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Abstract



Major clinical outcomes in patients not treated with antiretroviral therapy (ART) at baseline in SMART; a rationale for a trial to examine early treatment of HIV disease

Emery S.1, SMART Study Group and INSIGHT

Objectives: SMART randomized 5472 HIV infected patients with CD4+ cell counts > 350/mL to intermittent ART based on CD4+ cell count <250 cells/mL or > 350 cells/mL versus continuous ART (DC and VS arms respectively). Follow-up of patients not on ART at entry informs discussions on the optimal time to commence ART.
Methods: ART naïve (n=251) or patients who had not taken ART for > 6 months (n=227) were included. Categories of clinical outcome that comprised i) opportunistic disease (OD) and all cause mortality, ii) OD (fatal and non-fatal), iii) serious non-AIDS (cardiovascular, renal and hepatic disease, non-AIDS defining cancers, and deaths from non-OD causes), and iv) the composite of ii and iii, were assessed. Events were compared between the DC and VS arms using Cox models and summarized with hazard ratios (HR) and 95% confidence intervals (CI).
Results: 229 and 249 patients were randomized to the DC and VS arms. Median CD4+ cell count and plasma HIV RNA were 447 cells/
mL and 4.5 log copies/mL. Duration of ARV exposure was 17.6% and 90.0% for DC and VS patients respectively. Clinical events and HR (95%CI) are summarized below for an average 18 months follow-up. Results were similar for events in ART naïve patients.

EventsDC (rate)VS (rate)HR (DC/VS)95%CIp-value
OD/death15 (4.8)4 (1.1)4.361.44, 13.10.01
OD11 (3.5)3 (0.8)4.401.20, 15.70.02
Serious non-AIDS12 (3.9)2 (0.5)7.041.58, 31.50.01
Composite21 (7.0)5 (1.3)5.001.90, 13.40.001

Conclusions: These data indicate ART may reduce AIDS and non-AIDS morbidity and mortality in patients with early HIV disease. Along with observational studies, these results support the conduct of a randomized, controlled trial to determine the risks/benefits of commencing ART with CD4+ cell counts > 350/
mL.





4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no. WEPEB018


Suggested Citation
"EmeryS., et al. Major clinical outcomes in patients not treated with antiretroviral therapy (ART) at baseline in SMART; a rationale for a trial to examine early treatment of HIV disease. Poster exhibition: 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention: Abstract no. WEPEB018"