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

Misdiagnosis of HIV treatment failure based on clinical and immunological criteria in Eastern and Central Kenya