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
Presented at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Cape Town, South Africa, 19-22 July 2009, 1 pp.
Cost Effectiveness Analysis of Routine Laboratory or Clinically Driven Strategies for Monitoring Anti-Retroviral Therapy in Uganda and Zimbabwe (DART Trial)