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Towards HCV Elimination in Egypt by 2020 Towards HCV Elimination in Egypt by 2020 Prof. Gamal Esmat Prof. Hepatology &Ex. Vice President of Cairo University, Egypt Member of WHO Strategic Committee for Viral Hepatitis www.gamalesmat.com Elimination • Vision “A world where viral hepatitis transmission is stopped and everyone has access to safe, affordable and effective treatment and care” • 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 Geographic HCV prevalence 1996 Alexandria 5.9% (95% CI: 4.2-7.7) Cairo 8.2% (95% CI: 6.7-9.8) L Lower Egypt I 28.4% B (95% CI: 27.1-29.2) Y A Middle Egypt Red 26.5% Sea (95% CI: 23.7-29.4) Upper Egypt 19.4% (95% CI: 17.2-21.6) EGYPT Frank et al., (2000) SUDAN Trends in Percentage of population age 15-59 testing positive HCV Ab, Egypt 1996-2008-2015 Chart Title 1996 2008 2015 25.8 22.9 20.1 16.6 14.2 11.8 12 10 9 total Women Men 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): 350,000 Annual number of new patients treated: 45,000 Annual 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 750,000 500,000 250,000 Number Number of patients treated 0 2008 2010 2012 2014 2016 Year Polaris Observatory. Hepatitis C. Available at: http://polarisobservatory.org/polaris_view/graphs.htm (accessed November 2017) DAAs Battle Negotiation Phase Brands(1% of its USA price) National Victory Phase Generics(15% of the brands) 12 The cost of 3 months treatment(sofo+dacla) per patient Brand vs Generic( 1$=17 EP) 12,000 EP 10.545 10,000 8,000 Reduced by 85,5 % 6,000 4,000 2,000 EP 1.527 0 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) 28/07/2016 NO waiting lists Study Design Non-Cirrhotic Treatment Follow-up IFN Naïve RDV+SOF n=45 SVR4 SVR12 SVR24 Group 1a n=90 RDV+SOF+RBV n=45 SVR4 SVR12 SVR24 IFN- RDV+SOF n=40 SVR4 SVR12 SVR24 Group 2 Experienced n=80 RDV+SOF+RBV n=40 SVR4 SVR12 SVR24 Cirrhotic Treatment Follow-up IFN Naïve RDV+SOF n=31 SVR4 SVR12 SVR24 Group 1b n=60 RDV+SOF+RBV n=29 SVR4 SVR12 SVR24 IFN- RDV+SOF+RBV n=35 SVR4 SVR12 SVR24 Group 3 Experienced n=70 RDV+SOF+RBV n=35 SVR4 SVR12 SVR24 Time (weeks) 0 12 16 20 24 28 36 40 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%) SVR12 Outcomes in Non-Cirrhotic Patients (ITT) 100% 100% 100 98% 95% 80 60 Group 1a Group 2 40 Percent of Patients Percent 20 % % % 5 % % % % % 0 2.0 0 0 0 0 0 0 Treatment Naive IFN Experienced RDV+SOF RDV+SOF+RBV RDV+SOF RDV+SOF+RBV SVR12 Discontinuation Relapse 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 Cirrhotic Patients (ITT) 100 100% 93% 92% 86% 80 60 Group 1b Group 3 40 .% Percent of Patients Percent 20 % .% % % 7 10.5 4 4 % % % 3.5 0 0 0 0 Treatment Naive IFN Experienced RDV+SOF RDV+SOF+RBV RDV+SOF+RBV 12 Wk RDV+SOF+RBV 16 Wk SVR12 Discontinuation Relapse 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 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) HCV-infected Diagnosed IFN SVR patients patients 50% 6,000,000 20% 30% (3%) Waked I, et al. Arab J Gastroenterol 2014;15:45–52; National Registry, data on file IFN: interferon; SVR: sustained virological response Where Egypt is after 2014 HCV-infected Diagnosed DAA SVR patients patients 90–95% 6,000,000 20% 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) 97% 96% 100% 90% 93% 90% 78% 80% 70% 60% 50% Percent 40% 30% 20% 10% 0% SOF/IFN/RBV SOF/RBV SOF/SIM SOF/DAC SOF/DAC/RBV 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 Program Launched in August 2016 Screened 3,300,000 till August 2017 1,500,000 3,300,000 6 categories screened subjects 1,800,000 •Inpatients •Health care workers Field screening •Prisoners •First year students •Upper Egypt •Submitted for travel •All age groups •Blood banks Donors ELISA test Saliva rapid test Screening results till Aug 2017 3,300,000 HCV Ab +ve, 290400 HCV Ab -ve, HCV RNA - 3009600 ve 14% HCV RNA +ve 86% 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 Elimination of HCV in Egypt 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 Total number of treated patients in Egypt 2,005,000patients 25000 45000 1% 2% 350000 18% governmental support 1100000 HIO 55% 485000 private *Police & Army forces 24% Presidential initiative Before mass screening initiative in 1st Oct 2018 Where Egypt could go! (>2018) HCV-infected DiagnosedDiagnosed DAADAA SVRSVR patients patientspatients 6,000,000 90–95% 90–95% 90–95% Waked I, et al. Arab J Gastroenterol 2014;15:45–52; National Registry, data on file Slides with courtosy of Prof. H. Wedemeyer Phase 4 Screening for All 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.
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