A randomized study of intensified antiretroviral treatment monitoring versus standard-of-care for prevention of drug resistance and antiretroviral treatment switch.

Autor: Hermans LE; Virology, Department of Medical Microbiology, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.; Ezintsha, University of Witwatersrand, Johannesburg.; Infectious Diseases & HIV Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa., Ter Heine R; Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands., Schuurman R; Virology, Department of Medical Microbiology, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands., Tempelman HA; Ezintsha, University of Witwatersrand, Johannesburg.; Ndlovu Research Consortium, Elandsdoorn, South Africa., Burger DM; Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands., Vervoort SCJM; Nursing Service., Deville WLJM; Ndlovu Research Consortium, Elandsdoorn, South Africa.; Julius Global Health, The Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, the Netherlands., De Jong D; Virology, Department of Medical Microbiology, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands., Venter WDF; Ezintsha, University of Witwatersrand, Johannesburg.; Ndlovu Research Consortium, Elandsdoorn, South Africa., Nijhuis M; Virology, Department of Medical Microbiology, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.; Ndlovu Research Consortium, Elandsdoorn, South Africa.; HIV Pathogenesis Research Unit, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa., Wensing AMJ; Virology, Department of Medical Microbiology, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.; Ezintsha, University of Witwatersrand, Johannesburg.; Ndlovu Research Consortium, Elandsdoorn, South Africa.
Jazyk: angličtina
Zdroj: AIDS (London, England) [AIDS] 2022 Nov 15; Vol. 36 (14), pp. 1959-1968. Date of Electronic Publication: 2022 Oct 04.
DOI: 10.1097/QAD.0000000000003349
Abstrakt: 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.
(Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze: MEDLINE
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