The VACS Risk Index Responds to Treatment Interventions and Is Highly Correlated with and Predictive of Mortality Events in the Optima Study

• Activity Number: 423
• Type: Contributed
• Date/Time: Tuesday, August 2, 2011 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Katherine Anne Kirkwood*+ and Tassos Kyriakides and Sheldon T. Brown and Amy C. Justice and Mark Holodniy and Janet Tate and Joseph Goulet
• Companies: VA Cooperative Studies Program and VA Cooperative Studies Program and James J. Peters VA Medical Center and VA Connecticut Healthcare System, West Haven and VA Palo Alto Healthcare System and VA Connecticut Healthcare System, West Haven and VA Connecticut Healthcare System, West Haven
• Keywords: randomized trials ; mortality ; prognostic index ; biomarkers ; treatment

Abstract

Background: Reliable intermediate outcome measures are needed to assess clinical interventions in the current era of HIV treatment. We evaluated the performance of the Veterans Aging Cohort Study (VACS) Index which uses biomarkers to predict mortality.

Methods: VACS Index scores were determined from data collected in the Options In Management with Antiretrovirals (OPTIMA) multi-national study of treatment strategies in patients with advanced HIV. Mean scores by treatment arms were compared using repeated measures analysis. Logistic regression and survival analysis were carried out to compare index score levels. Proportional hazards regression is being explored to assess the utility of the index score as an outcome measure for future clinical trials.

Results: Log-rank comparisons of score strata highly correlated with mortality (p< .0001). The index performed well when applied to the OPTIMA data (c=.728).

Conclusions: The VACS Risk Index accurately predicted mortality and responded to changes in treatment. It may offer an efficient alternative endpoint for the design of randomized clinical interventions among patients with advanced HIV.