1. Achieving WHO Recommendations for HCV in the European Union
A. Hatzakis
Athens University Medical School
April 13, 2016

2. The 28 EU countries account for nearly 70% of the total European population
Countries in the European Union (population ~510 million)
Austria
Estonia
Italy
Portugal
Belgium
Finland
Latvia
Romania
Bulgaria*
France
Lithuania
Slovakia
Croatia
Germany
Luxembourg
Slovenia
Cyprus*
Greece
Malta
Spain
Czech Republic
Hungary
Netherlands
Sweden
Denmark
Ireland
Poland
United Kingdom
HCV disease burden models have been validated for 26 countries in the EU (98% of the EU population represented).
The model for Bulgaria has not been validated by local experts.
No assessment of Cyprus was conducted for this analysis.

3. In 2016, there are approximately 3
In 2016, there are approximately 3.6 million viremic HCV infections in the EU (0.7% prevalence)
Prevalence
(Viremic)
Total Infected
500,000
1,000,000
0.0%-0.6%
0.6%-0.8%
0.8%-1.3%
1.3%-2.9%
2.9%-12.0%
100,000
Source: Polaris Observatory (

4. In 2016, there are 3. 6M viremic infections, 1
In 2016, there are 3.6M viremic infections, 1.2M already diagnosed, ~1M treated and 500K cured in the European Union
33%
Median Age: 54
The viremic prevalence of HCV in EU is 0.7% with one third of infections already diagnosed.
In 2016, an estimated 133,000 patients (or 3.7% of total infected) are treated.
Source: Polaris Observatory (

5. There is a wide range of prevalence, diagnosis rates, and treatment rates across the European Union
Bubble Diameter: HCV Prevalence 2% 1%
0.5%
Source: Polaris Observatory (

6. 10 countries accounted for 85% of viremic HCV infections and 6 countries accounted for 80% of treated patients
Viremic HCV Infections (2015)
85% of Total
Number Treated & Treatment Rate
80% of Total
(Treatment Rate)
Source: Polaris Observatory (

7. The number of treated patients increased in 2014 and 2015 after a period of warehousing patients
Total Number Treated in EU
Source: Polaris Observatory (

8. Base 2014 Scenario – For comparison, the treatment paradigm in 2014 was extrapolated into the future
Continue to treat with Peg IFN based therapies
No treatment restrictions (treat anyone ≥F0)
Screening is continued each year to find new HCV cases
2014
2015
2016
2017
2020
2025
Treated
77,630
Newly Diagnosed
96,800
Fibrosis Stage
≥F0
New Infections
59,500
64,900
62,900
61,100
59,600
59,400
Treated Age
15-65
SVR
57%
Source: Polaris Observatory (

9. HCV infections will decline by 40%, while liver related deaths (LRD), HCC & decompensated cirrhosis (DC) will increase by 30, 15 & 25%

10. Current 2015 Scenario – Extrapolate future treatment paradigm based on the current (2015) practice
Switch to direct acting antivirals with higher SVR
Keep the number of treated constant
Treatment is limited to those ≥F2 until 2025
Expand screening to find ≥F2
2014
2015
2016
2017
2020
2025
Treated
77,630
133,300
Newly Diagnosed
96,800
101,600
111,800
167,700
243,120
Fibrosis Stage
≥F0
≥F2
≥F1
New Infections
59,500
64,900
62,900
61,100
59,600
47,600
Treated Age
15-65
SVR
57%
75%
85%
90%

11. HCV infections will decline by 70%, while HCV related morbidity and mortality will decrease by 45-55%

12. After 2030, less than 20,000 individuals need to be treated annually
Elimination Scenario – Increase screening, treatment and eligibility to achieve a 90% reduction in new infections (excluding immigration)
Switch to direct acting antivirals with higher SVR
Increase treatment to achieve a >60% reduction in liver related deaths, 90% reduction in total & new infections
Expand screening to find infected individuals to treat
Expand treatment to all patients (>=F0)
Starting in 2017, expand treatment up to age 70
2014
2015
2016
2017
2020
2025
Treated
77,630
133,300
159,900
191,900
230,300
Newly Diagnosed
96,800
101,600
132,100
171,700
188,900
207,800
Fibrosis Stage
≥F0
≥F2
New Infections
59,500
64,900
62,900
49,200
33,300
13,300
Treated Age
15-65
15-70
SVR
57%
75%
85%
90%
After 2030, less than 20,000 individuals need to be treated annually

13. Start to run out of patients to treat
HCV infections will decline 90% by 2030 and 95% by 2035, while LRD will decline 55% by 2030 and 70% by 2035
Start to run out of patients to treat

14. The HBsAg+ prevalence in 2016 is estimated to be 1%
HBsAg: In 2016, there are an estimated 5 million HBsAg+ individuals in the European Union (data for 97% of the infected population)
HBsAg+
(Prevalence)
<1.0%
1.0%-2.5%
2.5%-5.0%
5.0%-10.0%
>10%
Total Infected .
50,000
250,000
1,000,000
The HBsAg+ prevalence in 2016 is estimated to be 1%
Source: Polaris Observatory (

15. Eight countries accounted for 80% of all hepatitis B infections in the European Union
HBsAg+ Individuals (2016)
80% of Total
96% % of infants receiving 3 doses of HBV vaccine (2014)
94% 0%
80%
87%
96%
82%
95%
Source: Polaris Observatory (

16. HBeAg+: In 2016, it is estimated that 15
HBeAg+: In 2016, it is estimated that 15.5% of HBsAg+ individuals in the European Union are HBeAg+
HBeAg+ Prevalence
(% of HBsAg+)
<2.5%
2.5%-5.0%
5.0%-10.0%
10.0%-20.0%
>20%
Source: Polaris Observatory (

17. HDV: In 2016, it is estimated that 9
HDV: In 2016, it is estimated that 9.0% of HBsAg+ individuals in the EU are anti-HDV+, corresponding to 450,000 HDV infections
<2.5%
2.5%-5.0%
5.0%-10.0%
10.0%-20.0%
>20%
Anti-HDV+ Prevalence
(% of HBsAg+)
Source: Polaris Observatory (

18. It is feasible to eliminate HCV infection in the European Union
Conclusions:
There are an estimated 3.6 million HCV and 5.0 million HBV infections in the European Union
Eight countries in the European Union account for 80% of HBV infections
Birth dose vaccination of infants remain non-existing or very low among Western European countries
It is feasible to eliminate HCV infection in the European Union
Treatment has to be increased to 6-10% of total infections (coupled with active screening)
To reduce new infections, screening and treatment has to encompass all HCV infected individuals (≥F0) – most new infections occur among younger individuals who are F0 or F1
To reduce liver related deaths, eligibility has to increase to older patients – median age in EU is 54, and in 11 years half of the HCV infected population will be ineligible for treatment (if those above 65 are ineligible for treatment)