Table IV.

Treatment course, modification and discontinuation, and safety data according to regimen

Parameter	8 weeks no RBV n = 238	12 weeks no RBV n = 362	12 weeks + RBV n = 79
Treatment course, n (%):
Therapy discontinuation	0	2 (0.6)	1 (1.3)
Therapy modification	1 (0.4)	1 (0.3)	5 (6.3)
Patients with at least one AE, n (%)	7 (3)	52 (14.4)	32 (40.5)#
Serious adverse events*	0	1	1
Most common AEs (> 2%), n (%):
Weakness/fatigue	1 (0.4)	16 (4.4)	14 (17.7)#
Sleep disorder:	0	5 (1.4)	2 (2.5)
Headache	2 (0.8)	10 (2.8)	3 (4)
Anemia	0	2 (0.5)	6 (8)
Death in treatment course**	2	0	0

^#p < 0.001 vs. LDV/SOF without RBV.

^*Stomach cancer, stroke.

^**Not related to antiviral therapy: after bone-marrow transplantation in patient with aplastic anemia, unknown reason.

RBV – ribavirin, AE – adverse event.