- Significant liver fibrosis was rare in antiretroviral therapy (ART)-naïve HIV-positive persons with high CD4 counts.
- Immediate ART was associated with lower risk for liver fibrosis vs deferred treatment.
Why this matters
- The findings support current guidance to initiate ART in all patients with HIV irrespective of the CD4 count, particularly considering that modern ART regimens have a lower risk for hepatotoxicity.
- START study: 4580 ART-naïve HIV-positive persons with high CD4 counts (>500 cells/μL) received immediate ART (2273) or deferred treatment when their CD4 count was
- Outcomes: fibrosis (AST to platelet ratio index [APRI]>0.5 or fibrosis-4 index [FIB-4]>1.45), significant fibrosis (APRI>1.5 or FIB-4>3.25), hepatic flare and resolution of elevated APRI and FIB-4 scores.
- Funding: National Institute of Allergy and Infectious Diseases; National Institutes of Health Clinical Center; National Cancer Institute, National Heart, Lung, and Blood Institute; others.
- At baseline, confirmed significant fibrosis (APRI>1.5 and FIB-4>3.25) was reported in 1.1% of the patients by either APRI or FIB-4 and 0.3% of patients by both APRI and FIB-4.
- Median CD4 count was 651 cells/mm3.
- Immediate ART group participants were at lower risk of developing increased fibrosis scores than deferred group participants (HR, 0.66; P<.001>
- By both APRI and FIB-4, liver fibrosis markers normalised faster among those in the immediate ART group vs the deferred therapy ART group (HR, 1.58; P
- Among participants with APRI>0.5, normalisation occurred at a higher rate in the immediate vs deferred group (56.6 vs 40.9 per 100 person-years; HR, 1.63; P<.001>
- Among participants with FIB-4>1.45, normalisation rates were higher in the immediate vs deferred group (40.6 vs 27.1 per 100 person-years; HR 1.62; P<.001>
- Findings cannot be generalised to persons with lower CD4 counts or viral hepatitis coinfection.