title: Cost effectiveness analysis of clinically driven versus routine laboratory monitoring of antiretroviral therapy in Uganda and Zimbabwe.
abstract: BACKGROUND
  Despite funding constraints for treatment programmes in Africa, the costs and economic consequences of routine laboratory monitoring for efficacy and toxicity of antiretroviral therapy (ART) have rarely been evaluated.
  
  
  METHODS
  Cost-effectiveness analysis was conducted in the DART trial (ISRCTN13968779). Adults in Uganda/Zimbabwe starting ART were randomised to clinically-driven monitoring (CDM) or laboratory and clinical monitoring (LCM); individual patient data on healthcare resource utilisation and outcomes were valued with primary economic costs and utilities. Total costs of first/second-line ART, routine 12-weekly CD4 and biochemistry/haematology tests, additional diagnostic investigations, clinic visits, concomitant medications and hospitalisations were considered from the public healthcare sector perspective. A Markov model was used to extrapolate costs and benefits 20 years beyond the trial.
  
  
  RESULTS
  3316 (1660LCM;1656CDM) symptomatic, immunosuppressed ART-naive adults (median (IQR) age 37 (32,42); CD4 86 (31,139) cells/mm(3)) were followed for median 4.9 years. LCM had a mean 0.112 year (41 days) survival benefit at an additional mean cost of $765 [95%CI:685,845], translating into an adjusted incremental cost of $7386 [3277,dominated] per life-year gained and $7793 [4442,39179] per quality-adjusted life year gained. Routine toxicity tests were prominent cost-drivers and had no benefit. With 12-weekly CD4 monitoring from year 2 on ART, low-cost second-line ART, but without toxicity monitoring, CD4 test costs need to fall below $3.78 to become cost-effective (<3xper-capita GDP, following WHO benchmarks). CD4 monitoring at current costs as undertaken in DART was not cost-effective in the long-term.
  
  
  CONCLUSIONS
  There is no rationale for routine toxicity monitoring, which did not affect outcomes and was costly. Even though beneficial, there is little justification for routine 12-weekly CD4 monitoring of ART at current test costs in low-income African countries. CD4 monitoring, restricted to the second year on ART onwards, could be cost-effective with lower cost second-line therapy and development of a cheaper, ideally point-of-care, CD4 test.
authors.affiliation: Health Economics Group, Peninsula College of Medicine and Dentistry, Exeter University, Exeter, United Kingdom.
authors.forename: Antonieta
authors.initials: A
authors.lastname: Medina Lara
authors.forename: Jesse
authors.initials: J
authors.lastname: Kigozi
authors.forename: Jovita
authors.initials: J
authors.lastname: Amurwon
authors.forename: Lazarus
authors.initials: L
authors.lastname: Muchabaiwa
authors.forename: Barbara
authors.initials: B
authors.lastname: Nyanzi Wakaholi
authors.forename: Ruben E
authors.initials: RE
authors.lastname: Mujica Mota
authors.forename: A Sarah
authors.initials: AS
authors.lastname: Walker
authors.forename: Ronnie
authors.initials: R
authors.lastname: Kasirye
authors.forename: Francis
authors.initials: F
authors.lastname: Ssali
authors.forename: Andrew
authors.initials: A
authors.lastname: Reid
authors.forename: Heiner
authors.initials: H
authors.lastname: Grosskurth
authors.forename: Abdel G
authors.initials: AG
authors.lastname: Babiker
authors.forename: Cissy
authors.initials: C
authors.lastname: Kityo
authors.forename: Elly
authors.initials: E
authors.lastname: Katabira
authors.forename: Paula
authors.initials: P
authors.lastname: Munderi
authors.forename: Peter
authors.initials: P
authors.lastname: Mugyenyi
authors.forename: James
authors.initials: J
authors.lastname: Hakim
authors.forename: Janet
authors.initials: J
authors.lastname: Darbyshire
authors.forename: Diana M
authors.initials: DM
authors.lastname: Gibb
authors.forename: Charles F
authors.initials: CF
authors.lastname: Gilks
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000191:economics* / Q000627:therapeutic use / Q000633:toxicity; D018791:CD4 Lymphocyte Count / Q000191:economics*; D003362:Cost-Benefit Analysis; D003695:Delivery of Health Care / Q000191:economics; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics*; D006801:Humans; D008297:Male; D019057:Quality-Adjusted Life Years; D018675:Toxicity Tests / Q000191:economics*; D014454:Uganda; D015030:Zimbabwe
chemical_list: D019380:Anti-HIV Agents