title: Evaluation of clinical and immunological markers for predicting virological failure in a HIV/AIDS treatment cohort in Busia, Kenya.
abstract: BACKGROUND
  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).
  
  
  METHODS
  In 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).
  
  
  RESULTS
  Of 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.
  
  
  CONCLUSIONS
  In 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.
authors.affiliation: Médecins Sans Frontières, Operational Center Barcelona Athens, Barcelona, Spain. cecilia.ferreyra@barcelona.msf.org
authors.forename: Cecilia
authors.initials: C
authors.lastname: Ferreyra
authors.forename: Oliver
authors.initials: O
authors.lastname: Yun
authors.forename: Nell
authors.initials: N
authors.lastname: Eisenberg
authors.forename: Elena
authors.initials: E
authors.lastname: Alonso
authors.forename: Ashimosi S
authors.initials: AS
authors.lastname: Khamadi
authors.forename: Matilu
authors.initials: M
authors.lastname: Mwau
authors.forename: Martha Kihara
authors.initials: MK
authors.lastname: Mugendi
authors.forename: Ana
authors.initials: A
authors.lastname: Alvarez
authors.forename: Elena
authors.initials: E
authors.lastname: Velilla
authors.forename: Laurence
authors.initials: L
authors.lastname: Flevaud
authors.forename: Mireia
authors.initials: M
authors.lastname: Arnedo
authors.forename: David
authors.initials: D
authors.lastname: Dalmau
authors.forename: Paul
authors.initials: P
authors.lastname: Roddy
authors.forename: Andrea
authors.initials: A
authors.lastname: Bernasconi
authors.forename: Pedro Pablo
authors.initials: PP
authors.lastname: Palma
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000473:pathology / Q000821:virology; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D015415:Biomarkers / Q000378:metabolism*; D018791:CD4 Lymphocyte Count; D005260:Female; D006678:HIV / Q000235:genetics / Q000472:pathogenicity; D006801:Humans; D007630:Kenya; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012189:Retrospective Studies; D017211:Treatment Failure; D019562:Viral Load; D014944:World Health Organization
chemical_list: D015415:Biomarkers