HIV Infection, Treatment & Risk for Cardiovascular Disease

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Cardiovascular Risk Review Report

Review of CVD Risk Studies

Overview of CVD Risk Studies

CVD Summary Table

Presentations:
Gilbert l'Italien
Jonathan Sterne

HIV Infection, HIV Treatment and Risk for Cardiovascular Disease: An Independent Review of Ongoing Studies  

Background:

HAART related toxicities, several of which are risk factors for cardiovascular disease, have raised the concern that antiretroviral treatment may increase risk for cardiovascular disease (CVD) in HIV infected, treated individuals. Several groups have initiated studies investigating the relationship between exposure to combination antiretroviral treatment and CVD risk factors or cardiovascular disease.

One challenge faced by investigators addressing this issue is the fact that any increased risk for CVD, if it is real, will be relatively small compared to the decrease in HIV disease associated morbidity and mortality. The studies that have addressed CVD risk include retrospective studies of cohorts or databases as well as prospective studies. The approach to design and analysis has varied, with different stringencies applied to the definition of CVD, differences in time of follow up, and different definitions of “combination antiretroviral treatments”.

Not surprising considering the heterogeneity of the studies, the data coming out of these studies – and their interpretation -- have not presented a consistent message, some indicating that there is no increased risk, and others alerting to a significant increase in risk for CVD associated with HIV treatment. None of the studies has been able to assess individual drug class associations with risk. As strategies for HIV treatment shift from acute to chronic disease approaches, and the total exposure time of individual patients increases, it will become increasingly important to establish whether an increased risk exists, and if so, what the predictive factors for this are.

The Forum of Collaborative HIV Research will to convene a panel of experts to review and evaluate the ability of the currently ongoing studies to answer the question: is there increased risk for cardiovascular disease among HIV infected and/or treated individuals compared to appropriate controls, and if so, what are the variables associated with the increased risk.

Objectives:

  • List and describe the major studies that are addressing the issue of cardiovascular risk (not restricted to the oversight committee sponsored studies)
  • Review the study design and methodology for each study
  • Review the timeline for analysis
  • Evaluate the study’s ability to assess cardiovascular risk related to HIV and treatment within the given timeframe
  • Identify gaps that will potentially remain
  • Re-evaluate the approach: e.g. do we need more studies, more patients in the individual studies, longer follow-up?

Expected outcomes:

  • A roundtable discussion report
  • A document with evaluation and recommendations by the independent committee
  • A clearer understanding of where we are with regard to understanding this risk.

Project specific sponsors:
EMEA Oversight Committee