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Wednesday, 20 October 2004

This presentation is part of: Poster Session - Utility Theory; Health Economics; Patient & Physician Preferences; Simulation; Technology Assessment

THE IMPACT OF AIDS-RELATED EVENTS AND NON-AIDS SERIOUS ADVERSE EVENTS ON HEALTH-RELATED QUALITY OF LIFE IN A MULTINATIONAL TRIAL OF ANTIRETROVIRAL THERAPY

Sally S. Araki, PhD1, Daphne P. Guh, MSc2, Joel Singer, PhD3, Vilija Joyce, BA4, Vandana Sundaram, MPH5, Julie Munakata, MS4, Ariel K. Hill, AB4, Huiying Sun, PhD2, Susan C. Griffin, MSc, BSc6, Gillian D. Sanders, PhD7, Ahmed M. Bayoumi, MD, MSc8, Mark Holodniy, MD5, Sheldon Brown, MD9, Mark Sculpher, PhD6, Wei Yu, PhD4, Douglas K. Owens, MD, MS5, Aslam H. Anis, PhD3, and the OPTIMA Investigators10. (1) Stanford University, Center for Health Policy / Center for Primary Care and Outcomes Research, Stanford, CA, (2) St. Paul's Hospital, Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada, (3) University of British Columbia, Department of Health Care and Epidemiology, Vancouver, BC, Canada, (4) VA Palo Alto Health Care System, Health Economics Resource Center, Menlo Park, CA, (5) VA Palo Alto Health Care System, AIDS Research Center, Palo Alto, CA, (6) University of York, Centre for Health Economics, York, United Kingdom, (7) Duke University, Department of Medicine, Duke Clinical Research Institute, Durham, NC, (8) St. Michael's Hospital, University of Toronto, Inner City Health Research Unit, Toronto, ON, Canada, (9) Bronx VA Medical Center, Infectious Diseases, Bronx, NY, (10) VA Connecticut Health Care System, West Haven Cooperative Studies Program Coordinating Center (CSPCC), West Haven, CT

Purpose: In a three-nation randomized trial of management strategies (drug-free period and/or treatment intensification) for advanced HIV disease, we evaluated the impact of AIDS-related events (ARE) and non-AIDS related serious adverse events (SAE) on health-related quality of life.

Methods: From the 282 patients enrolled as of April 2004 in OPTIMA (Options in Management with Antiretrovirals - an ongoing study for patients with virologic failure and multi-drug resistant virus), we identified: 1) patients with ARE; 2) patients with SAE; and 3) a random control group of patients with no clinical events. We assessed utilities using the Health Utilities Index Mark 3 (HUI3) and EuroQol (EQ-5D) at baseline and at regularly scheduled visits thereafter. Concurrent events and those with missing utility data (at visit just before or after event) were excluded from the analysis. We performed t-tests to evaluate differences between pre- and post-event scores for each group.

Results: Excluding 38 deaths, there were 91 ARE in 53 patients (e.g., esophageal candidiasis, pneumocystis carinii pneumonia) and 205 SAE in 88 patients (e.g., chest infection, anemia); utility data were available for a total of 103 non-concurrent events. Mean utility scores did not change significantly from baseline (HUI3 0.58; EQ-5D 0.68) to pre-event (HUI3 0.57; EQ-5D 0.63) for patients with ARE and SAE, and were not significantly different from controls’ baseline scores (HUI3 0.60; EQ-5D 0.72). Mean HUI3 scores decreased pre- to post-event for patients with ARE (-0.09, p=0.07) and SAE (-0.09, p=0.02), while mean EQ-5D scores fell slightly (ARE: -0.04, p=0.43; SAE: -0.07, p=0.09). There were no significant changes in utility scores among controls. Comparing the decrement in pre- to post-event scores in ARE/SAE patients relative to the decrement in controls, we found that both ARE and SAE were associated with significant declines in HUI3 (ARE: p=0.05; SAE: p=0.02) but not EQ-5D score.

Conclusions: Both AIDS and non-AIDS clinical events were associated with declines in health-related quality of life in patients with advanced multi-drug resistant HIV. While HUI3 and EQ-5D scores both decreased, HUI3 showed a greater and significant decline associated with serious clinical events in this population. Formal decision analysis will indicate whether the observed utility changes translate into important differences when estimating the quality-adjusted life expectancy and cost-effectiveness of therapies for advanced HIV disease.


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