Medication costs associated with early initiation of antiretroviral therapy

The START Study randomly assigned 4685 persons with CD4+ counts >500 to either immediate treatment (2326 persons) or a group (2359) that had treatment delayed until the CD4+ count was <350 or clinical judgment dictated treatment. The average time in the study was three years. The immediate group (IG) had 42 serious clinical events and the delayed group (DG) had 96. Policy considerations for adopting these results should consider the cost of medications for early treatment, which is the purpose of this article. Cost of early treatment was estimated by assuming the delayed treatment group had been treated for the three-year average course of the study. However, 48% of the DG received ART before the study's end, so that portion of the group's time on ART was reduced to 1.5 years. Average wholesale prices in the United States of the five recommended ART regimens were discounted by 50% to reflect actual pricing. An average medication cost for the five regimens of $20,000 per person year was used. The three-year cost was $107,580,000 for the 52% who would have been treated for three years and for the 48% treated for an average of 1.5 years. The cost per clinical event avoided was $1,992,222. Formulae are provided that will allow the reader to adjust these results to reflect local prices and volumes. Additional factors to be considered should include the cost savings from avoiding serious clinical events, reduction in transmission of HIV for those being treated early in the infection and the issues associated with long-term adherence for those receiving ART at >500 CD4 counts.