Table 3

Adverse events (AEs) and management of anaemia

Sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks (n=283)SOF plus RBV for 16 weeks (n=38)Total (N=321)
EventN patients (%)N patients (%)N patients (%)
AEs occurred in >10% of patients234 (82.7)34 (89.5)268 (83.5)
 Fatigue110 (38.9)19 (50.0)129 (40.2)
 Anaemia 54 (19.1)14 (36.8)68 (21.2)
 Nausea51 (18.0)5 (13.2)56 (17.5)
 Headache44 (15.6)7 (18.4)51 (15.9)
 Insomnia41 (14.5)6 (15.8)47 (14.6)
 Rash37 (13.1)7 (18.4)44 (13.7)
 Flu-like symptoms36 (12.7)4 (10.5)40 (12.5)
 Dyspnoea29 (10.3)5 (13.2)34 (10.6)
 Back pain10 (3.5)5 (13.2)15 (4.7)
Serious AEs*11 (3.9)4 (10.5) 15 (4.7)
Anaemia management
 RBV dose reduction45 (15.9)12 (31.6)57 (17.8)
 Erythropoetin use7 (2.5)3 (7.9)10 (3.1)
 Blood transfusion7 (2.5)1 (2.6)8 (2.5)
 RBV discontinuation1 (0.4)0 (0)1 (0.3)
  • *Anaemia (2), abdominal pain (2), chest discomfort (1), chest pain (1), generalised oedema (2), multiorgan failure (1), bacterial peritonitis (2), gastroenteritis (1), upper respiratory tract infection (1), urinary tract infection (1), fall (1), fluid overload (1), hypovolaemia (1), hepatic encephalopathy (2), depression (1), chronic obstructive pulmonary disease (1) and stent placement (1). AE of anaemia reported by treatment provider, use of erythropoietin growth factors (such as eryphopoetin) or patient receiving a transfusion.