Table 2. Subject Disposition at Week 24 (Treated Analysis Set).
| Immediate Switch | Delayed Switch | |||
|---|---|---|---|---|
| N (%) | EFV/FTC/TDF (N = 79)Baseline—Wk 12 | EFV/FTC/TDF (N = 79) Wk 12 —Wk 24 | ABC/3TC + EFV (N = 78) Baseline—Wk 12 | EFV/FTC/TDF (N = 73) Wk 12 —Wk 24 |
| Subjects completing study treatment | 78 (98.7%) | 72 (91.1%) | 73 (93.6%) | 71 (91.0%) |
| Early Treatment Discontinuation | 1 (1.3%) | 6 (7.6%) | 5 (6.4%) | 2 (2.7%) |
| Adverse Events * | 1 (1.3%) | 2 (2.5%) | 1 (1.3%) | 2 (2.7%) |
| Pregnancy | 0 | 2 (2.5%) | 0 | 0 |
| Protocol Violation | 0 | 1 (1.3%) | 2 (2.5%) | 0 |
| Withdrew Consent | 0 | 1 (1.3%) | 1 (1.3%) | 0 |
| Investigator’s Decision | 0 | 0 | 1 (1.3%) | 0 |
*Adverse events leading to study drug discontinuation:
- Immediate Switch: emergent to EFV/FTC/TDF—anxiety; insomnia; night sweats
- Delayed Switch: emergent to ABC/3TC + EFV (baseline to Wk12)—depression
- Delayed Switch: emergent to EFV/FTC/TDF (Wk 12 to Wk 24)—sleep disorder; urticaria