12th Annual Conference of the British HIV Association 29 March–1 April 2006, Brighton, UK

SMART STRATEGIES FOR MANAGEMENT OF ANTIRETROVIRAL THERAPY

HIV Med 2006; 7(Suppl. 1):2 (abstract no. O7)

Adrian Palfreeman, Wafaa El-Sadr, Brian Gazzard, Jim Neaton, Fred Gordin and Abdel Babiker
MRC CTU, London, UK

The SMART study is a randomised international trial evaluating two antiretroviral strategies, the viral suppression (VS) and drug conservation (DC) strategies. Inclusion criteria were all patients with a CD4 count above 350 cells/µl. The VS arm was managed within current guidelines with continuous antiretroviral therapy (ART). The DC arm deferred or stopped ART until their CD4 count fell to less than 250. They then restarted ART until their CD4 count reached 350 when they stopped ART again. This approach was designed to preserve health whist minimising drug exposure. The study was designed to recruit 6000 patients for follow up over 6–9 years. Patients were seen at 1, 2 and then every 2 months in the first year and every 4 months thereafter. CD4 counts and HIV viral load were checked at each visit and genotypic resistance testing done on all samples with a viral load >1000 copies/ml. Recruitment to the study was stopped on 11th January 2006 with 5472 patients enrolled. As of 10th December 2005, 93 patients in the DC arm had reached a primary endpoint (disease progression or death) versus 47 patients in the VS arm (P>0.0001). These differences remained significant for serious progression of disease, death and for major toxicities. This effect was assessed across groups defined by nadir and baseline CD4 count; all favoured the VS arm. Following the release of these data, patients on the DC arm of SMART were asked to contact their physicians to discuss restarting ART. Follow-up of all patients in SMART continues.

2006-03-29
O7

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