Predictive markers for sustained viral suppression on dual bNAbs during ART interruption in children

Area of Science:

• Virology and Immunology
• Pediatric Infectious Diseases
• HIV/AIDS Research

Background:

• Identifying simple clinical markers is crucial for predicting outcomes in pediatric HIV treatment and cure studies.
• This study evaluated biomarker combinations during a specific phase of the Tatelo Study in Botswana, focusing on broadly neutralizing antibodies (bNAbs).

Purpose of the Study:

• To assess the predictive value of specific biomarkers for maintaining viral suppression in children undergoing HIV treatment with bNAbs.
• To evaluate combinations of qualitative DNA and enzyme immunosorbent assay (EIA) as potential predictors of treatment success.

Main Methods:

• Twenty-five children on antiretroviral therapy (ART) since birth received up to 24 weeks of bNAb-only treatment (VRC01LS+10-1074).
• Viral suppression was defined as maintaining HIV RNA < 400 copies/mL.
• HIV qualitative DNA and RNA levels were monitored bi-weekly, with EIA performed every 4-8 weeks.

Main Results:

• At the initiation of bNAb treatment, 52% of children had negative qualitative DNA, 68% had negative EIA, and 40% were negative for both.
• Children with negative qualitative DNA were significantly more likely to remain suppressed (69%) compared to those with positive/indeterminate results (17%).
• The combination of negative qualitative DNA and negative EIA demonstrated the highest prediction of sustained viral suppression (80% remained suppressed).

Conclusions:

• Negative qualitative DNA and EIA results at the start of dual bNAb therapy can predict the maintenance of viral suppression in children.
• The combination of negative qualitative DNA and EIA is a particularly strong predictor of sustained viral suppression.
• HIV RNA detection below the assay limit did not emerge as a useful biomarker for predicting viral failure in this cohort.