NTP Presentation

8/10/2019 NTP Presentation

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Introduction to the National TB

program in Georgia:

current status, challenges and

future prospective

National Center for TB and Lung

Diseases


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TB Epi-Snapshot

Georgia is one among 27 high MDR-TB burden countries

In 2013:

TB prevalence: 96 cases per 100,000

TB incidence (new and relapse): 76 cases per 100,000

Case detection rate (all forms) 78%

Laboratory-confirmed MDR-TBprevalence 11.2%among new and

38%among retreatment cases

Treatment success rate in 2012 for new and relapse cases excluding

those moved SLD treatment - 85%

Treatment success rate for M/XDR-TB in 2011 cohort50%

NTP Data Base. Global TB Reports


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Notified TB cases(absolute numbers)

66126435

5926

63656073

5862

6448 6311

5911 5836 5982

57965536

4975

43204476 4393

3900

43784096

3819

4244 42834063 4148

4458 43834226

3779

3133

2136 2042 2026 1987 1977 2043 2204

20281848

16881524 1413 1310 1196 1187

0

1000

2000

3000

4000

5000

6000

7000

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

All cases New cases Re-treated cases



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TB in adults (15+ age-group) and children (0-14 age-

group)(per 100,000)

142,1153,6 159

170,3154,6 155,7 150

127,7

111

88,8

61,849

60,2

43,6 45,335,838,1 33,6

27,128,2

24,50

20

40

60

80

100

120

140

160

180

Adults Children

4NTP Data Base. Global TB Reports


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new

cases, 1.0

all cases, 2.3

0

1

2

3

4

5

6

%

TB in prisons(per 100 prisoner)



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84

6,1 4,4 2,2 3,3

0

1020

30

40

50

60

70

80

90

Treatment success

Lost to follow-up

Failure

Died

Unknown

1stline treatment outcomes of the new pulmonary

bacteriologically confirmed TB cases

(2012 cohort, %)


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6,8% 6,8% 6,4%

11,3% 10,2% 9,5% 10,9% 9,2% 11,2%

27,4% 26,4%

32,0%

40,3%

31,1% 31,4% 31,7% 31,2%

38,1%

0,0%

10,0%

20,0%

30,0%

40,0%

50,0%

DRS 2006 2007 2008 2009 2010 2011 2012 2013

New TB Cases Re-treated TB Cases

Drug Resistance Surveillance(DRSDrug Resistance Survey conducted between July 2005 and June 2006)

MDR-TB prevalence, pulmonary cases



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DRSStudy (2005-2006)

revealed that:

6.8%among new and

27.4% among re-

treatment TB cases hadMDR-TB;

Independent Risk

Factors for MDR-TB:

Previous TB Treatment

OR=5.47 (95%CI, 3.86-

7.72), p


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Co-infectionTB/HIV

(%)

3,2 2,82,1

3,8

3,1

1,9

2,6

3,4

1,3

2,31,7

21,7

2,1

0

1

23

4

20

00

20

01

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

TB-HIV %

3,9

2,5

5,3 5,3

0

1

2

3

4

5

6

2010 2011 2012 2013

MDR-TB/HIV %



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Co-infectionTB/HCV


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XDR-TB

10% 10%9%

6%

9%

20%

0%

5%

10%

15%

20%

25%

2008 2009 2010 2011 2012 2013

XDR-TB among MDR-TB cases (%)



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Cases enrolled in 2ndline treatment

(absolute numbers)

466

636 633

741

666

526

400

500

600

700

800

2008 2009 2010 2011 2012 2013



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M/XDR-TB (2ndline) TOM

54%

20%

13%

8%

5%

Success Lost to follow-up Died Failure Not evaluated

52%

27%

10%

4%7%

54%

27%

8%

6% 5%

2008

20092010

50%

34%

6%3%

7%

2011



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Treatment Outcomes of MDR vs XDR

2011

50%

3%5%

36%

6%11%

21%

26% 26%

16%

0%

10%

20%

30%

40%

50%

60%

Cured or

treatment

completed

Treatment

failed

Died Lost to

follow-up

Not

evaluated*

MDR-TB

XDR-TB



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1stline treatment outcomes of nonMDR-

TB/HIV co-infected cases(86 cases, 2009-2011, %)

58.1

17.4

9.3

8.1

7

nonMDR-HIV

Success

Failure

Default

Death

Not evaluated


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2ndline treatment outcomes of MDR-TB/HIV

co-infected cases(65 cases, 2009-2011, %)

30.8

4.6

29.2

26.2

9.2

MDR-HIV

Success

Failure

Default

Death

Not evaluated


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2ndline treatment outcomes of XDR-TB/HIV

co-infected cases(5 cases, 2009-2011, %)

00

40

60

0

XDR-HIV

Success

Failure

Default

Death

Not evaluated


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MDR-TB cases managed and generated XDR-TB

(N and cumulative N)

2555

90135 175

225

466

636 633

741

666

526

0

100

200

300

400

500

600

700

800

2008 2009 2010 2011 2012 2013

XDR-TB among MDR-TB cases (cum. N) MDR-TB cases put on treatment (N)


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Impact of MDR-TB management on XDR-TB

Georgia example

54% 54%52%

Treatment

success rate %,

50%

20%

27% 27%

Default rate %,

34%

10% 10% 9%6%

9%

XDR-TB %, 20%

0%

10%

20%

30%

40%

50%

60%

2008 2009 2010 2011 2012 2013

Treatment success rate % Default rate % XDR-TB %


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Can MDR-TB case management generate additional XDR-TB?

Message: the higher the % of MDR-TBmanaged with current poor outcomes,the higher the % of XDR-TB generated

Blower S, Supervie V. Predicting the future of XDR tuberculosis. Lancet 2007


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Programmatic Management of M/XDR-TB

Process Summary

Treatment Success Rate

Treatment Strengthening

Universal Access to Quality TB and MDR-TB DiagnosisCase Detection

Smear Microscopy

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

DRS LJ + MGIT + HAIN + GeneXpert

First-line anti-TB Treatment / Pilot SLD Universal Access to SLD Treatment

Action is Needed


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3. Effective governance, adequate financing and monitoring of Georgias

TB response;

4. Human resources available at each level with the professional

competence and support to meet GeorgiasTB Response planstargets;

5. Prevent TB transmission in health facilities and prisons through

strengthening IC measures;

6. Empower TB patients and communities;7. Enhance TB/HIV collaboration to reduce the burden of TB in people

living with HIV and the burden of HIV in TB patients.

1. Universal coverage with qualityTB diagnostic services

2. Universal access to TB treatmentand patient support services

Georgia TB Response

Strategic Plan 2013-2015

Source:

NCDC, Overview of NTP, US-Georgia Pro gram -Developm ent Work sho p On HIV/TB/Hepatit is, June 17, 2014

Gl b l F d d S TB P Gl


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Global Fund and State TB Program at a Glance

Goal:

- To reduce TB prevalence,

mortality and transmission

- To prevent drug resistance

Beneficiaries: citizens of

Georgia who have symptoms

of TB and is defined as a

presumptive TB case by

physician

Objectives:

Coordinate the national TB

Surveillance system

Collect , analyze and report

the data on TB contact tracing Contribute to TB State Program

Development

Participate in TB State Program

and GF Program M&E

Activities with NCTBLD

Goal:

To reduce the burden of

tuberculosis in Georgia by

sustaining universal access

to quality diagnosis and

treatment of all forms oftuberculosis including

M/XDR-TB

Four mainobjectives:

To strengthen National TB

Control Program management, monitoring and

To improve diagnosis of TB including M/XDR-

TB.

To ensure quality treatment of all forms of TB

To ensure adherence to TB

treatment by intensive support and follow up

Global Fund Program

Implementation Unit

TB Surveillance UnitState Program Unit

State and GFATM funds

under one umbrella-NCDC

Source:



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TB Service Model in Georgia

Screening for Presumptive TB and referral

DOT locally under supervision of district TBteams

PHC/PrivateSector

Confirming TB diagnosis

Initiating in patient or outpatient treatment

Provide ongoing DOT monitoring and follow-up

DOT and DOT plus

NCTBLD &Specialized TB

services

Sputum microscopy, bacteriology, Gene Xpert

9 laboratories in the civilian and 2 inpenitentiary sector

Reference laboratory at National Center for TBand Lung Diseases (NCTBLD)

Laboratoryservices

Contact tracing and referral to furtherinvestigation in TB sites

NCDC and PublicHealth Services

www.ncdc.geSource:



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USAID URC TPPMdecins

Sans Frontires

(MSF)

FIND

Source:



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National Center forDisease Control and Public

HealthNCDCPH

Data Collection Information

System (IS)

State level

Central level Monthly reports

Samegrelo/

Zemo Svaneti

9 TB units

Imereti

13 units

Guria

3 units

Racha/Kvemo

Svaneti

4 TB units

Kakheti

8 TB units

Samckhe-

Javakheti

6 TB units

Adjara

6 TB units

Shida Kartli

4 TB units

Tbilisi 5 TB unitsNational Center of TB

and Lung Disease (NCTBLD)

PR PIU

Penitentiarysystem

16 prisons

Samegrelo

DB Manager

Imereti

DB Manager

Kakheti

DB Manager

Samckhe-

Javakheti

DB Manager

AdjaraDB Manager

Shida KartliDB Manager

Poti

DB Manager

Prison

DB Manager

Tbilisi

4 DB Managers

HIV/AIDS, Hepatitis, STI &

TB surveillance division

Primary datacollectionsites

First aggregationlevel (IAL)

Second aggregationlevel (central)

Electroni c data entry directly into the IS

Hardcopies: Weekly- TB-10/12, Hospital Admission Forms; Monthly - HI V data; Quarterl y - aggregate reports on case notif ication (Form TB-07)

and treatment outcomes (TB-08)

Sputum collection, transferr ing for smear microscopy and receiving the result s

Kutaisi

ZDL

Batumi

ZDL

Telavi

LSS

Akhaltsikhe

LSS

Reference

Lab

Ozurgeti

LSS

Gori

LSS

Poti

LSS

Zugdidi

LSS

Kvemo Kartli

7 TB units

Mckheta

4 TB units

Kvemo Kartli

DB Manager

Mckheta

DB Manager

Data Flow Diagram

Source:



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SWOT Analysis

Strengths:1. Universal countrywide access to TB and

M/XDR TB Diagnosis using conventionaland rapid WHO approved diagnostic

testsGF & FIND support;

2. Universal Access to 1stand 2ndline anti-

TB treatmentGF support;

3. Electronic web based TB data collection

system under NCTBLD.

Weaknesses:1. Weak legislative environment;

2. No lead agency responsible for TB response inthe country is identified;

3. State vs donor funding is 46% / 54%;

4. Ineffective funding model for TB services;

5. Infrastructure development;

6. Private service providers with suboptimal

funding;

7. High MDR TB default rate;

8. Stigma and low motivation to be treated;9. Pharmacovigilance.

10. Side effects management

11. Lack of medical equipment

12. Human resources!!!

Opportunities:

1. Minister of health recognizes TB as a

priority health problem;

2. New drugs and new treatment

guidelines and protocolsTA with USAID

support, Drugs GF and MSF France;

3. TB Program review planned for 6-14

November, 2014.

Threats:

1. Substantial decrease of donor (GF and

USAID) funding starting 2016;

2. Suboptimal implementation of new

drugs because of systematic challenges

as mentioned above;

3. Critical lack of new generation coming to

the field;

4. Unwillingness of the private sector toparticipate in the TB service delivery.

C t N ti l G id li d WHO iti


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Current National Guidelines and WHO position on new

drugs

National TB treatment guidelines updated in 2012 based on WHO 2011 update

and endorsed by ministerial decree in 2013 includes all recommendationsprovided;

Recent GLC mission (July 2014) recommended introduction of new drugs and

treatment regimens for X/MDR-TB patients that are in line with the

recommendations provided in 2014 Companion handbook to the WHO

guidelines for the programmatic management of drug-resistant tuberculosis;

Global Fund responded to the new recommendations effectively and approved

the new order prepared based on the new GLC recommendationscountry

will receive the drugs by April 2015;

Otherwise Georgian NTP shares WHOs position on new drugs: the regimens

which are markedly different from the ones which represent current norm andhave undergone GRADE review, should only be used within the context of

research and under close monitoring for a period of at least 12 months beyond

the end of treatment.

C t N ti l G id li


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Current National Guidelines

Treatment Regimens


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30


Treatment Regimens

Proteonamide


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31


Treatment Regimens


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Ongoing MSF France Approach

Mdecins Sans Frontires (MSF)-France

treatment project Implementation of new

Drug-Resistant Tuberculosis Treatments

started in Summer 2014;

MOU between MoLHSA, the NCTBLD and MSF to

was signed on September 4, 2014;


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MSF New DR-TB Treatment Approach

Main objective is to offer quality treatment to DR-TB patients with the

introduction of new regimens;Specific Objectives are to support NCTBLD Georgia with:

the identification of the DR-TB cases eligible and with their preparation for

the new regimen;

the introduction of new TB drugs through the CU mechanism;

the start and follow up treatment with new regimen;

the pharmacovigilance;

the implementation of a system of reporting compatible with the data

collection system;

registration of the new TB drugs (Bedaquiline, Delamanid and other drugswhich may become available);

the procurement of a secure and affordable supply of new TB drugs;

updating TB guideline/protocols as needed;

training corresponding staff on the use of side effects of new treatments

and other topics related to new DR-TB regimen.


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Who is Eligible?

XDR-TB

Pre-XDR - Fluoroquinolone

Pre-XDR- both injectables

Failures of MDR TBCurrently on MDR TB treatment and not clinically

improving after 4 months or

a failure by WHO 2013 definitions

Household Contact of patients with XDRTB or Pre-XDRTB, orwho have failed MDR TB treatment

Previous failure of MDRTB/XDRTB treatment, not currently on

treatment for whom a regimen could be constructed with

drugs not previously used


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What is new and different for those eligible?

Addition of new drugs through compassionate use

(Bedaquiline)

Addition of other 3rd line drugs

Linezolid

Imipenem

Other first and secondline drugs that are still active

Goal is to make up a strong regimen of at least 4 drugs

for whom the effectiveness is sure (or as sure as

possible).


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What are the Principles of constructing a new regimen? Extension of treatment

duration, a minimum of 24 months is recommended;

Extension of the period of injectable to 12 months or

possibly the whole treatment

Must include the maximum number of effective drugs possible;

Effectiveness of drugs should be assessed using:

DST for those with reliableDST ( Injectables, FQ, H, R, Z)

History of past use

Response to treatment (if a drug has been included in a

regimen that has failed and with not enough effective drugs

then its effectiveness must be put in question


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Optimization of pre-treatment status of patient is very important: Nutition

Nutritional assessment (height and weight but not only)

Nutritional supplements - vitamins (D, B1, B6, Mg, Fe)

Attention to protein

Nausea, vomiting, diarrhoea, annorexia, etc

Co-mobidities

Diabetes, hypertension etc, HIV

Consent, patient education and adherence support

Program Vision: Implementing new M/XDR-TB


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g p gtreatment regimens and new drugs in Georgia

Complex preparatory work must take place where all stakeholder

support is essential:

Develop framework for introduction of new drugs in Georgia; Establish a coordinating group that will develop a National

Implementation Plan of Bedaquiline and other new drugs

(Delamanid) introduction; update guidelines/protocols and conduct

training with an uptake of international expertise and TA, and have

oversight for the new recommendations; Improve NRL capacity in SLDST (Protheonamide, Moxifloxacin

testing);

Establish a system for effective Pharmacovigilance (PV) in the

country and improve management capacity of AEs;

Revise/update the M/XDR-TB treatment monitoring standard andschedule in line with current requirements (ECG, lipase test,

electrolytes);

Improve overall patient support for PMDT through HSS (including

patient-centered DOT, cash incentives, etc.) and nutritional support;


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Room for Considerations

o Will this MSF approach or routine implementation of

new drugs/regimens be enough to reach the targets?

o With current high loss to follow-up rate what are

cross-cutting systematic interventions that needs to

be addressed?o Establishing effective pharmacovigilance system in

the country?

o

Establishing flexible patient centered care throughHSS?

o Changing the TB funding model?

o Who should and will advocate for those changes?

Time to move from being Rationale


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Time to move from being Rationale

to being (com)Passionate

Documents

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