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)