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5th International AIDS Society Conference on HIV Pathogenesis and TreatmentCape Town - July 19 - 22, 2009 |
WHAT IS THE BENEFIT OF CONFIRMING DIAGNOSED IMMUNOLOGICAL FAILURE WITH VIROLOGICAL TESTING IN ART PATIENTS TREATED IN RURAL MALAWI?
IAS Conf HIV Pathog Treat 2009 Jul 19-22;5th: Abstract No. MOPDD105
M. McGuire1, R. Kanaphathipillai
1, R. Mogha1, M. Le Paih2, M. Stover1, B. Méa1, E. Szumilin3, A. Heinzelmann3, E. Mbale4, M. Pujades-Rodríguez5,6
1Médecins Sans Frontières, Chiradzulu, Malawi, 2Médecins Sans Frontières, Blantyre, Malawi, 3Médecins Sans Frontières, Paris, France, 4Ministry of Health, Chiradzulu, Malawi, 5Epicentre, Paris, France, 6University of Bern (ISPM), Bern, Switzerland
BACKGROUND: In most resource limited settings diagnosis of treatment failure is based on WHO clinical or immunological criteria. However, discordance between immunological and virological indicators may lead to premature switching to second-line therapy. In 2008 Médecins Sans Frontières began confirming cases of immunological failure with viral load (VL) testing before switching treatment. We evaluated the benefit of this strategy.
METHODS: We used routinely collected data from adults (≥15 years) treated with first-line antiretroviral regimens for >6 months and diagnosed with immunological failure between September and December 2008. Immunological failure was defined as a CD4 decline to either baseline or <50% of on-treatment peak values, or persistent CD4 <100 copies/mm3 after 1 year of treatment. We determined the positive predictive values of immunological failure criteria to diagnose virological failure (HIV RNA ≥10,000).
RESULTS: Overall, 318 patients met the immunologic failure criteria after a median of 28 months on ART. At initiation, median baseline CD4 was 170 copies/mm3, 19% with WHO stage 4. At suspicion of failure median CD4 count was 148 copies/mm3 and 12% had BMI <17.5 kg/m2; most patients (73%) were on nevirapine (NVP) + stavudine (d4T) + lamivudine (3TC). Of 114 (36%) patients with VL results, 33(28%) were undetectable (under 50), 29 (25%) 51-999, 28(25%) 1,000-9,999 and 24(21%) ≥10,000 HIV RNA copies/mL. Positive predictive values of immunological failure criteria to detect virological failure were 21% and 50% for =10,000 and >1,000 VL thresholds, respectively.
CONCLUSIONS: Overall the immunological criteria performed poorly, approximately one third had an undetectable VL and less than a quarter of patients diagnosed with immunological failure had virological failure (as defined by >10,000 HIV RNA copies/mL). Changing treatment on the only basis of immunological criteria would have led to the premature switch of a substantial proportion of patients.
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2009-07-22
MOPDD105
Operations Research to Improve Laboratory Diagnosis and Monitoring
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