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

TitleGenotype assays and third-line ART in resource-limited settings: a simulation and cost-effectiveness analysis of a planned clinical trial.
Publication TypeJournal Article
Year of Publication2012
AuthorsLorenzana SB, Hughes MD, Grinsztejn B, Collier AC, Luz PMendes, Freedberg KA, Wood R, Levison JH, Mugyenyi PN, Salata R, Wallis CL, Weinstein MC, Schooley RT, Walensky RP
JournalAIDS
Volume26
Issue9
Pagination1083-93
Date Published2012 Jun 1
ISSN1473-5571
KeywordsAnti-HIV Agents, Clinical Trials as Topic, Cost-Benefit Analysis, Female, Genotype, HIV Infections, Humans, Life Expectancy, Male, Middle Aged, Models, Biological, South Africa, Treatment Outcome
Abstract

OBJECTIVES: 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).

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.

DOI10.1097/QAD.0b013e32835221eb
Alternate JournalAIDS
PubMed ID22343964
PubMed Central IDPMC3424271
Grant ListAI069434 / AI / NIAID NIH HHS / United States
K24 AI062476 / AI / NIAID NIH HHS / United States
K24 AI062476 / AI / NIAID NIH HHS / United States
P30 AI060354 / AI / NIAID NIH HHS / United States
P30 AI060354 / AI / NIAID NIH HHS / United States
R01 AI058736 / AI / NIAID NIH HHS / United States
R01 AI058736 / AI / NIAID NIH HHS / United States
R01 AI093269 / AI / NIAID NIH HHS / United States
U01 AI068634 / AI / NIAID NIH HHS / United States
U01 AI068634 / AI / NIAID NIH HHS / United States
U01 AI068636 / AI / NIAID NIH HHS / United States
U01 AI068636 / AI / NIAID NIH HHS / United States
U01 AI069434 / AI / NIAID NIH HHS / United States