Evaluation of Clinical and Immunological Markers for Predicting Virological Failure in a HIV/AIDS Treatment Cohort in Busia, Kenya

Abstract

BackgroundIn resource-limited settings where viral load (VL) monitoring is scarce or unavailable, clinicians must use immunological and clinical criteria to define HIV virological treatment failure. This study examined the performance of World Health Organization (WHO) clinical and immunological failure criteria in predicting virological failure in HIV patients receiving antiretroviral therapy (ART).MethodsIn a HIV/AIDS program in Busia District Hospital, Kenya, a retrospective, cross-sectional cohort analysis was performed in April 2008 for all adult patients (>18 years old) on ART for ≥12 months, treatment-naive at ART start, attending the clinic at least once in last 6 months, and who had given informed consent. Treatment failure was assessed per WHO clinical (disease stage 3 or 4) and immunological (CD4 cell count) criteria, and compared with virological failure (VL >5,000 copies/mL).ResultsOf 926 patients, 123 (13.3%) had clinically defined treatment failure, 53 (5.7%) immunologically defined failure, and 55 (6.0%) virological failure. Sensitivity, specificity, positive predictive value, and negative predictive value of both clinical and immunological criteria (combined) in predicting virological failure were 36.4%, 83.5%, 12.3%, and 95.4%, respectively.ConclusionsIn this analysis, clinical and immunological criteria were found to perform relatively poorly in predicting virological failure of ART. VL monitoring and new algorithms for assessing clinical or immunological treatment failure, as well as improved adherence strategies, are required in ART programs in resource-limited settings.

Options to Expand HIV Viral Load Testing in South Africa: Evaluation of the GeneXpert® HIV-1 Viral Load Assay

“…South Africa has used VL testing preferentially for monitoring of ART since program inception, which, is now also strongly recommended by the World Health Organisation (WHO) [2]. There are currently over 3900 National Department of Health (NDoH) clinics providing ART initiation and monitoring services in South Africa [3].…”

Biomarkers in Immune Reconstitution Inflammatory Syndrome (IRIS) among People Living with Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS)

“…Our work also shed light on the age difference of male and female acquiring infection and provided evidence that in fact female are more prone to HIV infection than male at younger age. The HAART enrolled patients had significantly lower viral copy number in their serum compared to that of naïve but was not consistent with the relapsed number of CD4 count which may provide the case of immunological failure [13]. This study elicits the need of more study related to immunological parameters thus providing precise diagnosis and surveillance of HIV patients.…”

“…Serum albumin, which is not routinely measured in developing countries and is not available in most of the laboratory at ART center which is the most common laboratory parameter for nutritional assessment with low serum albumin indicating malnutrition [5,6,9,10,12]. Lipid profile abnormalities have been reported in the early stages of HIV infection and become more evident with the disease's progression [13,14]. There is large number of cytokines increase and serum triglyceride, HDL-cholesterol decrease during HIV infection [15].…”

A Study of People Living With Hiv-Aids [Plha] on First Line Highly Active Antiretroviral Therapy [Haart] With Immunological Failure

“…(8) also found that immunological and clinical failure had poor prediction of virological failure. The study showed the sensitivity of immunological and clinical failure to detect viral failure was 36.4%, specificity was 83.5% and the positive-predictive value was 12.3%.…”