ArticleIJTLD open2026
Pharmacokinetic modelling as a tool to assess TB treatment adherence: application to the REMEMBER study.
Article in IJTLD open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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18 authors.
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Abstract
backgroundThe REMEMBER (A5274) study found that the four-drug TB preventive regimen did not reduce mortality compared to isoniazid-only, raising adherence concerns. Using drug measurements and pharmacometrics, we assessed adherence in the four-drug arm by comparing participants who developed TB (cases) to those who did not (controls).
methodsUsing a 1:4 matched case-control design, we analysed stored blood samples at weeks 2, 4, and 8 since treatment start. Rifampicin and pyrazinamide were measured, and adherence was assessed using two thresholds: i) lower limit of quantification (LLOQ) and ii) personalised thresholds derived from pharmacokinetic simulations. Population pharmacokinetic models and Monte Carlo simulations were used to predict individualised thresholds assuming 100% adherence. Conditional logistic regression compared non-adherence between cases and controls.
resultsAmong 28 cases and 112 controls, the proportion of samples <LLOQ was 52% (cases) versus 45% (controls) for rifampicin and 20% (cases) versus 14% (controls) for pyrazinamide. Non-adherence was significantly higher in cases compared to controls for two pyrazinamide metrics: the week 4 LLOQ (
conclusionPoor adherence may have contributed to TB incidence in REMEMBER. While not definitive, personalised thresholds from model-based simulations remain useful for adherence assessment.
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