Retrospective Cohort Study
Copyright ©The Author(s) 2017.
World J Hepatol. Dec 28, 2017; 9(36): 1340-1345
Published online Dec 28, 2017. doi: 10.4254/wjh.v9.i36.1340
Table 1 Baseline characteristics
CharacteristicsTotal (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
Cirrhosis51 (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 index3.3 (0.5-23.2)2.5 (0.5-23.2)4.4 (1.5-10.7)< 0.001
NS5A RAVs
Y9322 (29)10 (21)12 (43)0.146
L316 (8)3 (6)3 (11)0.798
Y93/L315 (7)4 (9)1 (4)0.645
Treatment experienced52 (21)41 (25)11 (14)0.064
Previous HCC treatment16 (7)11 (7)5 (6)0.841
Table 2 Sustained virological response 12 rates according to clinical and demographical factors
ParametersnSVR 12 (%)P value
Sex0.6272
Male103100.0
Female14398.6
Age (yr)0.8287
< 7516799.4
≥ 757998.7
HCV RNA (log10IU/mL)0.7076
< 6.093100.0
≥ 6.015398.7
Liver fibrosis0.8811
No cirrhosis19599.5
Cirrhosis5198.0
Fib-4 index0.4634
< 3.25125100.0
≥ 3.2512198.3
Prior treatment0.8931
Treatment naïve19499.0
Treatment experienced52100.0
Previous HCC treatment0.2868
No23099.6
Yes1693.8
NS5A RAVs0.5471
None4897.9
Y9322100.0
L31683.3
Y93/L315100.0
Table 3 Safety profile
Total (n = 246)< 75 yr (n = 167)≥ 75 yr (n = 79)
Common adverse effects
Headache6 (2.4)4 (2.4)2 (2.5)
Pruritus2 (0.8)02 (2.5)
Constipation2 (0.8)2 (1.2)0
Stomatitis2 (0.8)2 (1.2)0
Skin eruption1 (0.4)1 (0.6)0
Chill1 (0.4)1 (0.6)0
Nausea1 (0.4)1 (0.6)0
Fever1 (0.4)1 (0.6)0
Insomnia1 (0.4)1 (0.6)0
Hematological abnormalities
Hemoglobin < 10.0 g/dL000
Platelet count < 50 × 109/L000
Laboratory abnormalities
Total bilirubin > 3.0 mg/dL000
Alanine aminotransferase > 5 × ULN000
Serum creatinine > 1.5 × baseline000
Death000
Discontinuation due to adverse effects2 (0.8)2 (1.2)0
Cerebral hemorrhage1 (0.4)1 (0.6)0
Skin eruption1 (0.4)1 (0.6)0

  • Citation: Ozono Y, Nagata K, Hasuike S, Iwakiri H, Nakamura K, Tsuchimochi M, Yamada Y, Takaishi Y, Sueta M, Miike T, Tahara Y, Yamamoto S, Shide K, Hidaka T, Kubuki Y, Kusumoto K, Ochiai T, Kato J, Komada N, Hirono S, Kuroki K, Shigehira M, Shimoda K. Efficacy and safety of sofosbuvir and ledipasvir in Japanese patients aged 75 years or over with hepatitis C genotype 1. World J Hepatol 2017; 9(36): 1340-1345
  • URL: https://www.wjgnet.com/1948-5182/full/v9/i36/1340.htm
  • DOI: https://dx.doi.org/10.4254/wjh.v9.i36.1340