TB R&D Weekly Update: 4-Drug Fixed Dose Combination Shows Comparable Efficacy and Safety

Lienhardt C, Cook SV, Burgos M, Yorke-Edwards V, Rigouts L, Anyo G, Kim SJ, Jindani A, Enarson DA, Nunn AJ; Study C Trial Group. Efficacy and safety of a 4-drug fixed-dose combination regimen compared with separate drugs for treatment of pulmonary tuberculosis: the Study C randomized controlled trial. JAMA. 2011 Apr 13;305(14):1415-23.

Continuing the theme from last week’s update on fixed-dose combinations (FDCs), we present a summary of this article by Christian Lienhardt (Leader of the Clinical Trial Capacity Subgroup, and affiliated with the Stop TB Partnership), et al., on the efficacy and safety of a 4-drug FDC when compared to a regimen of separately administered drugs. Key points from the article are:

  • Results suggest that a 4-drug FDC is as good or efficacious as a regimen using separate drugs.
  • The authors analyzed the data per protocol, intention-to-treat model based on analysis plan (model 1), and modified intention-to-treat model (model2); the per-protocol and model 2 analysis satisfied the criteria for non-inferiority defined in the protocol.
  • Safety data showed there were few adverse events and similar frequency in both regimens.
  • The study was a parallel-group, open-label, non-inferiority, randomized controlled trial conducted at 11 sites in Africa, Asia, Latin America, between 2003 ad 2008.

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Mycobacterium tuberculosis Complex Drug Resistance Pattern and Identification of Species Causing Tuberculosis in the West and Centre Regions of Cameroon

Catalysis Foundation for Health Selects BioFortis’ Labmatrix Database Software for International Tuberculosis Diagnostic Biomarker Study

Pvt pharma firms knock CSIR to develop TB drug

Bio-IT World Announces the Winners of its 2011 Best Practices Awards Program

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