Abstract

HIV genotype-resistance testing can help identify more effective antiretroviral treatment (ART) regimens for patients, substantially increasing the likelihood of viral suppression and immune recovery. We sought to evaluate the cost-effectiveness of genotype-resistance testing before first-line ART initiation in Brazil. We used a previously published microsimulation model of HIV disease (CEPAC-International) and data from Brazil to compare the clinical impact, costs, and cost-effectiveness of initial genotype testing (Genotype) with no initial genotype testing (No genotype). Model parameters were derived from the HIV Clinical Cohort at the Evandro Chagas Clinical Research Institute and from published data, using Brazilian sources whenever possible. Baseline patient characteristics included 69% male, mean age of 36 years (SD, 10 years), mean CD4 count of 347 per microliter (SD, 300/µL) at ART initiation, annual ART costs from 2012 US $1400 to US $13,400, genotype test cost of US $230, and primary resistance prevalence of 4.4%. Life expectancy and costs were discounted 3% per year. Genotype was defined as "cost-effective" compared with No Genotype if its incremental cost-effectiveness ratio was less than 3 times the 2012 Brazilian per capita GDP of US $12,300. Compared with No genotype, Genotype increased life expectancy from 18.45 to 18.47 years and reduced lifetime cost from US $45,000 to $44,770; thus, in the base case, Genotype was cost saving. Genotype was cost-effective at primary resistance prevalence as low as 1.4% and remained cost-effective when subsequent-line ART costs decreased to 30% of baseline value. Cost-inefficient results were observed only when simultaneously holding multiple parameters to extremes of their plausible ranges. Genotype-resistance testing in ART-naive individuals in Brazil will improve survival and decrease costs and should be incorporated into HIV treatment guidelines in Brazil.

Highlights

  • The Brazilian Ministry of Health’s response to the HIV/ AIDS epidemic is recognized worldwide as a bold program for a middle-income country.[1,2,3] One of the most striking characteristics of the program is the universal provision of antiretroviral treatment (ART) free of charge to patients, which was guaranteed in 1996 through the passage of a federal law.[4]

  • Genotype was cost-effective at primary resistance prevalence as low as 1.4% and remained cost-effective when subsequent-line ART costs decreased to 30% of baseline value

  • The outcomes of interest included per person life expectancy and costs, as well as the incremental cost-effectiveness ratios and net health benefit to provide comparative value of the Genotype strategy.[15]

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Summary

Introduction

The Brazilian Ministry of Health’s response to the HIV/ AIDS epidemic is recognized worldwide as a bold program for a middle-income country.[1,2,3] One of the most striking characteristics of the program is the universal provision of antiretroviral treatment (ART) free of charge to patients, which was guaranteed in 1996 through the passage of a federal law.[4]. The guidelines exclude the widespread use of genotype-resistance testing for ART-naive patients, which is only recommended for pregnant women or individuals known to have acquired infection from a partner receiving ART. This omission is noteworthy, given that the epidemiology and economics of HIV have been shown to favor the use of genotype-resistance testing after failing an ART regimen in resource-rich[6,7] and resource-limited settings,[8] and for patients who are ART naive in resource-rich settings.[9] By identifying individuals with primary resistance, genotype resistance testing can assist health care providers in determining ART regimens for patients that will have the highest likelihood of success. The Brazilian national guidelines emphasize the need for additional studies demonstrating the clear benefit of this initial genotype test strategy.[5]

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