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Adverse reactions associated with first-line regimens in patient initiating antiretroviral therapy

  • Pharmacoepidemiology and Prescription
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Abstract

Objective

To evaluate the prevalence of adverse drug reactions (ADR) and associated factors during the use of Highly Active Antiretroviral Therapy (HAART) in patients initiating treatment.

Methods

This is a cross-sectional analysis of a prospective study conducted in three public referral services specialized in HIV/AIDS care in Belo Horizonte, Brazil. Self-reported ADR and explanatory variables were obtained from face-to-face interview and from Information Systems. Associated factors with ADR were evaluated by logistic regression in SPSS software v.22.

Results

We included 399 patients, of which 85.5% reported at least one and 72.7% up to 5 ADRs after HAART initiation. Neurological reactions were the most frequent, with self-reported ADRs being distinct according to HAART regimen used. The global model showed higher chance of ADRs among females (OR = 3.52) and illicit drug users (OR = 2.28). Lower chance of ADRs was found for patients aged > 33 years (OR = 0.37), DTG/TDF/3TC users (OR = 0.41), and higher physical domain of quality of life (OR = 0.78). The model restricted to patients using the single-tablet regimen EFV/TDF/3TC showed lower ADRs among patients with CD4+ T lymphocyte count > 200 cells/mm3 (OR = 0.23) and higher independence domain of quality of life (OR = 0.74). The model restricted to DTG/TDF/3TC and to other regimens showed lower ADRs with higher physical domain of quality of life (OR = 0.74 and OR = 0.55, respectively).

Conclusions

The prevalence of self-reported ADRs to first-line antiretroviral regimens was high and patients using DTG/TDF/3TC had a smaller number of ADRs. In addition to HAART regimen, sociodemographic, clinical, and quality of life characteristics were associated with ADRs.

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Acknowledgements

This study was supported by the Foundation for Research Support of the State of Minas Gerais (FAPEMIG).

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Authors and Affiliations

  1. Faculdade de Farmácia, Universidade Federal de Minas Gerais–UFMG, Avenida Antônio Carlos 6627, Pampulha, Belo Horizonte, Minas Gerais, 31270-901, Brazil

    Jullye Campos Mendes, Maria das Graças Braga Ceccato, Adriano Max Moreira Reis & Micheline Rosa Silveira

  2. Faculdade de Medicina, Universidade Federal de Minas Gerais–UFMG, Avenida Professor Alfredo Balena 190, Santa Efigênia, Belo Horizonte, Minas Gerais, 30130-100, Brazil

    Palmira de Fátima Bonolo & Juliana de Oliveira Costa

  3. Instituto de Educação Continuada, Pontifícia Universidade Católica de Minas Gerais-PUC Minas, Rua Cláudio Manoel 1205, Funcionários, Belo Horizonte, Minas Gerais, 30140-100, Brazil

    Henrique dos Santos

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  1. Jullye Campos Mendes
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  2. Palmira de Fátima Bonolo
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  3. Maria das Graças Braga Ceccato
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Contributions

JCM was responsible for study design, data extraction, data analysis, drafting of the manuscript, critical review, and approval of the final manuscript. PFB was responsible for study design, drafting of the manuscript, critical review, and approval of the final manuscript. AMMR was responsible for study design, drafting of the manuscript, critical review, and approval of the final manuscript. JOC was responsible for data extraction, data analysis, and drafting of the manuscript. HD was responsible for data analysis. MGBC was responsible for study design and approval of the final manuscript. MRS was responsible for study design, drafting of the manuscript, critical review, and approval of the final manuscript.

Corresponding author

Correspondence to Jullye Campos Mendes.

Ethics declarations

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institution and/or national research committee and with the Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. Ethical clearance was sought and obtained.

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The authors declare that there was no conflict of interest.

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Mendes, J.C., Bonolo, P.d., Ceccato, M.d. et al. Adverse reactions associated with first-line regimens in patient initiating antiretroviral therapy. Eur J Clin Pharmacol 74, 1077–1088 (2018). https://doi.org/10.1007/s00228-018-2472-y

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  • DOI: https://doi.org/10.1007/s00228-018-2472-y

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