IVHEM 2019. November 22-23, 2019, Amsterdam

EVALUATION OF THE HEPATITIS C CARE CASCADE IN THE COUNTRY OF : MONITORING PROGRESS TOWARDS ELIMINATION

Tengiz Tsertsvadze,1,2 Amiran Gamkrelidze,3 Nikoloz Chkhartishvili,1 Akaki Abutidze,1 Lali Sharvadze,2,4 Maia Butsashvili,5 David Metreveli,6 Lia Gvinjilia,7 Shaun Shadaker,8 Muazzam Nasrullah,8 Tamar Gabunia, 9 Ekaterine Adamia,9 Stefan Zeuzem,10 Nezam Afdhal,11 Sanjeev Arora,12 Karla Thornton,12 Francisco Averhoff8 1Infectious Diseases, AIDS and Clinical Immunology Research Center, , Georgia; 2Ivane Javakhishvili Tbilisi State University, Tbilisi, Georgia; 3National Center for Disease Control and Public Health, Tbilisi, Georgia; 4Hepatology clinic HEPA, Tbilisi, Georgia; 5Health Research Union, Tbilisi, Georgia; 6Medical Center Mrcheveli, Tbilisi, Georgia; 7CDC Foundation, Tbilisi, Georgia; 8Centers for Disease Control and Prevention, Division of Viral Hepatitis National Center for HIV, Hepatitis, STD&TB Prevention, Atlanta, USA; 9Ministry of IDPs, Labour, Health and Social Affairs of Georgia, Tbilisi, Georgia; 10Goethe University Hospital, Frankfurt, Germany; 11Beth Israel Deaconess Medical Center Liver Center, Boston, USA; 12University of New Mexico, Albuquerque, USA

Infectious Diseases, AIDS and Clinical Immunology Research Center Disclosure

No relevant financial relationship exists

Infectious Diseases, AIDS and Clinical Immunology Research Center 12 COUNTRIES WORLDWIDE ON TRACK TO ELIMINATE HEPATITIS C INFECTION BY 2030 Georgia’s HCV elimination program builds on delivering a comprehensive response

Nationwide HCV Baseline and follow-up Active case screening seroprevalence surveys finding

Treating Unified secure (including retreatment) web-based all HCV-infected persons HCV information system

Elimination Public awareness Infection control and education

Surveillance Harm reduction Blood safety

Infectious Diseases, AIDS and Clinical Immunology Research Center Integration and Detection of HCV, TB and HIV at PHC level

Infectious Diseases, AIDS and Clinical Immunology Research Center Targets: 90-95-95 by 2020

90% 95% 95%

Diagnosed Treated Cured

Reducing the HCV prevalence by 90% towards zero new infections by 2020

Infectious Diseases, AIDS and Clinical Immunology Research Center HCV Treatment Sites within Elimination Program, October 31, 2019 (Total=40)

Total of 40 treatment sites: • 30 specialty clinics • 10 primary care centers 3 sites

Zugdidi 1 site Gori 1 site Sagarej Tbilisi o 1 site Marneul 3 sites 1 site Rustavii

155 physicians (ID specialists, gastroenterologist, primary care specialists )

Infectious Diseases, AIDS and Clinical Immunology Research Center Monitoring algorithm during antiviral therapy

7 Infectious Diseases, AIDS and Clinical Immunology Research Center Georgia Hepatitis C Elimination Program Care Cascade, April 28, 2015 – October 31, 2019

* Among persons with national ID number; ** Age ≥ 12 with no mortality data prior to confirmation *** Per-protocol, includes retreatments. Among 41,683 persons tested after their 1st round of treatment, 40,082 (96.2%) achieved SVR (Including 82.1% for SOF-based regimens, 98.1% for SOF/LED regimens, and 98.2% for SOF/VEL regimens). 1,510 persons were retreated with a 2nd round of treatment, with 94.2% (663/704) of those tested achieving SVR. Overall SVR by Intention-to-Treat analysis: 73.6%

Infectious Diseases, AIDS and Clinical Immunology Research Center Treatment outcomes by advanced fibrosis/cirrhosis status among persons with complete SVR data, Apr 2015 – Oct 2019

p<0.0001 98.7% 98.2% 99.0% 100%

80%

60%

40%

20%

0% All Advanced fibrosis Without advanced fibrosis Source: Georgia’s HCV Elimination Program Treatment Database

Infectious Diseases, AIDS and Clinical Immunology Research Center Decentralization of HCV diagnostics, treatment and care services in Primary healthcare centers (PHCs) in Georgia

Senaki Poti Khashuri Kobuleti Tbilisi Telavi Akhaltsikhe Akhalkalaki

• Integration of HCV diagnostics, treatment and care services in at least one PHC of each district of Georgia • HCV diagnostics, treatment and care services should be integrated in 69 PHCs across the country during the first phase of the program

Infectious Diseases, AIDS and Clinical Immunology Research Center Challenges/Gaps and Proposed Actions

Declined enrollment in the treatment program • lack of access to the treatment program (financial barriers)

• Absolutely all diagnostic testing is free of charge

Scarcity of treatment centers in some geographic, especially in rural areas

• Increase from original 4 sites to 40 sites by October 2019 • Full scale of HCV care decentralization in PHCs: total of 10 PHCs already established (69 PHCs envisioned across the country)

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

Technical Advisory Group (TAG) Centers for Diseases Control and prevention

World Health Organization

Daniel O’Day, Clifford Samuel, Graeme Robertson

Nezam Afdhal, Stefan Zeuzem, Geoffrey Dusheiko

Sanjeev Arora, Karla Thornton

David Sergeenko, Valeri Kvaratskhelia, Multisectoral Commission on Hepatitis C

Amiran Gamkrelidze

All HCV Clinical Care Provider Clinics

Infectious Diseases, AIDS and Clinical Immunology Research Center