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Home >> Publications >> Accuracy of WHO CD4 cell count criteria for virological failure of antiretroviral therapy.

Publication

Author(s):

Keiser O, MacPhail P, Boulle A, Wood R, Schechter M, Dabis F, Sprinz E, Egger M; ART-LINC Collaboration of the International Databases to Evaluate AIDS (IeDEA).

Pub Title:

Accuracy of WHO CD4 cell count criteria for virological failure of antiretroviral therapy.

Pub Date:

Oct 31 2009

Journal Issue:

10

Page Number:
1220-5

Journal:

Title: 
Tropical Medicine and International Health
Link: 
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-3156.2009.02338.x/abstract

PubMed: 19624478

Abstract
OBJECTIVES
: To examine the accuracy of the World Health Organization immunological criteria for virological failure of antiretroviral treatment.

METHODS: Analysis of 10 treatment programmes in Africa and South America that monitor both CD4 cell counts and HIV-1 viral load. Adult patients with at least two CD4 counts and viral load measurements between month 6 and 18 after starting a non-nucleoside reverse transcriptase inhibitor-based regimen were included. WHO immunological criteria include CD4 counts persistently <100 cells/microl, a fall below the baseline CD4 count, or a fall of >50% from the peak value. Virological failure was defined as two measurements > or =10 0000 copies/ml (higher threshold) or > or =500 copies/ml (lower threshold). Measures of accuracy with exact binomial 95% confidence intervals (CI) were calculated.

RESULTS: A total of 2009 patients were included. During 1856 person-years of follow up 63 patients met the immunological criteria and 35 patients (higher threshold) and 95 patients (lower threshold) met the virological criteria. Sensitivity [95% confidence interval (CI)] was 17.1% (6.6-33.6%) for the higher and 12.6% (6.7-21.0%) for the lower threshold. Corresponding results for specificity were 97.1% (96.3-97.8%) and 97.3% (96.5-98.0%), for positive predictive value 9.5% (3.6-19.6%) and 19.0% (10.2-30.9%) and for negative predictive value 98.5% (97.9-99.0%) and 95.7% (94.7-96.6%).

CONCLUSIONS: The positive predictive value of the WHO immunological criteria for virological failure of antiretroviral treatment in resource-limited settings is poor, but the negative predictive value is high. Immunological criteria are more appropriate for ruling out than for ruling in virological failure in resource-limited settings.

Comment in:

PMID: 19624478 [PubMed - indexed for MEDLINE]

PMCID: PMC3722497

 

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Citation:

Keiser O, MacPhail P, Boulle A, Wood R, Schechter M, Dabis F, Sprinz E, Egger M; ART-LINC Collaboration of the International Databases to Evaluate AIDS (IeDEA). Accuracy of WHO CD4 cell count criteria for virological failure of antiretroviral therapy. Trop Med Int Health. 2009 Oct;14(10):1220-5. doi: 10.1111/j.1365-3156.2009.02338.x. Epub 2009 Jul 14. PubMed PMID: 19624478; PubMed Central PMCID: PMC3722497.