Monitoring plasmatic concentrations of efavirenz for prediction of clinical outcomes in people living with HIV

Thaís Lorenna Souza Sales; Nathália  Soares Simões; Gustavo  Machado Rocha; Keyller  Bastos Borges; Cristiane  Aparecida Menezes de Pádua; Eduardo  Sérgio da Silva; Cristina  Sanches

Thaís Lorenna Souza Sales Departamento de Ciências da Saúde, Universidade Federal de São João del-Rei (UFSJ), Campus Centro-Oeste Dona Lindu, Divinópolis, MG, Brasil https://orcid.org/0000-0002-1571-3850
Nathália Soares Simões Departamento de Ciências da Saúde, Universidade Federal de São João del-Rei, Campus Centro-Oeste Dona Lindu, Divinópolis, MG, Brasil https://orcid.org/0000-0002-3881-9340
Gustavo Machado Rocha Departamento de Ciências da Saúde, Universidade Federal de São João del-Rei, Campus Centro-Oeste Dona Lindu, Divinópolis, MG, Brasil https://orcid.org/0000-0001-8255-1559
Keyller Bastos Borges Departamento de Ciências Naturais, Universidade Federal de São João del-Rei, Campus Dom Bosco, São João del-Rei, MG, Brasil https://orcid.org/0000-0003-1067-1919
Cristiane Aparecida Menezes de Pádua Departamento de Farmácia Social, Universidade Federal de Minas Gerais, Campus Pampulha, Belo Horizonte, MG, Brasil https://orcid.org/0000-0001-7083-3188
Eduardo Sérgio da Silva Departamento de Ciências da Saúde, Universidade Federal de São João del-Rei, Campus Centro-Oeste Dona Lindu, Divinópolis, MG, Brasil https://orcid.org/0000-0001-7409-9216
Cristina Sanches Departamento de Ciências da Saúde, Universidade Federal de São João del-Rei, Campus Centro-Oeste Dona Lindu, Divinópolis, MG, Brasil https://orcid.org/0000-0002-8562-1337

Keywords: Drug Monitoring, Efavirenz, Viral Load, D4 Lymphocyte Count, Drug-Related Side, Drug-Related Side Effects and Adverse Reactions

Abstract

Objective: To assess the ability of efavirenz plasma concentrations to predict clinical outcomes. Methods: This is a cross-sectional study in people living with HIV on efavirenz antiretroviral therapy. The ROC curve (Receiver Operating Characteristic) analysis was carried out in order to verify the variation in sensitivity and specificity between the efavirenz plasma concentration and the other variables of interest in the study. The study was approved by the Human Research Ethics Committee of the University of São João del-Rei, Central-West Dona Lindu Campus, as per CAAE 41775015.3.0000.5545. Results: Among the 108 patients included in the study, the median age was 54.5 years (IQ25%: 41.0; IQ75%: 63.0). The efavirenz plasma concentration was not able to predict outcomes such as viral suppression (AUC: 0.525; CI95%: 0.334 - 0.716; p = 0.803), immune response (AUC: 0.501; CI95%: 0.390 - 0.612; p = 0.982), presence of adverse events (1 adverse event - AUC: 0.326: CI95%: 0.156 - 0.497; p = 0.103) / ≥ 4 adverse events – AUC = 0.432; CI95%: 0.323 - 0.542; p = 0.232) and adherence (AUC = 0.537; CI95%: 0.423 - 0.651; p = 0.520). Conclusions: More studies are needed to estimate the relationship between clinical outcomes and efavirenz plasma concentrations in current clinical protocols. Therefore, the accumulation of evidence on the subject is essential to identify the feasibility of therapeutic monitoring of antiretrovirals for the purpose of optimizing parameters such as efficacy, safety and adherence.