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

Table 2 Selective exclusion criteria and number of patients excluded

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)

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
Protocols for SOF/VEL ASTRAL-1 and GLE/PIB EXPEDITION-2 studies may be obtained from:
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)