Tuberculosis 2013:basics, burden, impact, challenges,

innovations

Photo: Riccardo Venturi

GLOBAL TB PROGRAMME

Dr Mario RaviglioneDirector, Global TB Programme,

World Health Organization, Geneva, Switzerland

Geneva Journalism & Health Mentoring Initiative

Geneva, 20 May 2013

GLOBAL TB PROGRAMME

Overview

Basics

Burden of TB, TB/HIV, MDR-TB

Impact of interventions, and progress in TB care and control

Vision beyond 2015

Innovations necessary towards elimination

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• Tuberculosis (TB) is one of the oldest diseases of humans• TB is a major cause of death worldwide, it competes with

HIV/AIDS as the greatest killer globally due to a single infectious agent

• TB is also one of the top killers of women worldwide, half a million women died from TB in 2011

• TB is caused by the bacterium Mycobacterium tuberculosis• TB usually affects the lungs, although other organs are

involved in 15-30% of cases • If properly treated, TB caused by drug-susceptible strains is

curable in virtually all cases • If untreated, TB may be fatal within 5 years in 2/3 of cases • One third of world has latent TB infection

Tuberculosis: basics

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Mycobacterium tuberculosis complex: M. tuberculosis, M. bovis, M. microti, M. africanum,M. pinnipedii, M. caprae ( and M. canettii)

Robert Koch discovered the cause of TB 24 March 1882

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How is TB transmitted? ..Via aerosolised particles from infectious patients

TB linked to HIV infection, malnutrition, alcohol, drug and tobacco use, diabetes

Half a million women and over 65,000 children die of TB each year; 10 million “TB” orphans

Migrants, prisoners, minorities, refugees face risks, discrimination & barriers to care

Poor, crowded & poorly ventilated settings

Who carries the burden of tuberculosis?…mostly, the most vulnerable

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Estimated number of cases

Estimated number of deaths

1.4 million*(1.3–1.6 million)

8.7 million(8.3–9.0 million)

Up to 0.5 million

All forms of TB

Multidrug-resistant TB

HIV-associated TB 1.1 million (13%) (1.0–1.2 million)

430,000(400,000–460,000)

Source: WHO Global Tuberculosis Report 2012 * Including deaths attributed to HIV/TB

The Global Burden of TB -2011

Unknown, but probably > 150,000

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Incidence rates, 2011

Highest rates in Africa, linked to high rates of HIV infection~80% of HIV+ TB cases in Africa

Per 100 000 population≥300

150–29950–149

0–2425–49

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TB/HIV co-infection: 80% of burden in Africa

TB leading cause of death in PLHIV

¼ of PLHIV worldwide die due to TB.

PLHIV infected with TB 20-40 times

more likely to develop active TB.

Untreated, TB in PLHIV leads to death

in weeks

80% of all TB/HIV cases are in Africa

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Drug resistant TB: Major challenge

o Multi-drug resistant TB (MDR-TB)

• Second-line drugs, toxic, costly, lengthy

o Extensively drug resistant TB (XDR-TB)

• Almost incurable, fatal

o Drug resistant TB results from inadequate TB care and irrational use of drugs

o New York epidemic in early 90’s – Cost of response: US$ 1 billion

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The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines

for which there may not yet be full agreement. WHO 2012. All rights reserved

Estimated number of MDR-TB Cases, 2011>60% of all cases are in 6 countries

Russian Federation 44,000

(14% of global MDR burden)

India66,000

(21% of global MDR burden)

China61,000

(20% of global MDR burden)

Philippines11,000

(4% of global MDR burden)

Pakistan10,000

(3% of global MDR burden)

South Africa8,100

Based on old survey data

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Spotlight on XDR-TB

Case of Atlanta lawyer with presumed XDR-TB caused international concern

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To date, 84 countries have reported at least one XDR-TB case

About 9% of MDR-TB cases are XDR

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The case of Mumbai and the “TDR-TB outbreak”

Udwadia ZF, Amale RA, Ajbani KK, Rodrigues C. Totally drug-resistant tuberculosis in India. Clin Infect Dis. 2012 Feb 15;54(4):579–81.

The global response: Targets, Global Plan, and Stop TB Strategy

1. Pursue high-quality DOTS expansion

2. Address TB-HIV, MDR-TB, and needs of the poor and vulnerable

3. Contribute to health system strengthening

4. Engage all care providers

5. Empower people with TB and communities

6. Enable and promote research

Goal 6: to have halted by 2015 and begun to reverse the incidence…

2015: 50% reduction in TB prevalence and deaths compared to 1990

2050: elimination (<1 case per million population)

Pursue DOTS Address TB/HIV and

MDR-TB

Strengthen systems

THE WHO STOP TB STRATEGY

Engage all care providers

Empower communities

Promote research

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Incidence

Mortality

Global Progress

51 million patients cured, 1995-2011

20 million lives saved since 1995

2015 MDG and other international targets on track

BUT, TB incidence declining far too slowly, 1/3 of cases not in the system, MDR-TB un-tackled etc.

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Innovating with GeneXpert

WHO endorsement December 2010

Nearly 83 countries using it in March 2013

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WHO GLOBALTB PROGRAMME

The WHO Global TB Programme aims to advance universal access to

TB prevention, care and control, guide the global response to

threats, and promote innovation.

A World FREE of TBVISION:

MISSION:

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What we do: our core functions

Provide global leadership on TB; Develop policies, strategies and standards for TB prevention, care and control; Coordinate technical support to Member States, catalyze change, and build

sustainable capacity; Monitor the global TB situation, and measure progress in TB care, control, and

financing; Shape the TB research agenda and stimulate the generation, translation and

dissemination of valuable knowledge; Facilitate and engage in partnerships for TB action.

ZERO TB DEATHS

VISION

A WORLD FREE OF TB

The TB Elimination Strategy

ZERO TB CASES

ZERO TB SUFFERING

TOWARDS

Universal high-

quality TB care and

prevention

Bold policies and supportive

systems

Intensified research

and innovation

Proposed Pillars and Principles of the Post-2015 TB Strategy

Targets for 2025/2030

Target 1

75%/80% reduction in

deaths due to TB (compared with

2015)

Target 2

40%/60% reduction in TB incidence rate

(compared with 2015)

Target 3

No catastrophic expenditures for families

affected by TB

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CHALLENGES TO “ELIMINATION"?

1. Funding not secure; catastrophic expenditure for the poor

2. Only 2/3 of estimated cases reported or detected (late)

3. TB/HIV major impact in Africa

4. MDR-TB, with high burden in former USSR and China

5. Un-engaged non-state practitioners and communities, and the private sector

6. Weak health policies, systems and services

7. Social and economic determinants maintain TB

8. Research awakening: old diagnostics, drugs and vaccines

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ROADBLOCK 1: Lack of commitment

"…

…"

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ROADBLOCK 2: FundingU

S$ b

illio

ns

Funding gap vs Global Plan ~ US$2–3 billion per yearFunding gaps reported by countries US$0.7 billion in 2013

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Sputum smear microscopyDiscovered 1882

DIAGNOSTIC

1st-line TB drugs Discovered 1943-1970

TREATMENTVACCINE

BCGDeveloped 1920s

ROADBLOCK 3: Today, most used tools for TB control are old and not conducive to elimination

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ROADBLOCK 3: Bedaquiline – First drug in forty years

• Only data from Phase IIb trials available , further efficacy and safety data will be needed from rigorously conducted Phase III trials

• On December 28, 2012, the U.S. Food and Drug Administration approved bedaquiline

• Caution on use • WHO advises that a single drug deemed to

be effective should never be added alone to a regimen to which a patient is not responding to

• WHO has initiated a review process aimed at developing rapid interim guidance on the potential use of bedaquiline for the treatment of MDR-TB.

• Interim guidance from WHO in coming month

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1. For elimination one would need potent short treatments, mass TLTBI and potent pre- and post-exposure vaccines. None is available today

2. Basic research is fundamental to gain further knowledge and R&D pipelines must be expanded , nurtured and well-financed.

3. TB Vaccine development: we need a global coalition of all engaged agencies so that efforts are harmonised and coordinated. This is not a job for one agency only!

4. Increased financial resources for research: keep working together to provide the right messages to investors

ROADBLOCK 3: Research key for elimination

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What is in the pipelines for new diagnostics, drugs and vaccines in 2013?

Diagnostics:₋ 7 new diagnostics or diagnostic

methods endorsed by WHO since 2007;₋ 6 in development; ₋ yet no PoC test envisaged

Drugs:- 1 new drug approved in late 2012, but

probably little impact on epidemiology; - 1 expected to be approved in 2013; - a regimen and other 2-3 drugs likely to be

introduced in the next 4-7 years

Vaccines:₋ 11 vaccines in advanced phases of ₋ development; ₋ 1 just reported with no detectable efficacy

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Roadblock 4: Unregulated private sector

• Private sector is first point of care in many settings

• Diverse network of formal and informal providers ranging from hospitals, corporate sector to the traditional healers and quacks

• Contribution to finding people with TB between 10%-40% in countries

• Collaboration exists but still not enough in many settings. Efforts need to be made on both ends

• Untapped potential• Private sector engagement crucial in

closing the gap on case detection

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Roadblock 5: Taking on the Pharmaceutical Industry

• Lobbying, promotion, economic incentives and infiltration

• Quality differentiation based on level of regulation

• Counterfeit medicines• Drug resistance• BUT, we need them on our side!

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TB crosses borders

How would you increase

the profile of TB?

Question for you ?