Potential risks and benefits of HIV treatment simplification: A simulation model of a proposed clinical trial

Bruce R. Schackman, Callie A. Scott, Paul E. Sax, Elena Losina, Timothy J. Wilkin, John E. McKinnon, Susan Swindells, Milton C. Weinstein, Kenneth A. Freedberg

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Background. In recent studies, subjects who had achieved suppression of the human immunodeficiency virus (HIV) RNA level while receiving an initial 3-drug antiretroviral regimen successfully maintained suppression while receiving treatment with a "boosted" protease inhibitor (PI) alone. We projected the long-term outcomes of this treatment simplification strategy to inform the design of a proposed multicenter, randomized clinical trial. Methods. We used published studies to estimate the efficacy, adverse effects, and cost of a sequence of HIV drug regimens for the simplification strategy, compared with those outcomes for the current standard-of-care (SOC) strategy. Using a published simulation model of HIV disease, we projected life expectancy, discounted quality-adjusted life expectancy (QALE), and discounted lifetime medical costs for each strategy. Results. Subjects who have not developed PI-resistant HIV infection at the time of failure of the simplification regimen have a greater life expectancy (27.9 vs. 27.1 years) and QALE (14.9 vs. 14.7 years), compared with SOC subjects, because they receive an additional line of therapy without negative consequences for future treatment options. The QALE for the simplification strategy remains higher than that for the SOC, unless a large proportion of patients experiencing virologic failure while receiving the simplification regimen develop PI resistance. Depending on the probability of simplification regimen failure, the advantage is maintained even if HIV develops PI resistance in 42%-70% of subjects. Projected lifetime costs are $26,500-$72,400 per person lower for the simplification strategy than for the SOC strategy. Conclusions. An HIV treatment simplification strategy involving use of a boosted PI alone may lead to longer survival overall at lower cost, compared with the SOC combination therapy, because the simplification strategy potentially adds an additional line of therapy. The risk of emergence of PI resistance during treatment with a simplified regimen is a critical determinant of the viability of this strategy.

Original languageEnglish (US)
Pages (from-to)1062-1070
Number of pages9
JournalClinical Infectious Diseases
Volume45
Issue number8
DOIs
StatePublished - Oct 22 2007

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Protease Inhibitors
Standard of Care
Life Expectancy
Clinical Trials
HIV
Costs and Cost Analysis
Virus Diseases
Therapeutics
Quality of Life
Pharmaceutical Preparations
Randomized Controlled Trials
RNA
Survival

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Schackman, B. R., Scott, C. A., Sax, P. E., Losina, E., Wilkin, T. J., McKinnon, J. E., ... Freedberg, K. A. (2007). Potential risks and benefits of HIV treatment simplification: A simulation model of a proposed clinical trial. Clinical Infectious Diseases, 45(8), 1062-1070. https://doi.org/10.1086/521933

Potential risks and benefits of HIV treatment simplification : A simulation model of a proposed clinical trial. / Schackman, Bruce R.; Scott, Callie A.; Sax, Paul E.; Losina, Elena; Wilkin, Timothy J.; McKinnon, John E.; Swindells, Susan; Weinstein, Milton C.; Freedberg, Kenneth A.

In: Clinical Infectious Diseases, Vol. 45, No. 8, 22.10.2007, p. 1062-1070.

Research output: Contribution to journalArticle

Schackman, BR, Scott, CA, Sax, PE, Losina, E, Wilkin, TJ, McKinnon, JE, Swindells, S, Weinstein, MC & Freedberg, KA 2007, 'Potential risks and benefits of HIV treatment simplification: A simulation model of a proposed clinical trial', Clinical Infectious Diseases, vol. 45, no. 8, pp. 1062-1070. https://doi.org/10.1086/521933
Schackman, Bruce R. ; Scott, Callie A. ; Sax, Paul E. ; Losina, Elena ; Wilkin, Timothy J. ; McKinnon, John E. ; Swindells, Susan ; Weinstein, Milton C. ; Freedberg, Kenneth A. / Potential risks and benefits of HIV treatment simplification : A simulation model of a proposed clinical trial. In: Clinical Infectious Diseases. 2007 ; Vol. 45, No. 8. pp. 1062-1070.
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AU - Losina, Elena

AU - Wilkin, Timothy J.

AU - McKinnon, John E.

AU - Swindells, Susan

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