Background: Routine laboratory monitoring is part of the basic care package offered to people living with the\nHuman Immunodeficiency Virus (PLHIV). This paper aims to identify the proportion of PLHIVs with clinical and\nimmunological failure who are virologically suppressed and risk being misclassified as treatment failures.\nMethods: A retrospective analysis of patient viral load data collected between January 2013 and June 2014 was\nconducted. Of the patients classified as experiencing either clinical or immunological failure, we evaluated the\nproportion of true (virological) failure, and estimated the sensitivity and specificity of the immunological and clinical\ncriteria in diagnosing true treatment failure.\nResults: Of the 27,418 PLHIVs aged 2ââ?¬â??80 years on ART in the study period, 6.8% (n = 1859) were suspected of\ntreatment failure and their viral loads analysed. 40% (n = 737) demonstrated viral suppression (VL < 1000 copies/ml).\nThe median viral load (VL) was 3317 copies/ml (IQR 0ââ?¬â??47,547). Among the 799 (2.9%) PLHIVs on ART classified as\nhaving clinical failure, 41.1% (n = 328) of them had confirmed viral suppression. Of the 463 (1.7%) classified as having\nimmunological failure, 36.9% (n = 171) had confirmed viral suppression. The sensitivity of the clinical criteria in\ndiagnosing true failure was 61% (CI 58%ââ?¬â??65%) while that of the immunological criteria 38% (CI 35%ââ?¬â??42%). The\nspecificity of the clinical criteria was 34% (CI 30%ââ?¬â??39%) while that of the immunological criteria 66% (61%ââ?¬â??70%).\nAge below 20 years was associated with a high viral load (p < .001). Sex and ART regimen were not associated with\nthe viral load.\nConclusion: Clinical and immunological criteria alone are not sufficient to identify true treatment failure. There is need\nfor accurate treatment failure diagnosis through viral load testing to avoid incorrect early or delayed switching of\npatients to second-line regimens. This study recommends increased viral load testing in line with the Kenyaââ?¬â?¢s ART\nguidelines.
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