Safety and adverse events by treatment regimen
| Event* | Ledipasvir/sofosbuvir 8 weeks (n=43) | Ledipasvir/sofosbuvir + ribavirin 8 weeks (n=42) | Ledipasvir/sofosbuvir 12 weeks (n=79) | Ledipasvir/sofosbuvir+ribavirin 12 weeks (n=91) |
| Any AE | 16 (37) | 22 (52) | 33 (41) | 57 (63) |
| Treatment-related AE | 3 (7) | 10 (24) | 11 (14) | 32 (35) |
| Serious AE | 0 | 0 | 0 | 3 (3) |
| Discontinuation of treatment owing to an AE | 0 | 0 | 0 | 1 (1) |
| Death | 0 | 0 | 1 (1)† | 0 |
| Common AEs (occurring in >5% of patients receiving any treatment regimen) | ||||
| Headache | 4 (9) | 13 (31) | 12 (15) | 20 (22) |
| Fatigue | 4 (9) | 5 (12) | 8 (10) | 14 (15) |
| Anaemia | 0 | 2 (5) | 0 | 7 (8) |
| Constipation | 0 | 3 (7) | 0 | 3 (3) |
| Dyspepsia | 3 (7) | 1 (2) | 5 (6) | 6 (7) |
| Bronchitis | 3 (7) | 1 (2) | 3 (4) | 2 (2) |
| Abdominal pain | 0 | 2 (5) | 0 | 6 (7) |
| Fever | 1 (2) | 1 (2) | 1 (1) | 5 (5) |
| Laboratory abnormalities | ||||
| Haemoglobin, 8.5 to <10 g/dL | 0 | 1 (2) | 0 | 9 (10) |
| Lipase, >5.0×ULN | 1 (2) | 0 | 2 (3) | 1 (1) |
| Hyperglycaemia, >250 to 500 mg/dL | 0 | 1 (2) | 2 (3) | 1 (1) |
| Hyponatraemia, 121 to <125 mEq/L | 0 | 1 (2) | 0 | 1 (1) |
| Neutrophils, 500 to <750/mm3 | 0 | 0 | 2 (3) | 0 |
| APTT, >3.00×ULN | 1 (2) | 0 | 0 | 0 |
| INR, >2.0 to 3.0×ULN | 1 (2) | 0 | 0 | 0 |
| Lymphocytes, 350 to <500/mm3 | 0 | 0 | 0 | 1 (1) |
| Hyperkalaemia, >6.5 to 7.0 mEq/L | 0 | 0 | 0 | 1 (1) |
| Hyperbilirubinaemia, >2.5 to 5.0×ULN | 0 | 0 | 0 | 1 (1) |
| White blood cells, 1.00 to <1.50 GI/L | 0 | 0 | 0 | 0 |
| Platelets, 25 to <50 GI/L | 0 | 0 | 0 | 0 |
↵*All values are n (%) unless stated otherwise.
†Cause of death unknown.
AE, adverse event; APTT, active partial thromboplastin time; INR, international normalised ratio of prothrombin time; ULN, upper limit of normal.