Cost effectiveness analysis of clinically driven versus routine laboratory monitoring of antiretroviral therapy in Uganda and Zimbabwe

Lara, Antonieta Medina, Kigozi, Jesse, Amurwon, Jovita, Muchabaiwa, Lazarus, Wakaholi, Barbara Nyanzi, Mota, Ruben E. Mujica, Walker, A. Sarah, Kasirye, Ronnie, Ssali, Francis, Reid, Andrew, Grosskurth, Heiner, Babiker, Abdel G., Kityo, Cissy, Katabira, Elly, Munderi, Paula, Mugyenyi, Peter, Hakim, James, Darbyshire, Janet, Gibb, Diana M., Gilks, Charles F. and DART Trial Team (2012) Cost effectiveness analysis of clinically driven versus routine laboratory monitoring of antiretroviral therapy in Uganda and Zimbabwe. Plos One, 7 4: . doi:10.1371/journal.pone.0033672

Author Lara, Antonieta Medina
Kigozi, Jesse
Amurwon, Jovita
Muchabaiwa, Lazarus
Wakaholi, Barbara Nyanzi
Mota, Ruben E. Mujica
Walker, A. Sarah
Kasirye, Ronnie
Ssali, Francis
Reid, Andrew
Grosskurth, Heiner
Babiker, Abdel G.
Kityo, Cissy
Katabira, Elly
Munderi, Paula
Mugyenyi, Peter
Hakim, James
Darbyshire, Janet
Gibb, Diana M.
Gilks, Charles F.
DART Trial Team
Title Cost effectiveness analysis of clinically driven versus routine laboratory monitoring of antiretroviral therapy in Uganda and Zimbabwe
Journal name Plos One   Check publisher's open access policy
ISSN 1932-6203
Publication date 2012-04-24
Sub-type Article (original research)
DOI 10.1371/journal.pone.0033672
Open Access Status DOI
Volume 7
Issue 4
Total pages 10
Place of publication San Francisco, United States
Publisher Public Library of Science
Language eng
Formatted 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/mm3) 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. 
Keyword Resource-Limited Settings
Cd4 Cell Count
Viral Load
Poor Settings
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ
Additional Notes Article number e33672.

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Public Health Publications
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Citation counts: TR Web of Science Citation Count  Cited 13 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 19 times in Scopus Article | Citations
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