A randomized study of intensified antiretroviral treatment monitoring versus standard-of-care for prevention of drug resistance and antiretroviral treatment switch.
AIDS
; 36(14): 1959-1968, 2022 11 15.
Article
em En
| MEDLINE
| ID: mdl-35950949
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 96âweeks 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 1000âcopies/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 24âweeks. 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 â=â0.445). Time to detection of rebound was 375âdays [interquartile range (IQR) 348-515] in intervention participants and 360âdays [IQR 338-464] in controls [hazard ratio 0.88 (95% confidence interval (95% CI) 0.46-1.66]; P â=â0.683]. Duration of viral rebound was 87âdays [IQR 70-110] in intervention participants and 101âdays [IQR 78-213] in controls ( P â=â0.423). 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.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
/
2_ODS3
Base de dados:
MEDLINE
Assunto principal:
Infecções por HIV
/
Fármacos Anti-HIV
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Adult
/
Humans
Idioma:
En
Revista:
AIDS
Ano de publicação:
2022
Tipo de documento:
Article