Table 4. AEs Occurring during treatment or follow-up in patients treated With OBV/PTV/r ± DSV ± RBV.
| AE | PTV/r/OBV + RBV n = 269 |
PTV/r/OBV + DSV + RBV n = 929 |
PTV/r/OBV + DSV n = 1,186 |
Total N = 2,408 |
|---|---|---|---|---|
| Any AE | 77 (28.6) | 338 (36.4) | 180 (15.2) | 596 (24.8) |
| Severity | 3 (1.1) | 19 (2.0) | 17 (1.4) | 39 (1.6) |
| Any serious AE* | 1 (0.4) | 22 (2.4) | 25 (2.1) | 48 (2.0) |
| Death | 0 | 3 (0.3) | 5 (0.4) | 8 (0.3) |
| AEs related to OBV/PTV/r ± DSV** | 40 (14.9) | 127 (13.7) | 118 (9.9) | 286 (11.9) |
| OBV/PTV/r ± DSV discontinued | 2 (0.7) | 17 (1.8) | 10 (0.8) | 29 (4.9) |
| AEs related to RBV* | 64 (23.8) | 283 (30.5) | N/A | 347 (14.4) |
| RBV discontinued | 4 (1.5) | 57 (6.1) | N/A | 61 (5.1)** |
| RBV reduced/interrupted | 31 (11.5) | 146 (15.7) | N/A | 177 (14.8)** |
| AEs related to RBV | 64 (23.8) | 283 (30.5) | N/A | 347 (29.0)** |
Abbreviations: AE, adverse event; OBV/PTV/r ± DSV ± RBV, ombitasvir/paritaprevir/ritonavir plus dasabuvir with or without ribavirin.
Values are presented as n (%).
* There were 56 serious AEs, 5 probably/possibly related to OBV/PTV/r + DSV + RBV, 10 with OBV/PTV/r + DSV and 7 with RBV.
** Calculated over total of patients treated with RBV.