title: 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.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and Ensemble pour une Solidarité Thérapeutique Hospitalière En Réseau (ESTHER).
authors.affiliation: INSERM, UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR-S912, IRD, Marseille, France; Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur (ORS PACA), Marseille, France. Electronic address: sylvie.boyer@inserm.fr.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Boyer
authors.affiliation: INSERM, UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR-S912, IRD, Marseille, France; Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur (ORS PACA), Marseille, France.
authors.forename: Laura
authors.initials: L
authors.lastname: March
authors.affiliation: Central Hospital, UMI 233, Yaoundé, Cameroon.
authors.forename: Charles
authors.initials: C
authors.lastname: Kouanfack
authors.affiliation: French Ministry of Foreign Affairs, Yaoundé, Cameroon.
authors.forename: Gabrièle
authors.initials: G
authors.lastname: Laborde-Balen
authors.affiliation: INSERM, UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR-S912, IRD, Marseille, France.
authors.forename: Patricia
authors.initials: P
authors.lastname: Marino
authors.affiliation: Institut de Recherche pour le Développement (IRD), University Montpellier 1, UMI 233, Montpellier, France; Virology Laboratory IRD/IMPM/CREMER, Yaoundé, Cameroon.
authors.forename: Avelin Fobang
authors.initials: AF
authors.lastname: Aghokeng
authors.affiliation: Virology Laboratory IRD/IMPM/CREMER, Yaoundé, Cameroon.
authors.forename: Eitel
authors.initials: E
authors.lastname: Mpoudi-Ngole
authors.affiliation: Central Hospital, UMI 233, Yaoundé, Cameroon; Faculté de Médecine et des Sciences Biomédicales, University of Yaoundé 1, Yaoundé, Cameroon.
authors.forename: Sinata
authors.initials: S
authors.lastname: Koulla-Shiro
authors.affiliation: Institut de Recherche pour le Développement (IRD), University Montpellier 1, UMI 233, Montpellier, France; Department of Infectious and Tropical Diseases, University Hospital, Montpellier, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Delaporte
authors.affiliation: INSERM, UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR-S912, IRD, Marseille, France; Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur (ORS PACA), Marseille, France.
authors.forename: Maria Patrizia
authors.initials: MP
authors.lastname: Carrieri
authors.affiliation: INSERM, UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR-S912, IRD, Marseille, France; Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur (ORS PACA), Marseille, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Spire
authors.affiliation: Institut de Recherche pour le Développement (IRD), University Montpellier 1, UMI 233, Montpellier, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Laurent
authors.affiliation: INSERM, UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR-S912, IRD, Marseille, France; Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur (ORS PACA), Marseille, France.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Moatti
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D018791:CD4 Lymphocyte Count / Q000191:economics / Q000379:methods; D002163:Cameroon; D015510:Clinical Medicine / Q000191:economics* / Q000379:methods; D003362:Cost-Benefit Analysis; D003906:Developing Countries; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D019562:Viral Load / Q000191:economics* / Q000379:methods
chemical_list: D044966:Anti-Retroviral Agents