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Hepatitis C Disease Burden and
Strategies to Minimize its Consequences in the Future
Assumptions and Outputs for Romania
dr Corina Pop
Associate Profesor Internal Medicine and Gastroenterology Department
Carol Davila University of Medicine and Pharmacy Bucharest, Romania
OUTLINE
The big burning picture of HCV disease:
prevalence, incidence, demographics
Disease control strategies in order to minimize the future HCV disease burden
increasing the pool of diagnosed people
increasing access to therapy
increasing the level of therapy/treatment efficacy
• A global public health issue - significant morbidity and mortality
• Up to 180 million individuals chronically infected worldwide 2.5-3% of the world’s population) (WHO 2015)
• 350,000-500,000 people die annually of HCV-related causes
• 15 - 17 million persons (2% of adults) HCV infection in the Europe region (WHO 2015)
• Long-term HCV infection translates in a heavy burden of liver-related morbidity and mortality
• Hepatitis C the leading cause of liver cirrhosis, cancer, transplantation
THE MAGNITUDE OF HCV INFECTION worldwide
But it’s not all about prevalence!
• Silent epidemic
• 75% of infected people are not aware of their HCV-positive status and remain undiagnosed
• Diagnosed as advanced HCV-associated liver disease - cirrhosis, liver cancer
• Only 3-5% of infected individuals receive treatment annually worldwide
• Causing a large economic impact - costs for patient and society
• Costs increase with disease progression
HCV historical epidemiology in Romania: Prevalence & demographics at a glance
N or/and % Comments
Country Population 19.6 million
HCV Infection Prevalence • 3.23% seroprevalence in adult general population in Romania
• 86% viremic cases
A nationwide cross-sectional survey in general adult population conducted between 2006-2008 through a multistage random cluster
sampling method
Genotype distribution 1 2 3 4 OTHER
Genotype 1 is almost exclusively
1a 1b
99.1%
HCV route of transmission Nosocomial Sexual & perinatal – few cases IVDU – increasing in younger subjects
Major risk factor: unsafe blood supply & unsafe
medical procedures in the past
HCV gender distribution • Female 3.94% • Male 2.95%
Female gender significantly more affected
Age groups
19-29: 1.61% 30-39: 1.04% 40-49: 3.85% 50-59: 4.35% 60-69: 5.39%
A significantly increased risk in subjects >40
(born 1937-1975)
Regional/by counties • 4.25% Moldavia • 3.35% Walachia
• 2.63% Transylvania
Significant regional differences
N or/and % Comments
HCV Disease Burden
Leading cause of • chronic hepatitis
• liver cirrhosis
• 64% • 59%
HCC 49.5% out of HCC cases diagnosed in tertiary centers
Special populations
Chronic Kidney Disease >11-→20%
HIV/HCV co-infection ~40-50% out of HIV+ population
HCV diagnosis rate 16% Low
Treated
60,000 2002-2015
Peg/RBV 5850 2016
DAAs
>56,500 treated between 2002-20015 w/ Peg/RBV (~50% SVR in real life) A very fey in clinical trials and EAP 99% SVR
Historical epidemiology in Romania: Current HCV burden
HCV-related disease progression over time
Compensated
Cirrhosis
Hepatocellular
Carcinoma
Liver
Transplantation
Acute Hepatitis
Chronic
Hepatitis – F3
Liver Related
Death
Chronic
Hepatitis – F0
Chronic
Hepatitis – F1
Chronic
Hepatitis – F2
Decompensated
Cirrhosis
Spontaneously
Cured
Razavi H, Waked I, Sarrazin C, et al. The present and future disease burden of hepatitis C virus (HCV) infection with today's treatment paradigm. J Viral Hepat 2014; 21 Suppl 1: 34-59.
Trends in epidemiology of HCV-related diseases in Romania
the next 15 years
-
100,000
200,000
300,000
400,000
500,000
600,000
Total Infected Cases (Viremic) - Romania
Base
-
500
1,000
1,500
2,000
2,500
3,000
3,500
Liver related Deaths - Romania
Base
-
500
1,000
1,500
2,000
2,500
3,000
3,500
HCC - Romania
Base
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
Decompensated Cirrhosis - Romania
Base
1900
2400
increase by 25% increase by 30%
2700
3400
increase by 30%
6500 62,900
7500
66,700
Sibley A, Han KH, Abourached A, … Gheorghe L, et al. The present and future disease burden of hepatitis C virus infections with today’s treatment paradigm. J Viral Hepat 2015; 22 (Dec) (Suppl 4):21-41. doi: 10.1111/jvh.12476
decline by 20%
OUTLINE
The big burning picture of HCV disease:
prevalence, incidence, demographics
Disease control strategies in order to minimize the future HCV disease burden
increasing the pool of diagnosed people
increasing access to therapy
increasing the level of therapy/treatment efficacy
Increasing diagnosis/screening
WHO SHOULD BE SCREENED FOR HCV INFECTION: Birth cohort screening
-
20,000
40,000
60,000
80,000
Total Infected by Age
• An aggressive screening programme
• The birth cohort screening
HCV infected population - 2015
A NATIONAL SCREENING PROGRAMME
HCV
2017 European Structural Founds
Operational Programme
Human Resources Development
Increasing access
“… costs of the new antiviral agents DAAs
are
as breathtaking as
their effectiveness” (Jay H. Hoofnagle & Averell H. Sherker; NEJM 2014; 370: 1552-1553)
PARADIGM OF THERAPY in Romania
2015-2016
Restricted access:
• 5800 p reimbursed therapy
• F4 and a part of F3 • Inadequate options for sp populations:
NO decompensated cirrhosis
transplant recipients
Treatment option
Only 1 option:
Viekirax/Exviera
2017-2018
Restricted access:
• 10,000 p reimbursed therapy
• F4, F3 and a part of F2 • Adequate options for sp populations:
YES decompensated cirrhosis transplant recipients dialysis medical perssonel
Treatment option 3 options: Viekirax/Exviera or Zepatier or Harvoni
Limited prescription/settings: Academic Centers of Gastroenterology/Hepatology and Infectious Diseases
40,000
45,000
50,000
55,000
60,000
65,000
70,000
75,000
Cirrhosis
Base2000 treated/year, ≥F35000 treated/year, ≥F32000 treated/year, ≥F45000 treated/year, ≥F4
3,000 3,500 4,000 4,500 5,000 5,500 6,000 6,500 7,000 7,500 8,000
Decompensated Cirrhosis
Base2000 treated/year, ≥F35000 treated/year, ≥F32000 treated/year, ≥F45000 treated/year, ≥F4
1,000
1,200
1,400
1,600
1,800
2,000
2,200
2,400
HCC
Base2000 treated/year, ≥F35000 treated/year, ≥F32000 treated/year, ≥F45000 treated/year, ≥F4
TREATING 5000-10,000 HCV/year Predictable Outcomes
-
-
2,000
2,200
2,400
2,600
2,800
3,000
3,200 Liver related Deaths
Base SVR only
HOW TO IMPROVE THE THERAPY UPTAKE?
Active screening programme
National HCV Registry
Elimination of restricted access
Diagnosed = treated patient (waiting list?)
CONCLUSIONS
Increasing diagnosis
Access to therapy
High treatment efficacy
Education in order to prevent (re)infection
Increase capacity of screening- birth cohort screening
Increase capacity of treating more patients
Treatment providers/setting/resources
Adoption of new, more efficacious therapies for hepatitis C