thrombocytopenia [%] | |||
| Grade 1/2 | 57 | 46 | 0.567 |
| Grade 3/4 | 9 | 11 | 1.000 |
| Clinical adverse events [%] | |||
| Grade 1/2 | 67 | 61 | 0.769 |
| Grade 3/4 | 10 | 7 | 1.000 |
| Dose reduction PegIFN [%]† | 10 | 18 | 0.436 |
| % of total dose received | 87 | 81 | |
| Dose reduction RBV [%]† | 14 | 32 | 0.179 |
| % of total dose received | 91 | 78 | |
| Treatment discont. AEs [%] | - | 14 | 0.125 |
†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 (95% Confidence Interval) or median (95% range). SVR sustained virological response, IVDU intravenous drug abuse, ALT serum alanine aminotransferase, RBV ribavirin, GT HCV genotype, Tx Treatment, wks weeks, NRTI nucleos(t)ide reverse transcriptase inhibitor, AZT zidovudine, d4T stavudine, ABC abacavir, TDF tenofovir DF, Lod Level of detection, Treatment discont. AEs Treatment discontinuation due to adverse events.