Visceral leishmaniasis relapse hazard is linked to reduced miltefosine exposure in patients from Eastern Africa: a population pharmacokinetic/pharmacodynamic study.

ABSTRACT:

Background

Low efficacy of miltefosine in the treatment of visceral leishmaniasis was recently observed in Eastern Africa.

Objectives

To describe the pharmacokinetics and establish a pharmacokinetic/pharmacodynamic relationship for miltefosine in Eastern African patients with visceral leishmaniasis, using a time-to-event approach to model relapse of disease.

Methods

Miltefosine plasma concentrations from 95 patients (48 monotherapy versus 47 combination therapy) were included in the population pharmacokinetic model using non-linear mixed effects modelling. Subsequently a time-to-event model was developed to model the time of clinical relapse. Various summary pharmacokinetic parameters (various AUCs, Time > EC50, Time > EC90), normalized within each treatment arm to al

SUBMITTER: Dorlo TPC 

PROVIDER: S-EPMC5890687 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature