ArticleClinical drug investigation2018
Discontinuation of Efavirenz in Paediatric Patients: Why do Children Switch?
Article in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.
- Second-line HIV treatment failure in sub-Saharan Africa: A systematic review and meta-analysis.PloS one · 2019Pooled it
- Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events.Pharmacogenetics and genomics · 2018Trial
- Efavirenz metabolism and CNS toxicity in Ugandan children: impact of CYP2B6 genotype and plasma metabolite profiles.Frontiers in pharmacology · 2026Article
- Quantifying pediatric patient need for second- and third-line HIV treatment: A tool for decision-making in resource-limited settings.PloS one · 2019Article
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEfavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI) is used globally as first-line antiretroviral therapy (ART) in combination with a dual nucleoside backbone in adults and children from 3 years of age. Up to 40% of adults taking efavirenz report central nervous system (CNS) adverse effects, and the rates of discontinuation of efavirenz-based treatment are higher than other first-line regimens. Data on efavirenz discontinuation are more limited for children and adolescents.
objectiveIn this study, we aimed to describe our single-centre paediatric experience of efavirenz.
methodsRetrospective case-note audit of children and adolescents with perinatally acquired HIV who ever received efavirenz.
resultsFrom 1998 and 2014, 51 children and adolescents aged ≤ 18 years received efavirenz-based treatment. Median age at efavirenz initiation was 9.4 years (interquartile range [IQR] 7-13). More than half (30/51; 59%) subsequently switched off efavirenz-15 (29%) following virological failure with NNRTI-associated resistance mutations, and 16 (30%) after reporting adverse effects. Of those who experienced adverse effects, one-fifth (19.6%) described CNS adverse effects, including sleep disturbance, reduced concentration, headaches, mood change and psychosis. Four children (three males) developed gynaecomastia, two developed hypercholesterolaemia, and one child developed Stevens-Johnson syndrome. Comparison between those reporting side effects and the rest of the cohort showed no difference in age, sex, initial CD4 cell count, viral suppression, length of efavirenz-based treatment, weight, or efavirenz dose per kilogram. Median time to switch was 25 months (IQR 10-71) in those who experienced side effects and 22 months (IQR 12-50) for virological failure. One individual experienced both virological failure and adverse effects.
conclusionAlmost two-thirds of this paediatric cohort switched from efavirenz-based treatment to an alternative regimen, due in equal proportions to both virological failure and toxicity. The majority of side effects involved the CNS. First-line regimens with improved tolerability and a higher genetic barrier to resistance should be the preferred option for children.
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