Effectiveness and safety of generic and brand direct acting antivirals for treatment of chronic hepatitis C

doi:10.12998/wjcc.v10.i34.12566

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World Journal of Clinical Cases

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Observational Study

World J Clin Cases. Dec 6, 2022; 10(34): 12566-12577
Published online Dec 6, 2022. doi: 10.12998/wjcc.v10.i34.12566

Table 1 Comparison of baseline data between the two groups, n = 289

Variable	Generic, n (%)	Brand, n (%)	t (χ²)^a statistic	P
Total	140	149
Age (yr)			9.23^a	0.01
< 40	52 (37.1)	33 (22.1)
40-65	73 (52.1)	103 (69.1)
> 65	15 (10.7)	13 (8.7)
Sex			0.23^a	0.63
Female	59 (42.1)	67 (45.0)
Male	81 (57.9)	82 (55.0)
Co-morbidities			32.28^a	< 0.001
None	65 (46.4)	25 (16.8)
one to two	61 (43.6)	85 (57.0)
More than two	14 (10.0)	39 (26.2)
USD cirrhosis			15.10^a	< 0.001
No	113 (80.7)	89 (59.7)
Yes	27 (19.3)	60 (40.3)
HCV genotype			9.86^a	0.02
1	88 (62.9)	109 (73.2)
2	4 (2.9)	2 (1.3)
3	33 (23.6)	16 (10.7)
4	15 (10.7)	22 (14.8)
WBC (× 10⁹/L) ± SD	6.26 ± 3.34	5.82 ± 2.15	1.37	0.17
Haemoglobin (g/dL) ± SD	12.50 ± 2.52	12.80 ± 2.12	-1.1	0.27
Platelets (× 10⁹/L) ± SD	232.35 ± 108.08	189.01 ± 95.48	3.62	< 0.001
PT (sec) ± SD	14.11 ± 11.94	13.3 ± 1.88	0.8	0.43
PTT (sec) ± SD	24.16 ± 2.94	26.21 ± 3.79	-5.1	< 0.001
INR ± SD	1.08 ± 0.18	1.31 ± 2.22	-1.2	0.23
Creatinine (μmol/L) ± SD	66.86 ± 21.07	89.68 ± 148.85	-1.8	0.07
Albumin (g/L) ± SD	41.04 ± 5.11	38.81 ± 6.05	3.36	0.01
Total bilirubin (μmol/L) ± SD	17.68 ± 15.62	18.72 ± 18.26	-0.52	0.6
ALP (U/L) ± SD	93.31 ± 43.54	102.02 ± 43.79	-1.7	0.09
ALT (U/L) ± SD	71.66 ± 57.59	61.96 ± 41.47	1.65	0.1
gGT(U/L) ± SD	84.44 ± 109.99	101.76 ± 92.69	-1.45	0.15

^aP values based on Chi-square test or Student’s t-test as appropriate.

Data are presented as proportion (%) or mean ± SD or number. HCV: Hepatitis C virus; WBC: White blood cell count; USD: Ultrasound-diagnosed; PT: Prothrombin time; PTT: Partial thromboplastin time; INR: International normalized ratio; ALP: Alkaline phosphatase; ALT: Alanine aminotransferase; gGT: Gamma-glutamyl transpeptidase.

Table 2 Predictors of not achieving sustained virologic response in the overall sample identified using a multivariable regression model, n = 289

Variable	No SVR, n (%)	Crude OR, (95%CI)	Adjusted OR, (95%CI)	Adjusted P
Age (yr)
< 40	6 (7.1)	1	1
40-65	8 (4.5)	0.63 (0.21-1.87)	0.26 (0.67-0.99)	0.049
> 65	4 (14.3)	2.19 (0.57-8.42)	1.26 (0.23-6.96)	0.79
Sex
Female	8 (4.8)	1	1
Male	12 (7.4)	1.59 (0.58-4.36)	3.0 (0.87-10.37)	0.08
Co-morbidities
None	2 (2.2)	1	1
0ne to two	10 (6.8)	3.24 (0.69-15.12)	1.36 (0.22-8.38)	0.74
More than two	6 (11.3)	5.62 (1.09- 28.93)	3.63 (0.52-25.49)	0.19
USD cirrhosis
No	5 (2.5)	1	1
Yes	13 (14.9)	6.92 (2.39-20.10)	9.41 (2.47-35.84)	0.001
HCV genotype
1	10 (4.9)	1	1
3	6 (12.2)	2.69 (0.93-7.81)	3.56 (1.03-12.38)	0.044
4	2 (5.4)	1.10 (0.23-5.25)	0.69 (0.13-3.75)	0.67
DAC regimen
Generic	6 (4.3)	1	1
Brand	12 (8.1)	1.96 (0.71-5.36)	2.00 (0.57-7.04)	0.28
WBC (× 10⁹/L)		1.04 (0.89-1.21)
Haemoglobin (g/dL)		1.14 (0.92-1.41)
Platelets (× 10⁹/L)		1.00 (0.96-1.01)
PT (sec)		1.02 (0.95-1.05)
PTT (sec)		1.12 (0.98-1.29)
INR		0.99 (0.72-1.38)
Creatinine (μmol/L)		1.00 (0.98-1.01)
Albumin (g/L)		0.98 (0.90-1.06)
Total bilirubin (μmol/L)		0.99 (0.96-1.03)
ALP (U/L)		1.05 (0.99-1.02)
ALT (U/L)		1.01 (1.00-1.02)
gGT(U/L)		1.03 (1.00-1.06)

HCV: Hepatitis C virus; WBC: White blood cell count; USD: Ultrasound-diagnosed; PT: Prothrombin time; PTT: Partial thromboplastin time; INR: International normalized ratio; ALP: Alkaline phosphatase; ALT: Alanine aminotransferase; gGT: Gamma-glutamyl transpeptidase; SVR: Sustained virologic response; 95%CI: 95% confidence interval; OR: Odds ratio.

Table 3 Predictors of not achieving sustained virologic response in patients receiving only sofosbuvir-based therapy identified using a multivariable regression model, n = 223

Variable	No SVR, n (%)	Crude OR (95%CI)	Adjusted OR (95%CI)	Adjusted P
Age (yr)
< 40	5 (7.5)	1	1
40-65	6 (4.5)	0.58 (0.17-1.98)	0.30 (0.07-1.35)	0.12
> 65	20 (9.1)	1.24 (0.22-6.89)	0.69 (0.08-5.81)	0.73
Sex
Female	4 (4.3)	1	1
Male	9 (6.9)	1.66 (0.49-5.55)	2.33 (0.57-9.53)	0.24
Co-morbidities
None	2 (2.6)	1	1
0ne to two	7 (6.3)	2.47 (0.50-12.21)	1.03 (0.14-7.61)	0.98
More than two	4 (11.4)	4.77 (0.83-27.43)	3.45 (0.41-29.05)	0.26
USD cirrhosis
No	4 (2.6)	1	1
Yes	9 (13.2)	5.76 (1.71-19.42)	8.99 (1.83-44.16)	0.007
HCV genotype
1	6 (4.1)	1	1
3	6 (12.2)	3.30 (1.01-10.77)	4.44 (1.17-16.89)	0.03
4	1 (3.8)	0.95 (0.11-8.20)	0.95 (0.10-9.45)	0.96
DAC regimen
Generic	6 (4.3)	1	1
Brand	7 (8.4)	2.06 (0.67-6.34)	1.42 (0.34-5.94)	0.63
WBC (× 10⁹/L)		0.98 (0.80-1.21)
Haemoglobin (g/dL)		1.15 (0.89-1.48)
Platelets (× 10⁹/L)		1.00 (0.99-1.01)
PT (sec)		1.02 (0.95-1.06)
PTT (sec)		1.17 (1.00-1.37)
INR		1.00 (0.72-1.38)
Creatinine (μmol/L)		1.00 (0.97-1.03)
Albumin (g/L)		0.97 (0.90-1.06)
Total bilirubin (μmol/L)		0.99 (0.95-1.03)
ALP (U/L)		1.01 (1.00-1.02)
ALT (U/L)		1.01 (1.00-1.02)
gGT(U/L)		1.03 (1.00-1.07)

Table 4 Changes in laboratory parameters before or at the end of treatment (12 wk) among patients who received generic and brand direct antiviral agents

Variable	Period	Generic, mean ± SD	P	Brand, mean ± SD	P
WBC (× 10⁹/L)	wk 0	6.27 ± 3.34	0.15	5.82 ± 2.15	0.005
	EOT	6.67 ± 3.62		6.13 ± 2.40
Haemoglobin (g/dL)	wk 0	12.50 ± 2.52	0.17	12.81 ± 2.12	0.94
	EOT	12.71 ± 2.44		12.81 ± 2.25
Platelets (× 10⁹/L)	wk 0	232.35 ± 108.1	< 0.001	189.01 ± 95.48	< 0.001
	EOT	257.63 ± 113.11		210.85 ± 100.69
PT (sec)	wk 0	14.11 ± 11.93	0.52	13.32 ± 1.88	0.91
	EOT	13.31 ± 8.79		13.30 ± 1.91
PTT (sec)	wk 0	24.16 ± 2.91	0.001	26.20 ± 3.79	0.22
	EOT	23.14 ± 4.25		25.90 ± 3.22
INR	wk 0	1.08 ± 0.18	0.7	1.31 ± 2.22	0.31
	EOT	1.11 ± 0.87		1.12 ± 0.17
Creatinine (μmol/L)	wk 0	66.86 ± 21.07	0.05	89.68 ± 148.85	0.55
	EOT	70.50 ± 31.94		92.05 ± 138.93
Albumin (g/L)	wk 0	41.04 ± 5.11	< 0.001	38.82 ± 6.05	< 0.001
	EOT	42.78 ± 5.46		40.90 ± 5.48
Total bilirubin (μmol/L)	wk 0	17.68 ± 15.62	< 0.001	18.72 ± 18.26	0.004
	EOT	14.30 ± 12.64		15.14 ± 13.74
ALP (U/L)	wk 0	93.31 ± 43.55	< 0.001	102.02 ± 43.79	0.18
	EOT	77.32 ± 32.65		94.79 ± 73.56
ALT (U/L)	wk 0	71.66 ± 57.59	< 0.001	61.96 ± 41.47	< 0.001
	EOT	27.09 ± 33.56		29.09 ± 24.58
gGT(U/L)	w 0	84.44 ± 109.98	< 0.001	101.76 ± 92.69	< 0.001
	EOT	43.48 ± 62.65		50.64 ± 53.37

P values are based on paired t-tests. EOT: End of treatment; WBC: White blood cell count; PT: Prothrombin time; PTT: Partial thromboplastin time; INR: International normalized ratio; ALP: Alkaline phosphatase; ALT: Alanine aminotransferase; gGT: Gamma-glutamyl transpeptidase.

Citation: Abdulla M, Al Ghareeb AM, Husain HAHY, Mohammed N, Al Qamish J. Effectiveness and safety of generic and brand direct acting antivirals for treatment of chronic hepatitis C. World J Clin Cases 2022; 10(34): 12566-12577
URL: https://www.wjgnet.com/2307-8960/full/v10/i34/12566.htm
DOI: https://dx.doi.org/10.12998/wjcc.v10.i34.12566