Prof. Gamal EsmatProf. Hepatology &Ex. Vice President of Cairo University, Egypt

Member of WHO Strategic Committee for Viral Hepatitis

www.gamalesmat.com

Towards HCV Elimination in Egypt by 2020

Elimination

• Vision “A world where viral hepatitis transmission is stopped andeveryone has access to safe, affordable and effective treatment andcare”

• Elimination as a public health issue of concern -remove sustained transmission, remove hepatitis as a leading cause of mortality:

– Elimination and not eradication: long wave of prevalence will remain for decades

Global prevalence &genotype distribution

SUDAN

EGYPT

Upper Egypt

19.4%

(95% CI: 17.2-21.6)

Middle Egypt

26.5%

(95% CI: 23.7-29.4)

Alexandria 5.9%

(95% CI: 4.2-7.7)

Lower Egypt

28.4%

(95% CI: 27.1-29.2)

Cairo

8.2% (95% CI: 6.7-9.8)

LIBYA Red

Sea

Geographic HCV prevalence 1996

Frank et al., (2000)

Trends in Percentage of population age 15-59 testing positive HCV Ab, Egypt

1996-2008-2015

22.920.1

25.8

14.211.8

16.6

10 9

12

total Women Men

Chart Title

1996 2008 2015

Our aim

to maintain a disease Control (by reaching international prevalence disease rates with 2%infection rate compared with the current 7% infection rate).

To reach for disease Elemination(disease rate <1%)

Waked,……,Esmat.et.al .Ar.J.G.2014

Phase 1 Interferon Treatment for some

Opening of 23 national treatment centres, 2007-2013

Total number of patients treated with PEG-IFN (2007-2013): 350,000Annual number of new patients treated: 45,000Annual budget from the Ministry of Health: 90 million $

Better understanding of therapeutic targets

Phase 2 DAA Treatment for All

• Increase policymakers’ commitment to supporting the policy change necessary to prevent viral hepatitis transmission.

• Educate healthcare workers to prevent transmission of viral hepatitis in Egypt.

• Increase public awareness of viral hepatitis prevention.

• Promote safe injection practices in the community.

• Annual treatment of 200-350.000 patients by DAA.in 46 centers in 2015 aiming to reach 100 centers by the end of 2016

Egyptian National Plan of Action for the Preventton , Care & Treatment of Viral Hepatitis 2014–2018

The number of treated patients in Egypt has

increased dramatically with the introduction

of DAAs

Polaris Observatory. Hepatitis C. Available at:

http://polarisobservatory.org/polaris_view/graphs.htm (accessed November 2017)

2012 2014 20162010

250,000

500,000

750,000

02008

Year

Nu

mb

er

of

pati

en

ts t

reate

d

DAAs Battle

National Victory Phase

Generics(15% of the brands)

Negotiation Phase

Brands(1% of its USA price)

12

The cost of 3 months treatment(sofo+dacla) per patientBrand vs Generic( 1$=17 EP)

EP 10.545

EP 1.527

0

2,000

4,000

6,000

8,000

10,000

12,000

Reduced by 85,5 %

SOF-DAC/RBV

600.000 Patients in 2016

Money Saved Over 12 Months(600.000 Patients)

600,000

patients

15%

5,359,200,000 EP

Availability of the generic drugs in a reduced price encourage people to take medication from private sector (300.000 patients)

28/07/2016NO waiting lists

Study Design

Total patients enrolled = 300, all patients completed treatment evaluations as of the data cutoff for this report

High percentage of cirrhotic patients: 130/300 (43.3%)

IFN-Experienced

n=70

RDV+SOF+RBV n=35 SVR4 SVR12

SVR4 SVR12

SVR24

SVR24

Group 3

IFN-Experienced

n=80

RDV+SOF n=40

RDV+SOF+RBV n=40

SVR4 SVR12

SVR4 SVR12

SVR24

SVR24Group 2

RDV+SOF+RBV n=35

0 12 16 24 36Time (weeks)

20 40

IFN Naïven=60

RDV+SOF n=31

RDV+SOF+RBV n=29

SVR4 SVR12

SVR4 SVR12

SVR24

SVR24

Cirrhotic Treatment Follow-up

Group 1b

SVR4 SVR12IFN Naïven=90

RDV+SOF n=45

RDV+SOF+RBV n=45

SVR24

SVR4 SVR12 SVR24

Non-Cirrhotic Treatment Follow-up

Group 1a

28

Among the 170 non-cirrhotic patients enrolled, there were three early discontinuations unrelated to safety or efficacy failure, WITH NO RELAPSES

100% SVR12 in non-cirrhotic patients , excluding discontinuations

SVR12 Outcomes in Non-Cirrhotic Patients (ITT)P

erc

en

t o

f P

atie

nts

100

80

60

20

0

SVR12 Relapse

100% 98%

0%

100%95%

Treatment Naive IFN Experienced

RDV+SOF RDV+SOF+RBV RDV+SOF RDV+SOF+RBV

Discontinuation

0% 0% 0%

0%

0%2.0

%

5%

40

Group 2Group 1a

SVR12 Outcomes in Cirrhotic Patients (ITT)P

erc

en

t o

f P

atie

nts

100

80

60

20

0

SVR12 Relapse

93% 92%

0%

100%

86%

Treatment Naive IFN Experienced

RDV+SOF RDV+SOF+RBV RDV+SOF+RBV 12 Wk RDV+SOF+RBV 16 Wk

Discontinuation

7%

4% 1

0.5

.%

0%

0%4

%

3.5

.%

40

Among the 130 cirrhotic patients enrolled, there were two premature discontinuations (one safety related) and 6 virologic relapses

No relapses to date in the cirrhotic 16 week treatment cohort

Per protocol evaluation results in 94% SVR12 in cirrhotic patients

Group 1b Group 3

WHO adds ravidasvir to HCV recommendation guidelines

August 9, 2018

• The World Health Organization has added ravidasvir as a future pangenotypic direct-acting antiviral to the list of recommended therapies in their Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C

• Previously, ravidasvir has demonstrated high sustained virologic response rates in combination with other approved DAA regimens.

• One study of combined ravidasvir with Sovaldi(sofosbuvir, Gilead Sciences) among Egyptian patients had an overall SVR rate of 98%.

Where Egypt was (<2014)

IFN SVR

Waked I, et al. Arab J Gastroenterol 2014;15:45–52; National Registry, data on file IFN: interferon; SVR: sustained virological response

6,000,000 20% 30%50%

(3%)

Diagnosed

patients

HCV-infected

patients

Where Egypt is after 2014

SVRDAADiagnosed

patients

HCV-infected

patients

6,000,000 20% 90–95%90–95%

(16%)

Waked I, et al. Arab J Gastroenterol 2014;15:45–52; National Registry, data on file DAA: direct-acting antiviral agent

Treatment outcome for the different Protocols (Real Life)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

SOF/IFN/RBV SOF/RBV SOF/SIM SOF/DAC SOF/DAC/RBV

90%

78%

93% 97% 96%

Perc

ent

A. Elsharkawy, R. Fouad, W. El Akel, M. El Raziky, M. Hassany, G. Shiha, M. Said, I. Motawea, T. El Demerdash, S. Seif, A. Gaballah, Y. El Shazly, M. A. M. Makhlouf, I. Waked, A. O. Abdelaziz, A. Yosry, M. El Serafy, M. Thursz, W. Doss, G. Esmat . Sofosbuvir-based treatment regimens: real life results of 14 409 chronic HCV genotype 4 patients in Egypt. Aliment Pharmacol Ther 2017; 45: 681–687

Rasha Eletreby | Wafaa Elakel | Mohamed Said | Mohamed El Kassas| Sameh Seif | Tamer Elbaz | Maissa El Raziky | Siham Abdel Rehim| Samy Zaky | Rabab Fouad | Hadeel Gamal Eldeen | Mahmoud Abdo | Mohamed Korany | Ayman Yosry | Magdy El Serafy | Manal Hamdy El-Sayed | Yehia ElShazly | Imam Waked| Wahid Doss| Gamal Esmat. Real life Egyptian experience of efficacy and safety of Simeprevir/ Sofosbuvir therapy in 6211 chronic HCV genotype IV infected patients. Liver International 2016; 1–8

Phase 3(Targeted screening for HCV in Egypt)

• Families of HCV patients

• Healthcare providers

• Prisoners

• Students admitted to universities

• Patients attending intervention

procedures in hospitals

Esmat G, personal opinion ID: identification document

Screening ProgramLaunched in August 2016

Screened 3,300,000 till August 2017

3,300,000 screened subjects

1,500,000

6 categories

1,800,000

Field screening

Saliva rapid testELISA test

•Upper Egypt•All age groups

•Inpatients•Health care workers•Prisoners•First year students•Submitted for travel•Blood banks Donors

Screening results till Aug 2017 3,300,000

HCV Ab +ve, 290400

HCV Ab -ve, 3009600

HCV RNA +ve86%

HCV RNA -

ve14%

249744 patients need to be treated

Our aim

to maintain a disease Control (by reaching international prevalence disease rates with 2%infection rate compared with the current 7% infection rate).

To reach for disease Elemination(disease rate <1%)

Waked,……,Esmat.et.al .Ar.J.G.2014

Curing of 3,750,000 patients should be considered to reach 2% infection rates.

Curing of 5,000,000 patients to reach less than 1% infection rate, during selected

period of time.

Waked,……,Esmat.et.al .Ar.J.G.2014

Elimination of HCV in Egypt

Total number of treated patients in Egypt

110000055%

48500024%

35000018%

450002%

250001%

2,005,000patients

governmental support

HIO

private

*Police & Army forces

Presidential initiative

Before mass screening initiative in 1st Oct 2018

Where Egypt could go! (>2018)

SVRDAA

Slides with courtosy of Prof. H. Wedemeyer

Diagnosed

patients

Diagnosed

patientsDAA SVR

Waked I, et al. Arab J Gastroenterol 2014;15:45–52; National Registry, data on file

HCV-infected

patients

6,000,000 90–95% 90–95% 90–95%

Phase 4 Screening for All

www.thelancet.com/gastrohep Vol 3 October 2018

People treated so far have mostly been those living with the diagnosis, and a few hundred thousand who were identified through screening programs over the past year.

Epidemiological studies show that, in addition to those who have already been treated, there are 3–4 million individuals with undiagnosed HCV infection in Egypt.

This pool of undiagnosed individuals, if untreated, is at risk of progressive disease and is a potential source of infection over the coming years.

www.thelancet.com/gastrohep Vol 3 October 2018

On July 29, 2018,

Egypt embarked on the largest disease screening campaign in history.

By September, 2019, the Ministry, through the NCCVH, will screen all adults aged 18 years and older in Egypt

(currently a population of 59 million, targeting 52 million individuals after exclusion of those who have been treated or screened before).

Screening will include testing for HCV antibodies, and assessment for hypertension, diabetes, and obesity.

Campaign Phases and Governorates Distribution

Phase Time frame Boarder Gov. Lower Egypt Urban Gov. Upper Egypt

OneOctober-

December 2018

South Sinai Damietta Port Said Fayoum

MatrouhBehira

Alexandria AsuitQalubia

TwoDecember 2018-February 2019

North Sinai Kafr Elsheikh Cairo Sohag

Red Sea Menofia

Ismailia Beni Swif

Swiss Luxor

Aswan

ThreeMarch- April

2019New Valley

Gharbia

Giza

Menia

ShariqaQena

Dakahlia

39

مليون مواطن من بداية الحملة26.85

27• Million citizens from

1/10/2018 to 15/1 /2019

• Team componentMedical member (Physician,

pharmacist dentist)

Nurse and IT Specialist

43

لة نتائج المرحاألولى

44

نسبة تحقيق المستهدف الكلي بين

محافظات المرحلة األولى

85% 85%77% 76%

72% 71% 71%62% 59%

نسبة تحقيق المستهدف الكلي

%75= متوسط تحقيق المستهدف الكلي بين محافظات المرحلة األولى

45

نسب اإلصابة بفيروس سي بين

محافظات المرحلة األولى

%4= بفيروس سي بين محافظات المرحلة األولى متوسط اإلصابة

6%5%

4% 4%

3% 3% 3%2% 2%

نسبة اإلصابة فيروس سي

46

دل/ ملجم 200نسبة ارتفاع السكر العشوائي بالدم عن

بين محافظات المرحلة األولى

6% 5% 5%5%

4% 4% 4% 3% 3%

200نسبة ارتفاع السكر بالدم عن

%4= بين محافظات المرحلة األولى متوسط ارتفاع السكر بالدم

47

مل زئبق140/90نسبة ارتفاع ضغط الدم عن

بين محافظات المرحلة األولى

%21= مل زئبق بين محافظات المرحلة األولى 140/90متوسط ارتفاع ضغط الدم عن

30%27%

24%21% 21% 19% 17% 16% 16%

نسبة ارتفاع ضغط الدم

48

نسبة اإلصابة بالسمنة

بين محافظات المرحلة األولى

%37= متوسط اإلصابة بالسمنة بين محافظات المرحلة األولى

47% 46%42%

38% 38%31% 31% 31%

26%

نسبة اإلصابة بالسمنة بين محافظات المرحلة األولى

49

Flow of patients in screening initiative

All screened

HCV AB +ve

PCR testing

PCR +veLab tests

+ /- USTreatment

PCR -veHCV AB

-ve

Registrationموقع الحجز

HCV treatment Unitsوحدات العالج

Sourceشبكة ربط وحدات العالج

50

345903

553347

866768

0

100000

200000

300000

400000

500000

600000

700000

800000

900000

1000000

Till 24 Nov 2018 Mid Dec 2018 Mid Jan 2019

Total number *registered on nccvh.org.eg Since 1st October 2018 till 15 Jan 2019

*Automated registration from screening sites (first & second phase)

51

2019فبراير13نتائج المرحلة الثانية حتى

52

تحقيق المستهدف الكلي

%78= متوسط تحقيق المستهدف بين محافظات المرحلة الثانية

91%87%86%

76%76%75%74%72%68%66%

47%

نسبة تحقيق المستهدف الكلي بين محافظات المرحلة الثانية

53

نسب اإلصابة بفيروس سي

بين محافظات المرحلة الثانية

%4= بين محافظات المرحلة الثانية متوسط اإلصابة بفيروس سي

8% 8%

5%4% 4% 4% 3% 3% 3%

2% 2%

نسبة اإلصابة فيروس سي بين محافظات المرحلة الثانية

HCV treatment in 2013 and strategies to reduce

the burden of HCV by 2020

Waked I, et al. Arab J Gastroenterol 2014;15:45–52

2013

2020

a) Increase

efficacy only

b) Increase

efficacy and treatment

Treated (annual) 65,000 65,000 325,000

Treatment rate 1.1% 1.1% 7.1%

Average SVR 48% 90% (2014) 90%

Newly diagnosed (annual)

125,000 125,000 340,500

Common treatment age 15–59 15–59 15–74

Treated stages ≥ F2 ≥ F2 ≥ F0

6,000,000

4,045,000

280,000

0

1,000,000

2,000,000

3,000,000

4,000,000

5,000,000

6,000,000

7,000,000

Total infected

-95%

630,000

507,000

76,000

0

200,000

400,000

600,000

800,000

Compensated cirrhosis

-88%

16,000 16,000

2,400

0

5,000

10,000

15,000

20,000

HCC

-85%

138,000

110,000

17,000

0

50,000

100,000

150,000

Decompensated cirrhosis

-87%

2013

201320132013

2030a 2030b

2030a 2030b2030a 2030b2030a 2030b

Number of deaths/year from selected conditions,Global Burden of Disease Study 2010 and 2013

Endorsement of success

.

Endorsement of success

From Land Of History

We will Make HCV a History

THANK YOUplease visit

www.gamalesmat.com

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