Global Plan to STOP TB: Diagnostics WG

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Global Plan to STOP TB Diagnostics WG

• Jane Cunningham
• Medical Officer WHO/TDR/PDE
• Secretariat STOP TB Diagnostics Working Group

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The Global Plan Process.

• Planning workshop in Montreux Switzerland
  attended by the WG chair, secretariat and the WG
  Chair appointed focal point, Heidi Albert, Biotec
  Labs.
• The aim was to model the collective impact of
  proposed WG activities, assess whether the impact
  would be sufficient to meet the global TB targets
  for 2015, and estimate the costs involved

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The Global Plan Process.

• 1 --- Understand the MODEL !!!
• 2--- Teach modelers about DIAGNOSTICS !!!
• 3 -- Estimate costs for RD and
  implementation of diagnostics that don't exist
  !!!

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MODEL INPUTS - CONSTANTS          
constants symbol        
  HIV neg values used HIV pos values used values used
time step (yr) dt 1      
infectious contacts/person/yr b 11.0 bh 11.0  
reactivation rate/person/yr v 0.000113 vh 0.2  
proportion infections leading to progessive primary disease f 0.15 fh 0.7  
proportion active cases sm s 0.45 sh 0.3  
proportion infected persons susceptible to reinfection x 0.35 xh 0.75  
natural recovery rate from TB/patient/yr rec 0.065 rech 0.00  
background death rate/person/yr u 0.015 uh 0.15  
TB (ss) death rate/patient/yr ui 0.15 uih 0.25  
TB (ss-) death rate/patient/yr uin 0.070 uinh 0.25  
TB death rate post treatment ut 0.00      
relapse F to I ret 0.000 reth 0.00  
relative infectiousness F rel 0.00      
hiv scale hivsc 1.00      
efficacy IPT for HIV (TST)     eipt 0.4  
efficacy ARTCPT     eart 0.4  
efficacy CPT     ecpt 0.6  
           
  eqm 0   2006-2015  
DOTS DOTS (-2005) 1 cases m 22.770  
Enhanced DOTS DOTS (2006-) 0 HIV cases m 12.030  
HIV epidemic hiv 1      
ICF icf 0 deaths m 7.6780  
ART or CPT artcpt 0 HIV TB deaths m 4.3242  
CPT only cpt only 0      
IPT ipt 0 cost bn 11.384  
Vaccine vac 0 cost TB-HIV bn 0.788  
mdr epidemic mdr 0      
DOTS mdrt 0      
           
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Mechanisms
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The Global Plan Process.

• 1 --- Understand the MODEL !!!
• 2--- Teach modelers about DIAGNOSTICS !!!
• 3 -- Estimate costs for RD and
  implementation of diagnostics that don't exist
  !!!

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Sensitivity (HIV, pulm, e-p) smcases averted
overtreatment averted
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Targets for Test Introduction Leading to
Sustainable Adoption 2006-2015
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Working Group and Secretariat Strategic Plans

• In October 2004, the Coordinating Board asked
  each WG (plus the Partnership Secretariat) to
  provide by the end of April 2005 its draft
  strategic plan of activities and budgets
  necessary to contribute to achieving the 2015
  global TB control targets.
• 1st draft circulated in April/May 2005
• Final version September 2005

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Highlights of the Strategic Plan

• Vision to develop and introduce cost-effective
  and appropriate new diagnostic tools that are
  accessible to patients and will contribute
  towards improved control of the global TB
  epidemic and improve the quality of patient care.
  
• Ideal toolbox would contain diagnostic
  technologies, all of which perform equally well
  in HIV-infected subjects, to
• improve TB case detection both through high
  sensitivity/specificity and improved
  accessibility simple, accurate, inexpensive,
  same day, near-patient products are the ultimate
  goal
• rapidly and inexpensively identify drug resistant
  TB disease, enabling timely effective patient
  treatment to reduce both individual morbidity and
  continuing transmission
• reliably identify latent TB infection and define
  the risk of future progression to active disease,
  enabling rational use of preventive therapy in
  appropriate subjects

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Objectives

• OBJECTIVE 1 Address existing knowledge gaps
  obstructing development of new diagnostic tools
• OBJECTIVE 2 Development and evaluation of a
  portfolio of new diagnostic tools and
  demonstration of impact
• OBJECTIVE 3 Implementation of new diagnostic
  tools and ensuring access

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TB Diagnostics Development Pipeline 2005
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Objective 1 Targets Indicators

• Discovery science to identify new markers (also
  in HIV-infected subjects) with improved
  discriminative power for active disease (may be
  antigenic, immunological, proteomic or other) and
  drug resistance
• Indicators of grants publications
  targets/reagents, new technologies, sample
  requests from reference banks

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Objective 2 Targets Indicators

• Inclusion of related goals in research funding
  calls by major funding agencies
• Public sector product development agreements with
  industry
• Coordinated evaluation and demonstration projects
• Indicators of - funding opportunities Product
  Development agreements with industrial partners
  successfully completed Development and Technical
  Evaluations according to Product Specifications
  clinical evaluation and demonstration sites
  developed and authorized peer-reviewed
  publications reporting results from evaluation
  projects

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Targets for Test Introduction Leading to
Sustainable Adoption 2006-2015
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Objective 3 Targets Indicators

• Operational studies to demonstrate
  epidemiological and economic impact of new tools
  in high-burden settings
• Accelerated registration of products with proven
  utility
• National and international policy changes
  reflecting impact evidence on new diagnostics
• Creation of demand through communication to
  stakeholders (NTPs, MOH, technical and funding
  agencies.)
• Ensured access to proven technologies through
  inclusion in GDF or other procurement mechanisms
• Key Indicators of NTPs with new diagnostics in
  policy recommendations and implemented at
  district, local and point of care
• Modeling studies ---- FIND Symposium October
  21,2005

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Key Risk Factors

• Insufficient financial investment and timing of
  investment
• Technologies Fail
• Inadequate development of laboratory
  strengthening
• Impaired access to new products
• Interrupted product supply

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Acknowledgements Heidi Albert David Moore
Mark Perkins Afranio Kritski Ruth
McNerney Arend Kolk Chris Dye Andrea Pantoja
Bernadette Bourdin