1. Introduction
virologic failure, VF, HIV drug resistance
REGRESSION
Increasing HIV drug resistance (DR) among children with HIV (CHIV) on antiretroviral treatment (ART) is concerning. CHIV ages 1–14 years enrolled from March 2019 to December 2020 from five facilities in Kisumu County, Kenya, were included. Children were randomized 1:1 to control (standard-of-care) or intervention (point-of-care viral load (POC VL) testing every three months with targeted genotypic drug resistance testing (DRT) for virologic failure (VF) (≥1000 copies/mL)). A multidisciplinary committee reviewed CHIV with DRT results and offered treatment recommendations. We describe DR mutations and present logistic regression models to identify factors associated with clinically significant DR. We enrolled 704 children in the study; the median age was 9 years (interquartile range (IQR) 7, 12), 344 (49%) were female, and the median time on ART was 5 years (IQR 3, 8). During the study period, 106 (15%) children had DRT results (84 intervention and 22 control). DRT detected mutations associated with DR in all participants tested, with 93 (88%) having major mutations, including 51 (54%) with dual-class resistance. A history of VF in the prior 2 years (adjusted odds ratio (aOR) 11.1; 95% confidence interval (CI) 6.3, 20.0) and less than 2 years on ART at enrollment (aOR 2.2; 95% CI 1.1, 4.4) were associated with increased odds of major DR. DR is highly prevalent among CHIV on ART with VF in Kenya. Factors associated with drug resistance may be used to determine which children should be prioritized for DRT.Children living with human immunodeficiency virus (HIV) (CHIV) currently require life-long antiretroviral therapy (ART) and continue to have more limited medication options than adolescents and adults living with HIV [The World Health Organization (WHO) and others have expressed concerns that HIV drug resistance (DR) to ARVs will undermine the attainment of the global targets for HIV, and CHIV face unique challenges for DR [Kenya is heavily burdened by HIV, with an estimated 68,000 CHIV with around 85% on ART in 2022 [Understanding DR patterns and associated factors among children on ART in Kenya may inform algorithms used to manage children with VF. Here, we present DR testing (DRT) results from a randomized trial evaluating targeted DRT for children with VF accompanied by a collaborative, multidisciplinary case review to inform ART recommendations. We describe the drug resistance patterns, characteristics associated with major drug resistance, and clinical outcomes of CHIV undergoing DRT from this trial.