Efficacy and safety of sofosbuvir and ledipasvir in Japanese patients aged 75 years or over with hepatitis C genotype 1

Table 1 Baseline characteristics

Characteristics	Total (n = 246)	< 75 yr (n = 167)	≥ 75 yr (n = 79)	P value
Sex (male)	103 (42)	65 (39)	37 (47)	0.239
Age (yr)	69 (29-88)	65 (29-74)	78 (75-88)	< 0.001
Body weight (kg)	53 (35-91)	53 (38-91)	53 (35-78)	0.527
Cirrhosis	51 (21)	30 (18)	21 (26)	0.120
HCV RNA (log10IU/mL)	6.1 (1.6-7.3)	6.1 (1.6-7.3)	6.1 (4.0-6.8)	0.337
Hemoglobin (g/dL)	13.6 (9.0-16.8)	13.6 (9.5-16.8)	13.3 (9.0-15.9)	0.163
Platelets (× 109/L)	156 (26-340)	167 (26-340)	132 (57-278)	0.001
Aspartate aminotransaminase (U/L)	42 (17-191)	40 (17-191)	45 (20-155)	0.140
Alanine aminotransaminase (U/L)	38 (11-319)	38 (12-319)	37 (11-167)	0.341
eGFR (mL/min per 1.73 m2)	72 (36-132)	76 (38-132)	63 (36-98)	< 0.001
α-fetoprotein (ng/mL)	4 (1-382)	4 (1-382)	4 (1-74)	0.525
Fib-4 index	3.3 (0.5-23.2)	2.5 (0.5-23.2)	4.4 (1.5-10.7)	< 0.001
NS5A RAVs
Y93	22 (29)	10 (21)	12 (43)	0.146
L31	6 (8)	3 (6)	3 (11)	0.798
Y93/L31	5 (7)	4 (9)	1 (4)	0.645
Treatment experienced	52 (21)	41 (25)	11 (14)	0.064
Previous HCC treatment	16 (7)	11 (7)	5 (6)	0.841

Data are expressed as n (%) or median (range). eGFR: Estimated glomerular filtration rate; RAVs: Resistance-associated variants; HCC: Hepatocellular carcinoma.

Table 2 Sustained virological response 12 rates according to clinical and demographical factors

Parameters	n	SVR 12 (%)	P value
Sex			0.6272
Male	103	100.0
Female	143	98.6
Age (yr)			0.8287
< 75	167	99.4
≥ 75	79	98.7
HCV RNA (log10IU/mL)			0.7076
< 6.0	93	100.0
≥ 6.0	153	98.7
Liver fibrosis			0.8811
No cirrhosis	195	99.5
Cirrhosis	51	98.0
Fib-4 index			0.4634
< 3.25	125	100.0
≥ 3.25	121	98.3
Prior treatment			0.8931
Treatment naïve	194	99.0
Treatment experienced	52	100.0
Previous HCC treatment			0.2868
No	230	99.6
Yes	16	93.8
NS5A RAVs			0.5471
None	48	97.9
Y93	22	100.0
L31	6	83.3
Y93/L31	5	100.0

RAVs: Resistance-associated variants; HCC: Hepatocellular carcinoma; SVR: Sustained virological response.

Table 3 Safety profile

	Total (n = 246)	< 75 yr (n = 167)	≥ 75 yr (n = 79)
Common adverse effects
Headache	6 (2.4)	4 (2.4)	2 (2.5)
Pruritus	2 (0.8)	0	2 (2.5)
Constipation	2 (0.8)	2 (1.2)	0
Stomatitis	2 (0.8)	2 (1.2)	0
Skin eruption	1 (0.4)	1 (0.6)	0
Chill	1 (0.4)	1 (0.6)	0
Nausea	1 (0.4)	1 (0.6)	0
Fever	1 (0.4)	1 (0.6)	0
Insomnia	1 (0.4)	1 (0.6)	0
Hematological abnormalities
Hemoglobin < 10.0 g/dL	0	0	0
Platelet count < 50 × 109/L	0	0	0
Laboratory abnormalities
Total bilirubin > 3.0 mg/dL	0	0	0
Alanine aminotransferase > 5 × ULN	0	0	0
Serum creatinine > 1.5 × baseline	0	0	0
Death	0	0	0
Discontinuation due to adverse effects	2 (0.8)	2 (1.2)	0
Cerebral hemorrhage	1 (0.4)	1 (0.6)	0
Skin eruption	1 (0.4)	1 (0.6)	0

Data are expressed as n (%).