Pooled HIV-1 RNA viral load testing for detection of antiretroviral treatment failure in Kenyan children.

ABSTRACT

BACKGROUND: Pooled viral load (VL) testing with 2 different testing strategies was evaluated as a potential cost saving method to monitor antiretroviral therapy (ART) in HIV-infected children receiving ART in a resource-limited setting. METHODS: Archived samples collected from 250 HIV-1-infected children on first-line ART at various time points post-ART initiation were evaluated for pooled VL testing using a minipool + algorithm strategy. Additionally, samples collected in real time from 125 children on ART were assessed for virologic failure using a minipool strategy for pooled VL testing. Virologic failure was determined as HIV-1 RNA VLs >1500 copies/mL. RESULTS: Minipool + algorithm strategy for pooled VL testing of archived samples had estimated viral failure of 13.6%, with a relative efficiency (RE) of 23.6% (95% CI 18.5 to 29.4), and negative predictive value of 88%. This testing strategy would have resulted in 24% fewer assays needed for a cost savings of $1180 per 100 samples. The minipool strategy for pooled VL testing of samples obtained in real time yielded an estimated 23.2% of samples with viral failure and a RE of 8.0% (95% CI 3.9 to 14.2); however, had a minipool + algorithm pooling strategy been used, the RE would have increased to 20%. CONCLUSIONS: The minipool + algorithm strategy for pooled VL testing to detect virologic failure in HIV-1-infected children on ART was determined to be relatively efficient in detecting virologic failure, have high negative predictive value, with substantial cost savings. Pooling strategies may be important components of cost-effect strategies to reduce rates of viral failure and resistance, thus, improving clinical outcomes.