You are on page 1of 36

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

(per 100,000)
180
160
140
120
100
80
60
40
20
0

142,1

153,6

159

170,3

154,6

155,7 150
127,7
111

88,8
61,8

49

60,2
43,6

Adults

45,3

35,8 38,1 33,6

27,1 28,2 24,5

Children
1
NTP Data Base. Global TB Reports

TB in prisons
(per 100 prisoner)

6
5

4
3
2
1

all cases, 2.3


new
cases, 1.0

NTP Data Base. Global TB Reports

1st line treatment outcomes of the new pulmonary


bacteriologically confirmed TB cases
(2012 cohort, %)
90

84

80
70

60
50

Treatment success

40

Failure

30

Died

20

Unknown

10

Lost to follow-up

6,1

4,4

2,2

3,3

Drug Resistance Surveillance


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

MDR-TB prevalence, pulmonary cases


50,0%
40,3%

40,0%
32,0%
30,0%

27,4% 26,4%

38,1%
31,1% 31,4% 31,7% 31,2%

20,0%
10,0%

6,8%

6,8%

6,4%

11,3% 10,2%

9,5% 10,9%

9,2% 11,2%

0,0%

DRS

2006 2007 2008 2009 2010 2011 2012 2013


New TB Cases

Re-treated TB Cases
NTP Data Base. Global TB Reports

DRS Study (2005-2006)


revealed that:
6.8% among new and
27.4% among retreatment TB cases had
MDR-TB;
Independent Risk
Factors for MDR-TB:
Previous TB Treatment
OR=5.47 (95%CI, 3.867.72), p<0.001;
Female gender
OR=1.60 (95%CI, 1.022.32), p<0.04

Co-infection TB/HIV
(%)

TB-HIV %
4
3

3,2

3,8
2,1

3,4

3,1

2,8

MDR-TB/HIV %

2,6

1,9

2,3
1,3

2,1
1,7 2 1,7

2013

2012

2011

2010

2009

2008

2007

2006

2005

2004

2003

2002

2001

2000

6
5
4
3
2
1
0

5,3

5,3

2012

2013

3,9
2,5

2010

2011

NTP Data Base. Global TB Reports

Co-infection TB/HCV

XDR-TB
XDR-TB among MDR-TB cases (%)
25%

20%

20%

15%
10%

10%

10%

9%

9%
6%

5%
0%
2008

2009

2010

2011

2012

2013

NTP Data Base. Global TB Reports

Cases enrolled in 2nd line treatment


(absolute numbers)
800

741

700

636

666

633

600
526

500

466

400
2008

2009

2010

2011

2012

2013

NTP Data Base. Global TB Reports

M/XDR-TB (2nd line) TOM


2010

2009
6%

5%

4%

8%

7%

10%

52%

54%
27%

27%

2008
5%

2011

8%

6%

3%

7%

13%
54%

50%

20%

34%
Success

Lost to follow-up

Died

Failure

Not evaluated

NTP Data Base. Global TB Reports

Treatment Outcomes of MDR vs XDR


2011
60%
50%

50%

40%

36%

30%

26%

26%
MDR-TB

21%
20%

10%

16%

XDR-TB

11%
3%

5%

6%

0%
Cured or Treatment
treatment
failed
completed

Died

Lost to
Not
follow-up evaluated*
NTP Data Base. Global TB Reports

1st line treatment outcomes of nonMDRTB/HIV co-infected cases


(86 cases, 2009-2011, %)
nonMDR-HIV
7

8.1
Success

9.3

Failure

Default
58.1

17.4

Death
Not evaluated

2nd line treatment outcomes of MDR-TB/HIV


co-infected cases
(65 cases, 2009-2011, %)
MDR-HIV
9.2
30.8
Success
Failure

26.2

Default

Death
4.6

29.2

Not evaluated

2nd line treatment outcomes of XDR-TB/HIV


co-infected cases
(5 cases, 2009-2011, %)
XDR-HIV
0

40

Success
Failure
Default

60

Death
Not evaluated

MDR-TB cases managed and generated XDR-TB


(N and cumulative N)
800
741

700
636

600
500

666

633

526
466

400
300
200
100
0

25
2008

55
2009

90
2010

XDR-TB among MDR-TB cases (cum. N)

135
2011

175

2012

225

2013

MDR-TB cases put on treatment (N)

Impact of MDR-TB management on XDR-TB


Georgia example
60%
54%

54%

52%

50%

Treatment
success rate %,
50%

40%

Default rate %,
34%

30%

27%

20%

20%

10%

10%

0%

2008

27%
XDR-TB %, 20%

10%

2009

9%
2010

Treatment success rate %

6%
2011

Default rate %

9%
2012

XDR-TB %

2013

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


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

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

Programmatic Management of M/XDR-TB


Process Summary
Universal Access to Quality TB and MDR-TB Diagnosis
Case Detection

Smear Microscopy
2001

2002

2003

2004

DRS
2005

2006

LJ

+ MGIT + HAIN + GeneXpert

2007

2008

First-line anti-TB Treatment / Pilot SLD

2009

2010

Action
2011
2012is Needed
2013 2014

Universal Access to SLD Treatment

Treatment Success Rate


Treatment Strengthening

Georgia TB Response
Strategic Plan 2013-2015
1. Universal coverage with quality
TB diagnostic services
3.
4.
5.
6.
7.

2. Universal access to TB treatment


and patient support services

Effective governance, adequate financing and monitoring of Georgias


TB response;
Human resources available at each level with the professional
competence and support to meet Georgias TB Response plans targets;
Prevent TB transmission in health facilities and prisons through
strengthening IC measures;
Empower TB patients and communities;
Enhance TB/HIV collaboration to reduce the burden of TB in people
living with HIV and the burden of HIV in TB patients.

Source:
NCDC, Overview of NTP, US-Georgia Program-Development Workshop On HIV/TB/Hepatitis, June 17, 2014

Global Fund and State TB Program at a Glance


State and GFATM funds
under one umbrella-NCDC

State Program Unit


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

TB Surveillance Unit
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

Global Fund Program


Implementation Unit
Goal:
To reduce the burden of
tuberculosis in Georgia by
sustaining universal access
to quality diagnosis and
treatment of all forms of
tuberculosis including
M/XDR-TB
Four main objectives:
To strengthen National TB
Control Program management, monitoring and
To improve diagnosis of TB including M/XDRTB.
To ensure quality treatment of all forms of TB
To ensure adherence to TB
treatment by intensive support and follow up

Source:
NCDC, Overview of NTP, US-Georgia Program-Development Workshop On HIV/TB/Hepatitis, June 17, 2014

TB Service Model in Georgia


PHC/Private
Sector

Screening for Presumptive TB and referral


DOT locally under supervision of district TB
teams

NCTBLD &
Specialized TB
services

Confirming TB diagnosis
Initiating in patient or outpatient treatment
Provide ongoing DOT monitoring and follow-up
DOT and DOT plus
Sputum microscopy, bacteriology, Gene Xpert
9 laboratories in the civilian and 2 in
penitentiary sector
Reference laboratory at National Center for TB
and Lung Diseases (NCTBLD)

Laboratory
services
NCDC and Public
Health Services

Contact tracing and referral to further


investigation in TB sites

Source:

NCDC, Overview
of NTP, US-Georgia
Program-Development
Workshop On HIV/TB/Hepatitis,
June 17, 2014
www.ncdc.ge

FIND

USAID URC TPP

Mdecins
Sans Frontires
(MSF)

Source:
NCDC, Overview of NTP, US-Georgia Program-Development Workshop On HIV/TB/Hepatitis, June 17, 2014

Data Flow Diagram


TB DATA FLOW DIAGRAM

National Center for


Disease Control and Public
Health
HIV/AIDS, Hepatitis, STI &
NCDCPH
PR PIU

State level

TB surveillance division

Central level

Monthly reports

Reference
Lab
Second aggregation
level (central)

4 DB Managers

Prison

Data Collection Information


System (IS)

DB Manager

First aggregation
level (IAL)

Kvemo Kartli
DB Manager

Primary data
collection
sites

Kvemo Kartli
7 TB units

Mckheta

Samegrelo

Poti

Imereti

Kakheti

DB Manager

DB Manager

DB Manager

DB Manager

DB Manager

Mckheta
4 TB units

Zugdidi
LSS

Samegrelo/
Zemo Svaneti
9 TB units

Poti
LSS

Imereti
13 units

Kutaisi
ZDL

Racha/Kvemo
Svaneti
4 TB units

Tbilisi 5 TB units

Tbilisi

National Center of TB
and Lung Disease (NCTBLD)

Guria
3 units

Ozurgeti

LSS

SamckheJavakheti
DB Manager

Kakheti
8 TB units

Telavi
LSS

SamckheJavakheti
6 TB units

Akhaltsikhe

LSS

Penitentiary
system
16 prisons
Adjara

Shida Kartli

DB Manager

DB Manager

Adjara
6 TB units

Batumi
ZDL

Shida Kartli
4 TB units

Gori
LSS

Electronic data entry directly into the IS


Hardcopies: Weekly- TB-10/12, Hospital Admission Forms; Monthly - HIV data; Quarterly - aggregate reports on case notification (Form TB-07)
and treatment outcomes (TB-08)
Sputum collection, transferring for smear microscopy and receiving the results

Source:
NCDC, Overview of NTP, US-Georgia Program-Development Workshop On HIV/TB/Hepatitis, June 17, 2014

SWOT Analysis
Strengths:

Weaknesses:

1. Universal countrywide access to TB and


M/XDR TB Diagnosis using conventional
and rapid WHO approved diagnostic
tests GF & FIND support;
2. Universal Access to 1st and 2nd line antiTB treatment GF support;
3. Electronic web based TB data collection
system under NCTBLD.

1.
2.

Opportunities:
1. Minister of health recognizes TB as a
priority health problem;
2. New drugs and new treatment
guidelines and protocols TA 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 to
participate in the TB service delivery.

Weak legislative environment;


No lead agency responsible for TB response in
the 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!!!

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 recommendations
provided;
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 recommendations country
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 and
have 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.

Current National Guidelines


Treatment Regimens

Current National Guidelines


Treatment Regimens

Proteonamide

27

Current National Guidelines


Treatment Regimens

28

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;

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 drugs
which 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.

MSF New DR-TB Treatment Approach


Who is Eligible?

XDR-TB
Pre-XDR - Fluoroquinolone
Pre-XDR- both injectables
Failures of MDR TB
Currently 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, or
who 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

MSF New DR-TB Treatment Approach


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).

MSF New DR-TB Treatment Approach


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 reliable DST ( 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

MSF New DR-TB Treatment Approach


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


treatment 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 and
schedule 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;

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 through
HSS?
o Changing the TB funding model?
o Who should and will advocate for those changes?