Objective: This study compared costs and benefits of monitoring antiretroviral therapy (ART) between laboratory and clinical monitoring (LCM) and clinically driven monitoring (CDM) in HIV-infected adults enrolled in the DART trial in Uganda/Zimbabwe from the public health care sector perspective.
Methods: Individual patient data on health care resource utilisation and health outcomes of DART participants were extracted from trial records(2003-2008), and valued with primary and secondary cost estimates. We estimated total costs of first and second-line ART, CD4 tests, routine 3-monthly biochemistry/haematology tests for toxicity and extra laboratory investigations, clinic visits, concomitant medications and hospitalisations. The difference in days of survival between arms was estimated using Kaplan-Meier survival curves.
Results: 3316 (1660LCM; 1656CDM) ART-naive adults were included (65%female; median(IQR) age 37(32-42); CD4 86(31-139) cells/mm3) and followed for mean 4.9 years. LCM incurred an additional total per patient cost of $947 [95% CI: 876 - 1020]. Its overall survival benefit was 41 days [95% CI: -10, 88]; this translates into ICER of $8,441 per life-year gained.
Conclusions: Routine laboratory monitoring for toxicity or response to ART is a key cost driver for managing patients on ART and its costs should be weighed against its benefits in designing optimal ART roll-out programmes in Africa. Given the main DART trial results (presented in this conference), laboratory monitoring of toxicity is particularly expensive and provides no significant benefit. Cost of CD4 monitoring is lower but still substantial. Its targeted use may be cost-effective in specific situations.
Presented at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Cape Town, South Africa, 19-22 July 2009, 1 pp.