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
Infectious Diseases, AIDS and Clinical Immunology Research Center Infectious Diseases, AIDS and Clinical Immunology Research Center
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
Infectious Diseases, AIDS and Clinical Immunology Research Center Infectious Diseases, AIDS and Clinical Immunology Research Center
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
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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.
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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%
Infectious Diseases, AIDS and Clinical Immunology Research Center Infectious Diseases, AIDS and Clinical Immunology Research Center
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
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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
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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
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2020 Targets
90% 95% 95%
Diagnosed Treated Cured
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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
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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
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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
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Awareness
#Join #Cure #Future without C
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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
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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
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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
Infectious Diseases, AIDS and Clinical Immunology Research Center Infectious Diseases, AIDS and Clinical Immunology Research Center
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
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HCV Treatment
Infectious Diseases, AIDS and Clinical Immunology Research Center Infectious Diseases, AIDS and Clinical Immunology Research Center
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
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Health Information System: C Elimination
http://elimination.moh.gov.ge/
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Number of Patients Starting HCV Treatment (Apr 2015-Dec 2016)
0
5000
10000
15000
20000
25000
30000
Source: Hepatitis C Elimination Program Treatment Database
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
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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
Source: Hepatitis C Elimination Program Treatment Database
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
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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%
All Genotype 1 Genotype 2 Genotype 3
cirrhosis (n=2781) no cirrhosis (n=1986)
427
542
420
511
545
675
988
1150
759
800
650
1089
2065
2781
1724
1986
Source: Hepatitis C Elimination Program Treatment Database
p<0.0001 p<0.0001 p<0.16 p<0.0001
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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%
All Genotype 1 Genotype 2 Genotype 3
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
Source: Hepatitis C Elimination Program Treatment Database
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Progress and Projected Impact
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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
Diagnosed Treated Cured
Oct, 2015 Sept, 2016 Dec, 2016
Progress Towards 90-95-95
Source: Hepatitis C Elimination Program Treatment Database
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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
Diagnosed Treated Cured
Oct, 2015 Sept, 2016 Dec, 2016 Dec, 2020
Progress Towards 90-95-95
Source: Hepatitis C Elimination Program Treatment Database
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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
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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