Direct-acting antivirals for chronic hepatitis C treatment: The experience of two tertiary university centers in Brazil

doi:10.4254/wjh.v14.i1.195

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World Journal of Hepatology

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1948-5182

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Retrospective Cohort Study

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/women	51.1% (272)/48.9% (260)
High-blood pressure	44.1% (231/524)
Type 2 diabetes	29.7% (156/526)
BMI (n = 442)	27.01 ± 4.99
Dyslipidemia	20.8% (109/524)
Hypothyroidism	16.2% (85/524)
Psychiatric disorder	10.2% (53/521)
Previous alcohol use	19.2% (102/523)
HCV genotype
1A	37.0% (197)
1B	38.0% (202)
1 non-classified	3.5% (19)
2	0.8% (4)
3	20.1% (107)
4	0.4% (2)
5	0.2% (1)
HCV viral load (log IU/mL)	5.78 ± 0.75
Previous HCV treatment (n = 525)
None	46.3% (243)
Peg-IFN + RBV	46.1% (242)
Peg-IFN + PI	7.6% (40)
Liver fibrosis (Metavir classification)
F0/F1	8.8% (47)
F2	13.0% (69)
F3	20.7% (110)
F4	57.5% (306)
Liver-related complications (n = 306)
Ascites	30.3% (93)
Esophageal varices	72.0% (221)
Portal hypertensive bleeding	15.6% (48)
Hepatic encephalopathy	14.7% (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
INR	1.18 ± 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)
A	66.6% (204)
B or C	27.7% (85)
Non-classified	5.7% (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.

Table 2 Hepatitis C virus therapeutic regimens (n = 532)

Features of treatment	% (n)
Regimens
SOF + DCV + RBV	49.2% (262)
SOF + SMV	21.2% (113)
SOF + DCV	17.7% (94)
SOF + SMV + RBV	8.1% (43)
3D	2.3% (12)
3D + RBV	0.6% (3)
SOF + RBV	0.6% (3)
SOF + LED	0.2% (1)
SOF + LED + RBV	0.2% (1)
Duration
12 wk	77.2% (411)
24 wk	22.8% (121)
Use of RBV	58.6% (312)
Dose of RBV (mg/kg/day) mean ± SD	12.11 ± 3.01

3D: Veruprevir/ritonavir, ombitasvir and dasabuvir; HCV: Hepatitis C virus; LED: Ledipasvir; RBV: Ribavirin; SMV: Simeprevir; SOF: Sofosbuvir; DCV: Daclatasvir.

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
1	93.7% (392/418)	97.7% (392/401)
2	100% (4/4)	100% (4/4)
3	87.8% (94/107)	93.0% (94/101)
4	100% (2/2)	100% (2/2)
5	100% (1/1)	100% (1/1)
Treatment regimen
3D ± RBV	100% (15/15)	100% (15/15)
SOF + DCV	86.1% (81/94)	95.2% (81/85)
SOF + DCV + RBV	94.2% (247/262)	97.2% (247/254)
SOF + RBV	100% (3/3)	100% (3/3)
SOF + SMV	92% (104/113)	96.3% (104/108)
SOF + SMV + RBV	95.3% (41/43)	97.6% (41/42)
SOF + LED ± RBV	100% (2/2)	100% (2/2)
Presence of cirrhosis
No	94.6% (214/226)	98.6% (214/217)
Yes	91.1% (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.

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 ± 10.96	57.23 ± 12.61	0.811
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 ± 5.01	27.59 ± 4.65	0.459
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
1	79.5% (392)	66.7% (26)	0.083
3	19.1% (94)	33.3% (13)
Other	1.4% (7)	0% (0)
Previous HCV treatment
None	45.5% (222)	56.8% (21)	0.409
Peg-IFN + RBV	46.7% (228)	37.8% (14)
Peg-IFN + PI	7.8% (38)	5.4% (2)
Liver fibrosis (Metavir classification)
F0 / F1	8.6% (42)	7.7% (3)	0.218
F2	13.6% (67)	10.3% (4)
F3	22.2% (109)	10.3% (4)
F4	55.6% (273)	71.8% (28)
Presence of cirrhosis
No	43.4% (214)	30.8% (12)	0.124
Yes	56.6% (279)	69.2% (27)
Liver-related complications
Ascites	20.3% (84/413)	25.7% (9/35)	0.451^a
Esophageal varices	47.8% (197/412)	68.6% (24/35)	0.018^a
Portal hypertensive bleeding	9.7% (40/412)	22.9% (8/35)	0.039^a
Hepatic encephalopathy	8.5% (35/413)	28.6% (10/35)	0.001^a
AST (U/L)	60.41 ± 44.53	74.51 ± 50.36	0.043^a
ALT (U/L)	60.78 ± 55.75	76.19 ± 84.74	0.434
Total bilirubin (mg/dL)	1.12 ± 1.09	1.24 ± 0.95	0.384
Albumin (g/dL)	4.18 ± 2.73	3.70 ± 0.77	0.032^a
Platelets (/mm³)	142.64 ± 78.05	131.10 ± 65.19	0.532
INR	1.17 ± 0.21	1.32 ± 0.40	0.023^a
Creatinine (mg/dL)	1.23 ± 1.74	2.32 ± 3.77	0.694
Hemoglobin (g/dL)	13.74 ± 1.86	13.65 ± 2.34	0.798
Alpha-fetoprotein (ng/mL)	24.3 ± 107.22	13.20 ± 16.37	0.412
Child-Pugh classification (%)
A	72.0% (190)	56.0% (14)	0.124
B	25.8% (68)	44.0% (11)
C	2.3% (6)	0% (0)
Child-Pugh Score	5.91 ± 1.49	6.28 ± 2.01	0.109
MELD Score	9.98 ± 3.82	12.70 ± 4.81	0.001^a
Dose of ribavirin (mg/kg/day)	12.11 ± 3.01	12.07 ± 2.98	0.946

^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.

Table 5 Factors associated with failure to achieve sustained virologic response by intention-to-treat analysis

Variable	Univariate analysis
Variable	OR	95%CI	P value
Age	1.003	0.974-1.033	0.8349
Men	1.811	0.814-4.030	0.1458
High-blood pressure	1.029	0.530-1.999	0.9328
Type 2 diabetes	0.837	0.396-1.767	0.6400
BMI	1.024	0.954-1.099	0.5120
Dyslipidemia	1.851	0.902-3.800	0.0934
Hypothyroidism	1.416	0.626-3.206	0.4036
Psychiatric disorder	1.076	0.366-3.165	0.8940
Previous alcohol use	2.026	0.985-4.167	0.0551
Presence of cirrhosis	1.726	0.854-3.486	0.1281
Liver-related complications
Ascites	1.356	0.612-3.003	0.4526
Esophageal varices	2.381	1.137-4.988	0.0215^a
Portal hypertensive bleeding	2.756	1.173-6.471	0.0200^a
Hepatic encephalopathy	4.320	1.920-9.721	0.0004^a
AST	1.006	1.000-1.012	0.0707
ALT	1.003	0.999-1.007	0.1402
Total bilirubin	1.085	0.846-1.392	0.5198
Albumin	0.528	0.322-0.867	0.0115^a
Platelets	1.000	1.000-1.000	0.3813
INR	5.542	2.023-15.182	0.0009^a
Creatinine	1.117	1.056-1.312	0.0033^a
Hemoglobin	0.975	0.818-1.161	0.7741
Alpha-fetoprotein	0.995	0.980-1.010	0.5055
Child-Pugh score	1.166	0.901-1.511	0.2431
MELD score	1.143	1.060-1.233	0.0005^a
Ribavirin dose	0.996	0.832-1.192	0.9614
Treatment duration	1.024	0.962-1.090	0.4563

^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.

Table 6 Factors associated with the occurrence of adverse events during treatment

Variable	Univariate analysis			Multivariate analysis
Variable	OR	95%CI	P value	OR	95%CI	P value
Age	1.011	0.994-1.027	0.2086
Women	1.718	1.205-2.450	0.0028^a	2.191	1.145-1.192	0.0178^a
High-blood pressure	0.838	0.587-1.197	0.3315
Type 2 diabetes	0.994	0.675-1.461	0.9736
BMI	1.060	1.019-1.102	0.0040^a	1.107	1.038-1.180	0.0020^a
Dyslipidemia	0.714	0.458-1.114	0.1377
Hypothyroidism	0.971	0.603-1.565	0.9053
Psychiatric disorder	1.309	0.732-2.340	0.3633
Previous alcohol use	0.953	0.610-1.488	0.8307
Presence of cirrhosis	2.127	1.476-3.065	< 0.0001^a
Liver-related complications
Ascites	2.187	1.352-3.536	0.0014^a
Esophageal varices	2.795	1.874-4.169	< 0.0001^a	3.463	1.688-7.105	0.0007^a
Portal hypertensive bleeding	1.747	0.946-3.228	0.0749
Hepatic encephalopathy	3.524	1.762-7.044	0.0004^a
AST	1.000	0.997-1.004	0.8303
ALT	0.999	0.996-1.002	0.4848
Total bilirubin	1.283	1.052-1.564	0.0138^a
Albumin	0.432	0.314-0.595	< 0.0001^a
INR	3.835	1.539-9.560	0.0039^a	3.748	1.060-13.251	0.0403^a
Creatinine	0.934	0.845-1.032	0.1818
Hemoglobin	0.951	0.866-1.044	0.2910
Alpha-fetoprotein	0.998	0.993-1.003	0.3656
Child-Pugh score	1.196	1.014-1.410	0.0332^a
MELD score	1.071	1.019-1.126	0.0073^a
Ribavirin dose	1.249	1.132-1.379	< 0.0001^a
Treatment duration	1.071	1.034-1.109	0.0001^a	1.062	1.003-1.125	0.0406^a

^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.

Citation: Lourenço MS, Zitelli PMY, Cunha-Silva M, Oliveira AIN, Oliveira CP, Sevá-Pereira T, Carrilho FJ, Pessoa MG, Mazo DF. Direct-acting antivirals for chronic hepatitis C treatment: The experience of two tertiary university centers in Brazil. World J Hepatol 2022; 14(1): 195-208
URL: https://www.wjgnet.com/1948-5182/full/v14/i1/195.htm
DOI: https://dx.doi.org/10.4254/wjh.v14.i1.195