On-treatment safety and tolerability
| Patients, n (%) | DCV+SOF N=359 | DCV+SOF+RBV N=126 | All patients N=485 |
|---|---|---|---|
| Any AE | 217 (60) | 93 (74) | 310 (64) |
| Serious AEs | 64 (18) | 30 (24) | 94 (19) |
| Treatment-related serious AEs | 5 (1) | 6 (5) | 11 (2) |
| Grade 3 or 4 AEs | 41 (11) | 21 (17) | 62 (13) |
| AEs leading to discontinuation or death | 16 (4) | 12 (10) | 28 (6) |
| Deaths* | 8 (2) | 2 (2) | 10 (2) |
| AEs (any grade) in ≥5% of patients | |||
| Fatigue | 48 (13) | 15 (12) | 63 (13) |
| Anaemia | 10 (3) | 40 (32) | 50 (10) |
| Headache | 30 (8) | 6 (5) | 36 (7) |
| Nausea | 16 (4) | 16 (13) | 32 (7) |
| Diarrhoea | 19 (5) | 8 (6) | 27 (6) |
| Selected treatment-emergent grade 3 or 4 laboratory abnormalities†‡ | |||
| Haemoglobin <9 g/dL | 11 (3) | 13 (11) | 24 (5) |
| ALT >5×ULN | 3 (1) | 0 | 3 (1) |
| AST >5×ULN | 2 (1) | 0 | 2 (<1) |
| Total bilirubin >2.5×ULN | 11 (3) | 11 (9) | 22 (5) |
| Creatinine >1.8×ULN | 5 (1) | 0 | 5 (1) |
On-treatment safety includes events that occurred during treatment period and first 7 days after stopping treatment.
*No deaths reported as treatment related. Details on deaths (on-treatment and after treatment), serious AEs and AEs leading to discontinuation are summarised in online supplementary tables S1, S2 and S4.
†Data not available: haemoglobin, n=15; ALT, n=16; AST, n=29; total bilirubin, n=18; creatinine, n=24.
‡Grade 4 abnormalities included: haemoglobin <7 g/dL, n=5; ALT >10×ULN, n=1; AST >10×ULN, n=2; total bilirubin >5×ULN, n=3; creatinine ≥3.5×ULN, n=3.
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; DCV, daclatasvir; RBV, ribavirin; SOF, sofosbuvir; ULN, upper limit of normal.