The Egyptian HCV Control Program

Transcription

1 The Egyptian HCV Control Program Wahid Doss, MD Professor of Hepatology,Cairo University Head, National Committee for control of Viral Hepatitis, Egypt

2 Disclosure speaker interests Disclosure of speaker interest Conducted clinical trials for Gilead, Jansen, Abbvie

3 Global Prevalence of Hepatitis C

4 Countries Responsible for 80% of Global Infections 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)

5 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; 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 patients newly infected per year.

6 Current Disease Burden Estimates based on the 2015 Demographic and Health Survey (EDHS)

7 Incidence Current Disease Burden in Egypt Egyptian data /1,000 = 150, ,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 Mohamed MK, et al. Hepatology. 2005;42:683-7; 2. Miller FD & Abu-Raddad LJ. Proc Natl Acad Sci USA. 2010;107(33):

8 Burden of HBV and HCV in Egypt Over 20 Years HCV 15-22% -HBsAg 4.5% -HBcAb 22.5% 2008 (EDHS) -HCV RNA 9.8% (Age yrs) 2015 (EDHS) -HCV RNA 7% (Age yrs) -HCV-RNA 4.4% (Age 1-59 yrs) -HBsAg 1% -HBcAb 9.9% (1-59 yrs)

9 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

10 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: Plan of Action: Successful treatment program IC remains fragmented Hepatitis research units Over 15 liver transplant centres

11 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 16 th 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

12 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

13 Flow Chart for Treatment Enrollment National Program Patients register on website portal Management review (medical and administrative) for approval Patient gets approval for treatment Appointment (24 hrs later) & list of required tests Data Entry from centers (NNTC) Patient starts treatment Blood tests & Abdominal US Evaluation clinic & Enrolment FUP data in NNTC

14 Web-Based Registration System (Sept 2014) General information for the patients

15 Fields to be filled for registry online National ID Full name Mother name governorate Mobile no

16 Appointment given after 24 hrs of registry National ID

17 Appointment paper to be printed Instructions for the patients on their first visit Place of appointment Time of appointment Date of appointment National ID Name

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

19 FAQs

20 Number of Patients registered online 1,5 1 8,3 2 5

21 Number of Portal registry First 3 days Nov

22 Characteristics of registered patients Age groups Male/ Female >60 yrs % yrs % yrs %14 %37.81 % yrs % yrs %26 Females Males

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31 Chronology of Treatment Protocols Implemented by the National Program Date Implmented Protocol Inclusion criteria 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

32 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Timeline for treatment protocols Sof/IFN/RBV SOF/RBV SOF/SIM SOF/DAC SOF/DAC/RBV Generic Sofosbuvir

33 The total number of patients treated in Egypt (October 14 November 16) Patients % % % % NCCVH affiliated centers health insurance Cash Military & other hospitals

34 *Details of treatment outcome in DAA (IFN/SOF/RBV) protocol 450; 3% 366; 3% 537; 4% 11907; 90% SVR relapser NR DC Undefine d; 43 Hematolo gical; 36 Renal impairment ; 1 LF; 20 *for first group of patients whose outcome available= patients

35 *Details of treatment outcome in DAA (SOF/RBV) protocol 168; 2% 766; 10% 984; 12% SVR relapser NR Undefine d; 33 Hematolo gical; 30 Renal impairment ; ; 76% DC LF; 36 % *for first group of patients whose outcome available= 7958 patients

36 *Details of treatment outcome in DAA (SOF/SIM) protocol 129; 2% 156; 3% 136; 2% 5739; 93% SVR relapser NR DC Undefine d; 28 Hematolo gical; 3 LF; 65 HCC; 4 % *for first group of patients whose outcome available= 6160 patients

37 *Details of treatment outcome in DAA (SOF/DAC) protocol 108; 1% 259; 3% 100; 1% 9653; 95% SVR relapser NR DC Undefine d; 76 Hematolo gical; 5 HCC; 4 LF; 15 % *for first group of patients whose outcome available= patients

38 *Details of treatment outcome in DAA (SOF/DAC/RBV) protocol 89; 1% 183; 2% 166; 2% 7820; 95% SVR relapser NR DC Undefine d; 76 Hematolo gical; 5 HCC; 3 LF; 24 % *for first group of patients whose outcome available= 8258 patients

39 Percent Summary SVR for each treatment protocol 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 90% 93% 95% 95% 76% SOF/IFN/RBV SOF/RBV SOF/SIM SOF/DAC SOF/DAC/RBV

40 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

41 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

42 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)

43 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) Acknowledgement 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 Developmen and Printing of PoA Mr Henk Bekedam Dr Nasr Tantawy Ms Amy Kolwaite Ms Adeline Berner WHO country office team Dr Sahar Shorbagy (MoH) 12/5/

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