Table 4.
Safety and Tolerability on Treatment
| Parameter | DCV‐SOF‐RBV 12 Weeks (n = 24) | DCV‐SOF‐RBV 16 Weeks (n = 26) | Total (N = 50) |
|---|---|---|---|
| Any AE | 23 (95.8) | 24 (92.3) | 47 (94.0) |
| Deatha | 1 (4.2) | 0 | 1 (2.0) |
| SAEsb | 2 (8.3) | 3 (11.5) | 5 (10.0) |
| Congestive cardiomyopathy | 1 (4.2) | 0 | 1 (2.0) |
| Somnolence | 1 (4.2) | 0 | 1 (2.0) |
| Pneumonia | 0 | 1 (3.8) | 1 (2.0) |
| Arteriosclerosis | 0 | 1 (3.8) | 1 (2.0) |
| Basal cell carcinoma | 0 | 1 (3.8) | 1 (2.0) |
| AE leading to discontinuation | 0 | 0 | 0 |
| Grade 3‐4 AEsc | 2 (8.3) | 2 (7.7) | 4 (8.0) |
| RBV dose reductions | 2 (8.3) | 4 (15.4) | 6 (12.0) |
| AEs in ≥10% of patients overall (all grades) | |||
| Insomnia | 8 (33.3) | 7 (26.9) | 15 (30.0) |
| Fatigue | 6 (25.0) | 7 (26.9) | 13 (26.0) |
| Headache | 7 (29.2) | 5 (19.2) | 12 (24.0) |
| Irritability | 5 (20.8) | 2 (7.7) | 7 (14.0) |
| Asthenia | 2 (8.3) | 5 (19.2) | 7 (14.0) |
| Diarrhea | 1 (4.2) | 4 (15.4) | 5 (10.0) |
| Dyspnea | 2 (8.3) | 3 (11.5) | 5 (10.0) |
| Grade 3‐4 laboratory abnormalitiesd | |||
| Hemoglobin | 0 | 1 (3.8) | 1 (2.0) |
| Total bilirubin | 1 (4.2) | 1 (3.8) | 2 (4.0) |
a
Dilated cardiomyopathy on treatment day 72, considered unrelated to study treatment by the investigator. This single cardiac event is reported here as an SAE and a grade 3‐4 AE under the preferred term of “congestive cardiomyopathy”.
b
None were considered related to study treatment by the investigator.
c
Congestive cardiomyopathy (grade 4) plus gastrointestinal infection (grade 3; n = 1); somnolence (grade 3; n = 1); and pneumonia (grade 3; n = 1)—all unrelated to treatment. Treatment‐related anemia (grade 3; n = 1).
d
All listed events were of grade 3 intensity.