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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

    NTP Data Base. Global TB Reports

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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)

    NTP Data Base. Global TB Reports

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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

    NTP Data Base. Global TB Reports

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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 %

    NTP Data Base. Global TB Reports

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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 (%)

    NTP Data Base. Global TB Reports

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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

    NTP Data Base. Global TB Reports

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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

    NTP Data Base. Global TB Reports

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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

    NTP Data Base. Global TB Reports

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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:

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

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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:

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

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    USAID URC TPPMdecins

    Sans Frontires

    (MSF)

    FIND

    Source:

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

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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:

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

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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

    Current National Guidelines

    Treatment Regimens

    Proteonamide

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    31

    Current National Guidelines

    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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    MSF New DR-TB Treatment Approach

    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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    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).

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    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 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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    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

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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