An enhanced regimen as post-exposure chemoprophylaxis for leprosy: PEP++

Abstract The ongoing transmission of Mycobacterium (M.) leprae reflected in a very slow decline in leprosy incidence, forces us to be innovative and conduct cutting-edge research. Single dose rifampicin (SDR) as post-exposure prophylaxis (PEP) for contacts of leprosy patients, reduces their risk to...

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Main Authors: Liesbeth F Mieras, Anna T Taal, Wim H van Brakel, Emmanuelle Cambau, Paul R Saunderson, W Cairns S Smith, Cita Rosita S Prakoeswa, Linda Astari, David M Scollard, Dejair Caitano do Nascimento, Jacques Grosset, Hemanta K Kar, Shinzo Izumi, Laura Gillini, Marcos C L Virmond, Marieke G G Sturkenboom
Format: Article
Language:English
Published: BMC 2018-10-01
Series:BMC Infectious Diseases
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12879-018-3402-4
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author Liesbeth F Mieras
Anna T Taal
Wim H van Brakel
Emmanuelle Cambau
Paul R Saunderson
W Cairns S Smith
Cita Rosita S Prakoeswa
Linda Astari
David M Scollard
Dejair Caitano do Nascimento
Jacques Grosset
Hemanta K Kar
Shinzo Izumi
Laura Gillini
Marcos C L Virmond
Marieke G G Sturkenboom
author_facet Liesbeth F Mieras
Anna T Taal
Wim H van Brakel
Emmanuelle Cambau
Paul R Saunderson
W Cairns S Smith
Cita Rosita S Prakoeswa
Linda Astari
David M Scollard
Dejair Caitano do Nascimento
Jacques Grosset
Hemanta K Kar
Shinzo Izumi
Laura Gillini
Marcos C L Virmond
Marieke G G Sturkenboom
author_sort Liesbeth F Mieras
collection DOAJ
description Abstract The ongoing transmission of Mycobacterium (M.) leprae reflected in a very slow decline in leprosy incidence, forces us to be innovative and conduct cutting-edge research. Single dose rifampicin (SDR) as post-exposure prophylaxis (PEP) for contacts of leprosy patients, reduces their risk to develop leprosy by 60%. This is a promising new preventive measure that can be integrated into routine leprosy control programmes, as is being demonstrated in the Leprosy Post-Exposure Programme that is currently ongoing in eight countries. The limited (60%) effectiveness of SDR is likely due to the fact that some contacts have a preclinical infection beyond the early stages for which SDR is not sufficient to prevent the development of clinical signs and symptoms of leprosy. An enhanced regimen, more potent against a higher load of leprosy bacteria, would increase the effectiveness of this preventive measure significantly. The Netherlands Leprosy Relief (NLR) is developing a multi-country study aiming to show that breaking the chain of transmission of M. leprae is possible, evidenced by a dramatic reduction in incidence. In this study the assessment of the effectiveness of an enhanced prophylactic regimen for leprosy is an important component. To define the so called PEP++ regimen for this intervention study, NLR convened an Expert Meeting that was attended by clinical leprologists, public health experts, pharmacologists, dermatologists and microbiologists. The Expert Meeting advised on combinations of available drugs, with known efficacy against leprosy, as well as on the duration of the intake, aiming at a risk reduction of 80–90%. To come to a conclusion the Expert Meeting considered the bactericidal, sterilising and bacteriostatic activity of the potential drugs. The criteria used to determine an optimal enhanced regimen were: effectiveness, safety, acceptability, availability, affordability, feasibility and not inducing drug resistance. The Expert Meeting concluded that the enhanced regimen for the PEP++ study should comprise three standard doses of rifampicin 600 mg (weight adjusted when given to children) plus moxifloxacin 400 mg given at four-weekly intervals. For children and for adults with contraindications for moxifloxacin, moxifloxacin should be replaced by clarithromycin 300 mg (weight adjusted).
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spelling doaj.art-dcd880930d4c4ebf981b570331abf17d2022-12-21T18:13:55ZengBMCBMC Infectious Diseases1471-23342018-10-011811810.1186/s12879-018-3402-4An enhanced regimen as post-exposure chemoprophylaxis for leprosy: PEP++Liesbeth F Mieras0Anna T Taal1Wim H van Brakel2Emmanuelle Cambau3Paul R Saunderson4W Cairns S Smith5Cita Rosita S Prakoeswa6Linda Astari7David M Scollard8Dejair Caitano do Nascimento9Jacques Grosset10Hemanta K Kar11Shinzo Izumi12Laura Gillini13Marcos C L Virmond14Marieke G G Sturkenboom15Netherlands Leprosy ReliefNetherlands Leprosy ReliefNetherlands Leprosy ReliefNational Reference Center for mycobacteria and antimycobacterial resistanceAmerican Leprosy MissionsInstitute of Applied Health Sciences, University of AberdeenDermatology Health & Venereology, Faculty of Medicine, Airlangga UniversityDermatology Health & Venereology, Faculty of Medicine, Airlangga UniversityNational Hansen’s Disease ProgramsInstituto Lauro de Souza LimaJohns Hopkins University School of MedicineDepartment of Dermatology, Leprosy and STD, Paras HospitalsLeprosy Study Group, Institute of Tropical Disease, Airlangga UniversityGlobal Leprosy Programme, WHOInstituto Lauro de Souza LimaDepartment of Clinical Pharmacy and Pharmacology, University Medical Center GroningenAbstract The ongoing transmission of Mycobacterium (M.) leprae reflected in a very slow decline in leprosy incidence, forces us to be innovative and conduct cutting-edge research. Single dose rifampicin (SDR) as post-exposure prophylaxis (PEP) for contacts of leprosy patients, reduces their risk to develop leprosy by 60%. This is a promising new preventive measure that can be integrated into routine leprosy control programmes, as is being demonstrated in the Leprosy Post-Exposure Programme that is currently ongoing in eight countries. The limited (60%) effectiveness of SDR is likely due to the fact that some contacts have a preclinical infection beyond the early stages for which SDR is not sufficient to prevent the development of clinical signs and symptoms of leprosy. An enhanced regimen, more potent against a higher load of leprosy bacteria, would increase the effectiveness of this preventive measure significantly. The Netherlands Leprosy Relief (NLR) is developing a multi-country study aiming to show that breaking the chain of transmission of M. leprae is possible, evidenced by a dramatic reduction in incidence. In this study the assessment of the effectiveness of an enhanced prophylactic regimen for leprosy is an important component. To define the so called PEP++ regimen for this intervention study, NLR convened an Expert Meeting that was attended by clinical leprologists, public health experts, pharmacologists, dermatologists and microbiologists. The Expert Meeting advised on combinations of available drugs, with known efficacy against leprosy, as well as on the duration of the intake, aiming at a risk reduction of 80–90%. To come to a conclusion the Expert Meeting considered the bactericidal, sterilising and bacteriostatic activity of the potential drugs. The criteria used to determine an optimal enhanced regimen were: effectiveness, safety, acceptability, availability, affordability, feasibility and not inducing drug resistance. The Expert Meeting concluded that the enhanced regimen for the PEP++ study should comprise three standard doses of rifampicin 600 mg (weight adjusted when given to children) plus moxifloxacin 400 mg given at four-weekly intervals. For children and for adults with contraindications for moxifloxacin, moxifloxacin should be replaced by clarithromycin 300 mg (weight adjusted).http://link.springer.com/article/10.1186/s12879-018-3402-4Post-exposure prophylaxisChemoprophylaxisIntervention studyLeprosyRifampicinMoxifloxacin
spellingShingle Liesbeth F Mieras
Anna T Taal
Wim H van Brakel
Emmanuelle Cambau
Paul R Saunderson
W Cairns S Smith
Cita Rosita S Prakoeswa
Linda Astari
David M Scollard
Dejair Caitano do Nascimento
Jacques Grosset
Hemanta K Kar
Shinzo Izumi
Laura Gillini
Marcos C L Virmond
Marieke G G Sturkenboom
An enhanced regimen as post-exposure chemoprophylaxis for leprosy: PEP++
BMC Infectious Diseases
Post-exposure prophylaxis
Chemoprophylaxis
Intervention study
Leprosy
Rifampicin
Moxifloxacin
title An enhanced regimen as post-exposure chemoprophylaxis for leprosy: PEP++
title_full An enhanced regimen as post-exposure chemoprophylaxis for leprosy: PEP++
title_fullStr An enhanced regimen as post-exposure chemoprophylaxis for leprosy: PEP++
title_full_unstemmed An enhanced regimen as post-exposure chemoprophylaxis for leprosy: PEP++
title_short An enhanced regimen as post-exposure chemoprophylaxis for leprosy: PEP++
title_sort enhanced regimen as post exposure chemoprophylaxis for leprosy pep
topic Post-exposure prophylaxis
Chemoprophylaxis
Intervention study
Leprosy
Rifampicin
Moxifloxacin
url http://link.springer.com/article/10.1186/s12879-018-3402-4
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