Table.
Intention-to-treat (ITT) and per-protocol estimates of risk and risk difference, at 3 and 5 years after randomization, START trial 2009–2015.
| Follow-up | Analysis | Risk, % (95% CI) | Risk difference of immediate vs deferred, % (95% CI) |
|
|---|---|---|---|---|
| Immediate ART initiation (N= 2321§) |
Deferred ART initiation (N=2355§) |
|||
| 3 years | Intention-to-treat | 1.5 (0.9,2.1) | 3.9 (3.1,4.7) | −2.4 (−3.4,−1.4) |
| Per-protocol* | 1.5 (1.0,2.0) | 4.1 (3.3,5.1) | −2.7 (−3.8,−1.7) | |
| 5 years | Intention-to-treat | 3.2 (1.9,4.7) | 6.2 (4.7,8.0) | −3.1 (−5.2,−0.8) |
| Per-protocol* | 3.2 (2.0,4.6) | 7.0 (5.2,9.6) | −3.8 (−6.7,−1.5) | |
§
9 participants in START were excluded from this analysis due to missing baseline HIV-RNA, 5 in the immediate ART initiation group and 4 in the deferred ART initiation group.
*
Estimates under complete adherence to the protocolare adjusted, via the parametric g-formula, for sex, age, CD4 count and HIV-RNA at randomization, geographical area, the most recent CD4 count and HIV-RNA values, the number of months since the last CD4 and HIV-RNA measurements, ART initiation status and months since ART initiation.