EFV-based regimens | |||||
---|---|---|---|---|---|
Available data (n) | Simultaneous Interruptiona | Staggered Interruptionb | Controlsc | p valued | |
Total number, n | 559 | 161 | 82 | 316 | |
Median duration of EFV-based regimens, months (IQR) | 559 | 57 (27–73) | 31 (18–52) | 40 (23–65) | <0.001 |
Once-daily regimen at end of study, % | 378 | 66.0 | 53.7 | 69.2 | 0.097 |
Documented EFV-based regimen interruption, % e | 559 | 9.3 | 3.7 | 2.8 | 0.007 |
Frequency of plasma HIV-RNA assays | 559 | ||||
> 2 times/year, % | 14.9 | 32.9 | 22.2 | 0.030 | |
1–2 times/year, % | 57.1 | 48.8 | 60.4 | ||
< 1 time/year, % | 28.0 | 18.3 | 17.4 | ||
Primary outcome | |||||
Incidence of virological failure, cases per 1,000 person-years | 559 | 12.9 | 5.4 | 6.6 | |
Relative risk of having virological failure when compared to Control group, (95% CI) | 559 | 1.97 (0.62–6.38) | 0.83 (0.02–6.43) | ||
Secondary outcomes | |||||
Virological suppressiong at 24 (±3) months, % (Per-protocol-analysis) | 440 | 66.9 | 76.9 | 68.9 | 0.411 |
Median CD4 cell counts at 24 (±3) months, cells/μL (IQR) | 327 | 352 (258–524) | 387 (309–458) | 340 (237–473) | 0.483 |
Median increase from baseline in CD4 cell counts at 24 (±3) months, cells/μL (IQR) | 317 | 264 (184–374) | 292 (220–384) | 273 (178–383) | 0.647 |
Major opportunistic infections, % | 556 | 6.83 | 4.88 | 5.75 | 0.812 |
Paradoxical immune recovery syndrome, % | 541 | 4.55 | 2.60 | 2.90 | 0.603 |
Malignancy, % | 559 | 1.24 | 0.00 | 1.27 | 0.736 |
Non-AIDS defining conditions h, % | 559 | 0.62 | 0.00 | 0.32 | 1.000 |
Death, % | 559 | 3.10 | 0.00 | 1.58 | 0.206 |