I.

Baseline characteristics of patients before starting treatment

1. Baseline clinical data of patients
Treatment Treatment Test of Sig. crude Adjusted CI 95%
naive experienced (p-value) OD
Age in years 37.55(11.8) 40.56(11.7) -2.76(0.006) 1.022(0.006) 1.022(0.007) (1.006-1.04)
(Mean ±SD)
Gender: n (%)
‒ Male 105(47%) 123(51%) 0.7(0.4) 1.17(0.395) 1.154(0.44) (0.79-1.67)
‒ Female 118(53%) 118(49%)
BMI: n (%)
‒ Underweight 2(0.01%) 0(0%) 2.88(0.58) 1.006(0.7) 1.005(0.7) (0.98-1.03)
‒ Normal 37(16.6%) 35(14.5%)
‒ Overweight 63(28.25%) 69(28.6%)
‒ Obese 51(22.8%) 53(21.9%)
‒ Extremely obese 68(32.34%) 81(35%)
Child Class: n (%)
‒ Class A 92(41.3%) 98(40.7%) 0.017(0.89) 0.976(0.89) 0.985(0.94) (0.68-1.43)
‒ Class B 131(58.7%) 143(59.3%)
‒ Class C
Arrhythmia by ECG:
n (%)
‒ Negative 100% 100%
‒ positive
Liver by US: n (%)
‒ No cirrhosis 100% 100%
‒ Cirrhosis
Spleen by US: n (%)
‒ Normal 100% 100%
‒ Large
Ascites by US: n (%)
‒ None 100 % 100%
‒ Mild/moderate
‒ Severe
HCC by US: n (%)
‒ Negative 100 % 100%
‒ Positive
Esophageal varices by
UGITE: n (%)
‒ None 100% 100%
‒ Grade 1
‒ Grade 2
‒ Grade 3/4 0%
BMI: body mass index, ECG: Electrocardiography, US: ultrasound, HCC: hepatocellular carcinoma, UGITE: Upper
Gastro-intestinal Tract Endoscopy
 2. Baseline laboratory and viral load data of patients:
Treat Treatme Test of crude Adjuste CI 95%
ment nt Sig. (p- d OD
naive experien value)
ced
Hemoglobin (g/dL) 13.4(0. 13.45(0. - 1.066(0 1.064(0. (0.86-1.3)
88) 857) 0.59(0. .55) 56)
55)
WBC (x103 6.53(0. 6.4(0.84) 1.57(0. 0.84(0. 0.86(0.1 (0.697-
cells/mm3) 896) 116) 116) 7) 1.066)
ANC (x103 3.35(2. 3.45(2.3 - 1.018(0 1.015(0. (0.94-
cells/mm3) 36) 2) 0.45(0. .66) 703) 1.099)
66)
Platelets (x103 289.3(5 285.94(5 0.69(0. 0.999(0 0.999(0. (0.99-
cells/mm3) 4.2) 0.5) 49) .49) 59) 1.003)
INR 2.01(0. 2.01(0.5 0.09(0. 0.99(0. 0.97(0.8 (0.7-1.35)
57) 6) 93) 93) 7)
ALT (IU/L) 24.5(13 23.8(14. 0.55(0. 0.99(0. 0.99(0.5 (0.98-
.9) 24) 59) 59) 7) 1.009)
AST (IU/L) 32.05(1 32.33(10 - 1.003(0 1.002(0. (0.98-
0.2) .5) 0.29(0. .77) 8) 1.02)
77)
Albumin (g/dL) 4.45(0. 4.38(0.8 0.919(0 0.91(0. 0.92(0.4 (0.74-
895) 6) .36) 36) 2) 1.13)
Bilirubin (mg/dL) 1.69(0. 1.7(0.2) - 1.09(0. 1.15(0.7 (0.47-
196) 0.19(0. 85) 6) 2.87)
85)
AFP (IU/L) 47.96(4 50.2(43. - 1.001(0 1.001(0. (0.99-
0.4) 7) 0.57(0. .57) 5) 1.006)
56)
Urea (mg/dL) 17.73(8 17.64(8. 0.11(0. 0.99(0. 0.99(0.9 (0.98-
.67) 76) 19) 91) 5) 1.02)
Creatinine (mg/dL) 0.9(0.1 0.92(0.1 - 2.06(0. 2.1(0.18 (0.7-6.33)
7) 6) 1.3(0.1 19) 5)
9)
Creatinine 163.6(5 150.7(44 2.94(0. 0.99(0. 0.99(0.0 (0.98-
clearance (mL/min) 0.1) .44) 003) 004) 15) 0.99)
HCV-RNA Log10 492*10 397*105 1.308(0 1(0.19) 1(0.296) (1-1)
(IU/mL) 5
(745*105 .19)
(817*1 )
05)
Data are expressed as mean ± standard deviation, WBC: White blood cells, ANC:
Absolute neutrophilic count, INR: international normalized ratio, ALT: alanine
transaminase, AST: aspartate transaminase, AFP: alfa-fetoprotein, HCV: hepatitis C
virus, RNA: ribonucleic acid
 II. Follow-up characteristics of patients after 4 weeks of treatment
1. Clinical data of patients after 4 weeks of treatment
Treatment Treatment Test of Sig. crude Adjusted CI 95%
naive experienced (p-value) OD
Child Class: n (%)
‒ Class A 32.7% 34.02% 1.5(0.46)
‒ Class B 65.02% 61.82% 0.56(0.3) 0.58(.358) (0.19-1.82)
‒ Class C 4.16% 4.16% 0.51(0.2) 0.53(.268) (0.176-1.6)
Arrhythmia by ECG:
n (%)
‒ Negative 48% 52.3% 0.003(0.99) 0.99(0.99) 0.97(0.9) (0.67-1.4)
‒ positive 52% 47.7%
Ascites by US: n (%) .
‒ None 115(51.6%) 135(56%) 0.92(.34) 0.84(0.34) 0.85(0.39) (0.59-1.2)
‒ Mild/moderate 108(48.4%) 106(44%)
‒ Severe
HCC by US: n (%)
‒ Negative 100% 100%
‒ Positive 0% 0%
Esophageal varices by
UGITE: n (%)
‒ None 100% 100%
‒ Grade 1
‒ Grade 2
‒ Grade 3/4
BMI: body mass index, ECG: Electrocardiography, US: ultrasound, HCC: hepatocellular carcinoma, UGITE:
Upper Gastro-intestinal Tract Endoscopy
 2. Laboratory data of patients after 4 weeks of treatment
Treatme Treatme Test of crude Adjuste CI 95%
nt naive nt Sig. (p- d OD
experien value)
ced
Hemoglobin 12.4(0.87) 12.5(0.8 - 1.07(0.5 1.07(0.5 (0.9-1.3)
(g/dL) 6) 0.59(0.5 5) 5)
5)
WBC (x103 8.5(0.89) 8.4(0.85) 1.57(0.1 0.85(0.1 0.86(0.1 (0.7-
cells/mm3) 2) 1) 7) 1.07)
ANC (x103 5.05(2.36) 5.15(2.3 - 1.02(0.6 1.02(0.6 (0.94-
cells/mm3) 2) 0.45(0.6 6) 9) 1.09)
6)
Platelets (x103 210.3(54. 206.9(50 0.68(0.4 0.9(0.5) 0.99(0.6 (0.9-
cells/mm3) 24) .5) 9) ) 1.003)
INR 2.01(0.57) 2.01(0.5 0.09(0.9 0.99(0.9 0.97(0.8 (0.7-
6) 3) 3) 7) 1.35)
ALT (IU/L) 32.5(13.9 31.8(14. 0.55(0.5 0.99(0.5 0.99(0.5 (0.98-
5) 24) 9) 9) 8) 1.009)
AST (IU/L) 22.05(10. 22.3(10. - 1.003(0. 1.002(0. (0.99-
21) 5) 0.29(0.7 8) 8) 1.02)
7)
Albumin (g/dL) 3.85(0.89) 3.77(0.8 0.91(0.3 0.91(0.3 0.907(0. (0.7-
6) 6) 6) 36) 1.12)
Bilirubin 0.45(0.5) 0.41(0.4 - 1.09(0.8 1.17(0.7 (0.47-
(mg/dL) 9) 0.195(0. 5) 4) 2.9)
85)
AFP (IU/L) 77.96(40. 80.2(43. - 1.001(0. 1.002(0. (0.99-
1) 7) 0.57(0.5 57) 49) 1.006)
7)
Urea (mg/dL) 29.7(8.67) 29.6(8.8) 0.11(0.9 0.99(0.9 0.99(0.9 (0.98-
) ) ) 1.02)
Creatinine 0.701(0.1 0.72(0.1 - 1.59(0.0 1.6(0.02 (1.07-
(mg/dL) 7) 6) 1.3(0.19 23) ) 2.4)
)
Creatinine 181.6(64. 167.7(57 2.45(0.0 0.996(0. 0.996(0. (0.992-
clearance 59) .2) 15) 016) 024) 0.999)
(mL/min)
HCV-RNA Log10 221.14(36 187.5(33 1.3(0.19 1(0.192) 1.154(0. (0.798-
by PCR (IU/mL) 7.14) 5.13) 2) 45) 1.67)
Data are expressed as mean ± standard deviation, WBC: White blood cells, ANC:
Absolute neutrophilic count, INR: international normalized ratio, ALT: alanine
transaminase, AST: aspartate transaminase, AFP: alfa-fetoprotein, HCV: hepatitis C
virus, RNA: ribonucleic acid
 3. Primary Efficacy and Safety Endpoints after 4 weeks of treatment

Treatment Treatment Test of Sig. (p- crude Adjusted CI 95%

naive experienced value) OD
HCV-RNA by PCR: n
(%)
‒ Negative 83(37.2%) 97(40.25%) 0.45(0.5) 0.88(0.5) 0.9(0.57) (0.6-1.3)
‒ Positive 140(62.8%) 144(59.75%)
Anemia: n (%) 109(48.9%) 126(52.3%) 0.54(0.46) 1.22(0.295) 0.8(0.231) (0.55-1.16)
Arrhythmia: n (%) 116(52%) 126(52.3%) 0.003(0.95) 0.997(0.989 0.98(0.9) (0.67-1.42)
)
Hepatotoxicity: n (%) 115(51.5%) 132(54.8%) 0.48(0.49) 1.19(0.34) 1.1(0.57) (0.77-1.62)
HRS: n (%) 122(54.7%) 121(50.2%) 0.94(0.33) 0.84(0.36) 0.83(0.33) (0.57-1.2)
HCV: hepatitis C virus, RNA: ribonucleic acid, HRS: Hepatorenal syndrome