Abstract
Background:In treatment naive TB patients,the impact of food intake on the PK data of 1st line TB drugs is unknown in the early phase of treatment.Objectives:To assess impact of food intake on PK of isoniazid(INH), Rifampisin(RIF),pyrazinamide(PZA)and ethambutol(EMB) in treatment-naive TB patients.Methods:Randomized,cross-over trial in 20 patients.Subjects were administered INH,RIF,and EMB iv and PZA orally on day 1,and Fixed Drug Combination of all four on day 2&3 either while fasting or along with a high carbohydrate meal.Full PK curves were collected,and assayed by Liquid Chromatography-tandem Mass Spectrometry.Results:mean age was 41.8(SD=20)yrs,mean body mass index 17.48(SD=2.6)kg/m2.The PK data was shown in
Conclusions:In treatment naive TB patients,concomitant food intake substantially influenced PK of TB drugs.Area under the curve(AUC0-24,),maximum concentration(Cmax ) and bioavailability decreased significantly when drugs were taken with food.The impact of the differences found in drug exposure on treatment efficacy and tolerability should be evaluated in a randomized prospective study.
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