Table 4.
Safety profile
| SOF SMV (n=667) |
SOF SMV RBV (n=169) |
Total (n=836) |
|
|---|---|---|---|
| Most common Adverse Events, n (%) | |||
| Fatigue | 162 (24.3) | 60 (35.5) | 222 (26.6) |
| Headache | 106 (15.9) | 31 (18.3) | 137 (16.4) |
| Nausea | 90 (13.5) | 32 (18.9) | 122 (14.7) |
| Influenza like illness | 73 (10.9) | 20 (11.8) | 93 (11.1) |
| Rash/ Pruritus | 60 (9.0) | 27 (16.0) | 87 (10.4) |
| Insomnia | 53 (8.0) | 28 (16.6) | 81 (9.7) |
| Pruritus | 53 (8.0) | 27 (16.0) | 80 (9.6) |
| Anaemia | 8 (1.2) | 50 (29.6) | 58 (6.9) |
| Photosensitivity reaction | 45 (6.8) | 13 (7.7) | 58 (6.9) |
| Total patients with any AE | 499 (74.81) | 150 (88.76) | 649 (77.63) |
| Anemia | |||
| AE Anemia, n (%) | 8 (1.2) | 50 (29.6) | 58 (6.9) |
| SAE Anemia, n (%) | 1 (0.2) | 0 (0.0) | 1 (0.1) |
| Hemoglobin change, delta mean (range) | −0.4 (−6.0,+5.1) | −2.1 (−5.7,+1.3) | −0.8 (−6.0,+5.1) |
| Ribavirin dose reduction/ interruption | 0 (0.0) | 35 (20.7) | 35 (4.2) |
| Ribavirin discontinuation | 0 (0.0) | 10 (5.9) | 10 (1.2) |
| Erythropoietin use | 0 (0.0) | 9 (5.3) | 9 (1.1) |
| Blood transfusion | 5 (0.7) | 5 (3.0) | 10 (1.2) |
| Most common Serious Adverse Events, n (%) | |||
| Decompensating events | 9 (1.4) | 2 (1.2) | 10 (1.2) |
| Infections and infestations | 8 (1.2) | 1 (0.6) | 9 (1.1) |
| Cardiac failure | 4 (0.6) | 0 (0.0) | 4 (0.5) |
| Gastrointestinal hemorrhage | 3 (0.5) | 1 (0.6) | 4 (0.5) |
| Arrhythmia | 2 (0.3) | 1 (0.6) | 3 (0.4) |
| Abdominal pain | 2 (0.3) | 0 (0.0) | 2 (0.2) |
| Renal failure acute | 0 (0.0) | 2 (1.2) | 2 (0.2) |
| Dyspnea | 2 (0.3) | 0 (0.0) | 2 (0.2) |
| Thromboembolic events | 2 (0.3) | 0 (0.0) | 2 (0.2) |
| Total patients with any SAE | 32 (4.80) | 12 (7.10) | 44 (5.26) |
| Creatinine changea, delta mean (range)mg/dL | 0.0 (−5.6,+0.9) | 0.0 (−0.8,+0.8) | 0.0 (−5.6,+0.9) |
| Total Bilirubin changea, delta mean (range) mg/dL | 0.1 (−3.3,+3.4) | 0.5 (−10.1,+8.3) | 0.2 (−10.1,+8.3) |
| Deaths, n | 4 (0.6) | 1 (0.6) | 5 (0.6) |
a
The change in creatinine and bilirubin is defined as the change in value from study initiation to the end of treatment (EOT or the date closest to EOT, not exceeding 2 weeks post EOT and not preceding 8 weeks post start of treatment).