National Strategy for Control and Prevention of Viral Hepatitis:

An Update

Manal Hamdy El-Sayed Professor of Pediatrics Ain Shams University

National Committee for Control for Viral Hepatitis

11/6/2014 2

The National Committee for Control of Viral Hepatitis (NCCVH) Established by MoH in 2007 Objectives: • National Survey & Burden of Disease • Develop a National Strategy • Treatment Program • Prevention

• Awareness and media Campaign • Infection control

• Clinical Research • Management of advanced liver disease

http://www.pasteur-international.org/ip/resource/filecenter/document/01s-000042-0da/nsp-10-april-2008-final.pdf

11/6/2014 3

HCV National Survey: DHS 2008

www.measuredhs.com/pubs/pdf/FR220/FR220.pdf

3 3 3 7 813 17

23 25

4 5 612 14

2329

39 40

15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59

HCV antibody

HCV RNA

Percentage of HCV-infected individuals between 15-59 years Anti-HCV prevalence:

-15 years 3.8% -19 years 4.9%

11/6/2014 4

HCV Prevalence and Medical Procedures

13,6

22,2

13,2

25,3

12,2 15,3

9,2 14,1

8,6

16,7

7,9 7,3

0

10

20

30

% HCVABPOSITIVE

22,1 26,7

20,1

31,5

17,9

31,8

15,5 18,2 14

21,1

12,4

26,7

0

10

20

30

40

SURGERY BLOOD Tx DENTAL ANTI SCHISTOINJECTION

INJECTION FOROTHERS

REUSEDSYRINGES

WOMEN

MEN

11/6/2014 5

Patient Management Improved access to treatment, including the opening of

Viral Hepatitis Treatment Centers (VHTC): 26 centers nation-wide.

Treatment of 360,000 patients (2006-2014).

Reductions in the price of drugs, and expanded government subsidization of antiviral therapy.

Attaining optimal clinical management of all patients, (including pediatric patients and persons suffering from advanced liver disease)

11/6/2014 6

Treatment Centers allover Egypt (26)

11/6/2014 7

National Network for Treatment Centers (NNTC)

• A Network for all patients’ data from the Viral Hepatitis Treatment Centers nation-wide, was established with the main server located in National Hepatology Institute in Cairo.

• NNTC has pre-enrollment data and treatment of 360,000 HCV patients

11/6/2014 Free template from www.brainybetty.com 8

Recent Treatment Program Milestones 2014

• Negotiations for Sofosbuvir (March) • Fast track registration and MoU signed (July) • Guidelines approved nationally (August 2014) • National Patient enrolment for DAA treatment

September • First patient started treatment October 16th • Other DAAs will be introduced in 2015 (some

already under fast track registration)

11/6/2014 9

Cost Effectiveness Chart

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

P/R 48 P/R/SOF 12 WK R/SOF 24 WK *R/SOF 12 WK

120,000 L.E

12,000 L.E 9600 L.E 12,600 L.E 6600 L.E COST/PT

*NAÏVE, NON CIRRHOTIC, LOW VIREMIA,

SVR %

11/6/2014 10

Appointment Evaluation clinic

Physician (checklist)

Enrollment sheet

Data entry from centers

Realtime data in NNTC

Final Decision Regimen

Decision sent online

Start ttt, FUP sheet

Flow chart for treatment procedure

Online registration system

Registry Data First 4 Days

# of pts

Date

Registry Data Through October 27th

Date

Registry Data: Gender Distribution

11/6/2014 14

Males Females

Registry Data: Age Distribution

11/6/2014 15

Males

Anti-diversion mechanisms

11/6/2014 16

• Patient QR code Encrypted

• Patient QR code Unencrypted

Patient Name: Mohamed Fawzy Patient Address: 20 Salah Salem Street, Heliopolis,Cairo, Egypt Invoice date: 01/08/2016 Invoice Number: 6375627 Bill to Party: National Liver Institute in Cairo Payer: Ministry of health PCR count: 6575778 Product Name: Sovaldi 400MG Product Code: 255363 Batch Number: AB 3223 Expiry Date: 01/08/2018

PE:nk»Îh�ó~j#B`«ý7!%ÃÛA*Ó�&ý£Êf�Rú�ÍÜîT±;6ü<FMçà»®�=\Ûìû^�Ñv-á]ÌôÄÆ$à�I��»±Êȶ\±¾#§¹Æt&ñb1è�Ë#'³ñ?�Pzk1íOt£�Uèò¼V��Ùs)�µ;j�zy³U2Fìú +½T;

11/6/2014 17

Components of VH PoA 1. Strengthening surveillance to detect viral hepatitis

transmission and disease (acute and chronic) 2. Promoting Infection Control Practices to Reduce

Transmission of Viral Hepatitis 3. Improving blood safety to reduce transmission of viral

hepatitis 4. Eliminating Transmission of vaccine-preventable viral

hepatitis 5. Role of care & treatment in reducing transmission of viral

hepatitis 6. Educating providers and communities to reduce transmission

of viral hepatitis 7. Research Agenda for Viral Hepatitis

11/6/2014 18

Communication Plan

11/6/2014 19

11/6/2014 20

Proposed Disease Control Strategy

Wedemeyer et al. JVH, 2014 Waked et al, AJG, 2014

2014 2030 Base Case

6,000,000

4,420,000 -26% Increased treatment & SVR, reduce incidence 285,000 -95%

Increased treatment &SVR, without incidence reduction

1,250,000 -79%

-1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000 7,000,000

Total Infected Cases (Viremic) - Egypt

Basecase

Increased Efficacy & Treatment

Increased Efficacy & Treatment-No Incidence Reduction

11/6/2014 21

Key to Success • Data and situation analysis • Integration of efforts • Empowerment and demand

Patients Physicians NGOs

Organisations Foundations

Government Advocacy

Politicians

MEDIA

11/6/2014 22

Acknowledgement

NCCVH (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 PoA Mr Henk Bekedam Dr Nasr Tantawy Ms Amy Kolwaite Ms Adeline Berner WHO country office team Dr Sahar Shorbagy (MoH)