The importance of pharmacokinetics/pharmacodynamics assessment in Phase IIB/III trials for MDR-TB treatment

MULTIDRUG-RESISTANT TB (MDR-TB) TREATMENT outcomes are poor due to reduced potency of the drugs used, and because treatment adherence is affected by the prolonged duration of treatment and frequent adverse drug reactions.¹ In the absence of adequate randomised controlled trials, observational data and pooled analysis have been used for the development of MDR-TB treatment guidelines.² The traditional approach includes the use of at least five active drugs based on drug susceptibility testing (DST) for a treatment duration of at least 18 months, although shorter treatment options have recently been endorsed.³