Table 2.
SVR rates stratified by demographic, undetectable HCV RNA and discontinuation of study drug treatment
| Study 1 (relapsers) N = 109 | Study 2 (nonresponders) N = 32 | |
|---|---|---|
| Gender –n/N (%) | ||
| Male | 62/66 (93.9) | 8/17 (47.1) |
| Female | 34/43 (79.1) | 3/15 (20.0) |
| P-value | 0.0316 | 0.1475 |
| Age –n/N (%) | ||
| ≤49 | 18/20 (90.0) | 2/6 (33.3) |
| ≥50 | 78/89 (87.6) | 9/26 (34.6) |
| P-value | 1.0000 | 1.0000 |
| HCV RNA (log10 IU/mL) –n/N (%) | ||
| ≥7.0 | 26/30 (86.7) | 5/10 (50.0) |
| <7.0 | 70/79 (88.6) | 6/22 (27.3) |
| P-value | 0.7498 | 0.2515 |
| Prior therapy for chronic hepatitis C –n/N (%) | ||
| Interferon | 12/13 (92.3) | 1/1 (100.0) |
| Interferon plus ribavirin | 13/14 (92.9) | 2/2 (100.0) |
| Peginterferon | 3/3 (100.0) | – (–) |
| Peginterferon plus ribavirin | 68/79 (86.1) | 8/29 (27.6) |
| P-value | 0.9271 | 0.0333 |
| Undetectable –n/N (%) | ||
| ≤Week 4 | 90/98 (91.8) | 9/23 (39.1) |
| >Week 4 ≤end of treatment | 6/9 (66.7) | 2/7 (28.6) |
| P-value | 0.0487 | 1.0000 |
| Discontinuation of study drug treatment –n/N (%) | ||
| No discontinuation | 65/69 (94.2) | 9/20 (45.0) |
| Telaprevir only | 19/20 (95.0) | 2/7 (28.6) |
| All study drugs | 12/20 (60.0) | 0/5 (0.0) |
| P-value | 0.0007 | 0.1711 |
SVR, sustained virological response; HCV, hepatitis C virus.
SVR was defined as an undetectable HCV RNA level 24 weeks after the end of treatment.