- Clinical, virologic, immunologic, and safety data of START study participants support immediate antiretroviral therapy (ART) initiation in HIV-positive individuals with low pretreatment viraemia (RNA ≤3000 c/mL).
- Compared to deferred ART initiation, immediate initiation results in similar serious clinical outcomes rate, higher CD4 counts, a greater proportion of patients with suppressed viraemia and decreases in inflammatory and coagulation biomarkers levels (vascular adhesion molecule-1 [VCAM], D-dimer).
- The analysis of participants with HIV-RNA
Global HIV treatment guidelines recommend early ART initiation in HIV-positive individuals, regardless of baseline CD4 count. However, in those with low pretreatment HIV-RNA levels, the benefit of immediate ART is uncertain. This study investigates the effect of this strategy in HIV-positive people with pretreatment HIV RNA less than 3000 c/mL, a subgroup of the START study.
A total of 1,134 (median age 37 years, median CD4 713 cells/mL) were randomised to immediate (n=555) versus deferred (n=579) ART.
97% of participants in the immediate and 29% in the deferred arm initiated ART, at a median of 6 and 699 days, respectively.
Combined serious clinical outcomes (grade 4 adverse events not attributable to AIDS, unscheduled hospitalisations, death from any cause) were observed in 64 patients in the immediate group and 61 in the deferred arm (hazard ratio 1.10; 95% CI 0.77 to 1.56, P=0.595).
The mean difference in CD4 counts was 125 and 235 cells/mL at 12 and 35 months, respectively, and was higher in the immediate versus deferred treatment group (95% CI: 93 to 156 cells/mL and 187 to 283, respectively; P
There were changes in the measured soluble biomarkers at month 8 from baseline: D-dimer and VCAM levels significantly decreased and C-reactive protein increased in the immediate group.
CD4 counts and biomarkers did not change in those who maintained spontaneous virologic suppression.
The analysis of a subgroup of patients with HIV-RNA
Study results support immediate ART initiation in people with low viraemia, although equipoise remains for suppressors.
Limitations: limited power of subgroup analysis, short follow-up (mean of 3-year vs. 10 years in START); group demography not representative (high proportion of women and blacks and low proportion of hepatitis coinfection); adverse events collected only if classified as grade 4.