Document Detail


Monitoring of HIV viral load, CD4 cell count, and clinical assessment versus clinical monitoring alone for antiretroviral therapy in low-resource settings (Stratall ANRS 12110/ESTHER): a cost-effectiveness analysis.
MedLine Citation:
PMID:  23602084     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In low-income countries, the use of laboratory monitoring of patients taking antiretroviral therapy (ART) remains controversial in view of persistent resource constraints. The Stratall trial did not show that clinical monitoring alone was non-inferior to laboratory and clinical monitoring in terms of immunological recovery. We aimed to evaluate the costs and cost-effectiveness of the ART monitoring approaches assessed in the Stratall trial.
METHODS: The randomised, controlled, non-inferiority Stratall trial was done in a decentralised setting in Cameroon. Between May 23, 2006, and Jan 31, 2008, ART-naive adults were randomly assigned (1:1) to clinical monitoring (CLIN) or viral load and CD4 cell count plus clinical monitoring (LAB) and followed up for 24 months. We calculated costs, number of life-years saved (LYS), and incremental cost-effectiveness ratios (ICERs) with data from patients who had been followed up for at least 6 months. We considered two cost scenarios in which viral load plus CD4 cell count tests cost either US$95 (scenario 1; Abbott RealTime HIV-1 assay) or $63 (scenario 2; generic assay). We compared ICERs with a WHO-recommended threshold of three times the per-person gross domestic product (GDP) for Cameroon ($3670-3800) and an alternative lower threshold of $2385 to determine cost-effectiveness. We assessed uncertainty with one-way sensitivity analyses and cost-effectiveness acceptability curves.
FINDINGS: 188 participants who underwent LAB and 197 who underwent CLIN were followed up for at least 6 months. In scenario 1, LAB increased costs by a mean of $489 (SD 430) per patient and saved 0·103 life-years compared with CLIN (ICER of $4768 [95% CI 3926-5613] per LYS). In scenario 2, the incremental mean cost of LAB was $343 (SD 425) -ie, an ICER of $3339 (2507-4173) per LYS. A combined strategy in which LAB would only be used in patients starting ART with a CD4 count of 200 cells per μL or fewer suggests that 0·120 life-years would be saved at an additional cost of $259 per patient in scenario 1 (ICER of $2167 [95% CI 1314-3020] per LYS) and $181 in scenario 2 (ICER of $1510 [692-2329] per LYS) when compared with CLIN.
INTERPRETATION: Laboratory monitoring was not cost effective in 2006-10 compared with clinical monitoring when the Abbott RealTime HIV-1 assay was used according to the $3670 cost-effectiveness threshold (three times per-person GDP in Cameroon), but it might be cost effective if a generic in-house assay is used.
FUNDING: French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and Ensemble pour une Solidarité Thérapeutique Hospitalière En Réseau (ESTHER).
Authors:
Sylvie Boyer; Laura March; Charles Kouanfack; Gabrièle Laborde-Balen; Patricia Marino; Avelin Fobang Aghokeng; Eitel Mpoudi-Ngole; Sinata Koulla-Shiro; Eric Delaporte; Maria Patrizia Carrieri; Bruno Spire; Christian Laurent; Jean-Paul Moatti;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2013-04-18
Journal Detail:
Title:  The Lancet. Infectious diseases     Volume:  13     ISSN:  1474-4457     ISO Abbreviation:  Lancet Infect Dis     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-07-01     Completed Date:  2013-09-04     Revised Date:  2014-08-15    
Medline Journal Info:
Nlm Unique ID:  101130150     Medline TA:  Lancet Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  577-86     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 Elsevier Ltd. All rights reserved.
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Retroviral Agents / administration & dosage*
Antiretroviral Therapy, Highly Active / methods*
CD4 Lymphocyte Count / economics,  methods
Cameroon
Clinical Medicine / economics*,  methods
Cost-Benefit Analysis
Developing Countries
Drug Monitoring / methods*
Female
Follow-Up Studies
HIV Infections / drug therapy*,  immunology,  pathology,  virology
HIV-1 / isolation & purification
Humans
Male
Middle Aged
Treatment Outcome
Viral Load / economics*,  methods
Chemical
Reg. No./Substance:
0/Anti-Retroviral Agents
Investigator
Investigator/Affiliation:
M Biwolé-Sida / ; C Kouanfack / ; S Koulla-Shiro / ; A Bourgeois / ; E Delaporte / ; C Laurent / ; M Peeters / ; G Laborde-Balen / ; M Dontsop / ; S Kazé / ; J-M Mben / ; A Aghokeng / ; M G Edoul / ; E Mpoudi-Ngolé / ; M Tongo / ; S Boyer / ; M P Carrieri / ; F Marcellin / ; J-P Moatti / ; B Spire / ; C Abé / ; S-C Abega / ; C-R Bonono / ; H Mimcheu / ; S Ngo Yebga / ; C Paul Bile / ; S Abada / ; T Abanda / ; J Baga / ; P Bilobi Fouda / ; P Etong Mve / ; G Fetse Tama / ; H Kemo / ; A Ongodo / ; V Tadewa / ; H D Voundi / ; A Ambani / ; M Atangana / ; J-C Biaback / ; M Kennedy / ; H Kibedou / ; F Kounga / ; M Maguip Abanda / ; E Mamang / ; A Mikone / ; S Tang / ; E Tchuangue / ; S Tchuenko / ; D Yakan / ; J Assandje / ; S Ebana / ; D Ebo'o / ; D Etoundi / ; G Ngama / ; P Mbarga Ango / ; J Mbezele / ; G Mbong / ; C Moung / ; N Ekotto / ; G Nguemba Balla / ; G Ottou / ; M Tigougmo / ; R Beyala / ; B Ebene / ; C Effemba / ; F Eyebe / ; M-M Hadjaratou / ; T Mbarga / ; M Metou / ; M Ndam / ; B Ngoa / ; E B Ngock / ; N Obam / ; A M Abomo / ; G Angoula / ; E Ekassi / ; Essama / ; J J Lentchou / ; I Mvilongo / ; J Ngapou / ; F Ntokombo / ; V Ondoua / ; R Palawo / ; S Sebe / ; E Sinou / ; D Wankam / ; I Zobo / ; B Akono / ; A L Ambani / ; L Bilock / ; R Bilo'o / ; J Boombhi / ; F X Fouda / ; M Guitonga / ; R Mad'aa / ; D R Metou'ou / ; S Mgbih / ; A Noah / ; M Tadena / ; Ntcham / ; G Ambassa Elime / ; A A Bonongnaba / ; E Foaleng / ; R M Heles / ; R Messina / ; O Nana Ndankou / ; S A Ngono / ; D Ngono Menounga / ; S S Sil / ; L Tchouamou / ; B Zambou / ; R Abomo / ; J Ambomo / ; C Beyomo / ; P Eloundou / ; C Ewole / ; J Fokom / ; M Mvoto / ; M Ngadena / ; R Nyolo / ; C Onana / ; A Oyie / ; P Antyimi / ; S Bella Mbatonga / ; M Bikomo / ; Y Molo Bodo / ; S Ndi Ntang / ; P Ndoudoumou / ; L Ndzomo / ; S O Ngolo / ; M Nkengue / ; Nkoa / ; Y Tchinda /
Comments/Corrections
Comment In:
Lancet Infect Dis. 2013 Jul;13(7):560-1   [PMID:  23602085 ]

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