Guidelines For Clinical And Operational Management Of Drug .

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Guidelines for Clinical andOperational Management ofDrug-Resistant Tuberculosis2013International Union AgainstTuberculosis and Lung Disease

Guidelines for Clinical andOperational Management ofDrug-Resistant Tuberculosis2013José A. Caminero, editorwith contributions fromArmand Van DeunPaula I. FujiwaraIgnacio MonederoChen-Yuan ChiangAnthony D. HarriesHans L. RiederEinar HeldalArnaud TrébucqRaimond ArmengolEdith AlarcónCécile MacéChristophe PerrinRiitta A. DlodloGilles CesariDonald A. EnarsonInternational Union AgainstTuberculosis and Lung DiseaseThis publication was made possible thanks to the support of MISEREOR and theU.S. Centers for Disease Control and Prevention’s Coordinating Office for GlobalHealth and National Center for HIV, Viral Hepatitis, STDs and TB Prevention

EditorInternational Union Against Tuberculosis and Lung Disease (The Union)68 boulevard St Michel, 75006 Paris, FranceSuggested citationCaminero JA, ed. Guidelines for Clinical and Operational Managementof Drug-Resistant Tuberculosis. Paris, France: International Union AgainstTuberculosis and Lung Disease, 2013.First published online 22 March 2013; revised 6 May 2013. International Union Against Tuberculosis and Lung Disease (The Union)68 boulevard St Michel, 75006 Paris, FranceMarch 2013All rights reserved.No part of this publication may be reproduced without the permission of the authors andpublisher.ISBN: 979-10-91287-03-6

ContentsAbbreviations1 Justification for the Guidelinesix1Justification for the Guidelines: drug-resistant tuberculosis can be cured1The challenge of a new epidemic and the lack of anti-tuberculosismedicines2Lack of evidence in drug-resistant tuberculosis clinical andoperational management4Objectives of the Guidelines4References52 Historical background and global epidemiology ofMycobacterium tuberculosis resistanceHistorical background of anti-tuberculosis drug resistanceSurveillance of anti-tuberculosis drug resistance779Distribution and determinants of anti-tuberculosis drug resistance10References113 Basic concepts and definitions of drug resistance in tuberculosisBiological characteristics of Mycobacterium tuberculosis1314Basic concepts of resistance15Definitions of drug resistance in tuberculosis16Emerging drug resistance in Mycobacterium tuberculosis19Genetic markers of resistance to anti-tuberculosis drugs21Transmissibility and reproductive fitness of resistantMycobacterium tuberculosis23References244 Building a tuberculosis programme that addressesdrug resistance27Minimum requirements for the diagnosis of drug-resistant tuberculosis28Minimum requirements for the treatment of patients withdrug-resistant tuberculosis30

ivCONTENTSCost of services and how to budget for them32Training and supervision in drug-resistant tuberculosis patientmanagement34Framework for effective drug-resistant tuberculosis control:the Green Light Committee and other international alliances36References375 How drug resistance affects tuberculosis treatment outcomeand monitoring parameters39Effect of drug resistance on treatment outcome39Effect on treatment monitoring parameters42References456 High-risk groups for drug-resistant tuberculosis47Case finding and prioritisation of interventions47Failures, bacteriological relapses, defaulters and the dangers ofpoor adherence51References527 Laboratory diagnosis and treatment monitoring ofdrug-resistant tuberculosis55Diagnosis56Treatment monitoring66References698 Principles of treatment for susceptible and drug-resistanttuberculosis71Introduction: brief historical review of anti-tuberculosis chemotherapy72Bacteriological bases for the treatment of tuberculosis, includingdrug-resistant tuberculosis73Core versus companion drugs in the intensive and continuation phases79Rationale for an ideal initial treatment regimen80Rationale for an ideal drug-resistant tuberculosis treatment regimen84Conclusions96References989 Anti-tuberculosis drugs: mechanisms of action and rationalefor use99Introduction100Anti-tuberculosis drugs: mechanisms of action101

CONTENTSvRole of first-line oral anti-tuberculosis drugs in the management ofdrug-resistant tuberculosis101Fluoroquinolones: mechanism of action and role in the treatmentof drug-resistant tuberculosis107Injectable anti-tuberculosis drugs: mechanism of action and role in thetreatment of drug-resistant tuberculosis109Group 4—thioamides, cycloserine/terizidone and p-aminosalicylate:mechanism of action and ideal sequence of introduction in adrug-resistant tuberculosis regimen111Most effective drugs in Group 5 and recommended sequence of use113Cross-resistance among anti-tuberculosis drugs116Potential new drugs for drug-resistant tuberculosis treatment116New drugs from already known families118Conclusions119References11910 Adverse reactions to anti-tuberculosis drugs:practical approaches and appropriate management121Introduction121Adverse reactions to first-line anti-tuberculosis drugs122Adverse reactions to second-line anti-tuberculosis drugs124Initiation of multidrug-resistant tuberculosis treatment127Monitoring of adverse drug reactions128Management of adverse drug reactions129References13011 Drug-resistant tuberculosis and human immunodeficiency virus:update and management133Drug-resistant tuberculosis and HIV: reasons for and consequences ofassociation of the two diseases133Drug-resistant tuberculosis and HIV: clinical facts and typical andatypical tuberculosis presentation134Diagnosing tuberculosis and drug-resistant tuberculosis in personsliving with HIV135Management of HIV-positive patients with drug-resistant tuberculosis136Problems with co-treatment138Collaborative TB/HIV activities143References14512 Management of drug-resistant tuberculosis in special situations147Drug-resistant tuberculosis management during pregnancy147Drug-resistant tuberculosis management in diabetes mellitus patients154

viCONTENTSDrug-resistant tuberculosis management: other frequent co-morbidities156References15913 An optimised cascade of treatment regimens161Definitions161Rationale for a cascade of treatment regimens162Principles for the choice of first-line drug regimens163Daily versus intermittent treatment164Special situations in the treatment of tuberculosis164Second-line treatment regimens166Third-line treatment regimens for multidrug-resistant tuberculosis168Remaining issues171References17314 Tuberculosis infection control: minimal requirements givenlimited resourcesIntroduction177177Basic concepts regarding the propagation of Mycobacterium tuberculosis179Administrative control measures181Environmental control measures184Respiratory protection and personal protection measures186Monitoring and evaluation of infection control activities187Monitoring of latent tuberculosis infection and tuberculosis diseaseamong health-care workers187References18815 Treatment delivery and adherence: organising ambulatorydirectly observed treatment and social support191Introduction191What is directly observed treatment and why is it important?192What are the modalities of directly observed treatment?193What knowledge must the directly observed treatment supportperson have?194What factors affect adherence to treatment?195What interventions can improve adherence?196Organisation of supervised treatment198Factors that favour adherence to treatment200Infection control in the drug-resistant tuberculosis patient’s home200Strategies to improve adherence201Indicators used to assess treatment adherence202References202

CONTENTS16 Monitoring and evaluation of drug-resistant tuberculosismanagementvii205Introduction and objectives206Indicators207Definitions207What records are necessary for multidrug-resistant tuberculosispatient management?210How are results reported?213How are data tabulated, assessed and used to facilitate and improvemanagement of multidrug-resistant tuberculosis in the future?215References22517 Management of second-line medicines fortuberculosis treatment227Introduction227Selection of medicines to treat drug-resistant tuberculosis patients227Quantification228Procurement of drug-resistant tuberculosis medicines229Quality assurance of drug-resistant tuberculosis medicines purchased229Prices of drug-resistant tuberculosis medicines230Importation of drug-resistant tuberculosis medicines231Storage and distribution in-country231Rational use231References232Appendices233

Abbreviations2LI second-line injectable drugAFB acid-fast bacillusAm amikacinAmx/Clv amoxicillin/clavulanateART antiretroviral therapyARV antiretroviral (drug)ATS American Thoracic SocietyAUC24 area under the concentration-time curve from 0 to 24 hBTS British Thoracic SocietyCD4 cells CD4 T lymphocytesCf clofazimineCfx ciprofloxacinCm capreomycinCPC cetylpyridinium chlorideCs cycloserineDALY disability-adjusted years of lifeDM diabetes mellitusDOT directly observed treatmentDOTS originally an acronym for directly observed treatment, shortcourse, DOTS became the term used to describe the tuberculosiscontrol strategy recommended by the WHODR-TB drug-resistant tuberculosisDST drug susceptibility testingE ethambutolEBA early bactericidal activityEth ethionamideFDA fluorescein diacetate used for vital stainingFDC fixed-dose combinationFLD first-line drugFQ fluoroquinoloneGDF Global Drug FacilityGFATM The Global Fund to Fight AIDS, Tuberculosis and MalariaGfx gatifloxacin

xABBREVIATIONSGLCHHAARTHEPA filterHIVICGreen Light Committee (WHO)isoniazidhighly active antiretroviral therapyhigh-efficiency particulate air filterhuman immunodeficiency virusinfection controlICFintensified case findingIPTintermittent preventive nt tuberculosis; Mycobacterium tuberculosisstrain resistant to at least isoniazid and rifampicinNational Essential Medicines Listnon-tuberculous mycobacteriaNTPnational tuberculosis programmeOfxofloxacinPASp-aminosalicylate (p-aminosalicylic acid)PIHPartners in HealthPLHperson/people living with HIVPtoprothionamideQALYquality-adjusted years of lifeREMAresazurin microplate nal Green Light Committeestreptomycinsecond-line drugtuberculosisTB-immune reconstitution inflammatory syndromeTB TEchnical Assistance Mechanismtotally drug-resistant TBTdftenofovirThthiacetazoneThe UnionTLAUVGIViVWSWHOXDR-TBZInternational Union Against Tuberculosis and Lung Diseasethin layer agarultraviolet germicidal irradiationviomycinventilated workstationWorld Health Organizationextensively drug-resistant tuberculosis; multidrug-resistanttuberculosis plus resistance to fluoroquinolones plus onesecond-line injectable drugpyrazinamide

1Justification for the GuidelinesJosé A. CamineroDecades after tuberculosis (TB) became a curableillness in nearly all cases, the appearance of Mycocan be curedbacterium tuberculosis strains with resistance toThe challenge of a new epidemic andthe lack of anti-TB medicinesthe most active existing drugs has once again madeLack of evidence in DR-TB clinical andit a significant menace to global public health. Onceoperational managementObjectives of the Guidelinesagain, there is talk of incurable forms of TB, withthe accompanying alarm and fear this creates. Thefirst important message that must be sent to everyone tasked with managing TBpatients is that, with good clinical and operational case management, all forms ofdrug-resistant TB (DR-TB) have the potential for cure, including those cases witha very extensive pattern of resistance. Obviously, the chances for success are clearlyreduced as the patient’s patterns of resistance increase. Numerous publicationsnonetheless show that even TB cases with extensive patterns of resistance are curable with proper clinical and operational management.The problem we are facing is a new epidemic with practically no evidence tosupport one management protocol over another. There are controversies regardingchoice of clinical and operational management scenarios for DR-TB. While theinternational recommendations are quite valid and must be followed as closely aspossible, there remain many questions and doubts about the daily managementof these patients. Thus, it is of utmost importance to discuss the controversial aspects of TB management in depth to ensure that the best standard of care is offered. In view of the above, The Union has written these Guidelines to address anddiscuss each fundamental aspect of the clinical and operational management ofDR-TB patients. Justification for the Guidelines: DR-TB Justification for the Guidelines: drug-resistant tuberculosiscan be curedDR-TB is an important new challenge in our fight against M. tuberculosis.After decades during which scientific advances made it possible for TB to bediagnosed and treated with relative ease, this new form of the disease isreaching epidemic proportions around the world, and is again challengingthe medical community and humankind. In recent years, DR-TB has become a growing threat to global public health, a threat that has generated

2CHAPTER 1fear not only in the scientific and medical communities, but also among thegeneral public. Articles published in the world’s most renowned medicaljournals have been sounding the alarm about the possible consequences ofthis type of difficult-to-cure TB. The primary message which must be delivered to everyone responsible for managing TB cases is that for all forms ofDR-TB, cure is possible with optimal clinical and operational case management, including for those patients with a very long-standing pattern of resistance. Obviously, the chances for success are clearly reduced as the patient’s patterns of resistance increase. This is why urgent action is needed.The first premise to keep in mind when tackling the challenge of DR-TBcases is that all patients are potentially curable with good clinical and operational management. This was demonstrated in the era prior to the discoveryof rifampicin (R) and fluoroquinolones (FQs), when patients with resistanceto isoniazid (H) streptomycin (S) p-aminosalicylic acid (PAS) were verysimilar to current extensively drug-resistant TB (XDR-TB) patients. Indeed, anumber of publications from the pre-rifampicin era showed that the specificthree-drug combination (to which the patient’s organism was sensitive)could achieve bacteriological conversion and cure rates of over 80%. Thereare also recent publications demonstrating that a significant percentage ofmultidrug-resistant TB (MDR-TB) patients, as well as XDR-TB cases, can becured with appropriate treatment and management. Problems arise in trying to define the best standard of approach for treating these patients, because evidence is so scarce on this recent epidemic that there is unfortunately more controversy than evidence regarding the management ofDR-TB. The Union undertook the creation of these Guidelines to addresssuch controversial aspects of clinical and operational management and discuss them in depth, and to reasonably present the best management standards from the operational viewpoint of national tuberculosis control programmes (NTPs) and from the individualised and clinical viewpoint.The challenge of a new epidemic and the lack ofanti-tuberculosis medicinesHumankind’s fight against TB took a radical turn between 1950 and 1970with the onslaught of anti-TB drug research on drugs that rendered mostcases curable. Simultaneously, studies were conducted to determine whyM. tuberculosis may become resistant to these different drugs. The widelyheld belief at that time was that to prevent such resistance, it was necessaryto combine a minimum of three different drugs. Nearly all of the followingdrugs were discovered in that era: S, PAS, H, thiacetazone (Th), pyrazinamide(Z), kanamycin (Km), amikacin (Am), viomycin (Vi), capreomycin (Cm),ethionamide (Eth), cycloserine (Cs), clofazimine (Cf), R and ethambutol (E).

JUSTIFICATION FOR THE GUIDELINES3However, initial optimism has gradually given way to pessimism due to theappearance of more resistant forms of TB and the near absence of new drugdiscoveries in the last 45 years. In an era of the great antibiotic revolutionfor the treatment of all infectious diseases, only FQs have been incorporatedinto the arsenal against TB. The present armamentarium has proved insufficient in the face of the progressively virulent resistance of the bacillus,which has taken advantage of inadequate therapeutic practice. M. tuberculosis has continued to develop mono-resistance, poly-resistance, multidrugresistance (MDR-TB is defined as resistance to at least H R), extensive drugresistance (XDR-TB is defined as MDR-TB plus resistance to FQs and at leastto a second-line injectable) and the newly named, but not universally accepted, concept of totally drug-resistant TB (TDR-TB), that is resistant to allthe anti-TB drugs tested in the laboratory.Unfortunately, when a pharmacological combination therapy was developed over 40 years ago that led to TB cure in just 6 months, countrieswith economic resources ceased research for new drugs. The result has beenthere are scarcely a dozen drugs with the ability to fight a disease that needsat least three to four drugs administered in combination to conquer it. Themost effective drug to fight M. tuberculosis is R, probably the only one capable of killing the aggressor microorganism under all metabolic growthconditions. R-resistant TB is especially hard to cure and has resulted inpoorer prognoses in many regions of the world without access to the limitedarmamentum of anti-TB drugs. Perhaps the second-best drug is H, with itsunequalled ability to kill the bacilli in their continuous division phase, making it a crucial weapon in the early weeks of treatment.R and H are the two best drugs to fight M. tuberculosis because they arethe most effective, the best tolerated and the most inexpensive. Treatmentof R H-resistant M. tuberculosis is therefore less effective, much more prolonged and more poorly tolerated. This challenge has led to the coining ofa specific term, MDR-TB, to define this hard-to-manage TB. In MDR-TBcases, two other classes of drugs should be part of all treatment regimens,because they are the most active against M. tuberculosis in the face of R Hresistance. They are the FQs and the injectables (aminoglycosides and polypeptides), although among the latter, the most active, S, should not be considered an option due to the elevated rate of H resistance associated withthis drug in most of the world. As noted above, XDR-TB involves resistanceto the best-known drugs for fighting TB.These newer forms of DR-TB were an isolated and relatively unimportant problem until about 20 years ago. In the past 10 years or so, they havereached epidemic proportions in large areas around the globe. TB resistancewas thought eradicated in the 1950s and R resistance, first described in the1970s, did not become a concern until well into the 1990s. Massive and

4CHAPTER 1often indiscriminate use of R between the 1970s and 1990s gave rise toa truly worrisome situation. The problem is that because they were globally quite rare up until 2000, DR-TB cases were treated at leading centres inresource-rich countries, often according to rather disparate criteria and always with highly individualised clinical management. This individualisedclinical management is by any reckoning insufficient to tackle the DR-TBproblem. We are facing a new epidemic about which much is unknown,and learning to manage it one day at a time. Opportunities for success intreatment depend on the proper clinical and operational management ofthese patients.Lack of evidence in drug-resistant tuberculosis clinical andoperational managementAt this point in time, there is virtually no quality evidence to show that onediagnostic and/or therapeutic approach (i.e., based on randomised clinicalstudies) is better than another. Controversies thus outweigh solid evidencefor the clinical and operational management of these patients. Debatesabound regarding the best approach for dealing with a patient’s res

Mar 22, 2013 · Guidelines for Clinical and Operational Management of Drug-Resistant Tuberculosis 2013 . Role of fi rst-line oral anti-tuberculosis drugs in the management of drug-resistant tuberculosis 101 . come a growing threat to global publ

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