TABLE 2.
Efficacy outcomes (FDA Snapshot approach)
| Groupa | No./total no. (% [95% CI]) |
Difference (% [95% CI]) | |
|---|---|---|---|
| ISG | DSG | ||
| <50 copies/ml HIV-1 RNA | |||
| Week 24 | |||
| EFV | 76/78 (97.4 [91.0 to 99.7]) | 36/36 (100 [90.3 to 100]) | −2.6 (−8.0 to 2.9) |
| Non-EFV | 343/369 (93.0 [89.8 to 95.3]) | 175/187 (93.6 [89.1 to 96.6]) | −0.8 (−5.4 to 3.8) |
| ISG week 48 vs DSG week 24 | |||
| EFV | 73/78 (93.6 [85.7 to 97.9]) | 36/36 (100 [90.3 to 100]) | −6.4 (−13.3 to 0.4) |
| Non-EFV | 333/369 (90.2 [86.7 to 93.1]) | 175/187 (93.6 [89.1 to 96.6]) | −3.3 (−8.1 to 1.5) |
| ≥50 copies/ml HIV-1 RNAb | |||
| Week 24 | |||
| EFV | 1/78 (1.3 [0.0 to 6.9]) | 0/36 (0.0 [0.0 to 9.7]) | 1.3 (−3.6 to 6.2) |
| Non-EFV | 7/369 (1.9 [0.8 to 3.9]) | 4/187 (2.1 [0.6 to 5.4]) | −0.1 (−3.0 to 2.7) |
| ISG week 48 vs DSG week 24 | |||
| EFV | 0/78 (0.0 [0.0 to 4.6]) | 0/36 (0.0 [0.0 to 9.7]) | 0.0 (−4.2 to 4.2) |
| Non-EFV | 7/369 (1.9 [0.8 to 3.9]) | 4/187 (2.1 [0.6 to 5.4]) | −0.2 (−3.1 to 2.6) |
a
EFV, efavirenz.
b
Included participants who changed any component of background therapy to a new drug class, background components that were not permitted according to the protocol, or any background drug in the regimen because of lack of efficacy (perceived or documented) before study week 24, participants who discontinued the study drug or the study before study week 48 because of lack or loss of efficacy, and participants with ≥50 copies/ml HIV-1 RNA in the time window.