Real life efficacy and safety of direct-acting antiviral therapy for treatment of patients infected with hepatitis C virus genotypes 1, 2 and 3 in northwest China

doi:10.3748/wjg.v25.i44.6551

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World Journal of Gastroenterology

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1007-9327

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

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World J Gastroenterol. Nov 28, 2019; 25(44): 6551-6560
Published online Nov 28, 2019. doi: 10.3748/wjg.v25.i44.6551

Table 1 Regimens of direct-acting antivirals for treatment of hepatitis C virus infection

Patients		Genotype 1	Genotype 2	Genotype 3
Chronic hepatitis	Treatment naïve	SOF + LDV for 12 wk	SOF + RBV for 12 wk	SOF + DCV for 12 wk
Chronic hepatitis	Treatment experienced	SOF + LDV for 12 wk	SOF + RBV for 16-20 wk	SOF + DCV + RBV for 12 wk or 24 wk without RBV
Cirrhosis, compensated or decompensated		SOF + LDV + RBV for 12 wk or 24 wk without RBV	SOF + RBV for 16-20 wk	SOF + DCV + RBV for 24 wk

A fixed dose combination of sofosbuvir (SOF) and ledipasvir was administered once per day. One tablet each of SOF and daclatasvir should be taken daily. Ribavirin was 1000 or 1200 mg/d in patients < 75 kg or ≥ 75 kg, respectively. SOF: Sofosbuvir (400 mg); LDV: Ledipasvir (90 mg); DCV: Daclatasvir (60 mg); RBV: Ribavirin (200 mg).

Table 2 Baseline characteristics of hepatitis C virus patients based on genotype

	Total (n = 366)	Genotype 1 (n = 216)	Genotype 2 (n = 126)	Genotype 3 (n = 24)
Age (yr)	52.2 ± 12.0	51.7 ± 12.8	53.6 ± 10.0	49.8 ± 14.1
Gender (males, %)	174 (47.5)	101 (46.8)	62 (49.2)	11 (45.8)
TBIL (µmol/L)	19.63 ± 10.60	19.62 ± 10.77	19.52 ± 10.72	20.07 ± 8.47
ALT (U/L)	53.48 ± 45.18	56.95 ± 47.79	51.55 ± 40.35	54.33 ± 36.91
AST (U/L)	51.89 ± 39.12	50.79 ± 41.96	48.9 ± 33.74	53.5 ± 33.31
Albumin (g/L)	36.6 ± 8.6	38.9 ± 8.6	41.2 ± 8.5	36.6 ± 8.6
TCHO (mmol/L)	3.85 ± 0.60	3.81 ± 0.58	3.85 ± 0.66	4.14 ± 0.41
Hemoglobin (mg/dL)	120.3 ± 23.6	120.4 ± 23.3	121.2 ± 23.2	114.8 ± 27.9
Platelets (10⁹/L)	147.7 ± 75.8	144.5 ± 74.8	155.7 ± 77.8	134.3 ± 73.6
AFP (ng/mL)	4.69 ± 5.79	5.01 ± 7.33	4.30 ± 2.02	3.81 ± 2.27
Treatment experienced, n (%)	50 (13.7)	26 (12.0)	20 (15.9)	4 (16.7)
Cirrhosis, n (%)	154 (42.1)	96 (43.5)	46 (36.5)	12 (50)
HBV/HCV co-infection, n (%)	25 (6.8)	12 (5.6)	9 (7.1)	4 (16.7)
Diabetes mellitus, n (%)	17 (4.6)	12 (5.6)	4 (3.2)	1 (4.2)
Hypertension, n (%)	24 (6.6)	16 (7.4)	8 (6.3)	0 (0)
Fatty liver disease, n (%)	52 (14.2)	31 (14.4)	16 (12.7)	5 (20.8)

TBil: Total bilirubin; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; TCHO: Total cholesterol; AFP: Alpha fetoprotein; HCV: Hepatitis C virus; HBV: Hepatitis B virus.

Table 3 Baseline characteristics of hepatitis C virus patients based on severity of liver disease

	Non-cirrhosis (n = 212)	Cirrhosis (compensated and decompensated) (n = 154)	P value
Age (yr)	48.5 ± 12.6	57.3 ± 8.9	< 0.001
Gender (males, %)	115 (54.2)	77 (50.0)	0.423
TBil (µmol/L)	15.04 ± 8.78	25.95 ± 9.59	< 0.001
ALT (U/L)	41.74 ± 43.00	64.88 ± 44.81	0.029
AST (U/L)	31.47 ± 26.67	68.12 ± 43.44	0.034
Albumin (g/L)	44.5 ± 4.5	33.0 ± 8.6	< 0.001
TCHO (mmol/L)	3.86 ± 0.55	3.82 ± 0.66	0.349
Hemoglobin (mg/dL)	135.3 ± 10.6	99.5 ± 20.4	0.002
Platelets (10⁹/L)	195.3 ± 59.8	86.1 ± 32.2	< 0.001
AFP (ng/mL)	4.04 ± 1.79	5.58 ± 8.61	0.045
Log10 HCV RNA (IU/mL)	6.6 ± 0.8	6.3 ± 1.3	0.040
LSM (kPa)	5.71 ± 1.7	10.26 ± 5.1	< 0.001
Fibrosis 4 score	1.43 ± 1.0	7.49 ± 6.0	< 0.001
APRI	1.06 ± 0.9	2.3 ± 1.5	< 0.001

TBil: Total bilirubin; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; TCHO: Total cholesterol; AFP: Alpha fetoprotein; LSM: Liver stiffness measurement; APRI: AST-to-platelet ratio index.

Table 4 Baseline data for patients with and without sustained virological responses (by modified intention-to-treat analysis)

	Non-SVR12 (n = 11)	SVR12 (n = 315)	P value
Age (yr)	54.1 ± 13.5	51.8 ±11.9	0.098
Gender (males, %)	4 (36.4)	162 (51.4)3	0.080
TBil (µmol/L)	20.16 ± 10.13	19.58 ± 10.69	0.184
ALT (U/L)	62.45 ± 53.85	52.28 ± 46.14	0.034
AST (U/L)	42.73 ± 30.30	47.29 ± 39.74	0.516
Albumin (g/L)	37.7 ± 10.0	39.6 ± 8.6	0.214
TCHO (mmol/L)	3.93 ± 0.59	3.85 ± 0.60	0.879
Hemoglobin (mg/dL)	119.1 ± 15.0	119.5 ± 23.8	0.497
Platelets (10⁹/L)	165.6 ± 68.4	144.9 ± 76.0	0.167
AFP (ng/mL)	5.03 ± 4.49	4.77 ± 6.15	0.407
Log10 HCV RNA (IU/mL)	6.5 ± 0.6	6.5 ± 1.0	0.450
Cirrhosis, n (%)	5 (45.5)	138 (43.8)	0.621
Treatment experienced, n (%)	1 (9.1)	49 (15.6)	0.052

TBil: Total bilirubin; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; TCHO: Total cholesterol; AFP: Alpha fetoprotein; HCV: Hepatitis C virus; SVR12: Sustained virological response at post-treatment week 12.

Citation: Yang Y, Wu FP, Wang WJ, Shi JJ, Li YP, Zhang X, Dang SS. Real life efficacy and safety of direct-acting antiviral therapy for treatment of patients infected with hepatitis C virus genotypes 1, 2 and 3 in northwest China. World J Gastroenterol 2019; 25(44): 6551-6560
URL: https://www.wjgnet.com/1007-9327/full/v25/i44/6551.htm
DOI: https://dx.doi.org/10.3748/wjg.v25.i44.6551