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

  1. Milton C. Weinstein, PhD;
  2. Sue J. Goldie, MD, MPH;
  3. Elena Losina, PhD;
  4. Calvin J. Cohen, MD, MSc;
  5. John D. Baxter, MD;
  6. Hong Zhang, BA;
  7. April D. Kimmel, AB; and
  8. Kenneth A. Freedberg, MD, MSc
  1. 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.

    Abstract

    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 × 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.

    Article and Author Information

    • 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.

    Summary for Patients

    • Summaries for Patients:The Cost-Effectiveness of Testing HIV for Genetic Signs of Drug Resistance as a Guide to the Choice of Therapy Ann Intern Med March 20, 2001 134:S89
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    1. Ann Intern Med March 20, 2001 vol. 134 no. 6 440-450
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