A randomized study of intensified antiretroviral treatment monitoring versus standard-of-care for prevention of drug resistance and antiretroviral treatment switch: week 96 results of the ITREMA trial

Lucas E. Hermans, Rob Ter Heine, Rob Schuurman, Hugo A. Tempelman, David M. Burger, Sigrid C.J.M. Vervoort, Walter L.J.M. Deville, Dorien De Jong, Willem D.F. Venter, Monique Nijhuis, Annemarie M.J. Wensing

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Abstract

INTRODUCTION: Standard-of-care antiretroviral treatment (ART) monitoring in low and middle-income countries consists of annual determination of HIV-RNA viral load with confirmatory viral load testing in case of viral rebound. We evaluated an intensified monitoring strategy of three-monthly viral load testing with additional drug exposure and drug resistance testing in case of viral rebound. METHODS: We performed an open-label randomized controlled trial (RCT) at a rural South African healthcare clinic, enrolling adults already receiving or newly initiating first-line ART. During 96 weeks follow-up, intervention participants received three-monthly viral load testing and sequential point-of-care drug exposure testing and DBS-based drug resistance testing in case of rebound above 1000 copies/ml. Control participants received standard-of-care monitoring according to the WHO guidelines. RESULTS: Five hundred one participants were included, of whom 416 (83.0%) were randomized at 24 weeks. Four hundred one participants were available for intention-to-treat analysis. Viral rebound occurred in 9.0% (18/199) of intervention participants and in 11.9% (24/202) of controls ( P  = 0.445). Time to detection of rebound was 375 days [interquartile range (IQR): 348-515] in intervention participants and 360 days [IQR: 338-464] in controls [hazard ratio: 0.88 (95% confidence interval (95% CI): 0.46-1.66]; P  = 0.683]. Duration of viral rebound was 87 days [IQR: 70-110] in intervention participants and 101 days [IQR: 78-213] in controls ( P  = 0.423). In the control arm, three patients with confirmed failure were switched to second-line ART. In the intervention arm, of three patients with confirmed failure, switch could initially be avoided in two cases. CONCLUSION: Three-monthly viral load testing did not significantly reduce the duration of viraemia when compared with standard-of-care annual viral load testing, providing randomized trial evidence in support of annual viral load monitoring.

Original languageEnglish
Pages (from-to)1959-1968
Number of pages10
JournalAIDS (London, England)
Volume36
Issue number14
Early online date11 Aug 2022
DOIs
Publication statusPublished - 15 Nov 2022

Keywords

  • antiretroviral treatment
  • drug exposure testing
  • drug resistance
  • viral load monitoring

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