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.
Highlights
Substantial progress has been made over the last several years in the number of people receiving antiretroviral therapy (ART) for HIV/AIDS treatment
Global coverage of ART in low- and middle-income countries (LMICs) remains at 36% of the estimated overall need at the end of 2009 [3]
Adults (.18 years old) currently receiving a triple antiretroviral (ARV) drug regimen classified as standard 1st line therapy for $12 months; ARV-naıve at treatment start; who attended the clinic at least once within the previous 6 months; and given informed consent to participate in the study, were considered eligible for the study
Summary
Substantial progress has been made over the last several years in the number of people receiving antiretroviral therapy (ART) for HIV/AIDS treatment. Scale-up in subSaharan Africa was most dramatic: from 100,000 people on ART at the end of 2003 to 3.9 million people at the end of 2009 [3]. Despite these extraordinary gains, global coverage of ART in LMICs remains at 36% of the estimated overall need at the end of 2009 [3]. In 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)
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