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