Efficacy outcomes and reasons for non-response
| Parameter | DCV+SOF N=359 | DCV+SOF+RBV N=126 | All patients N=485 |
|---|---|---|---|
| SVR12, n/N (%) (95% CI) | |||
| mITT (primary efficacy analysis)* | 313/341 (92) (88.4 to 94.5) | 106/119 (89) (82.0 to 94.1) | 419/460 (91) (88.1 to 93.5) |
| As-observed† | 313/323 (97) (94.4 to 98.5) | 106/110 (96) (91.0 to 99.0) | 419/433 (97) (94.6 to 98.2) |
| ITT‡ | 313/359 (87) (83.3 to 90.5) | 106/126 (84) (76.6 to 90.0) | 419/485 (86) (83.0 to 89.3) |
| On-treatment and post-treatment HCV RNA <LLOQ TD or TND (as-observed), n/N (%) (95% CI)§ | |||
| Treatment week 4 | 244/353 (69) (64.0 to 73.9) | 99/119 (83) (75.2 to 89.4) | 343/472 (73) (68.4 to 76.6) |
| Treatment week 12 | 339/350 (97) (94.4 to 98.4) | 111/116 (96) (90.2 to 98.6) | 450/466 (97) (94.5 to 98.0) |
| Treatment week 24 | 314/315 (>99) (98.2 to 100) | 96/96 (100) (96.2 to 100) | 410/411 (>99) (98.7 to 100) |
| Post-treatment week 24 (SVR24) | 246/257 (96) (92.5 to 97.8) | 73/77 (95) (87.2 to 98.6) | 319/334 (96) (92.7 to 97.5) |
| Non-SVR12 (mITT), n (%) | 28/341 (8) | 13/119 (11) | 41/460 (9) |
| Virological failure | 10 (3) | 4 (3) | 14 (3) |
| Virological breakthrough | 1 (<1) | 0 | 1 (<1) |
| Relapse | 9 (3) | 4 (3) | 13 (3) |
| Non-virological failure¶ | 18 (5) | 9 (7) | 27 (6) |
| Discontinuation due to AE | 0 | 3 (2) | 3 (1) |
| Death during treatment | 8 (2) | 2 (2) | 10 (2) |
| Death during follow-up | 10 (3) | 4 (3) | 14 (3) |
*mITT population: all treated patients, except for those who were lost to follow-up, withdrew informed consent or withdrew for undocumented reasons.
†As-observed population: mITT population, except for those patients with non-virological failure.
‡ITT population: all patients who received ≥1 dose of the programme regimen.
§Based on patients with available data at each time point.
¶Patients with missing data at post-treatment week 12 caused by death or treatment discontinuation due to AEs were imputed as failures in the mITT and ITT analyses.
AE, adverse event; DCV, daclatasvir; ITT, intention-to-treat; LLOQ, lower limit of quantitation; mITT, modified intention-to-treat; RBV, ribavirin; SOF; sofosbuvir; SVR12, sustained virological response at post-treatment week 12; SVR24, sustained virological response at post-treatment week 24; TD, target detected; TND, target not detected.