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ARTICLE

Use of Genotypic Resistance Testing To Guide HIV Therapy: Clinical Impact and Cost-Effectiveness

Milton C. Weinstein, PhD; Sue J. Goldie, MD, MPH; Elena Losina, PhD; Calvin J. Cohen, MD, MSc; John D. Baxter, MD; Hong Zhang, BA; April D. Kimmel, AB; and Kenneth A. Freedberg, MD, MSc

20 March 2001 | Volume 134 Issue 6 | Pages 440-450

Background: Genotypic sequencing for drug-resistant strains of HIV can guide the choice of antiretroviral therapy.

Objective: To assess the cost-effectiveness of genotypic resistance testing for patients acquiring drug resistance through failed treatment (secondary resistance) and those infected with resistant virus (primary resistance).

Design: Cost-effectiveness analysis with an HIV simulation model incorporating CD4 cell count and HIV RNA level as predictors of disease progression.

Data Sources: Published randomized trials and data from the Multicenter AIDS Cohort Study, the national AIDS Cost and Services Utilization Survey, the Red Book, and an institutional cost-accounting system.

Target Population: HIV-infected patients in the United States with baseline CD4 counts of 0.250 x 10⁹ cells/L.

Time Horizon: Lifetime.

Perspective: Societal.

Interventions: Genotypic resistance testing and clinical judgment, compared with clinical judgment alone, in two contexts: after initial treatment failure (secondary resistance testing) and before initiation of antiretroviral therapy (primary resistance testing).

Outcome Measures: Life expectancy, quality-adjusted life expectancy, and cost-effectiveness in dollars per quality-adjusted life-year (QALY) gained.

Results of Base-Case Analysis: Secondary resistance testing increased life expectancy by 3 months, at a cost of $17 900 per QALY gained. The cost-effectiveness of primary resistance testing was $22 300 per QALY gained with a 20% prevalence of primary resistance but increased to $69 000 per QALY gained with 4% prevalence.

Results of Sensitivity Analysis: The cost-effectiveness ratio for secondary resistance testing remained under $25 000 per QALY gained, even when effectiveness and cost of testing and antiretroviral therapy, quality-of-life weights, and discount rate were varied.

Conclusions: Genotypic antiretroviral resistance testing following antiretroviral failure is cost-effective. Primary resistance testing also seems to be reasonably cost-effective and will become more so as the prevalence of primary resistance increases.

Author and Article Information

From Harvard School of Public Health, Boston University School of Public Health, Harvard Medical School, and Massachusetts General Hospital, Boston, Massachusetts; Community Research Initiative of New England, Brookline, Massachusetts; and Cooper Hospital/University of Medicine and Dentistry of New Jersey and Robert Wood Johnson Medical School, Camden, New Jersey.

Acknowledgments: The authors thank members of the research group on Cost-Effectiveness of Preventing AIDS Complications for valuable guidance: Donald E. Craven, MD; Runa Islam; A. David Paltiel, PhD; and George R. Seage, ScD, MPH. They also thank Karen Kuntz, PhD, and Lisa Sullivan, PhD, for helpful advice.

Grant Support: By the National Institute of Allergy and Infectious Diseases (R01-AI42006) and the Centers for Disease Control and Prevention (U64/CCU 114927).

Requests for Single Reprints: Milton C. Weinstein, PhD, Center for Risk Analysis, Harvard School of Public Health, 718 Huntington Avenue, Boston, MA 02115-5924.

Current Author Addresses: Drs. Weinstein and Goldie: Center for Risk Analysis, Harvard School of Public Health, 718 Huntington Avenue, Boston, MA 02115-5924.

Drs. Losina and Freedberg, Mr. Zhang, and Ms. Kimmel: Division of General Internal Medicine, Massachusetts General Hospital, 50 Staniford Street, Ninth Floor, Boston, MA 02114.

Dr. Cohen: Community Research Initiative of New England, 320 Washington Street, Third Floor, Brookline, MA 02445.

Dr. Baxter: Department of Medicine, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Education and Research Building, 401 Haddon Avenue, Second Floor, Camden, NJ 08103.

Author Contributions: Conception and design: M.C. Weinstein, S.J. Goldie, C.J. Cohen, K.A. Freedberg.

Analysis and interpretation of the data: M.C. Weinstein, S.J. Goldie, C.J. Cohen, J.D. Baxter, K.A. Freedberg.

Drafting of the article: M.C. Weinstein.

Critical revision of the article for important intellectual content: M.C. Weinstein, S.J. Goldie, E. Losina, C.J. Cohen, J.D. Baxter, K.A. Freedberg.

Final approval of the article: M.C. Weinstein, S.J. Goldie, E. Losina, C.J. Cohen, J.D. Baxter, H. Zhang, A.D. Kimmel, K.A. Freedberg.

Provision of study materials or patients: J.D. Baxter.

Statistical expertise: E. Losina.

Obtaining of funding: K.A. Freedberg.

Administrative, technical, or logistic support: A.D. Kimmel, K.A. Freedberg.

Collection and assembly of data: E. Losina, C.J. Cohen.

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HIV Resistance Testing in Clinical Practice: A QALY-fied Success
Michael S. Saag

Annals 2001 134: 475-477. [Full Text]  

Summaries for Patients
The Cost-Effectiveness of Testing HIV for Genetic Signs of Drug Resistance as a Guide to the Choice of Therapy

Annals 2001 134: S89. [Full Text]  

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