Table 2.
Patient Disposition and Week 96 Virologic Response Rates
| Treatment Arm, Age Group, Years | Both Treatment Arms, Age Group, Years |
|||||
|---|---|---|---|---|---|---|
| RPV | EFV | |||||
| <50 N=617 |
≥50 N=69 |
<50 N=625 |
≥50 N=57 |
<50 N=1242 |
≥50 N=126 |
|
| Disposition, n (%) | ||||||
| Completed Week 96 | 498 (81) | 56 (81) | 495 (79) | 50 (88) | 993 (80) | 106 (84) |
| Discontinuation due to adverse events | 24 (4) | 4 (6) | 53 (9) | 6 (11) | 77 (6) | 10 (8) |
| Discontinuation due to virologic failure | 46 (8) | 7 (10) | 19 (3) | 0 (0) | 65 (5) | 7 (6) |
| Discontinuation due to other reasonsa | 49 (8) | 2 (3) | 58 (11) | 1 (2) | 107 (9) | 3 (2) |
| Efficacy Parameters | ||||||
| HIV-1 RNA <50 copies/mL, FDA snapshot analysis, n (%) | 471 (76) | 53 (77) | 474 (76) | 48 (84) | 945 (76) | 101 (80) |
| HIV-1 RNA <50 copies/mL, TLOVR, n (%) | 480 (78) | 52 (75) | 482 (77) | 47 (82) | 962 (77) | 99 (79) |
| Median (range) change in CD4+ cell count from baseline, cells/mm3 | 263b (–108, 763) |
237c (37, 815) |
251d (–126, 1216) |
278e (–328, 763) |
257f (–126,1216) |
246g (–328, 815) |
RPV, rilpivirine; EFV, efavirenz; FDA, Food and Drug Administration; TLOVR, time to loss of virologic response.
aOther reasons included lost to follow-up, withdrew consent, noncompliant, ineligible to continue trial, and sponsor’s decision; bN=497; cN=58;dN=494; eN=49; fN=991;gN=107.