The Egyptian HCV Control Program

Wahid Doss, MD

Professor of Hepatology ,Cairo University

Head, National Committee for control of Viral Hepatitis, Egypt

Disclosure speaker interests

Disclosure of speaker interest

Conducted clinical trials for Gilead, Jansen, Abbvie

Global Prevalence of Hepatitis C

Countries Responsible for 80% of Global Infections

4

Gower, E., Estes C., Hindman, S., Razavi-Shearer, K., Razavi, H., Global epidemiology and genotype distribution of the hepatitis C virus, Journal of Hepatology (2014)

HCV burden in Egypt is the highest

in the world – a unique challenge

• HCV seroprevalence in Egypt in 2015 estimated to be 4.7% overall;

15-59 years 7%

– National epidemic with social, economic and political

implications. Leading public health challenge.

• Caused initially by extensive iatrogenic transmission during the era

of parenteral-antischistosomal-therapy mass-treatment campaigns.

• > 90% GT 4.

• MOH estimates 150,000–200,000 patients newly infected per year.

Current Disease Burden

• Estimates based on

the 2015

Demographic and

Health Survey

(EDHS)

Current Disease Burden in Egypt

Incidence

•Egyptian data1

– 2–2.25/1,000 = 150,000–200,000 new cases/year• Strongest predictor: Anti-HCV+ family member

(5.8/1,000 vs 1.0/1,000)

• 67% of sero-converters <20 years

• Highest incidence (14.1/1,000 PY) in children <10 years living in households with an anti-HCV+ parent

•Computer simulation:2

– 6.6/1,000 = 514,000 new cases per year

•Europe: 0.08/1,000 in 20093

1. Mohamed MK, et al. Hepatology. 2005;42:683-7; 2. Miller FD & Abu-Raddad LJ. Proc Natl Acad Sci USA. 2010;107(33):14757-62.3. http://www.euro.who.int/en/health-topics/communicable-diseases/hepatitis/data-and-statistics

Burden of HBV and HCV in Egypt Over 20 Years

1996-HCV 15-22%-HBsAg 4.5%-HBcAb 22.5%

2008 (EDHS)-HCV RNA 9.8%(Age 15-59 yrs)

2015 (EDHS)-HCV RNA 7%(Age 15-59 yrs)-HCV-RNA 4.4%(Age 1-59 yrs)-HBsAg 1% -HBcAb 9.9%(1-59 yrs)

Egyptian Government tackling HCV problem

Until 2006 Egypt did not have a comprehensive national

program for control of HCV:

– No large nationwide survey for the disease, accurate

prevelance data unavailable

– Government did not cover HCV therapy

– No national guidelines for treatment

– Limited infection control program

National Committee for Control of Viral Hepatitis Established in 2006

Targets

• National Survey & Burden of Disease

• Develop a National Strategy

• Treatment Program

• Prevention • Awareness

• Infection control

• Clinical Research

• Management of advanced liver disease (ALD)

Outcome

• HCV testing integrated in DHS survey 2008 and 2015

• National Strategy: 2008 -2012 Plan of Action: 2014-2018

• Successful treatment program

• IC remains fragmented

• Hepatitis research units

• Over 15 liver transplant centres

Developments 2011 through 2016

Treatment

• Clinical trials with DAAs (GT4)

• Negotiations & registration of Sofosbuvir 2014

• Web-based national patient enrolment for DAA treatment (>1.5 million so far)

• First patient started treatment Oct 16th 2014

• Other DAAs

introduced in 2015 and 2016

Prevention• Action plan launched Oct 2014

• Components (Surveillance, IC, Blood safety, Vaccination, IEC, Screening, care and treatment

Governorates Treatment centers in Egypt (55)

Treatment Centers

In the villages of the Nile Delta, half of all men older than 50 are infected with hepatitis C.Credit David Degner for The New York Times

Flow Chart for Treatment Enrollment National Program

Patients register on website portal

www.nccvh.org.eg

Appointment

(24 hrs later) & list of required tests

Blood tests

& Abdominal US

Evaluation clinic &

Enrolment

Data Entry from

centers (NNTC)

Management review (medical and

administrative) for approval

Patient gets approval for treatment

Patient starts treatment

FUP data in NNTC

General information for the patients

Web-Based Registration System (Sept 2014)

Fields to be filled for registry online

National IDFull name

Mother namegovernorateMobile no

Appointment given after 24 hrs of registry

National ID

Appointment paper to be printed

Place of appointmentTime of appointmentDate of appointmentNational IDName

Instructions for the patients on their first visit

List of labs required to be available on first visit,performed for free

FAQs

Number of Patients registered online

1,5 1 8,3 2 5

Number of Portal registry

103258

51237 51701

0

20000

40000

60000

80000

100000

120000

18-09-2014 19-09-2014 20-09-2014

Nov 2016First 3 days

972

1055

1015

920

940

960

980

1000

1020

1040

1060

1080

27-11-2016 28-11-2016 29-11-2016

Male/ Female Age groups

Males

Females

62.19%

37.81%

18-30 yrs%8 31-40

yrs%14

41-50 yrs

%26

51-60 yrs

%35

>60 yrs%17

Characteristics of registered patients

mNew sheet

New sheet

New sheet

New sheet

New sheet

New sheet

New sheet

New sheet

Chronology of Treatment Protocols Implemented by the National Program

Date Implmented Protocol Inclusion criteria

2007-2014 PegIFN-RBV F1-F3 patients

October 2014-May 2015 Sofosbuvir-PegIFN-RBV F3,F4 ;IFN tolerant

Sofosbuvir-RBV F3,F4 ;IFN intolerant up to Child B 8 (down to 7)

May 2015-November 2015 Sofosbuvir-PegIFN-RBV F0-F4, normal synthetic function

Sofosbuvir-Simeprevir F0-F4, impaired synthetic function up to Child A6

November 2015 Two DAAs ± RBV F0-F4, impaired synthetic function up to B7. Higher Child in special centers

Timeline for treatment protocolsD

ec-1

4

Jan

-15

Feb

-15

Mar

-15

Ap

r-1

5

May

-15

Jun

-15

Jul-

15

Au

g-1

5

Sep

-15

Oct

-15

No

v-1

5

Dec

-15

Jan

-16

Feb

-16

Mar

-16

Ap

r-1

6

May

-16

Jun

-16

Jul-

16

Sof/IFN/RBV

SOF/RBV

SOF/SIM

SOF/DAC

SOF/DAC/RBV

Generic Sofosbuvir

The total number of patients treated in Egypt (October ’14 –November ’16)

50604657%

25084629%

9964011%

250003%

881532 Patients

NCCVH affiliated centers

health insurance

Cash

Military & other hospitals

*Details of treatment outcome in DAA (IFN/SOF/RBV) protocol

*for first group of patients whose outcome available= 13260 patients

11907; 90%

450; 3%

366; 3%

537; 4%

SVR

relapser

NR

DC

LF; 20

Hematological; 36

Renal impairment

; 1

Undefined; 43

*Details of treatment outcome in DAA (SOF/RBV) protocol

*for first group of patients whose outcome available= 7958 patients

6040; 76%

984; 12%

168; 2%766; 10%

SVR

relapser

NR

DCLF; 36

Hematological; 30

Renal impairment

; 1

Undefined; 33

%

*Details of treatment outcome in DAA (SOF/SIM) protocol

*for first group of patients whose outcome available= 6160 patients

5739; 93%

129; 2%156; 3%

136; 2%

SVR

relapser

NR

DCLF; 65

Hematological; 3

HCC; 4

Undefined; 28

%

*Details of treatment outcome in DAA (SOF/DAC) protocol

*for first group of patients whose outcome available= 10120 patients

9653; 95%

108; 1%259; 3%

100; 1%

SVR

relapser

NR

DCLF; 15

Hematological; 5 HCC; 4

Undefined; 76

%

*Details of treatment outcome in DAA (SOF/DAC/RBV) protocol

*for first group of patients whose outcome available= 8258 patients

7820; 95%

89; 1%183; 2%

166; 2%

SVR

relapser

NR

DCLF; 24

Hematological; 5 HCC; 3

Undefined; 76

%

Summary SVR for each treatment protocol

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

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

90%

76%

93% 95% 95%

Pe

rce

nt

Economic Burden

• HCV infection is a huge economic burden in Egypt

– Direct healthcare cost US$ 670 Mln

– Indirect economic impact of disability US$ 3.7 Bln

– Close to 1.8% of the GDP (Similar to DM and CVD cost in the US)

– Intangible costs to society and families not assessed

• Treatment of large numbers of patients with effective therapy is the best option for control

– Curing a patient saves ~ US$ 10,000 for the next 15 years Preventing a case saves ~ US$ 20,000 for the next 40 years

– without active prevention there will be 1Mln more cases in 2030

Estes C, et al. Alim. Pharm. Ther. 2015

HCV Control in Egypt : Challenges

• Generics:

- Quality assurance

- Voluntary licensing

- Prequalification

• Lack of legislations

• Political competing priorities

• Lack of patient support groups

• Tailored protocols

• Access

- Remote areas

- Shorter duration & less visits

- Children

• Screening

- Rapid tests?

- Compulsory testing?

- Repeat Testing?

• Quality Assurance and monitoring

• Stigma

- Adults

- Children

HCV Control in Egypt : Constraints

• Fragmentation of health care delivery system

– Different health sectors (MoHP; MoHE; HIO; private; military; police and others…)

– poor coordination

– However, multi-sectoral VH action plan.

• Financial constraints (no specified budget for prevention).

• Address lessons & gaps for strengthening of treatment

program (only 45% report SVR, data incomplete)

12/5/2016 43

AcknowledgementNCCVH (2006-Current)

Prof Wahid Doss (Chair)

Prof Gamal Esmat

Prof Moustafa K Mohamed (late)

Prof Manal H El-Sayed

Dr Nasr El-Sayed (Former MoH)

Dr Arnaud Fontanet

Recent Members

Prof Magdy El-Serafy

Prof Ayman Yousry

Prof Ashraf Omar

Prof Wagida Anwar

Prof Maissa Shawky

Dr Amr Kandil (MoH)

WHO-TAG for Prevention, Control and

Treatment of Viral Hepatitis (June 2011)Dr. Arnaud Fontanet (Chair)

Prof Manal H El-Sayed (Vice Chair)

Dr Francisco Averhoff

Dr Steven Wieresma

Prof Gamal Esmat

Prof Wahid Doss

Prof Mohsen Gadallah

Dr Jaoad Mahjour

Ad hoc International Experts

Prof Mark Thursz

Dr David Goldberg

Special Acknowledgement for Efforts in Development and Printing of PoAMr Henk BekedamDr Nasr TantawyMs Amy KolwaiteMs Adeline BernerWHO country office teamDr Sahar Shorbagy (MoH)