Failure of immunologic criteria to appropriately identify antiretroviral treatment failure in Uganda
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Date
2009-03
Journal Title
Journal ISSN
Volume Title
Publisher
AIDS (London, England)
Abstract
Objective—Most antiretroviral treatment program in resource-limited settings use immunologic or
clinical monitoring to measure response to therapy and to decide when to change to a second line
regimen. Our objective was to evaluate immunologic failure criteria against gold standard virologic
monitoring.
Design—Observation cohort
Methods—Participants enrolled in an antiretroviral treatment program in rural Uganda who had at
least 6 months of follow-up were included in this analysis. Immunologic monitoring was performed
by CD4 cell counts every 3 months during the first year, and every 6 months thereafter. HIV-1 viral
loads were performed every 6 months.
Results—1133 participants enrolled in the Rakai Health Sciences Program antiretroviral treatment
program between June 2004 and September 2007 were followed for up to 44.4 months (median
follow-up 20.2 months; IQR 12.4–29.5 months). WHO immunologic failure criteria were reached
by 125 (11.0%) participants. A virologic failure endpoint defined as HIV-1 viral load (VL) >400
copies/ml on two measurements was reached by 112 participants (9.9%). Only 26 participants (2.3%)
experienced both an immunologic and virologic failure endpoint (2 VL>400 copies/ml) during
follow-up.
Conclusions—Immunologic failure criteria performed poorly in our setting and would have
resulted in a substantial proportion of participants with suppressed HIV-1 VL being switched
unnecessarily. These criteria also lacked sensitivity to identify participants failing virologically.
Periodic viral load measurements may be a better marker for treatment failure in our setting
Description
Keywords
HIV/AIDS, Antiretroviral therapy, Immunologic monitoring
Citation
Reynolds, S. J., Nakigozi, G., Newell, K., Ndyanabo, A., Galiwongo, R., Boaz, I., ... & Serwadda, D. (2009). Failure of immunologic criteria to appropriately identify antiretroviral treatment failure in Uganda. AIDS (London, England), 23(6), 697.doi:10.1097/QAD.0b013e3283262a78.