Table 5.
Results From Univariable and Multivariable Logistic Regression Models to Identify Independent Baseline Factors Predictive of Treatment Failure by ITT Analysis Considering All Categories of Liver‐Disease Severity (N = 2,369)
| Treatment Failures (n = 189) | Univariable | Multivariable | |||
|---|---|---|---|---|---|
| Variable | n (%) | OR (95% CI) | P | OR (95% CI) | P |
| Age (years) | 0.03 | 0.089 | |||
| <45 | 16 (5.6) | 1.00 | 1.00 | ||
| 45‐54 | 123 (7.3) | 1.40 (0.82‐2.40) | 1.27 (0.73‐2.19) | ||
| ≥55 | 50 (10.7) | 2.03 (1.13‐3.64) | 1.77 (0.98‐3.22) | ||
| Sex | 0.01 | 0.01 | |||
| Female | 27 (5.2) | 1.00 | 1.00 | ||
| Male | 162 (8.7) | 1.74 (1.14‐2.65) | 1.75 (1.14‐2.69) | ||
| HIV transmission category risk | 0.39 | ||||
| Non‐IDU | 13 (5.7) | 1.00 | |||
| IDU | 111 (8.1) | 1.46 (0.81‐2.65) | |||
| Other/unknown | 65 (8.4) | 1.53 (0.83‐2.83) | |||
| CDC clinical category | 0.01 | 0.04 | |||
| A/B | 64 (6.3) | 1.00 | 1.00 | ||
| C | 60 (10.3) | 1.72 (1.19‐2.48) | 1.65 (1.12‐2.41) | ||
| Unknown | 65 (8.5) | 1.39 (0.97‐1.99) | 1.30 (0.67‐2.54) | ||
| Nadir CD4+ T‐cell count, cells/mm3 | 0.02 | ||||
| ≥ 200 | 38 (5.5) | 1.00 | |||
| < 200 | 85 (9.3) | 1.74 (1.17‐2.58) | |||
| Unknown | 66 (8.6) | 1.60 (1.06‐2.42) | |||
| Baseline CD4+ T‐cell count, cells/mm3 | <0.001 | 0.01 | |||
| ≥200 | 95 (6.7) | 1.00 | 1.00 | ||
| <200 | 21 (16.0) | 2.64 (1.58‐4.40) | 2.30 (1.35‐3.92) | ||
| Unknown | 73 (8.8) | 1.33 (0.97‐1.83) | 1.22 (0.65‐2.30) | ||
| Baseline HIV RNA copies/mL | 0.90 | ||||
| <50 | 122 (7.9) | 1.00 | |||
| ≥50 | 6 (7.2) | 0.91 (0.39‐2.14) | |||
| Unknown | 61 (8.3) | 1.06 (0.77‐1.46) | |||
| Combination ART | 0.23 | ||||
| Yes | 183 (7.9) | 1.00 | |||
| No | 6 (12.8) | 1.71 (0.72‐4.08) | |||
| Liver stiffness, kPaa | <0.001 | ||||
| <9.5 | 66 (6.6) | 1.00 | |||
| 9.5‐12.5 | 21 (5.2) | 0.77 (0.46‐1.27) | |||
| 12.6‐19.4 | 18 (4.7) | 0.70 (0.41‐1.19) | |||
| ≥19.5 | 79 (14.4) | 2.38 (1.68‐3.36) | |||
| Unknown | 5 (13.2) | 2.13 (0.81‐5.65) | |||
| HCV genotype | 0.26 | ||||
| 1 | 102 (7.1) | 1.00 | |||
| 2 | 4 (14.8) | 2.26 (0.77‐6.67) | |||
| 3 | 29 (8.2) | 1.16 (0.75‐1.78) | |||
| 4 | 51 (9.6) | 1.39 (0.97‐1.97) | |||
| Other | 3 (10.7) | 1.56 (0.46‐5.26) | |||
| HCV RNA IU/mL | 0.047 | 0.01 | |||
| <800,000 | 46 (6.3) | 1.00 | 1.00 | ||
| ≥800,000 | 143 (8.7) | 1.42 (1.01‐2.00) | 1.63 (1.14‐2.36) | ||
| Naive for anti‐HCV therapy | 0.84 | ||||
| Yes | 122 (8.1) | 1.00 | |||
| No |
67 (7.8) 0 |
0.97 (0.71‐1.32) | |||
| Liver disease category | <0.001 | <0.001 | |||
| No cirrhosis | 87 (6.2) | 1.00 | 1.00b, c | ||
| Compensated cirrhosis | 72 (9.0) | 1.50 (1.08‐2.07) | 1.35 (0.96‐1.89)b, d | ||
| Decompensated cirrhosis | 30 (19.2) | 3.62 (2.30‐5.70) | 2.92 (1.76‐4.87)c, d | ||
| Anti‐HCV regimen | <0.001 | <0.001 | |||
| SOF/LDV | 107 (7.3) | 1.00 | 1.00 | ||
| SOF+DCV | 30 (8.7) | 1.21 (0.79‐1.84) | 1.10 (0.71‐1.70) | ||
| DSV+OBV/PTV/r | 16 (5.1) | 0.68 (0.40‐1.17) | 0.73 (0.42‐1.27) | ||
| OBV/PTV/r | 10 (7.6) | 1.04 (0.53‐2.04) | 1.40 (0.70‐2.79) | ||
| SOF+SMV | 17 (23.9) | 4.00 (2.24‐7.14) | 2.84 (1.53‐5.29) | ||
| SOF+RBV | 7 (21.9) | 3.56 (1.50‐8.42) | 3.41 (1.39‐8.36) | ||
| SMV+DCV | 2 (50.0) | 12.71 (1.77‐91.1) | 11.77 (1.59‐ 87.27) | ||
| SOF+SMV+DCV | 0 | — | — | ||
| SOF+OBV/PTV/r | 0 | — | — | ||
| Anti‐HCV treatment duration | 0.12 | ||||
| 8 weeks | 9 (6.9) | 0.94 (0.47‐1.90) | |||
| 12 weeks | 115 (7.3) | 1.00 | |||
| 16 weeks | 0 | — | |||
| 24 weeks | 65 (9.8) | 1.38 (1.01‐1.90) | |||
| Ribavirin use | 0.48 | ||||
| No | 127 (7.7) | 1.00 | |||
| Yes | 62 (8.6) | 1.12 (0.82‐1.54) |
a
Liver stiffness cutoffs: <9.5 kPa, cutoff accurate to rule out advanced fibrosis‐cirrhosis (METAVIR F3‐F4); ≤12.5 kPa, cutoff accurate to rule out liver cirrhosis; ≤19.5 kPa, cutoff accurate to rule out high‐risk of esophageal varices.
b
P = 0.015.
c
P < 0.001.
d
P < 0.001.
Abbreviations: CI, confidence interval; OR, odds ratio; IDU, injection drug user.