HV Epidemiology and Burden in Chelyabinsk Region

O.I. SagalovaChief Specialist/ Communicable Diseases, D.M., Ministry of health ChR

Moscow

October 25, 2018

Chelyabinsk Region

HAV incidence/100 000 in ChR

64,1

4

124,

9

164,

7

209,

7

115,

7

58,5

40,0

1

97,9

1

78,8

3

63,2

2

21,0

2

14,8

2

17,2

9

5,33 11

,74

9,29

4,9 11

,3

5,16

6,54 15

,87

9,69

6,05

69,5

9

44,1

718

,87

33,0

1

23,3

1

11,2

8 27,

77

0

50

100

150

200

250

300

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

пока

зате

ль

на 1

00 т

ыс.

нас

.

Россия

Челябинская

область

ChR population as of October 31,2017 –3,5 MM, including cities (82,6%), versus Russia

Данные Управления Роспотребнадзора по Челябинской области

Acute and chronic HBV and HCV (incl. chHBV and chHCV)

22,0623,97

20,5619,51

15,21

15,7516,68

13,9612,06 13,89

79,48

84,65

78,79

77,11

65,86

72,472,37

66,3164,34

59,24

1,49

1,42

1,30

1,19

1,15

0,76

0,52

0,853,

95

3,71

4,2

3,41

3,46

3,34

2,43

3,94

3,21

2,22

0,00

10,00

20,00

30,00

40,00

50,00

60,00

70,00

80,00

90,00

100,00

110,00

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

ХГВ ХГС Вирусный гепатит B

Вирусный гепатит C Носители HBsAg Носители гепатита С

Данные Управления Роспотребнадзора по Челябинской областиUnpublished data compiled by Center for Disease Analysis and register holder

Chronic HCA prevalence in TOP10 regions RF in 2017

87,9484,34

65,36 64,15 63,97

55,42 53,41 53,1 52,7348,16

ChVHC/ 100 000

заболеваемость ХГС на 100 тыс.населения

Форма 2, 2017

Estimated n HCV patients in ChR –108660

HCV elimination in ChR by 2030: myth or reality? Key health sector cascade efforts: current state in ChR?

Awareness and prevention

Follow-up and access toprofessional health care

Testing and diagnosis

Access to treastment

HCV burden

Monitoring and evaluation

Community awareness: mass media, Internet

? Risk group awareness

? Primary care awareness

? Prevention campaign

Testing rate max. 43%

Screening programs available

? Integration of GP and medical specialists

? Testing extrahepatic HCV

Integrating health care into penitentiaries and

health care systems

!! Higher GP role

!!! Access to care for diagnosed patients

Providing AVT for HCV

Access to direct-action AVT drugs

Patient register available

New tested case reporting

Evaluation of outcomes

Road to Elimination: Barriers and Best practicies in Hepatitis C Management. BCG, Boston, 2017

V

V

V

Limited fibrosis

V V

AVT financing

- ChR budget/ program

- MHI- Patients’ copay

V

ChR: ChHV etiology, n = 30057

Данные сегмента Челябинской области Регистра больных вирусными гепатитами, 13 октября 2018 года. https://hepreg.ru/main.html

4317; 53%

539; 7%

3237; 40%

7; 0%

Генотип 1 Генотип 2 Генотип 3 Генотип 4 - 6

HVC genotypes

78%

HCV mono-infections/ patients’ register without SVR – 21790

F0 - 9 961 (35,05%)

F1 - 6 538 (23,00%)

F2 - 4 994 (17,57%)

F3 - 2 964 (10,43%)

F4 - 3 967 (13,96%)

ChVHC fibrosis stages as comparable with the Russian HV register

RF

F2-F4 – 41,96%

F2-F4 – 31%

Данные Федерального Регистра больных вирусными гепатитами (2016) и регионального сегмента Челябинской области (13 октября 2018)

ChHCV health care cascade in ChR in 2015

Newly detected. 5 310 Secondary diagnosis 1 960

Total infected 103 350 Earlier diagnosed 41 240

1 Чуланов В.П., Пименов Н.Н., и др. Терапевтический архив 2015; 11: 5-10 2 Яшина Т.Л., Фаворов М.О., и др. Журнал микробиологии эпидемиологии и иммунобиологии 1993, (5): 46-9.

108 660

43 200

25.680

11.760

110

0

20.000

40.000

60.000

80.000

100.000

120.000

Общее число инфицированных

Диагностированные Без противопоказаний к

ПВТ

Ожидающие ПВТ Получившие ПВТ

Estimated n diagnosed (HCV-РНК +) =Total infected хх share diagnosed (43%)2

Estimated n infected:4,5% of ChR population1

х viremia prevalence (71%)

Projected ChHCV epidemiology pattern change in ChR: WHO scenario

Gradual increase in treated patients up to 3 320/ year;

Gradual increase in primary cases detected up to 7 270/ year;

Gradual incidence decline down to 530 cases/year;

≥F2 express fibrosis treatment.

Disease burden:

2015 2018 2019 2020 2025 2030

Primary cases 1 960 1 960 2 940 4 400 6 600 7 270

N treated 110 970 1 460 2 550 3 320 3 320

Infected cases 5 310 5 340 4 810 2 410 1 060 530

Fibrosis stages ≥F1 ≥F1 ≥F2 ≥F2 ≥F2 ≥F2

Age groups on

treatment15-64 15-64 15-64 15-64 15-69 15-69

SVR 59% 94% 95% 95% 95% 95%

2015

n ChHVC patients (with viremia) 108 660

Mortality from liver disease outcome 156

HCC rate 145

Decompensated cirrhosis 418

Unpublished data compiled by Center for Disease Analysis and register holder

Projected ChHCV epidemiology pattern: WHO strategy vs basic scenarios

Basic scenario

WHO scenario

Decrease in n infected (2015-2030) 55 078 Less new cases (2015-2030) 42 122

Increased n treated(2015-2030) 22 453 Increased n with SVR СВО (2015-2030) 21 351

0

500

1000

1500

2000

2500

3000

350020

15

2016

2017

2018

2019

2020

2021

2022

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2024

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2027

2028

2029

2030

Total treated

0

500

1.000

1.500

2.000

2.500

3.000

3.500

SVR rate

0

20.000

40.000

60.000

80.000

100.000

120.000

140.000

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

Total infected

0

1.000

2.000

3.000

4.000

5.000

6.000

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

Newly infected

Unpublished data compiled by Center for Disease Analysis and register holder

WHO strategy scenario: lives saved

Basic scenario

WHO scenario

Lives saved (2015-2030) 1 112

Cases prevented (2015-2030) 510 Cases prevented (2015-2030) 180

Lives saved (2015-2030) 7 694

0

200

400

600

800

1.000

Decompensated cirrhosis as ChHCVoutcome

0

50

100

150

200

250

300

350

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

Mortality from liver lesion

0

50

100

150

200

250

300

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

HCC rate in ChHCV

0500

1.0001.5002.0002.5003.0003.5004.000

Total mortality

WHO strategy can meaningfully revers ChHCVincidence in ChR to result in:- 51% reduction of those infected - 70% reduction of decompensated cirrhosis incidence- 66% reduction in HCC incidence

Key health sector cascade efforts for HCV control: current state in ChR

Awareness and prevention

Follow-up and access to treatment

Testing and diagnosis

Access to treatment

VHC burden in ChR

Monitoring and evaluation

HCV diagnosis rate max. 43%

Screening programs available

? Integration of GP and medical specialists

? Extrahepatic HCV testing

Integrating health care into penitentiaries and health sector systems

!! Increased role of GP

!!! Diagnosed patient’s access to health care

Providing AVT HCV

Access to AVT drugs

Patients’ register

available

Primary case reporting

Evaluation of outcomes

Road to Elimination: Barriers and Best practicies in Hepatitis C Management. BCG, Boston, 2017

V

V

V

Limited fibrosis

V V

AVT financing

- ChR budget/ program

- MHI- Patient’s copay

V

Community awareness: mass media, Internet

Risk group awareness

? Primary care awareness

Prevention campaigns

Осведомленность и предупреждение

VHC elimination: testing and diagnosis

Main barriers in implementation

Х Screening plans or regulations unavailable (not our case: СП 3.1.3112-13 “VHC prevention"

(Decree 58 of October 22, 2013)

Х Vaguely identified groups with HCV above average incidence, including age cohorts (blood recipients, patients after physician/coach follow-up exercises)

Х The patient has to go far to be screened.

Х PAVT of patients lost to follow-up after screening without PCR confirmation.

Х GP do not comply with screening regulations due to lack of knowledge and time, nor consider ChHCV a priority.

Х Limited access to treatment results in lost motivation to screening

Road to Elimination: Barrierrs and Best practicies in Hepatitis C Management. BCG, Boston, 2017

GP criteria for testing antibodies to HCV

96

84 82

73 70

47

24

0

10

20

30

40

50

60

70

80

90

100

Age cohortsIncreased liver enzymes

% r

esp

on

den

ts

Clinical symptoms

HIV Behavioral and other risks

Chronic liver diseases

Other chronic organ and

system diseases

I do not test for VHC

0

GP survey in ChR, 19.05.2018

Three-tier testing/treatment (also AVT) and D follow-up provided to ChVHC and viral cirrhosis patients (Decree 2111 of

13.12.2016 by ChR Ministry of Health: On VH Adult Patient Routing in ChR.

1. Communicable disease surgeries at polyclinics (or internists and GP, if no infectious disease physician is available);

2. Inter-district liver disease center in ChR south (Magnitogorsk);

3. Liver Disease Center of ChR Clinic, Ministry of Health RF (Chelyabinsk).

Modern VH serologic and molecular diagnosis available;

Intensive use of non-invasive fibrosis testing (Fibroscan US transient elastometry) at LDC CHR;

HCC screening for ChHBV (any fibrosis grade) and ChVHC (F3-F4) and subclinical Cushing syndrome (SCS) ;

HVB and HAV vaccine prophylaxis;

Systematic health worker training (all levels and specialties) by leading Russian professionals : 2017 - 2018 ChR conference:

Hepatitis Virus Agenda; 2 inter-disciplinary roundtables on HCV off-liver patterns; and presentations at regional conferences of

other medical specialties (nephrologists, GP);

Interface with patient associations (hemophilia, nephrology).

Extended collaboration of LDC ChR with other medical professionals (nephrologists, endocrinologists, rheumatologists,

hematologists, etc…). Involving nephrology, endocrinology and other patient in multi-disciplinary follow-up and AVT.

ChHCV treatments provided in 2017 - 2018

GP-detected ChHCV patients under follow-up by infectious disease physician

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

9

~25%0 ~75%~50%

17

~100%

14

19

41

% r

esp

on

den

ts

9,4%

18,8%

17,2%

14,1%

or, if unavailable, referral for consultation to Liver Disease Center ChR Clinic

GP survey, 19.05.2018

Осведомленность и предупреждение

HCV elimination: providing follow-up and access to treatment

Main barriers in implementation

Х Earlier diagnosed, not having treated due to lack of AVT drugs, not reported.

Х Patients, detected outside public health sector, do not reach medical specialists.

Х Ex-convicts.

Х Convicts and patients on physician/coach follow-up exercises

Х Diagnosed patients do not get follow-up at their residence due to various reasons (infectious disease physician or GP unavailable).

Х Patients are not routed as required by ChR Decree 2111 of December 13, 2016.

Road to Elimination: Barrierrs and Best practicies in Hepatitis C Management. BCG, Boston, 2017

Financing and total treated under the Public Commitments Program: Developing ChRHealth Sector in 2015-2018 (ChHBV – blue, ChHCV – orange)

0

20

40

60

80

100

120

2015 2016 2017 2018

доп.финансирование

основное финансирование38,

0

20.0

MM

ro

ub

les

19,6 19.0

57.0

88.0

50.0

56

30

62 67

109

141

0

20

40

60

80

100

120

140

160

Ко

ли

чест

во б

ол

ьны

х, а

бс.

2015 2016 2017

Годы

ХГВ

ХГС

Basic data, treatment regiments and SVR in H1 patients treated under the ChR Program in 2016-2017 гг., n=99

83; 84%

14; 14%2; 2%

3D

DCV+ASV

3D+SOF

Age 54 (29-71)

Liver cirrhosis, n (%) 67 (79%)

Treated earlier, n (%), including

- Triple with ID

- AVT drugs without IFN

19 (19%)

4 (5%)

1 (1%)

EVVD, n (%) 28 (28%)

DM2, n (%) 14 (14%)

CVD, n (%) 31 (31%)

Renal problems, n (%) 18 (18%)

GIT , n (%) 43 (43%)

Cryoglobulinemia , n (%) 32 (32%)

Early treatment termination due to SAE, n (%)

4 (4%) – 2 SVR, 2

– no response

Response to AVT, n (%):

- SVR12 90/91 (99%)

- relapse 1 (1%)

- no data 4

Summary: AVT effectiveness in ChVHC H1 patients, provided under PublicCommitments Program: Developing ChR Health Sector in 2016-2017,matched the respective clinical trial and global clinical practice data.

Thank you!