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SVR12 by HCV Genotype

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SVR12 by HCV Genotype HCV Treatment in the Era of DAA Prof. Gamal Esmat Prof. Hepatology & Vice President of Cairo University, Egypt Member of WHO Strategic Committee for Viral Hepatitis www.gamalesmat.com Global genotype distribution . Under auspices of Ministry of Health. Implemented in association with DHS Egypt and MACRO international. Funding from USAID and UNICEF. Hepatitis C testing undertaken at the central Laboratory of MOH. Household survey in 28 governorates. ELISA test used to determine presence of antibodies. Real time PCR testing for HCV RNA for all antibody positive samples to detect active infections. National Survey (DHS) 2015 (1 -59 years) 2015(1-59 Y) HCV Ab 6.3% HCV PCR 4.4% Percentage of women and men with an active hepatitis C infection by age, Egypt 2015 30 27.8 25 23.7 20 17.6 16.1 15 women 12.4 men 10 10.8 10.4 7.1 6.9 7.3 5 4.7 5.3 3.1 3.2 1.5 1.9 0 0.69 19-15 24-20 29-25 34-30 39-35 44-40 49-45 54-50 59-55 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 Evolution of HCV treatment and SVR rates 1989 2011 2013 2014/15 95–100 100 Number Column1 Genotype 2/genotype 3 85–97 80–90 61–79 76–82 80 66–79 60 31–44 42–46 40 33–36 18–39 6–19 11–19 10–22 SVR (%) SVR 20 0 24 48 78 DAA IFN monotherapy (weeks) IFN + ribavirin PegIFN PegIFN +PegIFN ribavirin + ribavirinSMV + BOC/TVR or SOF SOF+ + comb PegIFN + RBVRBV os Davis GL, et al. N Engl J Med 1989; 321:1501–1506; Poynard T, et al. N Engl J Med 1995; 332:1457–1462; McHutchison JG, et al. N Engl J Med 1998; 339:1485–1492; Poynard T, et al. Lancet 1998; 352: 1426–1432; Zeuzem S, et al. N Engl J Med 2000; 343:1666–1672; Linsay KL, et al. Hepatology 2001; 34:395–403; Pockros PJ, et al. Am J Gastroenterol 2004; 99:1298–1305; Manns MP, et al. Lancet 2001; 358:958–965; Fried MW, et al. N Engl J Med 2002; 347:975–982; Poordad F, et al. N Engl J Med 2011; 364:1195–1206; Jacobson IM, et al. N Engl J Med 2011; 364:2405–2416; Simeprevir prescribing information, November 2013; Lawitz E, et al. N Engl J Med 2013; 368:1878–1887; Zeuzem S, et al. Hepatology 2013; 58(Suppl 1):733A; AbbVie press release 2014 [Accessed 25-02-14]; Gilead press release 2013 [Accessed 25-02-14]; Sulkowski MS, et al. N Engl J Med 2014; 370:211–221. We now have highly efficacious DAAs that target different stages in the HCV lifecycle Summary of New England Journal of Medicine studies on IFN-free therapy Receptor binding in GT 1 patients published in 2014 and endocytosis Transport 96% and release Fusion and uncoating Virion assembly (+) RNA ER lumen Translation and LD NS5A inhibitors polyprotein LD processing LD Membranous web RNA replication ER lumen Non-NA NS5B inhibitors 3680/ NS3 protease NA NS5B inhibitors 3826 inhibitors SVR DAA: direct-acting antiviral agent; ER: endoplasmic reticulum; Lindenbach BD, Rice CM. Nature 2005;436(Suppl):933–8; GT: genotype; IFN: interferon; LD: luminal domain; NA: nucleos(t)ide analogue; Liang J, Ghany MG. N Engl J Med 2014;370:2043–7. NS: non-structural protein; SVR: sustained virological response Characteristics of DAA DAA PI 1st PI 2nd NS5A Inh. 1st NS5A Inh. 2nd NS5B NS5B non generation generation generation generation nucleos(t)ide nucleos(t)ide inh. inh. Efficacy Resistance profile Pangenotypic efficacy Adverse events Drug-drug interaction Good profile Average profile Least favorable profile Schinazi, et al. Liver Int 2014;34 Suppl 1:69-78 IFN-free regimens available in 2016 Paritaprevir/r Ombitasvir +/-Dasabuvir NS5A Grazoprevir Elbasvir inhibitors ‘…asvirs’ Sofosbuvir Daclatasvir Protease inhibitors Sofosbuvir Ledipasvir ‘…previrs’ Polymerase Simeprevir Sofosbuvir inhibitors ‘…buvirs’ Non-Nucs Nucleos(t)ide Sofosbuvir + RBV EASL Recommendations 2015, DOI: http://dx.doi.org/10.1016/j.jhep.2015.03.025. Accessed April 2015. HCV G4 the Egyptian Clinical Trials in AASLD meeting SF 2015 . Sof + RBV . Sof + PI (Simeprevir) . Sof + NS5A (Ravidasavir) . PI(Paritaprevir) + NS5A(Ombitasvir) HCV G4 the Egyptian Clinical Trials in AASLD meeting SF 2015 . Sof + RBV . Sof + PI (Simeprevir) . Sof + NS5A (Ravidasavir) . PI(Paritaprevir) + NS5A(Ombitasvir) Abstract ID: 1076 Day / Time: Sunday, Nov 15, 8:00 AM – 5:30 PM Sofosbuvir plus Ribavirin in the Treatment of Egyptian Patients with Chronic Genotype 4 HCV Infection W.H. Doss, M. Hassany, R. Hammad, National Hepatology and Tropical Medicine Research Institute, Cairo, EGYPT; P.J. Ruane, D. Ain, J. Riad, R. Meshrekey, Ruane Medical and Liver Health Institute, Los Angeles, California, UNITED STATES; , R. Soliman, W. Samir,G.Shiha Egyptian Liver Research Institute and Hospital, Mansoura, EGYPT; M. Khairy, R.F. Omar, M. Gamil, G.E. Esmat, University of Cairo, Cairo, EGYPT; D. Jiang, B. Massetto, S.J. Knox, K. Kersey, J.G. McHutchison, Gilead Sciences, Inc., Foster City, California, UNITED STATES Sofosbuvir + Ribavirin in GT 4 HCV G4 the Egyptian Clinical Trials in AASLD meeting SF 2015 . Sof + RBV . Sof + PI (Simeprevir) . Sof + NS5A (Ravidasavir) . PI(Paritaprevir) + NS5A(Ombitasvir) Abstract ID: 1163 Day / Time: Sunday, Nov 15, 8:00 AM – 5:30 PM Treatment of Hepatitis C Genotype 4 patients with Simeprevir and Sofosbuvir: Preliminary Results from a Phase IIa, Partially Randomised, Open-label Trial conducted in Egypt (OSIRIS) . M. El Raziky G. Van Dooren, Janssen Infectious Diseases BVBA, Beerse, BELGIUM; M. Gamil, M. Khairy, A. Elsharkawy, Cairo University, Cairo , EGYPT; R. Hammad, M. Hassany, W.H. Doss, National Hepatology and Tropical Medicine Research Institute, Cairo, EGYPT; M. El Raziky, Cairo University, Cairo , EGYPT; M. Saad Hashem, A. Gomaa, I. Waked, National Liver Institute, Menoufiya, EGYPT; S. Keim, Janssen-Cilag Portugal, Lisbon, PORTUGAL; R. Ryan, R. DeMasi, Janssen Research & Development LLC, Titusville, New Jersey, UNITED STATES; I. Londjon- Domanec, Janssen-Cilag, Paris, FRANCE COSMOS: SVR12 (ITT) in prior null responders, F0–F2 SVR12 Non-VF Relapse 24 weeks 12 weeks 4 7 4 7 (1/24) (1/15) (1/27) (1/14) 100 100 96 17 93 93 (26/27) (4/24) (13/14) 80 (14/15) 80 79 (19/24) 60 60 40 40 Patients (%) Patients 20 20 0 0 SMV + SOF + RBV SMV + SOF SMV + SOF + RBV SMV + SOF Intent-to-treat population; Non-VF, Non-virologic failure, patients who did not achieve SVR12 for reasons other than virologic failure Sulkowski M, et al. EASL 2014 O7 Lawitz E., et al. Lancet 2014. Published Online July 28, 2014. http://dx.doi.org/10.1016/S0140-6736(14)61036-9 OSIRIS: SMV + SOF in genotype 4 HCV infection in treatment-naïve and treatment-experienced patients (N=60) . Phase 2, partly randomized, open-label, multicentre study (Egypt) . SVR4 will be available by the end of this month. SMV + SOF F0–F3 n=40 SMV + SOF Primary endpoint: SVR12 F4 SMV + SOF n=20 0 8 12 NCT02278419 Sofosbuvir +Simeprevir in GT4 HCV G4 the Egyptian Clinical Trials in AASLD meeting SF 2015 . Sof + RBV . Sof + PI (Simeprevir) . Sof + NS5A (Ravidasavir) . PI(Paritaprevir) + NS5A(Ombitasvir) Abstract ID: 708 Day / Time: Saturday, Nov 14, 2:00 PM – 7:30 PM Efficacy and Safety of Co-Formulated Ombitasvir/Paritaprevir/Ritonavir with Ribavirin in Adults with Chronic HCV Genotype 4 Infection in Egypt (AGATE-II) . Gamal Esmat1, Wahid Doss2, Roula B Qaqish3, Imam Waked4, Gamal Shiha5, Ayman Yosry2, Mohamed Hassany2, Jennifer King3, Carolyn Setze3, Rebecca Redman3, Niloufar Mobashery3 . Affiliation(s): 1Cairo University, Cairo, Egypt; 2National Hepatology & Tropical Medicine Research Institute, Cairo, Egypt; 3AbbVie Inc, North Chicago, Illinois, United States; 4National Liver Institute, Menoufiya, Egypt; 5Egyptian Liver Research Institute And Hospital (ELRIAH), Dakahliah, Egypt Efficacy and Safety of Co-Formulated Ombitasvir/Paritaprevir/Ritonavir with Ribavirin in Adults with Chronic HCV Genotype 4 Infection in Egypt Esmat,et al-AASLD,,2015,Ab:a HCV G4 the Egyptian Clinical Trials in AASLD meeting SF 2015 . Sof + RBV . Sof + PI (Simeprevir) . Sof + NS5A (Ravidasavir) . PI(Paritaprevir) + NS5A(Ombitasvir) Abstract ID: LB-4 Day / Time: Monday, Nov 16, 3:45 PM – 4:00 PM Oral presentation High Virologic Response Rate in Egyptian HCV-Genotype 4 Patients Treated with Ravidasvir (PPI-668) and Sofosbuvir: Results of a Large Multicenter Phase 3 Registrational Trial . G. Esmat, M. El Raziky, T. Elbaz, M.M. Abouelkhair, H. Gamal El Deen, M.K. Ashour, Cairo University, Cairo, EGYPT; M. El Raziky, M.M. Abouelkhair, M.K. Ashour, Cairo Fatemic Hospital, Cairo, EGYPT; A. Gomaa, A. Sabry, I. Waked, National Liver Institute, Cairo, EGYPT; M. Abdel-Hamid, Minia Universtiy, Cairo, EGYPT; O. Nada, Ain Shams University, Cairo, EGYPT; S. Helmy, H. Abdel-Maguid, Pharco Pharmaceuticals, Alexandria, EGYPT; R. Colonno, N. Brown, E. Ruby, P. Vig, Presidio Pharmaceuticals, San Francisco, California, UNITED 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 % % % 0 5 .
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