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

doi:10.12998/wjcc.v10.i34.12566

Advanced Search

BPG is committed to discovery and dissemination of knowledge

Home / Archive / Volume 10, Issue 34

This Article

Academic Content and Language Evaluation of This Article

CrossCheck and Google Search of This Article

Academic Rules and Norms of This Article

Citation of this article

Corresponding Author of This Article

Research Domain of This Article

Article-Type of This Article

Open-Access Policy of This Article

Times Cited Counts in Google of This Article

Number of Hits and Downloads for This Article

Total Article Views (2890)

All Articles published online

The chart showing PDF series, WORD series, HTML series, Figures (1-1) series, Tables (1-4) series.

Item

Count

PDF

120

WORD

HTML

1112

Figures (1-1)

275

Tables (1-4)

283

Sum=1889

Publishing Process of This Article

The chart showing Browse series, Download series.

Item

Count

Browse

255

Download

746

Sum=1001

Dec 6, 2022 (publication date) through Nov 3, 2024

Times Cited of This Article

Times Cited (2)

Journal Information of This Article

Publication Name

World Journal of Clinical Cases

ISSN

2307-8960

Publisher of This Article

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

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