Copyright
©The Author(s) 2017.
World J Hepatol. Feb 8, 2017; 9(4): 217-223
Published online Feb 8, 2017. doi: 10.4254/wjh.v9.i4.217
Published online Feb 8, 2017. doi: 10.4254/wjh.v9.i4.217
Table 1 Demographic and laboratory characteristics n (%)
| Characteristic | A5294 | Historical controls | ||
| Treatment naïve (n = 135) | Treatment Exp (n = 122) | Treatment naïve (n = 183) | Treatment Exp (n = 87) | |
| Age (yr) | ||||
| Median | 51 | 53 | 48 | 48 |
| Q1, Q3 | 44, 57 | 49, 57 | 41, 52 | 42, 51 |
| Sex | ||||
| Male | 110 (81.5) | 93 (76.2) | 151 (82.5) | 74 (85.1) |
| Female | 25 (18.5) | 29 (23.8) | 32 (17.5) | 13 (14.9) |
| IV drug history | ||||
| Never | 71 (52.6) | 70 (57.4) | 73 (39.9) | 39 (44.8) |
| Currently | 0 | 0 | 4 (2.2) | 1 (1.1) |
| Previously | 64 (47.4) | 52 (42.6) | 106 (57.9) | 47 (54.0) |
| Race | ||||
| Asian | 2 (1.5) | 2 (1.6) | 1 (0.5) | 0 |
| Black or African American | 73 (54.1) | 53 (43.4) | 91 (49.7) | 24 (27.6) |
| White | 57 (42.2) | 58 (47.5) | 79 (43.2) | 59 (67.8) |
| American Indian | 0 | 2 (1.6) | 3 (1.6) | 1 (1.1) |
| More than One Race | 2 (1.5) | 2 (1.6) | 5 (2.7) | 0 |
| Unknown | 1 (0.7) | 5 (4.1) | 4 (2.2) | 3 (3.4) |
| BMI (kg/m2) | ||||
| Median | 26.3 | 27.5 | 25.7 | 26 |
| Q1, Q3 | 22.6, 29.6 | 25.0, 31.0 | 22.9, 29.4 | 23.6, 30.1 |
| Missing | 1 | 0 | 0 | 0 |
| IL28b genotype (RS 12979860) | ||||
| c/c | 32 (25.2) | 31 (27.2) | 38 (33.9) | 19 (31.1) |
| c/t | 61 (48.0) | 39 (34.2) | 51 (45.5) | 30 (49.2) |
| t/t | 34 (26.8) | 44 (38.6) | 23 (20.5) | 12 (19.7) |
| Missing | 8 | 8 | 71 | 26 |
| CD4 (cells/mm3) | ||||
| Median | 646 | 621.5 | 495 | 520 |
| Q1, Q3 | 462, 818 | 488.5, 858.5 | 373, 697 | 368, 706 |
| Missing | 2 | 2 | 0 | 0 |
| HIV RNA quantitation | ||||
| Unquantifiable | 133 (100.0) | 113 (92.6) | 129 (70.5) | 71 (81.6) |
| Quantifiable | 0 | 9 (7.4%) | 54 (29.5) | 16 (18.4) |
| Missing | 2 | 0 | 0 | 0 |
| HCV RNA (log10 IU/mL) | ||||
| Median | 6.7 | 6.9 | 6.5 | 6.6 |
| Q1, Q3 | 6.2, 7.1 | 6.5, 7.3 | 6.1, 6.8 | 6.3, 7.0 |
| Missing | 1 | 0 | 0 | 0 |
| Cirrhosis | ||||
| Yes | 18 (13.3) | 38 (31.1) | 20 (10.9) | 18 (20.7) |
| No | 117 (86.7) | 84 (68.9) | 163 (89.1) | 69 (79.3) |
| Baseline cART regimen | ||||
| No ART | 2 (1.5) | 6 (4.9) | 40 (21.9) | 11 (12.6) |
| EFV + 2 NRTIs | 58 (43.0) | 51 (41.8) | NA | NA |
| RAL + 2 NRTIs | 47 (34.8) | 45 (36.9) | NA | NA |
| LPV/RTV + 2 NRTIs | 4 (3.0) | 4 (3.3) | NA | NA |
| ATV/RTV + 2 NRTIs | 18 (13.3) | 10 (8.2) | NA | NA |
| DRV/RTV + 2 NRTIs | 6 (4.4) | 6 (4.9) | NA | NA |
Table 2 Sustained viral response rates
| A5294 participants (n = 257) | % SVR12 |
| Treatment naïve (n = 135) | 35.6 |
| Non-cirrhotic (n = 117) | 36.8 |
| Cirrhotic (n = 18) | 27.8 |
| Treatment experienced (n = 122) | 30.3 |
| Non-cirrhotic (n = 84) | 32.1 |
| Cirrhotic (n = 38) | 26.3 |
- Citation: Sherman KE, Kang M, Sterling R, Umbleja T, Marks K, Kiser JJ, Alston-Smith B, Greaves W, Butt AA, the ACTG 5294 BIRTH Study Team. Phase 3 trial of first generation protease inhibitor therapy for hepatitis C virus/human immunodeficiency virus coinfection. World J Hepatol 2017; 9(4): 217-223
- URL: https://www.wjgnet.com/1948-5182/full/v9/i4/217.htm
- DOI: https://dx.doi.org/10.4254/wjh.v9.i4.217