Table 2.
Virologic responses according to therapeutic regimens
| TOTAL N = 599 | Sofosbuvir + simeprevir | Sofosbuvir + simeprevir + ribavirin | Fisher p value | CMH p value (strati-fication: 12 weeks vs 24 weeks) | CMH p value (strati-fication: RBV vs no RBV) | |||
|---|---|---|---|---|---|---|---|---|
| 12 weeks n = 485 | 24 weeks n = 51 | 12 weeks n = 45 | 24 weeks n = 18 | |||||
| Negative HCV RNA | ||||||||
| Week 12 n/N (%) | 519/576 (90) | 422/469 (90) | 41/47 (87) | 43/44 (98) | 13/16 (81) | 0.1312 | 0.2779 | 0.1514 |
| Week 24n/N (%) | 60/65 (92) | 44/49 (90) | 16/16 (100) | 0.3219 | 0.1869 | |||
| Follow up week 4n/N (%) | 277/570 (49) | 318/341 (93) | 30/31 (97) | 39/40 (98) | 13/13 (100) | 0.7525 | 0.2341 | 0.3669 |
| SVR 12 (imputeda) n/N (%) | 555/599 (93) | 449/485 (93) | 46/51 (90) | 44/45 (98) | 16/18 (89) | 0.3742 | 0.3197 | 0.2538 |
| SVR 24 n/N (%) | 459/473 (97) | 374/385 (97) | 38/40 (95) | 37/38 (97) | 10/10 (100) | 0.7360 | 0.6713 | 0.6102 |
| SVR 12 in non cirrhotic patients n/N (%) | 244/257 (95) | 206/219 (94) | 18/18 (100) | 18/18 (100) | 2/2 (100) | 0.5937 | 0.2887 | 0.2887 |
| SVR 12 in cirrhotic patients n/N (%) | 304/335 (91) | 236/259 (91) | 28/33 (85) | 26/27 (96) | 14/16 (88) | 0.4043 | 0.3882 | 0.1293 |
| SVR 12 in treatment naïve patientsn/N (%) | 160/173 (92) | 130/141 (92) | 12/13 (92) | 14/14 (100) | 4/5 (80) | 0.3637 | 0.6195 | 0.4809 |
| SVR 12 in treatment experienced patients n/N (%) | 395/426 (93) | 319/344 (93) | 34/38 (89) | 30/31 (97) | 12/13 (92) | 0.6749 | 0.3874 | 0.3635 |
| Last treatment | ||||||||
| PEG/RBV n/N (%) | 365/394 (93) | 300/324 (93) | 32/35 (91) | 24/25 (96) | 9/10 (90) | 0.8073 | 0.6462 | 0.6214 |
| First generation PI/PEG/RBV n/N (%) | 30/32 (94) | 19/20 (95) | 2/3 (67) | 6/6 (100) | 3/3 (100) | 0.3750 | 0.2637 | 0.1122 |
| Response profile | ||||||||
| Not respondersn/N (%) | 108/117 (92) | 87/94 (93) | 8/9 (89) | 9/10 (90) | 4/4 (100) | 0.6151 | 0.9339 | 0.9864 |
| Respondersb n/N (%) | 99/102 (97) | 84/86 (98) | 8/9 (89) | 4/4 (100) | 3/3 (100) | 0.4040 | 0.5154 | 0.1537 |
| Unknown n/N (%) | 188/207 (91) | 148/164 (90) | 18/20 (90) | 17/17 (100) | 5/6 (83) | 0.4343 | 0.3647 | 0.5569 |
| SVR 12 in Cirrhotic Treatment experienced patients n/N(%) | 230/258 (89) | 178/200 (89) | 23/27 (85) | 18/19 (95) | 11/12 (92) | 0.8219 | 0.3407 | 0.5044 |
| SVR 12 in patients with genotype 1a n/N (%) | 127/141 (90) | 99/110 (90) | 10/11 (91) | 13/14 (93) | 5/6 (83) | 0.8660 | 0.9608 | 0.7862 |
| SVR 12 in patients with genotype 1b infection n/N (%) | 280/297 (94) | 237/251 (94) | 20/22 (91) | 18/18 (100) | 5/6 (83) | 0.2403 | 0.6111 | 0.2015 |
| SVR 12 in patients with genotype 4 infection n/N (%) | 121/132 (92) | 89/99 (90) | 16/17 (94) | 10/10 (100) | 6/6 (100) | 0.9150 | 0.2283 | 0.5850 |
| SVR 12 in patients with genotype 1 not subtyped n/N (%) | 27/29 (93) | 24/25 (96) | 0/1 (0) | 3/3 (100) | 0.0764 | 0.7290 | 0.0005 | |
HCV Hepatitis C Virus, SVR Sustain virological response, PI Protease inhibitor, RBV Ribavirin, PEG Pegylated interferon.
aimputed: missing SVR12 measurements were imputed using SVR24 measurement if available (n = 52), otherwise using SVR4 measurement (n = 6). We imputed a virological failure in patients who died before SVR12 and therefore could not be evaluated (n = 4) and in patients who were lost of follow up (n = 7) and had no measurement of the virological response after end of therapy. b responders = patients with negative HCV RNA on last treatment - includes one patient with sustained virological response who was re-infected