title: Positive Predictive Value of the WHO Clinical and Immunologic Criteria to Predict Viral Load Failure among Adults on First, or Second-Line Antiretroviral Therapy in Kenya.
abstract: Routine HIV viral load (VL) monitoring is the standard of care for persons receiving antiretroviral therapy (ART) in developed countries. Although the World Health Organization recommends annual VL monitoring of patients on ART, recognizing difficulties in conducting routine VL testing, the WHO continues to recommend targeted VL testing to confirm treatment failure for persons who meet selected immunologic and clinical criteria. Studies have measured positive predictive value (PPV), negative predictive value, sensitivity and specificity of these criteria among patients receiving first-line ART but not specifically among those on second-line or subsequent regimens. Between 2008 and 2011, adult ART patients in Nyanza, Kenya who met national clinical or immunologic criteria for treatment failure received targeted VL testing. We calculated PPV and 95% confidence intervals (CI) of these criteria to detect virologic treatment failure among patients receiving a) first-line ART, b) second/subsequent ART, and c) any regimen. Of 12,134 patient specimens tested, 2,874 (23.7%) were virologically confirmed as treatment failures. The PPV for 2,834 first-line ART patients who met either the clinical or immunologic criteria for treatment failure was 34.4% (95% CI 33.2-35.7), 33.1% (95% CI 24.7-42.3) for the 40 patients on second-line/subsequent regimens, and 33.4% (95% CI 33.1-35.6) for any ART. PPV, regardless of criteria, for first-line ART patients was lowest among patients over 44 years old and highest for patients aged 15 to 34 years. PPV of immunological and clinical criteria for correctly identifying treatment failure was similarly low for adult patients receiving either first-line or second-line/subsequent ART regimens. Our data confirm the inadequacy of clinical and immunologic criteria to correctly identify treatment failure and support the implementation of routine VL testing.
authors.affiliation: US Centers for Disease Control and Prevention (CDC), Nairobi, Kenya.
authors.forename: Anthony
authors.identifier: http://orcid.org/0000-0002-4281-6345
authors.initials: A
authors.lastname: Waruru
authors.affiliation: US Centers for Disease Control and Prevention (CDC), Nairobi, Kenya.
authors.forename: Hellen
authors.initials: H
authors.lastname: Muttai
authors.affiliation: US Centers for Disease Control and Prevention (CDC), Nairobi, Kenya.
authors.forename: Lucy
authors.initials: L
authors.lastname: Ng'ang'a
authors.affiliation: US Centers for Disease Control and Prevention (CDC), Atlanta, United States of America.
authors.forename: Marta
authors.initials: M
authors.lastname: Ackers
authors.affiliation: US Centers for Disease Control and Prevention (CDC), Atlanta, United States of America.
authors.forename: Andrea
authors.initials: A
authors.lastname: Kim
authors.affiliation: US Centers for Disease Control and Prevention (CDC), Nairobi, Kenya.
authors.forename: Fredrick
authors.initials: F
authors.lastname: Miruka
authors.affiliation: Kenya Medical Research Institute, Kisumu, Kenya.
authors.forename: Opiyo
authors.initials: O
authors.lastname: Erick
authors.affiliation: Kenya Medical Research Institute, Kisumu, Kenya.
authors.forename: Julie
authors.initials: J
authors.lastname: Okonji
authors.affiliation: Kenya Medical Research Institute, Kisumu, Kenya.
authors.forename: Tolbert
authors.initials: T
authors.lastname: Ayuaya
authors.affiliation: San Francisco Department of Public Health, San Francisco, United States of America.|University of California San Francisco, San Francisco, United States of America.
authors.forename: Sandra
authors.initials: S
authors.lastname: Schwarcz
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007630:Kenya; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011379:Prognosis; D012680:Sensitivity and Specificity; D017211:Treatment Failure; D019562:Viral Load / Q000187:drug effects*; D014944:World Health Organization; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents