National Hepatitis C Elimination Program of Georgia

Transcription

1 European Roundtable on Hepatitis Cure & Eradication September 2015, Frankfurt, Germany National Hepatitis C Elimination Program of Georgia Tengiz Tsertsvadze MD, PhD Director General Infectious Diseases, AIDS and Clinical Immunology Research Center Professor of Medicine, Tbilisi State University

2 GEORGIA Russia Black Sea GEORGIA Area: 69,700 km 2 Population: 3.7 million GNI per capita: $3,720 Lower-middle income economy Turkey Armenia Azerbaijan

3 Prevalence of HCV in General Population of Georgia Data of % ( 170, 000 adults) General population (age: 18-65) Patients with HCV Ketevan Stvilia, Tengiz Tsertsvadze, Lali Sharvadze, Malvina Aladashvili, Carlos del Rio, Mark H. Kuniholm, and Kenrad E. Nelson. J Urban Health Mar; 83(2):

4 HCV Infection in Key Populations Tsertsvadze T. In: Frontiers in Research. Humana Press. 2008: Shapatava et al. Drug Alcohol Depend Apr;82 Suppl 1:S35-8. Richards et al. Int J Tuberc Lung Dis. 2006;10: CIF, Tanadgoma. BSS Survey among MSM in Tbilisi, 2010.

5 HCV Genotype Distribution Source: Infectious Diseases, AIDS and Clinical Immunology Research Center

6 HCV Recombinant 2k/1b in Georgia NS5B and 5 UTR/Core sequencing studies indicate that more than half of HCV genotype 2 patients in Georgia are actually infected with 2k/1b recombinant strain Results from some studies and our own experience suggest that in patients with 2k/1b recombinant virus, regimens used for genotype 1 are more effective Karchava M et al. Hepatol Res Feb 16. doi: /hepr Hedskog C, Hepatology Feb;61(2):

7 Availability of Diagnostic and Treatment Methods Diagnostic Methods 1984 ELISA 1985 Western blot 1995 Qualitative and Quantitative PCR 2003 HCV Genotyping (INNO Lipa) 2003 Real-time PCR 2007 Liver Elastography and other noninvasive markers 2010 IL28B Genotyping 2010 NS5B & 5 UTR/Core region sequencing 1996 Interferon alpha Monotherapy 1998 Interferon alpha + Ribavirin 2001 Pegilated Interferon alpha 2002 PegInterferon + Ribavirin 2011 Triple therapy: Peg.INF + RBV + Telaprevir or Boceprevir 2014 Sofosbuvir containing regimen Treatment Methods

8 National Hepatitis C Treatment Programs Since 2011 Free of charge Hepatitis C treatment for HIV/HCV co-infection patients with pegylated interferon and ribavirin Since 2014 Free of charge Hepatitis C treatment at the penitential system (prisoners) with pegylated interferon and ribavirin Since patients received treatment 406 patients received treatment Hepatitis C treatment access program for general population with 60% price reduction on combination of pegylated interferon and ribavirin 851 patients received treatment Since 2015 Implementation of urgent/phase I activities of hepatitis C Elimination Program treatment with Sofosbuvir containing rgeimens patients received treatment

9 NATIONAL HEPATITIS C ELIMINATION PROGRAM

10 Georgia

11 Gilead CEO John Martin and Prime Minister Irakli Garibashvili sign memorandum of understanding 21 April 2015, Tbilisi, Georgia Gilead Committed to provide Sofosbuvir and Ledipasvir/Sofosbuvir free of charge

12 Rationale for Choosing Georgia as a Model Country for HCV Elimination High prevalence of HCV infection in general population Small size of the country (69,700 km 2 ) with population of 3.7 million Strong Governmental commitment towards ending HCV epidemic Availability of all modern HCV diagnostic and treatment methods Strong human resource capacity in the field of hepatitis C Existence of effective systems, including logistic and control mechanisms, for implementing large-scale health programs Best practice experience in the field of HIV/AIDS, namely achievement of universal access to antiretroviral therapy (ART)

13 National Hepatitis C Elimination Program GOAL Elimination of HCV infection in the country (zero new infections) through identifying and treating all hepatitis C patients and through wide-scale implemention of prevention interventions

14 National Hepatitis C Elimination Program Phase I 2015 Treat 5,000 patients: F3/F4 fibrosis Severe extrahepatic manifestations HIV/HCV co-infection Phase II Implementation of large scale combination HCV prevention strategy, including seek, test and treat

15 HCV Screening Key Prevention Interventions Health sector based screening Community based screening Target groups for HCV screening Key population at risk (PWID, MSM, FSW) Specific patient groups: HIV/AIDS patients, TB patients, STI patients, patients on hemodialysis, patients with hemophilia, patients with oncohematologic disorders Blood donors, pregnant women Healthcare workers, students, law enforcement personnel Prisoners Migrants Other key prevention interventions Harm reduction Infection control Awareness rising

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17 Technical Advisory Group Represented by world renowned HCV experts Mission: To advise on program planning and implementation To provide guidance and propose mechanisms for partnerships and resource mobilization Monitor program activities and progress toward the achievement of elimination goals

18 ANTIVIRAL TREATMENT

19 Pre-Treatment Evaluation HCV RNA quantification HCV genotyping Evaluation of liver fibrosis (FIB4 and transient elastography) HBsAg, Anti-HBs, Anti-HIV Complete blood count ALT, AST, G-GT, alkaline phosphatase, bilirubin, albumin, creatinine, glucose, INR ANA, TSH Abdominal ultrasound

20 Sofosbuvir-Containing Regimens (prior to Harvoni release) HCV genotype Option 1 Option 2 Genotype 1 Genotype 2 Genotype 3 Sofosbuvir 400mg daily PEG IFN alpha weekly Ribavirin 1000 or 1200 mg daily Duration: 12 weeks Sofosbuvir 400mg daily Ribavirin 1000 or 1200 daily Duration: 12 weeks ( weeks for cirrhotic and/or treatment experienced patients) Sofosbuvir 400mg daily PEG IFN alpha weekly Ribavirin 1000 or 1200 daily Duration: 12 weeks Sofosbuvir 400mg daily Ribavirin 1000 or 1200 daily Duration: 24 weeks Prescribed only if no other interferon free regimen is available Sofosbuvir 400mg daily PEG IFN alpha weekly Ribavirin 1000 or 1200 daily Duration: 12 weeks Sofosbuvir 400mg daily Ribavirin 1000 or 1200 daily Duration: 24 weeks Patients with decompensated cirrhosis (all genotypes) Sofosbuvir 400 mg daily and Ribavirin 1000 or 1200 mg daily Duration: 48 weeks Treatment approach for Genotype 4 is the same as for Genotype 1

21 Harvoni-Containing Regimens (after Harvoni release) HCV genotype Option 1 Option 2 Genotype 1 Genotype 1 (decompensated cirrhosis) Genotype 1 (previous failure of sofosbuvir) Genotype 3 Ledipasvir/Sofosbuvir 400/90mg daily Duration: 12 weeks (24 weeks for treatment experienced patients with cirrhosis) Ledipasvir/Sofosbuvir 400/90mg daily Ribavirin initial dose 600mg daily Duration: 12 weeks Ledipasvir/Sofosbuvir 400/90mg daily Ribavirin 1000 or 1200 mg daily Duration: 12 weeks for patients without cirrhosis; 24 weeks for cirrhotic patients Ledipasvir/Sofosbuvir 400/90mg daily Ribavirin 1000 or 1200 mg daily Duration: 24 weeks for treatment experienced patients with cirrhosis Ledipasvir/Sofosbuvir 400/90mg daily Ribavirin 1000 or 1200 mg daily Duration: 12 weeks for treatment experienced patients with cirrhosis Ledipasvir/Sofosbuvir 400/90mg daily Ribavirin initial dose 600mg daily Duration: 24 weeks for patients with previous sofosbuvir failure

22 Timeline of HCV treatment monitoring Measurements Treatment period (weeks) After completion of therapy Clinical assessment X X X X Complete blood count X X X X X X X X ALT, AST, Bilirubin (total and direct), creatinine level X X X X X X X HCV RNA quantitative X X** X** X** X TSH X* * for Interferon-containing regimens. ** HCV RNA level is measured at week 12, 20 or 24 (end of treatment).

23 Early Results: 1 September ,564 Patients registered with the program 3,022 Patients started treatment 139 Patients completed treatment 137 Patients achieved ETR

24 End of Treatment Response (ETR) by HCV Genotype G1 G2 G3 TOTAL # patients who completed treatment # patients with ETR ETR rate 98.6% 100.0% 97.8% 98.6%

25 STRATEGY FOR

26 Targets: WHO By % of people living with HCV are diagnosed 90% of those diagnosed are treated 90% of those treated are cured Draft Global Health Sector Strategy on viral hepatitis,

27 By 2020 Targets: Georgia % of people living with HCV are diagnosed 95% of those diagnosed are linked to HCV care 95% of those linked to HCV care are treated 95% of those treated are cured

28 Projected Cascade of HCV Care 95% 95% 95% 95%

29 Testing/ counseling TasP HCV Treatment Infection control Blood safety Combination HCV Prevention Harm reduction Drug/alcohol treatment Awareness raising Advocacy

30 Sofosbuvir Harvoni Hepatitis C Elimination Program in Georgia + V+