15th Annual Conference of the British HIV Association 1-3 April 2009, Liverpool, UK

A PILOT STUDY OF CHANGES IN SURROGATE BIOMARKERS OF CARDIOVASCULAR DISEASE IN INDIVIDUALS INTERRUPTING ANTIRETROVIRAL THERAPY INITIATED IN PRIMARY HIV INFECTION

HIV Med 2009 Apr 1-3 (Suppl 1);15:6 (abstract no. O4)

E Hamlyn, M McClure and S Fidler
Imperial College, London, UK

BACKGROUND: Data from the SMART study indicates that interruption of long term antiretroviral therapy (ART) in chronic HIV infection is associated with increased rates of cardiovascular events and death, and correlates with raised levels of systemic biomarkers IL-6 and D-dimer. The role of intermittent short course ART (SCART) in Primary HIV infection (PHI) is currently under investigation in the SPARTAC trial. If shown to confer an immunological benefit, the risks of interrupting ART in PHI must be evaluated. The aim of this study was to investigate the impact of interrupting a short course of ART in PHI on levels of IL-6 and D-dimer.

METHODS: Thirty patients with PHI received either a 3-month course of SCART (n=25) or no therapy (n=5) in an open non-randomised pilot study. D-dimer and IL-6 levels were analysed from frozen plasma samples at 4 time-points; baseline, week 12 on ART, and 4–8 weeks and 6–12 months after discontinuing therapy.

RESULTS: In those receiving SCART, IL-6 declined significantly on commencing ART (P=0.01, 95% CI: 0.11, 0.66) corresponding with viral suppression. 4–8 weeks following treatment discontinuation there was a further decrease in IL-6 levels (P=0.005, 95% CI: 0.06, 0.31), and at 6–12 months levels had risen but were not significantly different from those at the time of virological suppression. D-dimer levels decreased significantly on starting ART, but did not significantly rebound on treatment discontinuation. There were no significant changes in biomarkers across the 4 time-points in those who declined ART although the numbers were too small to draw any conclusions. Of the 30 patients, one patient in the treatment arm suffered an acute cardiovascular event.

CONCLUSIONS: These data suggest that, contrary to chronic HIV infection, levels of IL-6 and D-dimer do not immediately rebound on discontinuing SCART after treatment interruption in PHI. These findings will be further evaluated using the SPARTAC cohort.

2009-04-01
O4

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