Table 2.
Virologic success in the ADVANCE Trial by the presence of WHO-defined pretreatment drug resistance.
| Total cohort | Efavirenz arm | Dolutegravir arms | Interaction P valuea | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PDR | No PDR | P valuea | PDR | No PDR | P valuea | PDR | No PDR | P value | ||
| Primary outcomeb | 73/112 (65%) | 606/714 (85%) | <0.001 | 12/20 (60%) | 215/249 (86%) | 0.002 | 61/92 (66%) | 391/465 (84%) | <0.001 | 0.39 |
| Secondary outcomec | 86/105 (82%) | 646/687 (94%) | <0.001 | 13/19 (68%) | 218/234 (93%) | <0.001 | 73/86 (85%) | 428/453 (94%) | 0.001 | 0.26 |
| 48-week Snapshotd | 84/122 (69%) | 630/752 (84%) | <0.001 | 11/24 (46%) | 213/265 (80%) | <0.001 | 73/98 (75%) | 417/487 (86%) | 0.006 | 0.10 |
| 96-week Snapshotd | 71/122 (58%) | 593/752 (79%) | <0.001 | 11/24 (46%) | 198/265 (75%) | 0.002 | 60/98 (61%) | 395/487 (81%) | <0.001 | 0.64 |
| Mean change in log10 viral load from baseline to 12 weeks (SD) | 2.63 (0.95) | 2.66 (0.79) | 0.78 | 2.00 (0.73) | 2.61 (0.75) | 0.004 | 2.80 (0.94) | 2.68 (0.81) | 0.34 | 0.001 |
aP values for the total cohort and treatment arms represent results of chi-squared tests for the primary and secondary outcomes and results of two-sided t tests for the change in viral load outcome. P values for the interaction terms represent two-sided tests of significance for interaction terms between pretreatment drug resistance and efavirenz vs dolutegravir terms in logistic regression models.
bPrimary outcome: Virologic success in our primary outcome was defined as achievement of a sustained viral load < 1000 copies/mL from 12 weeks, <200 copies/mL from 24 weeks, and <50 copies/mL from 48 weeks onwards. Individuals who are censored after 48 weeks with virologic suppression are considered as achieving virologic success.
cSecondary outcome: Virologic success in our secondary outcome was defined as the absence of two consecutive visits with a viral load > 200 copies/mL. Individuals who are censored with a single viral load > 200 copies/mL are considered failures, whereas those who discontinue with virologic suppression are considered as achieving virologic success.
d48 and 96-week Snapshot outcome refer to Food and Drug Administration-defined Snapshot outcomes for HIV therapeutic trials.
PDR: presence of WHO-defined pretreatment drug resistance.