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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