NTP_Presentation2

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

84

6,1 4,4 2,2 3,30

102030405060708090

Treatment successLost to follow-upFailureDiedUnknown

1st line treatment outcomes of the new pulmonary bacteriologically confirmed TB cases

(2012 cohort, %)

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

MDR-TB prevalence, pulmonary cases


DRS Study (2005-2006) revealed that:

6.8% among new and 27.4% among re-treatment TB cases had MDR-TB;

Independent Risk Factors for MDR-TB:

Previous TB Treatment OR=5.47 (95%CI, 3.86-7.72), p<0.001;

Female gender OR=1.60 (95%CI, 1.02-2.32), p<0.04

Co-infection – TB/HIV(%)

3,2 2,82,1

3,83,1

1,92,6

3,4

1,32,3

1,7 2 1,72,1

01234

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

TB-HIV %

3,9

2,5

5,3 5,3

0123456

2010 2011 2012 2013

MDR-TB/HIV %


Co-infection – TB/HCV

XDR-TB


Cases enrolled in 2nd line treatment (absolute numbers)

466

636 633

741

666

526

400

500

600

700

800

2008 2009 2010 2011 2012 2013


M/XDR-TB (2nd line) 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

2009 2010

50%

34%

6%3%

7%

2011


Treatment Outcomes of MDR vs XDR2011


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

(86 cases, 2009-2011, %)

58.1

17.4

9.3

8.17

nonMDR-HIV

SuccessFailureDefaultDeathNot evaluated

2nd line 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


2nd line treatment outcomes of XDR-TB/HIV co-infected cases(5 cases, 2009-2011, %)

00

40

60

0XDR-HIV


MDR-TB cases managed and generated XDR-TB (N and cumulative N)

Impact of MDR-TB management on XDR-TBGeorgia example

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-TBProcess Summary

Treatment Success RateTreatment 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

3. Effective governance, adequate financing and monitoring of Georgia’s TB response;

4. Human resources available at each level with the professional competence and support to meet Georgia’s TB Response plan’s targets;

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 quality TB diagnostic services

2. Universal access to TB treatment and patient support services

Georgia TB Response Strategic Plan 2013-2015

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

Goal:- To reduce TB prevalence,mortality and transmission- To prevent drug resistanceBeneficiaries: citizens ofGeorgia who have symptomsof TB and is defined as apresumptive TB case byphysician

Objectives:• Coordinate the national TBSurveillance system• Collect , analyze and reportthe data on TB contact tracing• Contribute to TB State ProgramDevelopment• Participate in TB State Programand GF Program M&EActivities with NCTBLD

Goal:To reduce the burden oftuberculosis in Georgia bysustaining universal accessto quality diagnosis andtreatment of all forms oftuberculosis includingM/XDR-TB

Four main objectives:• To strengthen National TBControl 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 TBtreatment by intensive support and follow up

Global Fund Program Implementation Unit

TB Surveillance UnitState Program Unit

State and GFATM funds State and GFATM funds ““under one umbrella-NCDC”under one umbrella-NCDC”


TB Service Model in Georgia

დაავადებათა კონტროლისა და საზოგადოებრივი ჯანმრთელობის ეროვნული

ცენტრიwww.ncdc.ge


USAID – URC TPPMédecins

Sans Frontières(MSF)

FIND


National Center for Disease Control and Public

Health NCDCPH

Data Collection Information System (IS)

TB DATA FLOW DIAGRAM

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 units National Center of TB

and Lung Disease (NCTBLD)

PR – PIU

Penitentiary system

16 prisons

Samegrelo DB Manager

Imereti DB Manager

Kakheti DB Manager

Samckhe-Javakheti

DB Manager

Adjara DB Manager

Shida Kartli DB Manager

Poti DB Manager

Prison DB Manager

Tbilisi 4 DB Managers

HIV/AIDS, Hepatitis, STI & TB surveillance division

Primary data collection sites

First aggregation level (IAL)

Second aggregation level (central)

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

Kutaisi ZDL

BatumiZDL

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


SWOT AnalysisStrengths: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 anti-TB treatment – GF support;3.Electronic web based TB data collection system under NCTBLD.

Weaknesses:1.Weak legislative environment;2.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 management11.Lack of medical equipment12.Human resources!!!

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.

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 WHO’s 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 GuidelinesTreatment Regimens

26

Current National GuidelinesTreatment Regimens…

Proteonamide

27

Current National GuidelinesTreatment Regimens…

Ongoing MSF France Approach

Médecins Sans Frontières (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 ApproachMain 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

LinezolidImipenem

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 ApproachWhat 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 ApproachOptimization 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 Considerationso 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?

NTP_Presentation2

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