Table 2.
Reasons for nonresponse
| Outcome, n (%) | Treatment‐naïve | Treatment‐experienced | ||||
|---|---|---|---|---|---|---|
| Without cirrhosis | Cirrhosis | Without cirrhosis | Cirrhosis | |||
| 8 weeks N = 208 | 12 weeks N = 294 | 12 weeks N = 69 | 12 weeks N = 49 | 16 weeks N = 22 | 16 weeks N = 51 | |
| Virologic failure | ||||||
| On‐treatment failure | 1a (<1) | 1 (<1) | 1a (1) | 1 (2) | 0 | 1a (2) |
| Relapse, n/N (%) | 5/200 (2.5) | 4/281b (1.4) | 0/67 | 4/48b (8.3) | 1/22 (4.5) | 2/50 (4.0) |
| Difference, % (95% CI) | 1.1% (−1.5, 4.4) | – | 3.8% (−14.4, 16.2) | – | ||
| Premature discontinuation | 0 | 4 (1) | 0 | 0 | 0 | 0 |
| Missing SVR12 data | 4 (2) | 5 (2) | 1 (1) | 0 | 0 | 0 |
CI, confidence interval; mITT, modified intention‐to‐treat; SVR12, sustained virologic response at posttreatment week 12.
a
This patient was nonadherent and was excluded in mITT efficacy analysis.
b
One of these patients was nonadherent and excluded in mITT efficacy analysis.