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Jan 27, 2022 (publication date) through Oct 30, 2025
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Publication Name
World Journal of Hepatology
ISSN
1948-5182
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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Retrospective Cohort Study
Copyright ©The Author(s) 2022.
World J Hepatol. Jan 27, 2022; 14(1): 195-208
Published online Jan 27, 2022. doi: 10.4254/wjh.v14.i1.195
Table 1 Characteristics of patients with hepatitis C virus (n = 532)
HCV patients (n = 532), % (n) or mean ± SD
Age (yr)56.88 ± 11.08
Men/women51.1% (272)/48.9% (260)
High-blood pressure44.1% (231/524)
Type 2 diabetes29.7% (156/526)
BMI (n = 442)27.01 ± 4.99
Dyslipidemia20.8% (109/524)
Hypothyroidism 16.2% (85/524)
Psychiatric disorder 10.2% (53/521)
Previous alcohol use 19.2% (102/523)
HCV genotype
1A37.0% (197)
1B38.0% (202)
1 non-classified3.5% (19)
20.8% (4)
320.1% (107)
40.4% (2)
50.2% (1)
HCV viral load (log IU/mL)5.78 ± 0.75
Previous HCV treatment (n = 525)
None46.3% (243)
Peg-IFN + RBV46.1% (242)
Peg-IFN + PI 7.6% (40)
Liver fibrosis (Metavir classification)
F0/F18.8% (47)
F213.0% (69)
F320.7% (110)
F457.5% (306)
Liver-related complications (n = 306)
Ascites30.3% (93)
Esophageal varices72.0% (221)
Portal hypertensive bleeding15.6% (48)
Hepatic encephalopathy14.7% (45)
AST (U/L)61.41 ± 45.06
ALT (U/L)61.87 ± 58.29
Total bilirubin (mg/dL)1.13 ± 1.08
Albumin (g/dL)4.15 ± 2.64
Platelets (/mm3)141.82 ± 77.21
INR1.18 ± 0.23
Creatinine (mg/dL)1.31 ± 1.96
Hemoglobin (g/dL)13.73 ± 1.90
Alpha-fetoprotein (ng/mL)23.59 ± 103.61
Child-Pugh classification (n = 306)
A66.6% (204)
B or C27.7% (85)
Non-classified5.7% (17)
Child-Pugh Score (n = 289)5.94 ± 1.54
MELD Score 10.17 ± 3.95
ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BMI: Body mass index; HCV: Hepatitis C virus; INR: International normalized ratio; MELD: Model for end-stage liver disease; Peg-IFN: Pegylated-interferon; PI: Protease inhibitor (boceprevir or telaprevir); RBV: Ribavirin.
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Table 2 Hepatitis C virus therapeutic regimens (n = 532)
Features of treatment
% (n)
Regimens
SOF + DCV + RBV49.2% (262)
SOF + SMV21.2% (113)
SOF + DCV17.7% (94)
SOF + SMV + RBV8.1% (43)
3D2.3% (12)
3D + RBV0.6% (3)
SOF + RBV0.6% (3)
SOF + LED0.2% (1)
SOF + LED + RBV0.2% (1)
Duration
12 wk77.2% (411)
24 wk22.8% (121)
Use of RBV58.6% (312)
Dose of RBV (mg/kg/day) mean ± SD12.11 ± 3.01
3D: Veruprevir/ritonavir, ombitasvir and dasabuvir; HCV: Hepatitis C virus; LED: Ledipasvir; RBV: Ribavirin; SMV: Simeprevir; SOF: Sofosbuvir; DCV: Daclatasvir.
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Table 3 Sustained virologic response rates according to therapeutic regimens, hepatitis C virus genotypes and cirrhosis
SVR
ITT (n = 532), % (n)
m-ITT (n = 509), % (n)
Global 92.6% (493/532)96.8% (493/509)
Genotype
193.7% (392/418)97.7% (392/401)
2100% (4/4)100% (4/4)
387.8% (94/107)93.0% (94/101)
4100% (2/2)100% (2/2)
5100% (1/1)100% (1/1)
Treatment regimen
3D ± RBV100% (15/15)100% (15/15)
SOF + DCV86.1% (81/94) 95.2% (81/85)
SOF + DCV + RBV94.2% (247/262)97.2% (247/254)
SOF + RBV100% (3/3)100% (3/3)
SOF + SMV92% (104/113)96.3% (104/108)
SOF + SMV + RBV95.3% (41/43)97.6% (41/42)
SOF + LED ± RBV100% (2/2)100% (2/2)
Presence of cirrhosis
No94.6% (214/226)98.6% (214/217)
Yes91.1% (279/306)95.5% (279/292)
3D: Veruprevir/ritonavir, ombitasvir and dasabuvir; DCV: Daclatasvir; HCV: Hepatitis C virus; ITT: Intention-to-treat; m-ITT: Modified intention-to-treat; LED: Ledipasvir; RBV: Ribavirin; SMV: Simeprevir; SOF: Sofosbuvir; SVR: Sustained virologic response.
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Table 4 Variables associated with sustained virologic response by intention-to-treat analysis (n = 532)
SVR (n = 493), % (n) or mean ± SD
Non-SVR (n = 39), % (n) or mean ± SD
P value
Age (yr)56.85 ± 10.9657.23 ± 12.610.811
Men/women 50.1% (247)/49.9% (246)64.1% (25)/35.9% (14)0.092
High-blood pressure 44.0% (214/486)44.7% (17/38)0.932
Type 2 diabetes 29.9% (146/488)26.3% (10/38)0.639
BMI (n = 442)26.97 ± 5.0127.59 ± 4.650.459
Dyslipidemia 20.0% (97/486)31.6% (12/28)0.089
Hypothyroidism 15.8% (77/486)21.1% (8/38)0.401
Psychiatric disorder 10.1% (49/484)10.8% (4/37)0.781
Previous alcohol use 18.6% (90/485)31.6% (12/38)0.051
HCV genotype
179.5% (392)66.7% (26)0.083
319.1% (94)33.3% (13)
Other1.4% (7)0% (0)
Previous HCV treatment
None45.5% (222)56.8% (21)0.409
Peg-IFN + RBV46.7% (228)37.8% (14)
Peg-IFN + PI 7.8% (38)5.4% (2)
Liver fibrosis (Metavir classification)
F0 / F18.6% (42)7.7% (3)0.218
F213.6% (67)10.3% (4)
F322.2% (109)10.3% (4)
F455.6% (273)71.8% (28)
Presence of cirrhosis
No43.4% (214)30.8% (12)0.124
Yes56.6% (279)69.2% (27)
Liver-related complications
Ascites20.3% (84/413)25.7% (9/35)0.451a
Esophageal varices47.8% (197/412)68.6% (24/35)0.018a
Portal hypertensive bleeding9.7% (40/412)22.9% (8/35)0.039a
Hepatic encephalopathy 8.5% (35/413)28.6% (10/35)0.001a
AST (U/L)60.41 ± 44.5374.51 ± 50.360.043a
ALT (U/L)60.78 ± 55.7576.19 ± 84.740.434
Total bilirubin (mg/dL)1.12 ± 1.091.24 ± 0.950.384
Albumin (g/dL)4.18 ± 2.733.70 ± 0.770.032a
Platelets (/mm3)142.64 ± 78.05131.10 ± 65.190.532
INR1.17 ± 0.211.32 ± 0.400.023a
Creatinine (mg/dL)1.23 ± 1.742.32 ± 3.770.694
Hemoglobin (g/dL)13.74 ± 1.8613.65 ± 2.340.798
Alpha-fetoprotein (ng/mL)24.3 ± 107.2213.20 ± 16.370.412
Child-Pugh classification (%)
A72.0% (190)56.0% (14)0.124
B25.8% (68)44.0% (11)
C2.3% (6)0% (0)
Child-Pugh Score5.91 ± 1.496.28 ± 2.010.109
MELD Score9.98 ± 3.8212.70 ± 4.810.001a
Dose of ribavirin (mg/kg/day)12.11 ± 3.0112.07 ± 2.980.946
aP value < 0.05. Chi-square test, Fisher's exact test, and Mann-Whitney test. ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BMI: Body mass index; HCV: Hepatitis C virus; INR: International normalized ratio; ITT: Intention-to-treat; Peg-IFN: Pegylated-interferon; PI: Protease inhibitor (boceprevir or telaprevir); RBV: Ribavirin; SVR: Sustained virologic response.
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Table 5 Factors associated with failure to achieve sustained virologic response by intention-to-treat analysis
VariableUnivariate analysis
OR
95%CI
P value
Age1.0030.974-1.0330.8349
Men 1.8110.814-4.0300.1458
High-blood pressure 1.029 0.530-1.9990.9328
Type 2 diabetes 0.837 0.396-1.7670.6400
BMI1.024 0.954-1.0990.5120
Dyslipidemia 1.851 0.902-3.8000.0934
Hypothyroidism 1.416 0.626-3.2060.4036
Psychiatric disorder 1.076 0.366-3.1650.8940
Previous alcohol use 2.026 0.985-4.1670.0551
Presence of cirrhosis1.7260.854-3.4860.1281
Liver-related complications
Ascites1.3560.612-3.0030.4526
Esophageal varices2.3811.137-4.9880.0215a
Portal hypertensive bleeding2.7561.173-6.4710.0200a
Hepatic encephalopathy4.3201.920-9.7210.0004a
AST 1.0061.000-1.0120.0707
ALT 1.0030.999-1.0070.1402
Total bilirubin1.0850.846-1.3920.5198
Albumin0.5280.322-0.8670.0115a
Platelets1.0001.000-1.0000.3813
INR5.5422.023-15.1820.0009a
Creatinine1.1171.056-1.3120.0033a
Hemoglobin 0.9750.818-1.1610.7741
Alpha-fetoprotein 0.9950.980-1.0100.5055
Child-Pugh score1.1660.901-1.5110.2431
MELD score1.1431.060-1.2330.0005a
Ribavirin dose0.9960.832-1.1920.9614
Treatment duration1.0240.962-1.0900.4563
aP value < 0.05. Univariate logistic regression. ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BMI: Body mass index; HCV: Hepatitis C virus; INR: International normalized ratio; MELD: Model for end-stage liver disease; OR: Odds ratio; SVR: Sustained virologic response.
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Table 6 Factors associated with the occurrence of adverse events during treatment
VariableUnivariate analysis
Multivariate analysis
OR
95%CI
P value
OR
95%CI
P value
Age1.0110.994-1.0270.2086
Women 1.7181.205-2.4500.0028a2.1911.145-1.1920.0178a
High-blood pressure 0.838 0.587-1.1970.3315
Type 2 diabetes 0.9940.675-1.4610.9736
BMI1.0601.019-1.1020.0040a1.1071.038-1.1800.0020a
Dyslipidemia 0.7140.458-1.1140.1377
Hypothyroidism 0.971 0.603-1.5650.9053
Psychiatric disorder 1.3090.732-2.3400.3633
Previous alcohol use 0.9530.610-1.4880.8307
Presence of cirrhosis2.1271.476-3.065< 0.0001a
Liver-related complications
Ascites2.1871.352-3.5360.0014a
Esophageal varices2.7951.874-4.169< 0.0001a3.4631.688-7.1050.0007a
Portal hypertensive bleeding1.7470.946-3.2280.0749
Hepatic encephalopathy3.5241.762-7.0440.0004a
AST 1.0000.997-1.0040.8303
ALT 0.9990.996-1.0020.4848
Total bilirubin1.2831.052-1.5640.0138a
Albumin0.4320.314-0.595< 0.0001a
INR3.8351.539-9.5600.0039a3.7481.060-13.2510.0403a
Creatinine0.9340.845-1.0320.1818
Hemoglobin 0.9510.866-1.0440.2910
Alpha-fetoprotein 0.9980.993-1.0030.3656
Child-Pugh score1.1961.014-1.4100.0332a
MELD score1.0711.019-1.1260.0073a
Ribavirin dose1.2491.132-1.379< 0.0001a
Treatment duration1.0711.034-1.1090.0001a1.0621.003-1.1250.0406a
aP value < 0.05. Logistic regression. ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BMI: Body mass index; HCV: Hepatitis C virus; INR: International normalized ratio; MELD: Model for end-stage liver disease; OR: Odds ratio.
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