TY - JOUR
T1 - A randomized study of intensified antiretroviral treatment monitoring versus standard-of-care for prevention of drug resistance and antiretroviral treatment switch
T2 - week 96 results of the ITREMA trial
AU - Hermans, Lucas E.
AU - Ter Heine, Rob
AU - Schuurman, Rob
AU - Tempelman, Hugo A.
AU - Burger, David M.
AU - Vervoort, Sigrid C.J.M.
AU - Deville, Walter L.J.M.
AU - De Jong, Dorien
AU - Venter, Willem D.F.
AU - Nijhuis, Monique
AU - Wensing, Annemarie M.J.
N1 - Funding Information:
This project was supported by the Netherlands Organisation for Health Research and Development (ZonMW) and NWO-WOTRO Science for Global Development through grant no. 205300004 and additional funding for dissemination and implementation (VIMP). ARK Diagnostics, Inc. provided immunoassay drug exposure testing kits free of charge, but was not involved in the design, execution, or analysis of the study.
Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.
PY - 2022/11/15
Y1 - 2022/11/15
N2 - 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.
AB - 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.
KW - antiretroviral treatment
KW - drug exposure testing
KW - drug resistance
KW - viral load monitoring
UR - https://www.scopus.com/pages/publications/85140933716
U2 - 10.1097/QAD.0000000000003349
DO - 10.1097/QAD.0000000000003349
M3 - Article
C2 - 35950949
SN - 0269-9370
VL - 36
SP - 1959
EP - 1968
JO - AIDS (London, England)
JF - AIDS (London, England)
IS - 14
ER -