Table 1.
Selection of Exclusion Criteria—Each Exclusivea
| Criteria | Trial-Specific Exclusion Criteria |
Simeprevir Trial (GT1) N = 410 No. (%) |
PHOTON-1 Trial (GT 1, 2, or 3) N = 530 No. (%) |
TURQUOISE-I Trial (GT 1): N = 410 No. (%) |
ION-4 Trial (GT 1 or 4) N = 421 No. (%) |
ALLY-2 Trial (GT 1, 2, 3, or 4) N = 541 No. (%) |
|---|---|---|---|---|---|---|
| Combined antiretroviral therapy Regimensb–f | Supplementary Table 1 | 291 (71) | 336 (63) | 301 (73) | 334 (79) | 44 (8) |
| Active illicit drug use (excluding marijuana) | Supplementary Table 2 | 221 (54) | 294 (55) | 221 (54) | 223 (53) | NA |
| CD4 T-cell count (cells/mm3) | <300b | |||||
| <200c,d,f | ||||||
| <100e | 77 (19) | 57 (11) | 39 (10) | 12 (3) | 47 (9) | |
| Human immunodeficiency virus RNA (copies/mL) | >50b,c,e,f | |||||
| >40d | 70 (17) | 82 (15) | 73 (18) | 71 (17) | 80 (15) | |
| Active psychiatric disorderg | NA | NA | NA | NA | 65 (12) | |
| Neutrophils (cells/mm3) | <1.5b | |||||
| <1.2d | ||||||
| <0.75f | 35 (9) | NA | 10 (2) | NA | 2(<1) | |
| Albumin (g/dL) | <3.3b | |||||
| <3.0c,e,f | ||||||
| <2.8d | 53 (11) | 25 (4) | 12 (3) | 19 (5) | 22 (4) | |
| Hemoglobin (g/dL) | <110 (female) or <120 (male)b–e | |||||
| <100f | 44 (11) | 47 (9) | 35 (9) | 36 (9) | 9 (2) | |
| Platelets (cells/mm3) | <90,000b | |||||
| <60,000c,d | ||||||
| <50,000e,f | 33 (8) | NA | 8 (2) | 7 (2) | 8 (2) | |
| Decompensated liver diseaseh | 30 (7) | 38 (7) | 30 (7) | 31 (7) | 39 (7) | |
| AIDS illnessi | 14 (3) | 16 (3) | 14 (3) | 14 (3) | 21 (4) | |
| Hypertension (mmHg) | Systolic blood pressure ≥160 or diastolic blood pressure ≥100 | NA | NA | NA | NA | 14 (3) |
| Coinfection with hepatitis B | HBsAg positive | 13 (3) | 17 (3) | 13 (3) | 14 (3) | 18 (3) |
| Serum creatinine (mg/dL) or Cockcroft-Gault equation (mL/min) | <1.5b | |||||
| <60 mL/minc–e | ||||||
| <50 mL/minf | 9 (2) | 56 (11) | 40 (10) | 43 (10) | 41(8) | |
| Age (y) | <18c,e,f | |||||
| <18 and >70b,d | 5 (1) | 3 (<1) | 5 (1) | 2 (<1) | 3(<1) | |
| Body mass index (kg/m2) | <18c,e | |||||
| ≤18 and>38d | ||||||
| ≤18 and>35f | NA | 22 (4) | 20 (5) | 20 (5) | 40 (7) | |
| Bilirubin (mg/dL) | >3b–e | |||||
| > 2f | 3 (<1) | 3 (<1) | 3 (<1) | 3 (<1) | 3 (<1) | |
| International normalized ratio | >1.5 | 4 (<1) | 4 (<1) | 4 (<1) | 5 (<1) | NA |
| Alpha-fetoprotein (ng/mL) | <50b | |||||
| <100d,f | 6 (1) | NA | 4(<1) | NA | 4(<1) | |
| Aspartate Aminotransferase (U/L) | <10× ULNb,c,e | |||||
| <7× ULNd | 3 (<1) | 5 (<1) | 5 (1) | 3 (<1) | NA | |
| Alanine Aminotransferase (U/L) | <10× ULNb,c,e,f | |||||
| <7× ULNd | 1 (<1) | 1 (<1) | 7 (2) | 1 (<1) | 1 (<1) |
Abbreviations: NA, not applicable; ULN, upper limit of normal.
a The n (%) of the cohort population excluded based on each of the individual criteria.
b Simeprevir trial allowed: raltegravir, efavirenz, and rilpivirine.
c PHOTON-1 trial (sofosbuvir) allowed: tenofovir/emtricitabine with atazanavir/ritonavir, darunavir/ritonavir, efavirenz, raltegravir, or rilpivirine.
d TURQUOISE-I trial (ombitasvir, paritaprevir/ritonavir/dasabuvir) allowed: tenofovir/emtricitabine with atazanavir/ritonavir, darunavir/ritonavir, raltegravir.
e ION-4 trial (ledipasvir/sofosbuvir) allowed: tenofovir/emtricitabine with efavirenz, raltegravir, or ripilvirine.
f ALLY-2 trial (daclatasvir/sofosbuvir) only excluded unboosted protease inhibitors and cobicistat.
g Active severe psychiatric disorders include, but are not limited to, schizophrenia, psychosis, bipolar disorder, posttraumatic stress disorder, mania, and similar.
h Decompensated liver disease includes, but is not limited to, radiologic evidence of a history or presence of ascites, bleeding varices, or hepatic encephalopathy.
i Presence of AIDS-defining opportunistic infections.