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Table 4 Selective exclusion criteria and number of patients excluded by race (black versus non-black)

From: Contemporary HCV pangenotypic DAA treatment protocols are exclusionary to real world HIV-HCV co-infected patients

Exclusion criteria

Trial specific criteria

SOF/VEL ASTRAL-1 no. (%)

Difference

(sig level)

GLE/PIB Expedition-2 no. (%)

Difference (sig level)

  

Black

N = 117

Non-black N = 102

 

Black

N = 117

Non-black

N = 102

 

HIV VL

> 50 copies/mL

16 (14)

16 (16)

2%

(p 0.677)

   
 

> 20 copies/ mL

   

22 (19)

22 (22)

2.8% (p 0.607)

ART regimen

 

70 (60)

57 (56)

3.9% (p 0.561)

60 (51)

43 (42)

9% (p 0.184)

CD4 count

< 100 cells/mm3

5 (4)

4 (4)

0.4% (p 0.585)

   
 

< 200 cells/mm3

   

15 (13)

13 (13)

0.1% (p 0.982)

Hepatic decompensation

 

13 (11)

16 (16)

4.6% (p 0.318)

13 (11)

16 (16)

4.6% (p 0.318)

Other liver disease (HBV, NASH, hemochromatosis)

 

0

5 (5)

4.9% (p 0.021)

0

5 (5)

4.9% ( p 0.021)

Solid organ transplantation

 

1 (< 1)

1 (< 1)

0.13% (p 0.716)

1 (< 1)

1 (< 1)

0.13% (p 0.716)

Psychiatric disorder

 

58 (50)

56 (55)

5.3% (p 0.435)

58 (50)

56 (55)

5.3% (p 0.435)

Malignancy (within previous 5 yrs)

 

10 (8)

2 (2)

6.5% ( p 0.039)

10 (8)

2 (2)

6.5% ( p 0.039)

Active EtOH or IVDU

 

45 (38)

14 (14)

24.8% (p < 0.001)

45 (38)

14 (14)

24.8% (p < 0.001)

ALT > 10x ULN

 

0

1 (< 1)

0.98% (p 0.466)

0

1 (< 1)

0.98% (p 0.466)

AST >10x ULN

 

1 (< 1)

1 (< 1)

0.13% (p 0.716)

1 (1)

1 (1)

0.13% (p 0.716)

D. bili > 3 mg/dL

 

4 (3)

4 (4)

0.5% (p 0.561)

4 (3)

4 (4)

0.5% (p 0.561)

Platelets

< 50,000/μL

7 (6)

4 (4)

2.1% (p 0.549)

   
 

< 60,000/μL w/ cirrhosis or < 90,000/μL w/o cirrhosis

   

11 (9)

11 (11)

1.4% (p 0.732)

HbA1c > 8.5%

 

5 (4)

0

4.3% (p 0.063)

5 (4)

0

4.3% (p 0.063)

CrCl

< 60 mL/min

18 (15)

10 (10)

5.6% (p 0.217)

   
 

< 50 mL/min

   

14 (12)

6 (6)

6.1% (p 0.119)

Hemoglobin

< 10 g/dL

10 (8)

6 (6)

2.6% (p 0.450)

   
 

< 12 g/dL (men), < 11 g/dL (women)

   

25 (21)

14 (14)

7.7% (p 0.138)

Albumin < 3 g/dL

 

11 (9)

8 (8)

1.6% (p0.675)

11 (9)

8 (8)

1.6% (p 0.675)

INR

>1.5x ULN

3 (3)

3 (3)

0.3% (p 0.592)

   
 

> 2.3

   

3 (3)

3 (3)

0.3% (p 0.592)

Overall excluded

 

108 (92)

87 (85)

7% (p 0.099)

110 (94)

88 (86)

7.7% (p 0.054)

Overall excluded without ART regimen criterion

 

92 (79)

75 (74)

5.1% (p 0.378)

100 (85)

78 (76)

9% (p 0.089)

  1. ALT alanine aminotransferase, ART antiretroviral therapy, AST aspartate aminotransferase, bili bilirubin, CrCl creatinine clearance, EtOH ethanol (alcohol), GLE glecaprevir, HBV Hepatitis B virus, HCV Hepatitis C virus, HIV Human immunodeficiency virus, INR international normalized ratio, IVDU intravenous drug use, NASH non-alcoholic steatohepatitis, PIB pibrentasvir, SOF sofosbuvir, VEL velpatasvir, VL viral load
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BMC Infectious Diseases

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