| Abstract O44 – Table 1. Virological outcomes by the presence of key baseline and post‐baseline factors. | |||||
|---|---|---|---|---|---|
| Three baseline factors: RPV RAMs,b subtype A6/A1,c and BMI ≥30 kg/m2 | Two baseline factors + CAB and RPV PKa: RPV RAMs,b subtype A6/A1,c low initial CAB trough,a and low initial RPV trougha | ||||
| Baseline factors (number) | Virological suppression, n (%)d | CVF, n (%)e | Factors (number) | Virological suppression, n (%)d | CVF, n (%)e |
| 0 | 844/970 (87.0) | 4/970 (0.4)f | 0 | 584/664 (88.0) | 0/664 (0)i |
| 1 | 343/404 (84.9) | 8/404 (2.0)g | 1 | 339/396 (85.6) | 5/396 (1.3)j |
| ≥2 | 44/57 (77.2) | 11/57 (19.3)h | ≥2 | 190/232 (81.9) | 17/232 (7.3) |
| Total (95% CI) | 1231/1431 (86.0) (84.1% to 87.8%) | 23/1431 (1.6) (1.0% to 2.4%) | ≥3 | 28/39 (71.8) | 8/39 (20.5)k |
| 18/1224 (1.47)l | Total (95% CI) | 1113/1292 (86.1) (84.1% to 88.0%) | 22/1292 (1.7) (1.1% to 2.6%) | ||
BMI, body mass index; CAB, cabotegravir; CVF, confirmed virological failure; FDA, Food and Drug Administration; NPV, negative predictive value; PK, pharmacokinetic; PPV, positive predictive value; RAM, resistance‐associated mutation; RPV, rilpivirine.
aBelow first quartile; bscreening plasma samples were used for reverse transcriptase genotype analysis for participants in the FLAIR study. Baseline genotyping of participant samples from the ATLAS and ATLAS‐2M studies was carried out retrospectively in peripheral blood mononuclear cell (PBMC) samples (pro‐viral DNA); cHIV‐1 subtype A1 or A6 classification based on Los Alamos National Library panel from HIV Sequence database (June 2020); dbased on the FDA Snapshot algorithm of HIV‐1 RNA <50 copies/mL at week 48 for ATLAS, week 124 for FLAIR, and week 152 for ATLAS‐2M; edefined as two consecutive measurements of HIV‐1 RNA ≥200 copies/mL; fPPV 0.4%; NPV 95.9%; sensitivity 17.4%; specificity 31.4%; gPPV 2.0%; NPV 98.5%; sensitivity 34.8%; specificity 71.9%; hPPV 19.3%; NPV 99.1%; sensitivity 47.8%; specificity 96.7%; iPPV 0%; NPV 96.5%; sensitivity 0%; specificity 47.7%; jPPV 1.3%; NPV 98.1%; sensitivity 22.7%; specificity 69.2%; kPPV 20.5%; NPV 98.9%; sensitivity 36.4%; specificity 97.6%; lanalysis dataset for the multivariable modelling.