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Global Management and Definitions for Tuberculosis in 2019

Learn about the evolving definitions and strategies in TB management to combat the global burden of the disease. Explore the latest estimates and innovations critical to ending the TB epidemic.

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Global Management and Definitions for Tuberculosis in 2019

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  1. Evoluzione delle definizioni per la gestione della tubercolosi Marina Tadolini Clinica di Malattie Infettive – Prof. Viale Dipartimento di Scienze Mediche e Chirurgiche Alma Mater Studiorum Università di Bologna in collaborazione con GB Migliori WHO Collaborating Centre for TB and Lung Disease, Maugeri Institute, IRCCS Tradate, Italy GTN (Global Tuberculosis Network)

  2. The Global Burden of TB, latest estimates 2017 Estimated number of cases Estimated number of deaths • 10 million (133 per 100,000) • 6.4 million males • 3.6 million females • 1 million children All forms of TB • 1.6 million* • 1 million in males • 0.6 million in women • 0.23 in children * Including deaths attributed to HIV/TB HIV-associated TB 0.9 million (9%) 300,000 Multidrug-resistant TBMDR/RR-TB 230,000 558,000 Latently infected 1.7 billion Source: WHO Global Report, 2018

  3. TB is in every countryHighest incidence rates in Africa and parts of Asia Source: WHO Global Report, 2018

  4. Top 10 Causes of Deaths Globally, 2016 (N= 56.9M)

  5. Estimates of TB disease burden 2000–2017 Peak of the epidemic 10m 1.3m 6.4m 0.3m 0.9 m Falling 1.4% per year (2000-2015). 18% drop between 2000 and 2015 47% decline between 1990 and 2015

  6. Innovations and Research are critical to break the trajectory of the TB epidemic • Better diagnostics, including new point-of care tests; • Safer, easier and shorter treatment regimens; • Safer and more effective treatment for latent TB infection; • Effective pre- and post-exposure vaccines.

  7. EndTB targets will not be achieved…if we only address active TB

  8. TUBERCULOSIS INFECTION IS A SPECTRUM Pai M et al, Clin Microbiol Rev2014; 27: 3-20

  9. Esmail et Al, The ongoingchallenge of latenttuberculosis, 2015

  10. Esmail et Al, The ongoingchallenge of latenttuberculosis, 2015

  11. Methodology No Xpert MTB/RIF Xpert MTB/RIF

  12. Global status of national TB prevalence surveys since 2007

  13. Many TB cases don’t report symptoms meeting criteria for presumptive TB 30 40 50 60 70 80 Proportion symptom screening negative and CXR positive

  14. Houben et Al. Spotting the oldfoe: revisiting the case definition for TB, Lancet RespirMed 2019

  15. Future testsshould…

  16. MDR-TB e XDR-TB MDR TB = Strains resistant to at least INH and RIF (most important 1st-line drugs) XDR TB = MDR TB strains with additional resistance to any fluoroquinolone and any of the 3 injectable second-line drugs (amikacin, kanamycin, capreomycin)

  17. Drug-resistant TB is in every country it has been measured (report 2018)

  18. MDR/RR-TB: 3 countries, almost 50% cases

  19. MDR-TB treatment (until August 2018) • Longer regimen (20-24 months) i.e. 8 FQ-Am-Cs-Eth-Lzd-Z/12 FQ-Cs-Eth-Lzd-Z • Shorter regimen (9-12 months) 4-6 Km-Mfx-Pto-Cfz-Z-Hhigh-dose-E / 5 Mfx-Cfz-Z-E

  20. Oneday of MDR-TB treatment

  21. Bedaquiline Pretomanid Delamanid

  22. Programmatic use of BQ in high and lowburdencountries Questions: Effectiveness? Safety? Borisov et At, Effectiveness and safety of bedaquiline-containingregimens in the treatment of MDR- and XDR-TB: a multicentrestudy, ERJ 2017

  23. Treatment success in the cohortsstarting BQ treatment before 31 Dec 2014: success ~77%!! Borisov et At, Effectiveness and safety of bedaquiline-containingregimens in the treatment of MDR- and XDR-TB: a multicentrestudy, ERJ 2017

  24. Safety of BQ BQ interrupted for AE: 25/428 cases (5.8%) Borisov et At, Effectiveness and safety of bedaquiline-containingregimens in the treatment of MDR- and XDR-TB: a multicentrestudy, ERJ 2017

  25. ERJ 2017

  26. NEWS: BQ replacinginjectables in South Africa!! (June 2018)

  27. Revised second line drugs clasisfication

  28. Revisedlonger/individualized treatment regimen: • Kanamycin and capreomycin are no longer in the regimen to treat MDR/RR-TB;  • Bedaquiline and linezolidhavebeenupgraded and prioritized;  • Alloral

  29. Time to revise definitions?

  30. Lange et Al, Lancet RespMed, April 2018

  31. Global TB Network (GTN)(hosted by WAidid) World Association for InfectiousDiseases and ImmunologicalDisorders

  32. GB Migliori and GTN, CID, Nov 2018

  33. GB Migliori and GTN, CID, Nov 2018

  34. GB Migliori and GTN, CID, Nov 2018

  35. Treating M/XDR-TB is difficult!

  36. Global TB Consilium • Officiallaunch: October 2018 • Call for experts (closed on November 16, 2019): more than 30 applicationsreceived • 33 difficult-to-treatcasessubmittedas of March 2019 • Most common questions: management of MDR/XDR-TB cases, use of new drugs, management of pediatriccases • Workingthrough e-mail at the moment • Electronic platform under development

  37. The Global TB Consilium principles: Case reviewing • Target time for full review: 2-3 days

  38. Ifyouneed help tbconsilium@gmail.com Grazie per l’attenzione!

  39. DLM: 112 cases in addition to ‘Otsuka trials’

  40. Natural history of tuberculosis: the basis Largelyendogenous • Performance of cell-mediatedimmunity • Medical conditions: HIV/AIDS, diabetes, malnutrition, use of steroids or TNF-a inhibitors, tobacco-relatedlungdisease, alcohol abuse, etc. Largelyexogenous • Particles/volume x exposure time • Production of infectious droplets • Clearance of air Poverty, poor living conditions, malnutrition, inequities Risk Factors Risk Factors Risk Factors Risk Factors Linked to access: Failed or late diagnosis, inadequate treatment, type of TB, co-morbidities InfectiousTuberculosis Latent (sub-clinical)Infection Death Exposure Non-infectiousTuberculosis 1.6 M / yr 1.7 billion 10 M / yr

  41. TB Case definition

  42. Primary objective Bacteriologically-confirmed Pulmonary TB 15 years of more

  43. What is measured in a national TB prevalence survey? Susceptible population Cured Prevalent TB “Self-cure” Death

  44. Choosing the treatment regimen in patients with confirmed MDR/RR-TB • Confirmed resistance or suspected ineffectiveness to a medicine in the shorter MDR-TB regimen (except isoniazid resistance) • Exposure to >1 second-line medicines in the shorter MDR-TB regimen for >1 month • Intolerance to >1 medicines in the shorter MDR-TB regimen or risk of toxicity (e.g. drug-drug interactions) • Pregnancy • Extrapulmonary disease • At least one medicine in the shorter MDR-TB regimen not available NO YES FAILING REGIMEN, DRUG INTOLERANCE, RETURN AFTER INTERRUPTION >2 MONTHS, EMERGENCE OF AN EXCLUSION CRITERION Shorter MDR-TB regimen Longer (individualized) MDR-TB regimens

  45. Treatment outcome per area: success 10% lower in Africa Borisov et At, Effectiveness and safety of bedaquiline-containingregimens in the treatment of MDR- and XDR-TB: a multicentrestudy, ERJ 2017

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