Table 4.

Patient safety profile

	SMV/SOF (n=119)	SMV/SOF/RBV (n=32)	Total (n=151)
Most common Adverse Events, n (%)
Fatigue	31 (26.1)	7 (21.9)	38 (25.2)
Headache	20 (16.8)	8 (25.0)	28 (18.5)
Infections and infestations	20 (16.8)	2 (6.2)	22 (14.6)
Rash/Pruritus	17 (14.3)	4 (12.5)	21 (13.9)
Influenza like illness	12 (10.1)	6 (18.8)	18 (11.9)
Nausea/Vomiting	13 (10.9)	4 (12.5)	17 (11.3)
Anemia	4 (3.4)	12 (37.5)	16 (10.6)
Total patients with reported AEs	86 (72.3)	28 (87.5)	114 (75.5)
All Serious Adverse Events, n (%)
Renal failure acute	3 (2.5)	1 (3.1)	4 (2.7)
Abdominal pain upper	2 (1.7)	0 (0.0)	2 (1.3)
Infections	2 (1.7)	0 (0.0)	2 (1.3)
Hepatic decompensation	1 (0.8)	1 (3.1)	2 (1.3)
Anemia	1 (0.8)	0 (0.0)	1 (0.7)
Hepatic arteriovenous malformation	0 (0.0)	1 (3.1)	1 (0.7)
Nausea	0 (0.0)	1 (3.1)	1 (0.7)
Esophageal stenosis	0 (0.0)	1 (3.1)	1 (0.7)
Edema	1 (0.8)	0 (0.0)	1 (0.7)
Pyrexia	1 (0.8)	0 (0.0)	1 (0.7)
Cholangiolitis	0 (0.0)	1 (3.1)	1 (0.7)
Hepatic enzyme increased	1 (0.8)	0 (0.0)	1 (0.7)
Dehydration	0 (0.0)	1 (3.1)	1 (0.7)
Hyperglycemia	1 (0.8)	0 (0.0)	1 (0.7)
Hypervolemia	1 (0.8)	0 (0.0)	1 (0.7)
Suicide	0 (0.0)	1 (3.1)	1 (0.7)
Pneumonia aspiration	1 (0.8)	0 (0.0)	1 (0.7)
Pulmonary embolism	1 (0.8)	0 (0.0)	1 (0.7)
Hematoma	1 (0.8)	0 (0.0)	1 (0.7)
Total patients with reported SAEs	12 (10.1)	6 (18.8)	18 (11.9)
Mean change in laboratory values, baseline to end of treatment
Creatinine change, mean (range)	0.01 (−0.84,+0.68)	−0.06 (−0.85,+0.33)	−0.01 (−0.85,+0.68)
Total Bilirubin change, mean (range)	−0.2 (−5.3,+2.5)	−1.2 (−8.0,+0.9)	−0.4 (−8.0,+2.5)
Immunosuppression dose change, mean (range)
TAC	0 (−6,+2)	0 (−2,+4)	0 (−6,+4)
CSA	−18 (−275,+125)		−17 (−275,+125)
Everolimus/ Sirolimus	0 (−2,+0.5)	0 (−1, +2)	0 (−2,+2)
MMF/MPA	−20 (−1000,+1000)	104 (0–750)	14 (−1000,+1000)