Abstract
In a randomized clinical trial of early versus standard antiretroviral therapy (ART) in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm³ in Haiti, early ART decreased mortality by 75%. We assessed the cost-effectiveness of early versus standard ART in this trial. Trial data included use of ART and other medications, laboratory tests, outpatient visits, radiographic studies, procedures, and hospital services. Medication, laboratory, radiograph, labor, and overhead costs were from the study clinic, and hospital and procedure costs were from local providers. We evaluated cost per year of life saved (YLS), including patient and caregiver costs, with a median of 21 months and maximum of 36 months of follow-up, and with costs and life expectancy discounted at 3% per annum. Between 2005 and 2008, 816 participants were enrolled and followed for a median of 21 months. Mean total costs per patient during the trial were US$1,381 for early ART and US$1,033 for standard ART. After excluding research-related laboratory tests without clinical benefit, costs were US$1,158 (early ART) and US$979 (standard ART). Early ART patients had higher mean costs for ART (US$398 versus US$81) but lower costs for non-ART medications, CD4 cell counts, clinically indicated tests, and radiographs (US$275 versus US$384). The cost-effectiveness ratio after a maximum of 3 years for early versus standard ART was US$3,975/YLS (95% CI US$2,129/YLS-US$9,979/YLS) including research-related tests, and US$2,050/YLS excluding research-related tests (95% CI US$722/YLS-US$5,537/YLS). Initiating ART in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm³ in Haiti, consistent with World Health Organization advice, was cost-effective (US$/YLS <3 times gross domestic product per capita) after a maximum of 3 years, after excluding research-related laboratory tests. ClinicalTrials.gov NCT00120510.
Highlights
In November 2009, the World Health Organization (WHO) changed its guidelines to recommend starting antiretroviral therapy (ART) in all HIV-infected patients when the CD4 cell count is less than 350 cells/mm3 rather than 200 cells/mm3 on the basis of results of the CIPRA HT-001 randomized trial conducted in Haiti, and a post hoc analysis nested within the SMART trial [1,2,3]
A randomized, open-label clinical trial of early versus standard ART in HIV-infected adults with no history of an AIDS-defining illness and a CD4 cell count between 200 and 350 cells/mm3 was conducted at the Center of the Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections (GHESKIO) in Port-au-Prince, Haiti
The mean cost per patient of ART during the study was higher in the early treatment group than the standard treatment group (US$398 versus US$81; p,0.0001) and the early group had higher per patient nurse and pharmacist costs during the study
Summary
In November 2009, the World Health Organization (WHO) changed its guidelines to recommend starting antiretroviral therapy (ART) in all HIV-infected patients when the CD4 cell count is less than 350 cells/mm rather than 200 cells/mm on the basis of results of the CIPRA HT-001 randomized trial conducted in Haiti, and a post hoc analysis nested within the SMART trial [1,2,3]. At the end of 2009, 14.6 million people with HIV in low- and middle-income countries were considered in need of ART under the current WHO guidelines, and 5.3 million were receiving treatment [4]. At the end of 2009 HIV prevalence in Haiti was estimated at 120,000 individuals of whom 26,000, or 43% of those with CD4 cell count ,350 cells/mm, were receiving ART [6]. In a randomized clinical trial of early versus standard antiretroviral therapy (ART) in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm in Haiti, early ART decreased mortality by 75%. In 2009, more than a third of people in low- and middle-income countries who needed ART were receiving it, on the basis of guidelines that were in place at that time
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