Assessment of WHO criteria for identifying ART treatment failure in Vietnam from 2007 to 2011

• Published in: PloS one Vol. 12; no. 9; p. e0182688
• Main Authors: Le, Nicole K, Riggi, Emilia, Marrone, Gaetano, Vu, Tam Van, Izurieta, Ricardo O, Nguyen, Chuc Kim Thi, Larsson, Mattias, Do, Cuong Duy
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 06.09.2017; Public Library of Science (PLoS)
• Subjects: Acquired immune deficiency syndrome; Adult; AIDS; Antimicrobial agents; Antiretroviral agents; Antiretroviral drugs; Antiretroviral therapy; Antiretroviral Therapy, Highly Active; Biology and Life Sciences; Body mass; CD4 antigen; Confidence intervals; Criteria; Diagnostic systems; Diagnostic Techniques and Procedures; Disease transmission; Drugs; Failure analysis; Female; Guidelines as Topic; HIV; Human immunodeficiency virus; Humans; Immunology; Male; Medical diagnosis; Medicin och hälsovetenskap; Medicine and Health Sciences; Patient outcomes; Patients; People and Places; Reference Standards; Sensitivity; Sensitivity analysis; Social Sciences; Test procedures; Treatment Failure; Treatment outcome; Vietnam; World Health Organization; Vietnam
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0182688

We evaluated the sensitivity and specificity of the WHO immunological criteria for detecting antiretroviral therapy (ART) treatment failure in a cohort of Vietnamese patients. We conducted a stratified analysis to determine the effects of BMI, peer support, adherence to antiretroviral (ARV) drugs, age, and gender on the sensitivity and specificity of the WHO criteria. We conducted a retrospective cohort study of 605 HIV-infected patients using data previously collected from a cluster randomized control trial study. We compared the sensitivity and specificity of CD4+ counts to the gold standard of virologic testing as a diagnostic test for ART failure at different time points of 12, 18, and 24 months. The sensitivity [95% confidence interval (CI)] of the WHO immunological criteria based on a viral load ≥ 1000 copies/mL was 12% (5%-23%), 14% (2%-43%), and 12.5% (2%-38%) at 12, 18, and 24 months, respectively. In the same order, the specificity was 93% (90%-96%), 98% (96%-99%), and 98% (96%-100%). The positive predictive values (PPV) at 12, 18, and 24 months were 22% (9%-40%), 20% (3%-56%), and 29% (4%-71%); the negative predictive values (NPV) at the same time points were 87% (84%-90%), 97% (95%-98%), and 96% (93%-98%). The stratified analysis revealed similar sensitivities and specificities. The sensitivity of the WHO immunological criteria is poor, but the specificity is high. Although testing costs may increase, we recommend that Vietnam and other similar settings adopt viral load testing as the principal method for determining ART failure.