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    Future tb research nhung Future tb research nhung Presentation Transcript

    • FUTURE RESEARCH MOVEMENTFOR TUBERCULOSIS CONTROLFUTURE RESEARCH MOVEMENTFOR TUBERCULOSIS CONTROLA/Prof. Nguyen Viet Nhung, MD., PhDVice director, National Lung Hospital, Hanoi, Viet NamDeputy Manager, National Tuberculosis control ProgramVice President, Viet Nam Association against TB and Lung DiseasesRegional Green Light Committee - WHO / WPR
    • Looking beyond 2015:RationaleAt the 65th World Health Assembly in May 2012, Member States called upon WHO todevelop a new post-2015 TB strategy and targets and present this to Member States atthe 67th World Health Assembly in 2014. Some States also urged WHO to start theformal process through the Executive Board and World Health Assembly in 2013.
    • Start DevelopingDraft Global strategyfor TB prevention, treatment and carepost-2015Dr Malgosia GrzemskaStop TB DepartmentWorld Health OrganizationTAG TB/WPROPhnom Penh, Cambodia, 23-25 October 2012
    • Moving towards a new approach:Addressing the most vulnerableHalf a million women andover 70,000 children die ofTB each year; 10 million“TB” orphansPoor, crowded & poorly ventilatedsettingsTB linked to HIV infection, malnutrition,alcohol, drug and tobacco use, diabetesHalf a million women andover 70,000 children die ofTB each year; 10 million“TB” orphansMigrants, prisoners, minorities,refugees face risks, discrimination& barriers to care
    • Moving towards a new approach:Addressing key challengesCase detectionA third of cases notdiagnosed/reportedTB/HIV co infectionSpecial challenge in AfricaMultidrug - resistant TBSpecial challenge in EasternEuropeBottlenecks for financing ofresearch and innovationCase detectionA third of cases notdiagnosed/reportedTB/HIV co infectionSpecial challenge in AfricaMultidrug - resistant TBSpecial challenge in EasternEuropeWeak health policies,systems, financing, andservicesUnder-engagedcommunities andproviders
    • The way forward:Expansion with Innovation• Greater commitment• Active case finding• Molecular diagnosis• Treat all forms of TB• Treatment of latent TB• Research andinnovation• Much greater engagement ofall providers and community• Much stronger system support• Social protection• Whole-of-governmentapproach• Major drive for InnovationMore and BetterStop TB Strategy• (Enhanced and)innovative TBcare/DOTS• Bold policies andsupportive systems• Intensified researchand innovation• Greater commitment• Active case finding• Molecular diagnosis• Treat all forms of TB• Treatment of latent TB• Research andinnovationMore andBetter DOTS• Much greater engagement ofall providers and community• Much stronger system support• Social protection• Whole-of-governmentapproach• Major drive for Innovation• (Enhanced and)innovative TBcare/DOTS• Bold policies andsupportive systems• Intensified researchand innovationPost-2015TB Strategy
    • Proposed three pillarsEstablishing anew post-2015 strategyInnovative TB CareBoldpolicies andsupportivesystems IntensifiedresearchandinnovationWHOandPartnersSupporttocountriesSurveillance,MonitoringandEvaluationIntensifiedresearchandinnovationWHOandPartnersSupporttocountriesSurveillance,MonitoringandEvaluation
    • Innovative TB CareBold policies andsupportive systemsIntensified ResearchVision: A world free of TBDRAFT Post-2015 TB StrategyCORE PRINCIPLES:Government stewardship with adequate financingEngagement of communities and civil society; Collaboration with private sectorPromotion of human rights, ethics and equityAdaptation of the strategy and targets at country levelMonitoring and evaluation across all strategy componentsInnovative TB CareRapid diagnosis and systematicscreening of contacts and otherhigh-risk populationsTreatment of all forms of TB withpatient supportManagement of drug-resistant TB,TB/HIV and other co-morbiditiesPreventive treatment of high-riskpopulationsBold policies andsupportive systemsPolicies pursuing a system-wideapproach for integration of TB care inall health servicesUniversal Health Coverage with freeTB care and social protectionRegulatory framework including vitalregistration, mandatory case-notification, infection control andrational use of quality-assured drugsWhole-of-government approach toaddressing social determinants of TBincluding poverty reduction, foodsecurity, healthy living and workingconditionsIntensified ResearchDiscovery, development and rapiduptake of new diagnostics, drugsand vaccinesResearch to optimizeimplementation and adoptinnovationsSept 2012
    • Six categories ofTB Research1. Epidemiology2. Fundamental research3. Diagnostics4. Treatment5. Vaccines6. Operational andpublic health research1. Epidemiology2. Fundamental research3. Diagnostics4. Treatment5. Vaccines6. Operational andpublic health research
    • 1. Epidemiology– Determine the burden of TB– Understand variations in the dynamics of TB indifferent settings and identify the social andbiological drivers of M. tuberculosis transmissionat population level2. Fundamental research– Characterize human TB by modern biochemical,clinical and epidemiological approaches– Better understand the host–pathogen interaction– Use ‘discovery science’ to identify biomarkersthat can better differentiate the stages of thedisease spectrum.1. Epidemiology– Determine the burden of TB– Understand variations in the dynamics of TB indifferent settings and identify the social andbiological drivers of M. tuberculosis transmissionat population level2. Fundamental research– Characterize human TB by modern biochemical,clinical and epidemiological approaches– Better understand the host–pathogen interaction– Use ‘discovery science’ to identify biomarkersthat can better differentiate the stages of thedisease spectrum.
    • 3. Diagnostics– Evaluate biomarkers identified in fundamentalstudies for use as diagnostic tools– Design and validate a set of tools for diagnosis ofactive drug-sensitive and drug-resistant TB andlatent TB infection that are feasible and applicableat various health-care levels in high-burden settings– Improve existing diagnostic tests for active drug-sensitive and drug-resistant TB and latent TBinfection at various health-care levels in high-burden settings– Evaluate new diagnostic tools, and conductdemonstration studies, followed by evaluation ofthe programmatic impact of all diagnostic tools3. Diagnostics– Evaluate biomarkers identified in fundamentalstudies for use as diagnostic tools– Design and validate a set of tools for diagnosis ofactive drug-sensitive and drug-resistant TB andlatent TB infection that are feasible and applicableat various health-care levels in high-burden settings– Improve existing diagnostic tests for active drug-sensitive and drug-resistant TB and latent TBinfection at various health-care levels in high-burden settings– Evaluate new diagnostic tools, and conductdemonstration studies, followed by evaluation ofthe programmatic impact of all diagnostic tools
    • 4. Treatment– Develop new drugs and treatment strategies– Develop a shorter regimen for drug-susceptible TBthat can be used in combination with HIVtreatment– Develop a safer, more efficacious, shorter regimenfor drug-resistant TB that is compatible with HIVtreatment– Develop safe, reliable, user-friendly drug regimenssuitable for all forms of TB in children andcompatible with HIV treatment– Develop safer, more effective, shorter regimens forTB infected individuals– Develop safer, shorter, highly effective regimensfor drug-susceptible and drug-resistant latent TBinfection that are compatible with HIV treatmentand suitable for children4. Treatment– Develop new drugs and treatment strategies– Develop a shorter regimen for drug-susceptible TBthat can be used in combination with HIVtreatment– Develop a safer, more efficacious, shorter regimenfor drug-resistant TB that is compatible with HIVtreatment– Develop safe, reliable, user-friendly drug regimenssuitable for all forms of TB in children andcompatible with HIV treatment– Develop safer, more effective, shorter regimens forTB infected individuals– Develop safer, shorter, highly effective regimensfor drug-susceptible and drug-resistant latent TBinfection that are compatible with HIV treatmentand suitable for children
    • 5. Vaccines– Conduct fundamental research as a basis for thedevelopment of effective TB vaccines– Conduct research and clinical testing to betterunderstand the safety and efficacy of BCG andcandidate vaccines– Develop standardized assays and findbiomarkers for use in clinical trials to identifycorrelates of protection– Develop new pre- and post-exposure vaccines,new adjuvants and new delivery platforms– Improve and standardize preclinical assays toevaluate immunogenicity and potentialprotective efficacy of new TB vaccines– Improve and standardize testing of TB vaccinesin clinical trials5. Vaccines– Conduct fundamental research as a basis for thedevelopment of effective TB vaccines– Conduct research and clinical testing to betterunderstand the safety and efficacy of BCG andcandidate vaccines– Develop standardized assays and findbiomarkers for use in clinical trials to identifycorrelates of protection– Develop new pre- and post-exposure vaccines,new adjuvants and new delivery platforms– Improve and standardize preclinical assays toevaluate immunogenicity and potentialprotective efficacy of new TB vaccines– Improve and standardize testing of TB vaccinesin clinical trials
    • 6. Operational and public health research– Improve TB case detection and diagnosis– Investigate methods to improve access to treatment and treatmentdelivery for drug-sensitive and drug-resistant TB– Institute sustainable collaboration with all private and publicproviders of TB care and control– Address priority operational research questions at global, regional ornational level to improve implementation of collaborative TB andHIV activities, and also in respect of other diseases or conditions inwhich the risk for TB is increased– Design collaborative activities in other disease programmes orsituations in which TB risk is increased– Investigate methods to encourage community participation, toincrease the effectiveness of all interventions (e.g. case-finding,access to treatment and care delivery)– Optimize infection control to reduce TB transmission– Improve measurement of disease burden by effective surveillance,monitoring and evaluation of TB programmes– Ensure that countries have the capacity to perform TB-relatedoperational research to improve TB programme performance6. Operational and public health research– Improve TB case detection and diagnosis– Investigate methods to improve access to treatment and treatmentdelivery for drug-sensitive and drug-resistant TB– Institute sustainable collaboration with all private and publicproviders of TB care and control– Address priority operational research questions at global, regional ornational level to improve implementation of collaborative TB andHIV activities, and also in respect of other diseases or conditions inwhich the risk for TB is increased– Design collaborative activities in other disease programmes orsituations in which TB risk is increased– Investigate methods to encourage community participation, toincrease the effectiveness of all interventions (e.g. case-finding,access to treatment and care delivery)– Optimize infection control to reduce TB transmission– Improve measurement of disease burden by effective surveillance,monitoring and evaluation of TB programmes– Ensure that countries have the capacity to perform TB-relatedoperational research to improve TB programme performance
    • Five priority areas1. Access, screening anddiagnosis of TB;2. Sustainable collaboration withall care-providers for TBcontrol;3. Prevention of TB in peopleliving with HIV, and jointtreatment of HIV and TB;4. Access to and delivery oftreatment for drug-susceptibleand M/XDR-TB;5. Capacity-building foroperational research.1. Access, screening anddiagnosis of TB;2. Sustainable collaboration withall care-providers for TBcontrol;3. Prevention of TB in peopleliving with HIV, and jointtreatment of HIV and TB;4. Access to and delivery oftreatment for drug-susceptibleand M/XDR-TB;5. Capacity-building foroperational research.
    • KEY FACTS AND MESSAGES ON FUTURE TB RESEARCHGlobal TB Report 2012 - WHO• Develop new TB diagnostics, drugs, and vaccines• WHO has endorsed several new diagnostic testsor methods since 2007, including XpertMTB/RIF that has the potential to transform TBcare. Other new tests, including point- of- caretests, are in development.• 11 vaccine candidates for TB prevention inPhase I or Phase II trials and oneimmunotherapeutic vaccine in a Phase III trial. Itis hoped that one or two of the candidates in aPhase II trial will enter a Phase III trial in thenext 2–3 years, with the possibility of licensing atleast one new vaccine by 2020.• Develop new TB diagnostics, drugs, and vaccines• WHO has endorsed several new diagnostic testsor methods since 2007, including XpertMTB/RIF that has the potential to transform TBcare. Other new tests, including point- of- caretests, are in development.• 11 vaccine candidates for TB prevention inPhase I or Phase II trials and oneimmunotherapeutic vaccine in a Phase III trial. Itis hoped that one or two of the candidates in aPhase II trial will enter a Phase III trial in thenext 2–3 years, with the possibility of licensing atleast one new vaccine by 2020.
    • • 11 new or repurposed anti-TB drugs in clinical trials.– Phase III trials of 4-month regimens for the treatment of drug-susceptible TB are expected in 2013.– 2 new compounds are being evaluated for use as an adjunct tocurrent optimized regimens for MDR-TB; one compound recentlymoved to a Phase III trial and the other is expected to do so beforethe end of 2012.– A new three - drug combination regimen that could be used totreat both drug-sensitive TB and MDR-TB and shortentreatment duration has been tested in a Phase II study of earlybactericidal activity, with encouraging results.• Funding for TB research and development has increased inrecent years, but stagnated between 2009 and 2010. At US$630 million in 2010, funding falls far short of the annualtarget of US$ 2 billion specified in the Global Plan to StopTB 2011–2015.• 11 new or repurposed anti-TB drugs in clinical trials.– Phase III trials of 4-month regimens for the treatment of drug-susceptible TB are expected in 2013.– 2 new compounds are being evaluated for use as an adjunct tocurrent optimized regimens for MDR-TB; one compound recentlymoved to a Phase III trial and the other is expected to do so beforethe end of 2012.– A new three - drug combination regimen that could be used totreat both drug-sensitive TB and MDR-TB and shortentreatment duration has been tested in a Phase II study of earlybactericidal activity, with encouraging results.• Funding for TB research and development has increased inrecent years, but stagnated between 2009 and 2010. At US$630 million in 2010, funding falls far short of the annualtarget of US$ 2 billion specified in the Global Plan to StopTB 2011–2015.
    • Lead OptimizationPreclinicalDevelopmentGLPTox.Phase I Phase II Phase IIIDelamanid (OPC-67683)GatifloxacinMoxifloxacinRifapentineAZD5847Bedaquiline (TMC-207)LinezolidNovel Regimens2PA-824RifapentineSQ-109Sutezolid (PNU-100480)CPZEN-45DC-159aQ201SQ609SQ641Preclinical DevelopmentDiscovery1Clinical DevelopmentDiarylquinolineDprE InhibitorsGyrB inhibitorsInhA InhibitorsLeuRS InhibitorsMGyrX1 inhibitorsMycobacterial GyraseInhibitorsPyrazinamide AnalogsRiminophenazinesRuthenium (II) complexesSpectinamidesTranslocase-1 InhibitorsGlobal TB Drug PipelineBTZ043TBA-354AZD5847Bedaquiline (TMC-207)LinezolidNovel Regimens2PA-824RifapentineSQ-109Sutezolid (PNU-100480)CPZEN-45DC-159aQ201SQ609SQ641DiarylquinolineDprE InhibitorsGyrB inhibitorsInhA InhibitorsLeuRS InhibitorsMGyrX1 inhibitorsMycobacterial GyraseInhibitorsPyrazinamide AnalogsRiminophenazinesRuthenium (II) complexesSpectinamidesTranslocase-1 InhibitorsChemical classes: fluoroquinolone, rifamycin, oxazolidinone, nitroimidazole, diarylquinoline, benzothiazinone1 Ongoing projects without a lead compound series can be viewed at http://www.newtbdrugs.org/pipeline-discovery.php.2 Combination regimens: first clinical trial (NC001) of a novel TB drug regimen testing the three drug combination of PA-824,moxifloxacin, and pyrazinamide was initiated November 2010 and completed in 2011 with promising results. The secondclinical trial (NC002) of this regimen was launched in March 2012 and will test the efficacy of the regimen in drug-sensitiveand multidrug-resistant patients. The third clinical trial (NC003) will evaluate PA-824, TMC-207, pyrazinamide andclofazimine in combinations and is scheduled to begin September 2012.Updated: June 18, 2012www.newtbdrugs.org4 Repurposed Drugs6 New Drugs3 New ClassesDrugs currently in the regulatoryreview processDrugs currently in the regulatoryreview process
    • • TB Diagnosis– Techniques– Approach• Treatment– Drugs / Regimens– Delivery Management• Prevention– Infection control– Vaccination– Preventive therapy• Specific categories– Smear negative– TB/HIV– Pediatric TB– M/XDR TB• Research Partnership• TB Diagnosis– Techniques– Approach• Treatment– Drugs / Regimens– Delivery Management• Prevention– Infection control– Vaccination– Preventive therapy• Specific categories– Smear negative– TB/HIV– Pediatric TB– M/XDR TB• Research Partnership
    • Acknowledgements• WHO/Stop TB Department:• Diana Elizabeth Weil, Malgosia Grzemska, Mukund Waman Uplekarand group for developing a New TB control Strategy post 2015• Christian Lienhardt and GROUP in development of the “AnInternational Roadmap for Tuberculosis Research” and “Prioritiesin Operational Research to Improve Tuberculosis Care and Control”• WHO/WPRO: Catharina Van Weezenbeek• NTP Viet Nam: Dinh Ngoc Sy and staff• WHO/Stop TB Department:• Diana Elizabeth Weil, Malgosia Grzemska, Mukund Waman Uplekarand group for developing a New TB control Strategy post 2015• Christian Lienhardt and GROUP in development of the “AnInternational Roadmap for Tuberculosis Research” and “Prioritiesin Operational Research to Improve Tuberculosis Care and Control”• WHO/WPRO: Catharina Van Weezenbeek• NTP Viet Nam: Dinh Ngoc Sy and staff
    • Togetherfor a World free of TB !THANKS YOUFOR YOUR ATTENTIONvietnhung@yahoo.com