When to start antiretroviral therapy in resource-limited settings

Walensky, R.P.; Wolf, L.L.; Wood, R.; Fofana, M.O.; Freedberg, K.A.; Martinson, N.A.; Paltiel, A.D.; Anglaret, X.; Weinstein, M.C.; Losina, E.; Messou, E.èn.; Seyler, C.; Touré, S.; Yazdanpanah, Y.; Kumarasamy, N.; Ganesh, J.; Ganesh, A.K.; Gray, G.; McIntyre, J.; Mohapi, L.; Cotich, K.; Goldie, S.; Horsburgh, C.R.; Kimmel, A.; Lipsitch, M.; McCormick, A.; Rydzak, C.; Seage, G.R.; Zhang, H.; Hsu, H.E.; Bassett, I.V.; Bender, M.A.; Chung, S.; Ciaranello, A.; Linas, B.P.; Lu, Z.; Morris, B.; Sax

Annals of Internal Medicine 151(3): 157-166

2009


ISSN/ISBN: 1539-3704
PMID: 19620143
DOI: 10.7326/0003-4819-151-3-200908040-00138
Document Number: 207359
The results of international clinical trials that are assessing when to initiate antiretroviral therapy (ART) will not be available for several years. To inform HIV treatment decisions about the optimal CD4 threshold at which to initiate ART in South Africa while awaiting the results of these trials. Cost-effectiveness analysis by using a computer simulation model of HIV disease. Published data from randomized trials and observational cohorts in South Africa. HIV-infected patients in South Africa. 5-year and lifetime. Modified societal. No treatment, ART initiated at a CD4 count less than 0.250 x 10(9) cells/L, and ART initiated at a CD4 count less than 0.350 x 10(9) cells/L. Morbidity, mortality, life expectancy, medical costs, and cost-effectiveness. If 10% to 100% of HIV-infected patients are identified and linked to care, a CD4 count threshold for ART initiation of 0.350 x 10(9) cells/L would reduce severe opportunistic diseases by 22,000 to 221,000 and deaths by 25,000 to 253,000 during the next 5 years compared with ART initiation at 0.250 x 10(9) cells/L; cost increases would range from $142 million (10%) to $1.4 billion (100%). Either ART initiation strategy would increase long-term survival by at least 7.9 years, with a mean per-person life expectancy of 3.8 years with no ART and 12.5 years with an initiation threshold of 0.350 x 10(9) cells/L. Compared with an initiation threshold of 0.250 x 10(9) cells/L, a threshold of 0.350 x 10(9) cells/L has an incremental cost-effectiveness ratio of $1200 per year of life saved. Initiating ART at a CD4 count less than 0.350 x 10(9) cells/L would remain cost-effective over the next 5 years even if the probability that the trial would demonstrate the superiority of earlier therapy is as low as 17%. This model does not consider the possible benefits of initiating ART at a CD4 count greater than 0.350 x 10(9) cells/L or of reduced HIV transmission. Earlier initiation of ART in South Africa will probably reduce morbidity and mortality, improve long-term survival, and be cost-effective. While awaiting trial results, treatment guidelines should be liberalized to allow initiation at CD4 counts less than 0.350 x 10(9) cells/L, earlier than is currently recommended. National Institute of Allergy and Infectious Diseases and the Doris Duke Charitable Foundation.

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