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Table 2 Selective exclusion criteria and number of patients excluded

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
N = 219, no. (%)
GLE/PIB Expedition-2
N = 219, no. (%)
HIV VL > 50 copies/mL 32 (15)  
  > 20 copies/ mL   44 (20)
ART regimen   127 (58) 103 (47)
CD4 count < 100 cells/mm3 9 (4)  
  < 200 cells/mm3   28 (13)
Hepatic decompensation   29 (13) 29 (13)
Other liver disease (HBV, NASH, hemochromatosis)   5 (2) 5 (2)
Solid organ transplantation   2 (1) 2 (1)
Psychiatric disorder   114 (52) 114 (52)
Malignancy (within previous 5 yrs)   12 (5) 12 (5)
Active EtOH or IVDU   59 (27) 59 (27)
ALT > 10x ULN   1 (< 1) 1 (< 1)
AST > 10x ULN   2 (1) 2 (1)
D. bili > 3 mg/dL   8 (4) 8 (4)
Platelets < 50,000/μL 11 (5)  
  < 60,000/μL w/ cirrhosis or < 90,000/μL w/o cirrhosis   22 (10)
HbA1c > 8.5%   5 (2) 5 (2)
CrCl < 60 mL/min 28 (13)  
  < 50 mL/min   20 (9)
Hemoglobin < 10 g/dL 16 (7)  
  < 12 g/dL (men), < 11 g/dL (women)   39 (18)
Albumin < 3 g/dL   19 (9) 19 (9)
INR > 1.5x ULN 6 (3)  
  > 2.3   6 (3)
Overall excluded   195 (89) 198 (90)
Overall excluded without ART regimen criterion   167 (76) 178 (81)
  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
  2. Protocols for SOF/VEL ASTRAL-1 and GLE/PIB EXPEDITION-2 studies may be obtained from:
  3. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1512610/suppl_file/nejmoa1512610_protocol.pdf (SOF/VEL) and https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6137115/ (GLE/PIB)