title: The cost-effectiveness of HLA-B*5701 genetic screening to guide initial antiretroviral therapy for HIV.
abstract: OBJECTIVE
  To evaluate the clinical impact and cost-effectiveness of HLA-B*5701 testing to guide selection of first-line HIV regimens in the United States.
  
  
  METHODS
  Cost-effectiveness analysis using a simulation model of HIV disease. The prevalence of HLA-B*5701 and the probabilities of confirmed and unconfirmed severe systemic hypersensitivity reaction among patients taking abacavir testing HLA-B*5701 positive and negative were from the Prospective Randomized Evaluation of DNA Screening in a Clinical Trial study. The monthly costs of abacavir-based and tenofovir-based regimens were $1135 and $1139, respectively; similar virologic efficacy was assumed and this assumption was varied in sensitivity analysis.
  
  
  METHODS
  Simulated cohort of patients initiating HIV therapy.
  
  
  METHODS
  The interventions are first-line abacavir, lamivudine, and efavirenz without pretreatment HLA-B*5701 testing; the same regimen with HLA-B*5701 testing; and first-line tenofovir, emtricitabine, and efavirenz.
  
  
  METHODS
  Quality-adjusted life years and lifetime medical costs discounted at 3% per annum, cost-effectiveness ratios ($/QALY).
  
  
  RESULTS
  Abacavir-based treatment without HLA-B*5701 testing resulted in a projected 30.93 years life expectancy, 16.23 discounted quality-adjusted life years, and $472,200 discounted lifetime cost per person. HLA-B*5701 testing added 0.04 quality-adjusted months at an incremental cost of $110, resulting in a cost-effectiveness ratio of $36,700/QALY compared with no testing. Initiating treatment with a tenofovir-based regimen increased costs without improving quality-adjusted life expectancy. HLA-B*5701 testing remained the preferred strategy only if abacavir-based treatment had equal efficacy and cost less per month than tenofovir-based treatment. Results were also sensitive to the cost of HLA-B*5701 testing and the prevalence of HLA-B*5701.
  
  
  CONCLUSIONS
  Pharmacogenetic testing for HLA-B*5701 is cost-effective only if abacavir-based treatment is as effective and costs less than tenofovir-based treatment.
authors.affiliation: Department of Public Health, Weill Cornell Medical College, New York, New York 10021, USA. brs2006@med.cornell.edu
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Schackman
authors.forename: Callie A
authors.initials: CA
authors.lastname: Scott
authors.forename: Rochelle P
authors.initials: RP
authors.lastname: Walensky
authors.forename: Elena
authors.initials: E
authors.lastname: Losina
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Freedberg
authors.forename: Paul E
authors.initials: PE
authors.lastname: Sax
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000191:economics; D003362:Cost-Benefit Analysis; D015224:Dideoxynucleosides / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D016527:Drug Costs / Q000706:statistics & numerical data; D004342:Drug Hypersensitivity / Q000191:economics / Q000209:etiology / Q000235:genetics / Q000517:prevention & control; D005260:Female; D005820:Genetic Testing / Q000191:economics* / Q000379:methods; D015658:HIV Infections / Q000188:drug therapy* / Q000191:economics / Q000235:genetics*; D015235:HLA-B Antigens / Q000235:genetics*; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D063065:Organophosphonates / Q000191:economics / Q000627:therapeutic use; D010597:Pharmacogenetics / Q000191:economics; D019057:Quality-Adjusted Life Years; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects; D012680:Sensitivity and Specificity; D000068698:Tenofovir; D016896:Treatment Outcome; D000099227:Abacavir
chemical_list: D000225:Adenine; D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D015235:HLA-B Antigens; D063065:Organophosphonates; D018894:Reverse Transcriptase Inhibitors; D000068698:Tenofovir; D000099227:Abacavir; C484830:HLA-B*57:01 antigen
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