Biomarkers of treatment response in clinical trials of novel antituberculosis agents

Felicity M. R. Perrin, Marc C. I. Lipman, Timothy D. McHugh, Stephen H. Gillespie

Research output: Contribution to journalReview articlepeer-review

58 Citations (Scopus)

Abstract

Global initiatives have been launched to develop improved tuberculosis chemotherapy. New drugs and potential treatment-shortening regimens require careful assessment in clinical trials, but existing markers of treatment outcome-clinical cure and relapse-require prolonged follow-up of patients. There is, therefore, a need to find alternative biomarkers or surrogate endpoints predictive of response. Effective treatment requires drugs with sterilising activity to produce clinical cure without relapse, and thus a useful biomarker for a drug under trial must predict the likelihood of relapse. We explore the strengths and weaknesses of existing biomarkers, which assess either host response or mycobacterial load. Change in mycobacterial burden is likely to be the best indicator of treatment outcome, but the optimum study techniques remain undefined. Finally, we propose methods to assess candidate markers, and how these candidate markers could be implemented in future clinical trials.

Original languageEnglish
Pages (from-to)481-490
Number of pages10
JournalLancet Infectious Diseases
Volume7
Issue number7
DOIs
Publication statusPublished - Jul 2007

Keywords

  • EARLY BACTERICIDAL ACTIVITY
  • DIAGNOSED PULMONARY TUBERCULOSIS
  • SURROGATE END-POINTS
  • RESOLUTION COMPUTED-TOMOGRAPHY
  • RANDOMIZED CONTROLLED-TRIAL
  • GAMMA-INTERFERON ASSAY
  • SPUTUM VIABLE COUNTS
  • CELL-BASED ASSAY
  • MYCOBACTERIUM-TUBERCULOSIS
  • STERILIZING ACTIVITIES

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