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Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial.

ABSTRACT: To project the clinical and economic outcomes of a genotype assay for selection of third-line antiretroviral therapy (ART) in resource-limited settings, as per the planned international A5288 trial (MULTI-OCTAVE).We used the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-International Model to compare three strategies for patients who have failed second-line ART in South Africa: sustained second-line: no genotype assay, all patients remain on second-line ART; A5288: genotype to determine the resistance profile and assign an appropriate regimen; or population-based third-line: no genotype, all patients switch to a potent third-line regimen. Model inputs are from published data in South Africa. Resistance profiles, ART regimens, and efficacy data were those used for trial planning.Projected life expectancy for sustained second-line, A5288, and population-based third-line are 61.1, 103.8, and 104.2 months. Compared to sustained second-line ($12?,460), per person lifetime costs increase for the A5288 ($39,?250) and population-based ($44,?120) strategies. The incremental cost-effectiveness ratio of A5288, compared to sustained second-line, is $7500/year of life saved (YLS), and for population-based third-line, compared to A5288, is $154?,500/YLS. In the A5288 strategy, very late presentation to care, coupled with lengthy delays to obtain the genotype, dramatically reduces 5-year survival, making the population-based third-line strategy more attractive.We project that, whereas the public health approach to third-line therapy is unaffordable, genotype assays and third-line ART in resource-limited settings will increase survival and be cost-effective compared to the population-based approach, supporting the value of an efficacy study.

SUBMITTER: Lorenzana SB

PROVIDER: S-EPMC3424271 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial.

Lorenzana Sarah B SB Hughes Michael D MD Grinsztejn Beatriz B Collier Ann C AC Luz Paula Mendes PM Freedberg Kenneth A KA Wood Robin R Levison Julie H JH Mugyenyi Peter N PN Salata Robert R Wallis Carole L CL Weinstein Milton C MC Schooley Robert T RT Walensky Rochelle P RP

AIDS (London, England) 20120601 9

<h4>Objectives</h4>To project the clinical and economic outcomes of a genotype assay for selection of third-line antiretroviral therapy (ART) in resource-limited settings, as per the planned international A5288 trial (MULTI-OCTAVE).<h4>Methods</h4>We used the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-International Model to compare three strategies for patients who have failed second-line ART in South Africa: sustained second-line: no genotype assay, all patients remain on secon ...[more]

PMID: 22343964

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Project description:As national HIV programs across the world mature and continue to scale up towards UNAIDS' 90-90-90 targets, it is increasingly important to accurately estimate HIV treatment needs in pediatric patient populations to prepare for anticipated increases in demand. This is particularly vital in sub-Saharan Africa, where the bulk of the global pediatric HIV burden remains concentrated, and for treatment-experienced populations, for which data are severely limited. This article discusses the conceptual framework behind and application of a five-year country-level quantification and decision-making tool aimed at providing national HIV programs and their partners with a better understanding of their evolving national HIV treatment and programming needs for second-and third-line pediatric populations. The conceptual framework of the algorithm which undergirds the tool is the patient pathway, along which key influencing factors that determine whether pediatric HIV patients are linked to care, remain in treatment, and are appropriately switched to later lines of treatment are accounted for quantitatively. Excel-based and arithmetic, the algorithm is designed to use available national, regional, and global data for factors impacting patient estimates including treatment coverage; routine viral load testing; viral load non-suppression; confirmed treatment failure; and patient loss to follow up-outcomes for which data are generally very limited in this patient population. The ultimate output of the tool is an estimate of the aggregate annual number of patients by treatment line. Given the limitations in available data for pediatric HIV, particularly for patients on second- and third-line treatments, this tool may help fill a data gap by providing a mechanism for policymakers to scenario plan, thus aiding resource allocation decisions for pediatric HIV program scale-up. The tool may be used to streamline national antiretroviral procurement of later lines of treatment, especially in resource-limited settings, and may also be used to add value to broader HIV policy and planning processes at the national level.

Project description:BackgroundMycetoma is a chronic mutilating disease of the skin and the underlying tissues caused by fungi or bacteria. Although recently included in the list of neglected tropical diseases by the World Health Organization, strategic control and preventive measures are yet to be outlined. Thus, it continues to pose huge public health threat in many tropical and sub-tropical countries. If not detected and managed early, it results into gruesome deformity of the limbs. Its low report and lack of familiarity may predispose patients to misdiagnosis and delayed treatment initiation. More so in situation where diagnostic tools are limited or unavailable, little or no option is left but to clinically diagnose these patients. Therefore, an overview of clinical course of mycetoma, a suggested diagnostic algorithm and proposed use of materials that cover the exposed susceptible parts of the body during labour may assist in the prevention and improvement of its management. Furthermore, early reporting which should be encouraged through formal and informal education and sensitization is strongly suggested.Main textAn overview of the clinical presentation of mycetoma in the early and late phases, clues to distinguish eumycetoma from actinomycetoma in the field and the laboratory, differential diagnosis and a suggested diagnostic algorithm that may be useful in making diagnosis amidst the differential diagnosis of mycetoma is given. Additionally, a proposed preventive measures which may be helpful in the community is also provided. Since treatment is currently based on expert opinion, we encourage active research to establish treatment guideline for it.ConclusionSince delay in visiting health facility results into gruesome complication, early presentation, recognition and initiation of appropriate choice of regimen is helpful in reducing complications. The clinical overview of mycetoma and the suggested algorithm may enhance suspicion and possibly increase recognition of mycetoma in the community and further guide in differentiation of eumycetoma from actinomycetoma. There is an urgent need for research funding for mycetoma, a disease plagued by severe physical disabilities and social stigma leading to isolation.

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Dataset Information

Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial.

Publications

Genotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial.

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