Edward Nardell, MD Brigham & Womens Hospital Division of Global Health Equity Pulmonary Division...

Edward Nardell, MD

Brigham & Women’s HospitalDivision of Global Health Equity

Pulmonary Division

Harvard Medical SchoolHarvard School of Public Health

Partners In Health

Annual New England Clinicians ConferenceNewport, Rhode Island

May 1, 2010

Can the Global MDR/XDR TBEpidemic be Controlled?

Importance

• More than 50 of US cases are foreign-born• Global TB problem is our TB problem• As global MDR epidemic escalates, more

foreign-born MDR/XDR cases will inevitably be seen here.

• International travel exposes tourists and students, and especially humanitarian and medical workers to the risk of MDR/XDR transmission.

“Stemming the Tide of Multidrug Resistant TB:Major Barriers to Addressing the Growing Epidemic”

• A White Paper for the Institute of Medicine of the National Academies – November, 2008– Harvard Medical School

– Partners in Health

– Brigham & Women’s Hospital

Lead authors: Salmaan Keshavjee, MD, PhD

Kwonjune Seung, MD

IOM Workshop (11/5/08) and Report

• IOM Report: “Addressing the Threat of Drug-resistant Tuberculosis: A Realistic Assessment of the Challenge”

• Key issues addressed:1. Limitations of global TB estimates2. Role of HIV in MDR spread3. Importance of Transmission Control4. Limited diagnostic capacity5. Low rates of treatment6. Bottleneck in the procurement and distribution of high

quality drugs7. The need for new TB drugs

The Problem

• 500,000 new MDR-TB cases per year– At least 1.5 million (est.) prevalent cases

• WHO Global Plan to Stop TB: 2006-2015– 800,000 people with active MDR-TB to be treated by 2015– Revised goal stimulated by XDR concern

• Universal access to MDR-TB treatment• Treat 1.6 million cases by 2015

– ONLY 10% cases currently being treated, and only 22,000 (1.5%) have ever been treated (since 1996) with quality assured drugs under the Green Light Committee (GLC) mechanism.

The 4th Global Report on anti-TB drug resistance in the world

11683

330

50

100

150

200

Total countries 4th report Never previously reported

India

Russia

China

Kenya

Uganda

DR Congo

Indonesia

South Africa

Ethiopia

Philippines

Viet Nam

Tanzania

Brazil

Thailand

Nigeria

Bangladesh

Pakistan

Afghanistan

Mozambique

Myanmar

Zimbabwe

CambodiaSub-national data available

Nationwide data available

No survey data

0.0 5.0 10.0 15.0 20.0 25.0

Dominican Republic*

Georgia

Heilongjiang Province, China

Inner Mongolia Autonomous Region, China

Henan Province, China

Orel Oblast, RF

Armenia

Lithuania

Liaoning Province, China

Latvia

Ivanovo Oblast, RF*

Mary El Oblast, RF

Estonia

Kazakhstan*

Tashkent, Uzbekistan

Tomsk Oblast, RF

Donetsk Oblast, Ukraine

Republic of Moldova

Baku City, Azerbaijan

Indicates survey data reported in an earlier phase of the project

19 settings with ≥ 6% MDR among new cases,1994-2007

MDR-TB among new and previously treated cases, 1994- 2007

0.0 10.0 20.0 30.0 40.0 50.0 60.0

Heilongjiang Province, China

Inner Mongolia Autonomous Region, China

Henan Province, China

Orel Oblast, Russian Federation

Armenia

Lithuania

Liaoning Province, China

Latvia

Ivanovo Oblast, Russian Federation*

Mary El Oblast, Russian Federation

Estonia

Kazakhstan*

Tashkent, Uzbekistan

Tomsk Oblast, Russian Federation

Donetsk, Ukraine

Republic of Moldova

Baku City, Azerbaijan

* Sub-national coverage in India, China, Russia, Indonesia.

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 2006. All rights reserved

MDR-TB among new TB cases, 1994-2007

< 3%

3-6 %

> 6 %

No data




MDR-TB among previously treated TB cases, 1994-2007

< 6%

6 - 20%

20 - 40 %

No data

>40 %

Eastern Europe, 16.4%

Africa high HIV incidence, 11.9%

Latin America, 2.5%

Eastern Mediterranean Region, 5.2%

Central Europe, 0.2%

Established Market Economies, 0.3%

South-east Asia, 30.6%

Western Pacific Region, 31.2%

Africa low HIV incidence, 1.7%

489,000 (95% CI: 455,000 - 614,000)

4.8% of all cases (95% CI: 4.6% - 6.0%)

Estimated MDR TB incident cases by region,2006

Trends: scenario I

TB notification rate

0.00

0.01

0.02

0.03

0.04

1994 1996 1998 2000 2002 2004 2006

MDR-TB among all TB cases

Any INH resistance among all TB cases

0.00

0.05

0.10

0.15

0.20

1994 1996 1998 2000 2002 2004 2006

0

25

50

75

100

125

150

1995 1997 1999 2001 2003 2005

Hong Kong, SAR 1995-2006

Trends: scenario II

5375

50 53 64 51 51 42

0

50

100

150

200

250

300

350

400

450

1998 1999 2000 2001 2002 2003 2004 2005

71 86 83 99 95 80 114

91

0

100

200

300

400

500

600

700

800

900

1000

1998 1999 2000 2001 2002 2003 2004 2005

64 61 75 84 86 104 12

7

0

100

200

300

400

500

600

700

800

900

1000

1999 2000 2001 2002 2003 2004 2005

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

1997 1999 2001 2003 2005

p=0.0169

New cases tested, New MDR % MDR among new

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

1997 1999 2001 2003 2005

p=0.6213

0

10

20

30

40

50

60

70

80

90

100

1997 1999 2001 2003 2005 2007

Latvia

0

10

20

30

40

50

60

70

80

90

100

1997 1999 2001 2003 2005

Lithuania

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

1997 1999 2001 2003 2005

p=0.3260


0

10

20

30

40

50

60

70

1997 1999 2001 2003 2005 2007

Estonia

Trends: scenario III

0.00

0.01

0.02

0.03

0.04

0.05

0.06

0.07

1995 1997 1999 2001 2003 2005 2007

0.00

0.10

0.20

0.30

0.40

0.50

0.60

0.70

1995 1997 1999 2001 2003 2005 2007

% MDR-TB among new cases

% Any INH resistanceamong new cases

Peru 1996-2005

0

50

100

150

200

1995 1997 1999 2001 2003 2005 2007


Trends: scenario IV

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

1997 1999 2001 2003 2005

p=0.0068

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

1997 1999 2001 2003 2005

p=0.00552748 57 73 59

95 77

0

100

200

300

400

500

600

1999 2000 2001 2002 2003 2004 2005


10 11 19 23 28

0

50

100

150

200

250

300

350

400

1999 2000 2001 2002 2003 2004 2005 20060

20

40

60

80

100

120

1998 2000 2002 2004 2006

Orel Oblast

0

20

40

60

80

100

120

1998 2000 2002 2004 2006

Tomsk Oblast

New DST, New MDR % MDR among new

The Pathogen is Changing: Emergence of aggressive Beijing strains

• In South Korea, aggressive Beijing strains comprise >90% of new cases.(Cliff Barry, MD)

• Some strains show a propensity toward acquiring drug resistance.




XDR-TB among MDR-TB cases, 2002-2007

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< 3% or less than 3 cases in one year of surveillance

3 - 10%

> 10%

No data

Report of at least one case

MDR-TB & HIV in the 4th DRS Report

MDRAny

resistanceDR in HIV unknownTB cases

(%)DR in HIV positive

TB cases (%)

Odds Ratio 2.1 1.5

(95% CL) (1.4 to 3.0) (1.1 to 2.1)p value < 0.01 < 0.05

765/5,162 (14.8)

1,782/5,162 (34.5)

39/148 (26.4)

66/148 (44.6)

MDRAny

resistanceDR in HIV negative TB cases

(%)DR in HIV positive

TB cases (%)

Odds Ratio 1.5 1.4

(95% CL) (1.1 to 2.0) (1.1 to 1.8)p value < 0.01 < 0.05

272/1,143 (23.8)

551/1,143 (48.2)

97/307 (31.6)

173/307 (56.4)

Latvia, 2001-2005 Donetsk, Ukraine, 2006

Resistance patterns (n=243)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

inh rif emb pza sm km cm ethio fq cs

not tested

sensitive

resistant

Anti-tuberculosis medications received in individualized treatment regimens (N=244)

Medication* (daily doses, unless specified)N %

H (300 mg, 900 mg biweekly) 5 2.

R (600 mg) 0 0

E (15-20 mg/kg) 63 26

Z (20-30 mg/kg) 178 73

S (1000 mg, 15 mg/kg) 0 0

KM (1000 mg, 15 mg/kg) 114 47

CM (1000 mg, 15 mg/kg) 154 63

AMK (1000 mg, 15 mg/kg) 2 1

Fluoroquinolone (CPX 1500 mg, OFX 800 mg, LFX 500 mg) 241 99

CS (500-1000 mg) 243 99.6

Ethio / prothio (500-1000 mg) 184 75

PAS (8 mg) 217 89

Amox-Clav (1500-2000 mg) 20 8

Rifabutin (300 mg) 4 2

LEGEND:H isoniazid, R rifampin, E ethambutol, Z pyrazinamide, S streptomycin, KM kanamycin, CM capreomycin, AMK amikacin, CS cycloserine, CPX ciprofloxacin, OFX ofloxacin, Ethio ethionamide, Prothio prothionamide, PAS para-aminosalicylic acid, Amox-Clav amoxacillin-clavulanate)

Most patients received ofloxacin as their fluoroquinolone

• Median time in treatment : 18.5 months [range 1.0 to 42.4]

• Median duration of injectable drug: 8.6 months [0-27.5]

• Experienced at least one adverse event: 73.3%

• Event resulted in permanent discontinuation of a drug: 28.7%

• Regimen included: parenteral agent, FQ, PAS, prothio/ethio, CS

• Median number of drugs: 6 [range 4-7]

• Baseline comorbid conditions: 28.3%

Patient Demographics (n=244)

Characteristics of MDR-TB patients (n=244)

Characteristic (N, if not 244)Frequency (%)

Median (range)

Number of patients who received surgery Thoracoplasty Segmental resection (one or more) Lobectomy Pneumonectomy

24 (9.8)45141

Percent missed doses* 5% [0, 45%]

Time to culture conversion in months (n=218)

2 [1, 18]

Duration of therapy in months All patients Cures Failures Deaths Defaults

18.5 [1.0, 42.4]18.8 [16.1, 42.4]18.9 [10.1, 28.1]10.9 [1.8, 22.9]9.2 [1.0, 15.7]

* Defined as the percent of doses among all prescribed doses missed throughout DOTS-Plus treatment, as recorded on the treatment administration forms

Summary of adverse events, N=244

0

10

20

30

40

50

60

70

80

Nause

a an

d vo

mitin

g

Arthra

lgia

Diarrh

ea

Hypok

alem

ia

Hypot

hyro

idism

Hepat

otox

icity

Rash

Ototo

xicity

Psych

osis

Seizur

e

Nephr

otox

icity

Depre

ssion

Neuro

path

y

Adverse Event

% o

f p

ati

en

ts

TREATMENT OUTCOMES (N=244)

Cure77.0%

Failure6.6%

Death4.9%

Default11.5%

Barriers to Large Scale Effective Treatment

1. Diagnostic capacity - extremely limited- True point of care testing non-existent

2. Drug supply - limited quality-assured second-line drugs even for the 2% being treated under GLC mechanism

- Exacerbated by limited demand for quality-assured second-line drugs in high MDR burden countries

3. MDR-TB not integrated into NTP - “pilot program” mentality ≠ universal access

Barriers to Large Scale Effective Treatment

4. Technical assistance – inadequate – not long-term to build capacity

5. Transmission control – non-existent in congregate settings

Transmission Risk

• Unsuspected, inadequately treated cases– In 3 separate guinea pig exposure studies nearly all

infections were due to drug resistant cases that were unsuspected and therefore on inadequate treatment.

Transmission stopped for 4 months: Treated drug susceptible patients – Study 1

GP infections stoppedwhen drug susceptiblepatients on treatment were introduced, and resumed when drug resistant cases were admitted.

Number of exposed GPs

Importance of Transmission in TomskGlemanova, et al., Bull WHO, 2007; 85:703-711.

• Retrospective study of the role of non-adherence and default and the acquisition of multidrug resistance

• Substance abuse was a strong predictor of non-adherence (OR 7.3 (2.89-18.46)– But non-adherence NOT associated with MDR-TB

• MDR-TB occurred among adherent patients who had been hospitalized in the course of therapy compared to those treated as out-patients– OR 6.34 (1.34 – 29.72) – began treatment in hospital– OR 6.26 (1.02 – 38.35) – hospitalized later during treatment

IOM White Paper Recommendations

• Diagnostics– Sustainable funding for building lab capacity in-country for

DST/rapid testing with external QA– Technical assistance – long-term on-site – Laboratory networks in-country- specimen transport, data

management, coordination and certification of private laboratories

• Use of excess laboratory capacity in wealthy nations while poor nations build capacity

– Research – point of care testing, ie, a dipstick as used for HIV, 99% sensitive and costs $1 – revolutionized HIV treatment.

Recommendations

• Drug supply– WHO and partners to stimulate number of manufacturers of quality

assured second-line drugs– Availability at pre-negotiated prices via the GDF and through direct

purchase by countries– GDF should streamline approval of manufactures as they progress

through WHO Essential Drug Monitoring (EDM) prequalifying process – allowing large countries to purchase QA drugs in-country

– GLC should institute a transparent system to quantify demand for second-line drugs

– GDF should maintain a buffer stock of drugs for 5,000 patients for rapid delivery.

– Research to optimize current regimens and develop at least 3 new TB drugs with fast-track through the regulatory process

Recommendations

• Treatment Delivery– Universal treatment of MDR TB side-by side with drug

susceptible TB and integrated with current HIV treatment initiatives.

– Technical assistance – needs to be long-term regional assistance – regional centers of excellence

– Community-based ambulatory MDR treatment in collaboration with private doctors and laboratories.

– Transmission control – fully integrated into NTP programs with resources, training, and implementation strategies and monitoring

– PEPFAR and other large global initiatives need to prioritize MDR TB treatment. GFATM and UNITAID have done so.

• Impact of vertical programs on other programs.

PEPFAR Approach

• US President’s Emergency Plan for AIDS relief (PEPFAR)– Substantial funding: up to $7 billion in FY 2011 budget– Supply chain management for forecasting demand and delivering

drugs, fast tracked FDA approval of ne w and generic ARVs, fostered community-based treatment, invested in laboratory surveillance, transport and reporting, with specific performance targets

• Downside: Local health infrastructure often inadequate and further strained by well-funded, focused programs– Training takes ½ staff out of the clinic in Malawi (Keith Joseph, MD)– Fewer HCWs available for other programs

• Huge HR problem in high MDR regions

• Health system strengthening is an essential part of the solution, but no small undertaking.

The short term prognosis is not good

Edward Nardell, MD Brigham & Womens Hospital Division of Global Health Equity Pulmonary Division...

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