Revealed That: Among New and Among Re-Treatment TB Cases Had MDR-TB

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
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
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
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*
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:
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:
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:
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

Treatment Regimens
Proteonamide
23

Treatment Regimens
24
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.

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

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).

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

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?

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DRS Study (2005-2006)

NTP Data Base. Global TB Reports

NTP Data Base. Global TB Reports

Cases enrolled in 2nd line treatment

NTP Data Base. Global TB Reports

M/XDR-TB (2nd line) TOM

NTP Data Base. Global TB Reports

Treatment Outcomes of MDR vs XDR

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

2nd line treatment outcomes of MDR-TB/HIV

2nd line treatment outcomes of XDR-TB/HIV

MDR-TB cases managed and generated XDR-TB

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

MDR-TB cases put on treatment (N)

Impact of MDR-TB management on XDR-TB

Treatment success rate %

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

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

Programmatic Management of M/XDR-TB

+ MGIT + HAIN + GeneXpert

First-line anti-TB Treatment / Pilot SLD

Universal Access to SLD Treatment

Treatment Success Rate

2. Universal access to TB treatment

Effective governance, adequate financing and monitoring of Georgias

Global Fund and State TB Program at a Glance

State Program Unit

Global Fund Program

TB Service Model in Georgia

Screening for Presumptive TB and referral

Contact tracing and referral to further

USAID URC TPP

Data Flow Diagram

National Center for

Data Collection Information

Electronic data entry directly into the IS

1. Universal countrywide access to TB and

Weak legislative environment;

Current National Guidelines and WHO position on new

Current National Guidelines

Current National Guidelines

Current National Guidelines

Ongoing MSF France Approach

MSF New DR-TB Treatment Approach

MSF New DR-TB Treatment Approach

MSF New DR-TB Treatment Approach

MSF New DR-TB Treatment Approach

MSF New DR-TB Treatment Approach

Program Vision: Implementing new M/XDR-TB

Room for Considerations

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