The START trial
START included asymptomatic HIV infected adults (n = 4,685) with good immune function (CD4+ cell counts >500/mm3). Participants were randomised to immediate ART or deferred therapy (CD4+ cell count <350/mm3 or until the development of AIDS-related symptoms).5
The primary clinical endpoint was a composite outcome that included any serious AIDS-related event, death from AIDS or any AIDS-defining illnesses, as well as any serious non-AIDS events, including death.5
- In participants who began ART immediately, there was a 56% reduction in the risk of primary endpoint outcomes (HR = 0.43; 95% confidence interval [Cl] 0.30 – 0.62; p <0.001) compared to deferred treatment.5
- The benefits of immediate ART were evident across all subgroups (including men and women, older and younger, high and low plasma HIV-1 RNA levels, residents of high-income and low/middle-income countries).5
The TEMPRANO trial
TEMPRANO was a multicentre, randomised controlled trial of more than 2,000 participants and was designed to assess the benefits of early ART, 6 months of concomitant isoniazid prophylaxis (IPT), or both.6 HIV-infected participants with CD4 counts of <800 cells/mm3 were randomised to four treatment arms of either immediate or deferred ART, both with and without IPT.
The primary study endpoint was a combination of all-cause deaths, AIDS diseases, non-AIDS malignancies, and non-AIDS invasive bacterial diseases.
- Early ART reduced the risk of death or severe HIV-related illness by 44% (HR = 0.56; 95% CI: 0.41-0.76; p = 0.0002) compared with deferred ART.6
- On the basis of these results, the study team concluded that early ART is beneficial in reducing the rate of clinical events.6
In the RAPID programme (an intensive, same-day appointment incorporating a social needs assessment, medical provider evaluation, and initiation of ART), time to virological suppression was improved for HIV-positive individuals initiated on the same day as diagnosis (n=39) compared to participants treated with a standard initiation protocol (n=47).7
The RapIT trial investigated the effect on medication uptake and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible PLHIV to be dispensed their first supply of ART on the day of their first HIV-related clinic visit. The trial demonstrated improvements in the uptake of ART and viral suppression in the rapid-initiation arm (n=187) compared with participants in the standard-initiation arm (n=190).8
In the SABES study, investigators assessed HIV-1 viral load dynamics in plasma and semen from 57 participants randomised to initiate ART immediately after diagnosis (n=26) or 24 weeks later (n=31). Compared to the deferred treatment protocol, immediate initiation of ART lead to a rapid reduction in plasma and semen viral load.9
The ART observational study evaluated the impact of very early ART initiation and regimen type on time to viral suppression in 86 participants with newly-diagnosed HIV infection who initiated ART within 30 days of diagnosis. The median time from an offer of immediate ART to starting ART was 8 days. The results demonstrated that treatment initiated at the initial visit led to rapid and reliable viral suppression in acute, early and chronic HIV infection. Time to viral suppression was significantly shorter in those receiving an integrase inhibitor- (n=56) versus a protease inhibitor-based regimen (n=30; p = 0.022).10