Cost-effectiveness analysis of UGT1A1 genetic testing to inform antiretroviral prescribing in HIV disease.

Schackman BR, Haas DW, Becker JE, Berkowitz BK, Sax PE, Daar ES, Ribaudo HJ, Freedberg KA
Antivir Ther. 2013 18 (3): 399-408

PMID: 23264445 · PMCID: PMC3744167 · DOI:10.3851/IMP2500

BACKGROUND - Homozygosity for UGT1A1*28/*28 has been reported to be associated with atazanavir-associated hyperbilirubinaemia and premature atazanavir discontinuation. We assessed the potential cost-effectiveness of UGT1A1 testing to inform the choice of an initial protease-inhibitor-containing regimen in antiretroviral therapy (ART)-naive individuals.

METHODS - We used the Cost-Effectiveness of Preventing AIDS Complications computer simulation model to project quality-adjusted life years (QALYs) and lifetime costs (2009 USD) for atazanavir-based ART with or without UGT1A1 testing, using darunavir rather than atazanavir when indicated. We assumed the UGT1A1-associated atazanavir discontinuation rate reported in the Swiss HIV Cohort Study (a *28/*28 frequency of 14.9%), equal efficacy and cost of atazanavir and darunavir and a genetic assay cost of $107. These parameters, as well as the effect of hyperbilirubinaemia on quality of life and loss to follow up, were varied in sensitivity analyses. Costs and QALYs were discounted at 3% annually.

RESULTS - Initiating atazanavir-based ART at CD4(+) T-cell counts <500 cells/μl without UGT1A1 testing had an average discounted life expectancy of 16.02 QALYs and $475,800 discounted lifetime cost. Testing for UGT1A1 increased QALYs by 0.49 per 10,000 patients tested and was not cost-effective (>$100,000/QALY). Testing for UGT1A1 was cost-effective (<$100,000/QALY) if assay cost decreased to $10, or if avoiding hyperbilirubinaemia by UGT1A1 testing reduced loss to follow-up by 5%. If atazanavir and darunavir differed in cost or efficacy, testing for UGT1A1 was not cost-effective under any scenario.

CONCLUSIONS - Testing for UGT1A1 may be cost-effective if assay cost is low and if testing improves retention in care, but only if the comparator ART regimens have the same drug cost and efficacy.

MeSH Terms (12)

Adult Antiretroviral Therapy, Highly Active Cost-Benefit Analysis Female Genetic Testing Genotype Glucuronosyltransferase HIV Infections Humans Male Middle Aged Quality-Adjusted Life Years

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