Evidence map›Paper›PMID 22343964›Full record

ArticleAIDS (London, England)2012

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

Sarah B Lorenzana, Michael D Hughes, Beatriz Grinsztejn, Ann C Collier, Paula Mendes Luz, Kenneth A Freedberg, Robin Wood, Julie H Levison, Peter N Mugyenyi, Robert Salata and 4 more

Abstract read
In one paragraph

Article in AIDS (London, England), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Antiretroviral resistance testing in HIV-positive people.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Trial
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  15. Authors' Reply: Is Genotype Testing Really Cost-Effective for Primary Resistance in Brazil?Journal of acquired immune deficiency syndromes (1999) · 2016
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Sarah B LorenzanaDivision of Infectious Disease, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, MA 02114, USA.
Michael D Hughes
Beatriz Grinsztejn
Ann C Collier
Paula Mendes Luz
Kenneth A Freedberg
Robin Wood
Julie H Levison
Peter N Mugyenyi
Robert Salata
Carole L Wallis
Milton C Weinstein
Robert T Schooley
Rochelle P Walensky

Funding

AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI ROBERT A. PARKER · 2004 to 2026
$94.4M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
Optimizing HIV Care in Less Developed CountriesR01AI058736 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI Kenneth Alan Freedberg, Emily Parker Hyle · 2004 to 2026
$21.5M
Novel Methods to Inform HIV/TB Clinical Trial DevelopmentR01AI093269 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI REDDY, KRISHNA P · 2011 to 2024
$6.8M
UW Clinical HIV Integrated Research ProgramU01AI069434 · NIAID · UNIVERSITY OF WASHINGTON · PI COLLIER, ANN CORNWALL · 2007 to 2011
$5.6M
UW Clinical HIV Integrated Research ProgramUM1AI069434 · NIAID · UNIVERSITY OF WASHINGTON · PI COLLIER, ANN CORNWALL · 2012 to 2013
$2.3M
Optimal Strategies for Management of HIV DiseaseK24AI062476 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI FREEDBERG, KENNETH ALAN · 2004 to 2008
$512k
NIAID NIH HHS AI069434NIAID NIH HHS K24 AI062476NIAID NIH HHS P30 AI060354NIAID NIH HHS R01 AI058736NIAID NIH HHS R01 AI093269NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069434NIAID NIH HHS UM1 AI069434
6 · The paper itself

Abstract

objectivesTo 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).

methodsWe 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.

resultsProjected 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.

conclusionsWe 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.

Indexed as

Anti-HIV AgentsClinical Trials as TopicCost-Benefit AnalysisFemaleGenotypeHIV InfectionsHumansLife ExpectancyMaleMiddle AgedModels, BiologicalSouth AfricaTreatment OutcomeAnti-HIV Agents

Identifiers

PMID22343964
PMCPMC3424271

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.