Table 2.
Description and Cox Model of Factors Associated With Virological Failure Among Subjects Randomized to Dolutegravir Monotherapy, N = 164
| Variables | No Virological Failure N = 254 | Virological Failure N = 18 | Univariate Analysis Hazard Ratio (95% CI) | P Value | Multivariate Analysis* Hazard Ratio (95% CI) |
P Value |
|---|---|---|---|---|---|---|
| Gender, n (%) | ||||||
| Male | 221 (87.0%) | 18 (100%) | 1 | .09** | ||
| Female | 33 (13.0%) | 0 (0%) | NA | |||
| Age at baseline, mean (SD) | 45 (12) | 50 (11) | 1.04 (1.01–1.08) | .05 | ||
| Ethnicity, n (%) | ||||||
| White | 219 (86.2%) | 15 (83.3%) | 1 | |||
| Black | 27 (10.6%) | 3 (16.7%) | 1.62 (0.47–5.59) | .58** | ||
| Other | 8 (3.2%) | 0 | NA | |||
| Time before first ART (days)a, n (%) | ||||||
| <90 | 117 (52.0%) | 3 (20.0%) | 1 | 1 | ||
| ≥90 | 108 (48.0%) | 12 (80.0%) | 4.62 (1.30–16.38) | .008 | 5.16 (1.60–16.65) | .006 |
| HIV transmission group, n (%) | ||||||
| Men who have sex with men | 182 (71.7%) | 12 (66.7%) | 1 | .94 | ||
| Heterosexual | 56 (22.0%) | 5 (27.8%) | 1.21 (0.43–3.43) | |||
| Other | 16 (6.3%) | 1 (5.5%) | 0.96 (0.13–7.40) | |||
| Nadir CD4-T cells count (/mm3), n (%) | ||||||
| <350 | 133 (52.4%) | 15 (83.3%) | 4.23 (1.22–14.60) | .009 | 12.10 (3.92–37.40) | <.001 |
| ≥350 | 121 (47.6%) | 3 (16.7%) | 1 | 1 | ||
| Zenith viral load (log copies/mL)***, mean (SD) | 4.62 (0.80) | 4.78 (0.58) | 1.15 (0.62–2.13) | .664 | ||
| BMI (kg/m) at baselinea, mean (SD) | 24.9 (3.8) | 25.5 (3.5) | 1.05 (0.93–1.17) | .47 | ||
| Duration of cART before inclusion*** (days), median (IQR) | 1651 (763–3435) | 1973 (1537–3841) | 1.00 (1.00–1.00) | .845 | ||
| INI 1st-generation exposure, n (%) | ||||||
| Yes | 30 (11.8%) | 1 (5.6%) | 0.46 (0.06–3.44) | .39 | ||
| No | 224 (88.2%) | 17 (94.4%) | 1 | |||
| Presence of a PCR signal at baselinea, n (%) | ||||||
| Yes | 39 (15.4%) | 7 (38.9%) | 3.38 (1.31–8.71) | .02 | 4.84 (3.68–6.38) | <.001 |
| No | 214 (84.6%) | 11 (61.1%) | 1 | 1 | ||
| CD4 T-cell count at baseline (/mm3), mean (SD) | 779.2 (273.9) | 742.2 (233.2) | 0.97 (0.88–1.06)*** | .47 | ||
| HIV DNA at baseline (log/106 PBMCs)b, n(%) | ||||||
| <2.7 | 128 (85.9%) | 7 (43.7%) | 1 | 1 | ||
| ≥2.7 | 21 (14.1%) | 9 (56.3%) | 6.01 (2.24–16.15) | <.001 | 3.81 (1.99–7.30) | <.001 |
Abbreviations: BMI, body mass index; cART, combined antiretroviral therapy; CI, confidence interval; DNA, deoxyribonucleic acid; HIV, human immunodeficiency virus; IQR, interquartile range; NA, nonapplicable; PCR, polymerase chain reaction; PBMCs, peripheral blood mononuclear cells; SD, standard deviation.
Presence of missing data (between <1% and 11%).
Presence of missing data (between 38% and 41%).
*HIV transmission group variable did not meet the proportional risk hypothesis.
**Log-rank test.
***HR represents an increase of 50 cells.