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Infectious Diseases, AIDS and Clinical Immunology Research Center

HCV Elimination Program in Georgia: Successes and Challenges

Nikoloz Chkhartishvili, MD, MS, PhD

Deputy Executive Director for Research

Infectious Diseases, AIDS and Clinical Immunology Research

Center

Infectious Diseases, AIDS and Clinical Immunology Research Center Infectious Diseases, AIDS and Clinical Immunology Research Center

GEORGIA

Armenia Turkey

Russia

Azerbaijan

Black Sea

Area: 69,700 km2

Population: 3.7 million

GNI per capita: $4,160

Upper-middle income economy

Georgia


Hepatitis C Epidemiology in Georgia

HCV in General Population

% Estimated number

anti-HCV+ 7.7% 208 800

HCV RNA+ 5.4% 150 300

HCV Genotype Distribution

41%

25%

34%

0%

10%

20%

30%

40%

50%

G1 G2 G3

2015 National Survey

Stvilia K et al. J Urban Health. 2006 Mar;83(2):289-98.. Baliashvili D et al. Abstract THU-203; EASL 2017.

% Estimated number

anti-HCV+ 6.7% 200 000

2002 Tbilisi Survey


Prevalence of Chronic HCV Infection by Gender and Age Categories: 2015 National Survey

0,7% 1,9% 2,2%

3,3% 1,7%

3,3% 1,9%

11,9%

18,6%

7,9%

5,1% 3,9%

0%

4%

8%

12%

16%

20%

18-29 30-39 40-49 50-59 60-69 70+

Women Men

Gamkrelidze A. Burden of HCV and risk factors for transmission: Implications for targeted interventions and screening and linkage to care EASL2017


HCV in Key Populations

66% 69%

34%

21%

11% 7%

0%

10%

20%

30%

40%

50%

60%

70%

80%

PWID HIV+ PWID HIV+ perosns TB Patients STI Patients MSM

CIF, Bemoni. IBBS Survey among PWID, 2015. Chkhartishvili N et al. AIDS Res Hum Retroviruses. 2014;30:560-6. Lomtadze N at al. PLoS One. 2013;8(12):e83892. Tsertsvadze T. In: Frontiers in Research. Humana Press. 2008:257-261. CIF, Tanadgoma,. IBBS survey among MSM, 2015.


Risk Factors for HCV: 2015 National Survey

Baliashvili D et al. Prevalence and genotype distribution of hepatitis C virus in Georgia: A 2015 nationwide population-based survey. Abstract THU-203; EASL 2017.

Injection drug use (IDU), 33.6%

Blood transfusion, 15.1%

IDU + Blood transfusion, 4.6%

None reported, 46.7%


National Hepatitis C Elimination Program

2011 2012 2013 2014 2015

Free PEG/RBV for

HIV/HCV co-infected Free PEG/RBV

for prisoners

60% price reduction on

PEG/RBV for general public

National Hepatitis C

Elimination Program


Rationale for Choosing Georgia

High prevalence of HCV infection in general population

Small size and population of the country

Strong Governmental commitment towards ending HCV epidemic

Existing human and technical capacities

Availability of effective systems for implementing large-scale health

programs

Best practice experience in the field of HIV/AIDS


Elimination of HCV infection in the country through identifying and treating all hepatitis C patients

strengthened by effective prevention interventions

Detection Treatment Prevention

The Goal of the National Hepatitis C

Elimination Program

Reducing the HCV prevalence by 90% (to 0.5%) by 2020


2020 Targets

90% 95% 95%

Diagnosed Treated Cured


Strategic Plan on Hepatitis C Elimination

Promote advocacy, awareness, education and partnership

Prevent HCV transmission

Identify people living with HCV

Improve HCV laboratory diagnostics

Provide treatment and care

Improve HCV surveillance

1

2

3

4

5

6

Strategic

Directions


Hepatitis C Elimination Strategy: National Budget Allocations (USD)

7.951.005

10.117.255

11.863.372

13.536.229 13.692.989

0

2.000.000

4.000.000

6.000.000

8.000.000

10.000.000

12.000.000

14.000.000

16.000.000

2016 2017 2018 2019 2020

57,160,850 USD to be allocated by government over 2016-2020

Source: 2016-2020 National Hepatitis C Elimination Strategy


Partnership

• National hepatitis C elimination commission

– Established by ministerial decree

– Ministry of health, NCDC, public health and clinical experts, researchers, civil society

• U.S. Centers for Disease Control and Prevention (CDC)

– Technical assistance

– International Technical Advisory Group (TAG)

• Gilead Sciences

– Donation of SOF and LDV/SOF

• LIFER and ECHO Projects

– Development of national treatment protocols

– Education and human capacity strengthening


Awareness

#Join #Cure #Future without C


Prevent HCV Transmission

• Decrease HCV incidence among people who inject drugs

(PWID)

– Promote harm reduction (Syringe/needle exchange; Opioid

substitution treatment)

– Intensify HCV detection in PWID

– Ensure linkage to care and treatment of HCV positive PWID

Challenge: Repressive drug policy


Drug Policy Reform

Georgian Prime Minister Giorgi Kvirikashvili addressed the parliament of Georgia to make the legislative changes to the current drug policy and make it more human and European by the autumn sessions. http://agenda.ge/news/81136/eng

http://agenda.ge/news/81136/eng


Prevent HCV Transmission

• Prevent healthcare related transmission of HCV

– Improve blood safety

– Improve prevention and control in healthcare and non-healthcare

settings

– Approved regulations on IPC

• “Approval of nosocomial infection surveillance, prevention, and control regulations”

Ministerial order №01-38/N of September 7, 2015

• “Approval of technical regulations on disinfection and sterilization in medical, public health, and public

facilities” Governmental decree №185 of April 24, 2015

• “Technical regulation - Approval of sanitary norms of IPC in public facilities on performing esthetic and

cosmetic procedures”

Governmental resolution №473 of September 14, 2015

• “Technical regulation – Approval of sanitary regulations on waste collection, storage, and treatment in

medical-prophylactic facilities”

Governmental decree №64 of January 15, 2014


Identify People Living with HCV

168121 1790 44410 53852 48025 18900 83910 2453 26159 11217 14053

1,3%

24,9%

45,0%

0,4% 4,9% 7,4%

17,5%

31,4%

13,8%

1,5%

37,4%

0%

20%

40%

60%

80%

100%

472 890 persons screened in 2015-2016

50 962 (10.8%) positive for anti-HCV

Source: National Center for Disease Control and Public Health


HCV Treatment


HCV Treatment Sites within Elimination Program, December 31, 2016 (Total=27)

Source: Hepatitis C Elimination Program Treatment Database

Gori

Rustavi

Zugdidi

Batumi

Kutaisi

Tbilisi

2 sites

4 sites 1 site

2 sites

1 site

15 sites

Total: 27 sites

139 physicians

Gurjaani

Lanchkhuti

1 site

1 site

Increase from four (4) sites

when program launched in

April 2015


Health Information System: C Elimination

http://elimination.moh.gov.ge/




Number of Patients Starting HCV Treatment (Apr 2015-Dec 2016)

0

5000

10000

15000

20000

25000

30000


SOF Introduced (n=7 193)

LDV/SOF Introduced (n=20 402)

Apr-15 Jun-15 Aug-15 Oct-15 Dec-15 Feb-16 Apr-16 Jun-16 Aug-16 Oct-16 Dec-16

Treat F3 or F4 fibrosis, HIV/HCV, Severe extrahepatic

Treat ALL

27 595 Persons Started Treatment


SVR among Patients Treated with SOF-based Regimens (Dec 31, 2016, n=4 774)

79,5%

67,7%

80,4%

89,6% 89,8%

80,3%

95,4% 96,2%

69,9%

54,6%

76,0% 80,3%

0%

20%

40%

60%

80%

100%

All Genotype 1 Genotype 2 Genotype 3

All IFN/SOF/RBV SOF/RBV

p<0.0001 p<0.0001 p<0.0001 p<0.0001


230

241

1099

1143

617

812

648

807

2055

2289

1738

2485

3793

4774

724

902

471

862

1195

1764

1747

1950

847

1053

Data for 7 G4 patients not shown


SVR of SOF-based Treatment by Cirrhosis (Dec 31, 2016)

74.2%

59.7%

78.8% 85.9% 86.8%

80.7% 82.2%

94.9%

0%

20%

40%

60%

80%

100%


cirrhosis (n=2781) no cirrhosis (n=1986)

427

542

420

511

545

675

988

1150

759

800

650

1089

2065

2781

1724

1986


p<0.0001 p<0.0001 p<0.16 p<0.0001


SVR among Patients Treated with LDV/SOF- based Regimens (Dec 31, 2016 n=1588)

98,2% 98,1% 99,2% 97,6% 97,1% 96,9% 98,1% 97,6% 98,8% 98,9% 100% 97,6%

0%

20%

40%

60%

80%

100%


Total Cirrhosis No cirrhosis

580

597

979

991

432

446

627

634

106

108

150

150

41

42

203

208

1559

1588

1059

1080

256

258

244

250



Progress and Projected Impact


14.375

3.722

30.053

19.338

3.250

36.322

27.595

5.356

0

5.000

10.000

15.000

20.000

25.000

30.000

35.000

40.000


Oct, 2015 Sept, 2016 Dec, 2016

Progress Towards 90-95-95



14.375 3.722

30.053 19.338

3.250

36.322 27.595

5.356

135.200 128.500

122.100

0

20.000

40.000

60.000

80.000

100.000

120.000

140.000

160.000


Oct, 2015 Sept, 2016 Dec, 2016 Dec, 2020

Progress Towards 90-95-95



Modeling study shows that Georgia is on the path to achieving the HCV elimination target by 2020

Impact on prevalence Impact on incidence

Walker J et al. Projected impact and pathways to success of the hepatitis C virus elimination program in Georgia, 2015-2020. Abstract PS-125. EASL 2017

% reduction in prevalence 2015 to 2020 % reduction in incidence2015 to 2020


Acknowledgement

• Akaki Abutidze, Infectious Diseases, AIDS and Clinical Immunology Research Center

• Eka Adamia, Ministry of Labour, Health and Social Affairs of Georgia

• Shaun Shadaker, Centers for Disease Control and Prevention

• Josephine Walker, University of Bristol

National Commission, Clinical Group and Scientific

Committee of Elimination Program

Documents

HCV Elimination Program in Georgia: Successes and Challengesregist2.virology-education.com/2017/13thCoinfection/35_Nikoloz... · HCV Elimination Program in Georgia: Successes and