Current trends in CHC 1st genotype treatment
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1 Current trends in CHC 1st genotype treatment Tarik Asselah MD, PhD Professor of Medicine Hepatology, Chief INSERM UMR 1149, Hôpital Beaujon, Clichy, France
2 Disclosures Employee of Paris Public University Hospitals (AP-HP, Beaujon s Hospital) and University of Paris Principal investigator for research grants : Funds paid to Hospital (AP-HP) Consultant, expert and speaker for: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, Merck Sharp Dohme, Roche. Grants from : ANR, CNRS, INSERM, University of Paris, ANRS 2
3 Epidemiology of HCV in Russia HCV infection is revealed in all regions of Russian Federation Revealed CHC cases more than 1,9 million* > 60% - able-bodied population new CHC cases annually less than 15% of CHC patients receive treatment GT CHC others In most cases patients with CHC have 1b GT Fibrosis stages * Estimated number Chulanov V., et al. Therapeutic archive. 2015(11). P. 5-10
4 Goal Is Elimination of Hepatitis C Infection 2030 WHO Targets 90% Diagnosed 80% Treated 65% Reduced Mortality Monitoring and Evaluation Provider Education Improve Treatment Access Secure Political Commitment National Planning Capacity Assessment Partnership Developme nt WHO. Towards the elimination of hepatitis B and C by Mitruka K, et al. MMWR Morb Mortal Wkly Rep. 2015;64:
5 Strategies for HCV elimination Test & Treat Universal HCV screening Linkage to care : Treat all diagnosed with optimal DAAs Prevention Harm reduction Infection control Blood safety Awareness Increase awareness Fights barriers and stigma Advocacy Schinazi & Asselah. From HCV to HBV cure. Liver Int. 2017;37 S1:73-80.
6 Top Priorities for Direct-Acting Antiviral Agents Potency (SVR) Genotype Coverage Resistance Barrier Safety/Tolerability Treatment Duration Half life & Pills burden Drug-drug Interaction Access/Cost Schinazi & Asselah. From HCV to HBV cure. Liver Int. 2017;37 S1:73-80.
7 Direct-acting antivirals 5 NTR Structural proteins Nonstructural proteins 3 NTR Capsid Envelope glycoproteins Metalloprotease Serine protease RNA helicase Cofactors RNA polymerase C E1 E2 NS1 NS2 NS3 NS4A NS4B NS5A NS5B Protease Inhibitors «previr» Telaprevir Boceprevir Narlaprevir Simeprevir Paritaprevir Glecaprevir Grazoprevir Voxilaprevir Sovaprevir ACH-2684 NS5A Inhibitors «.asvir» Daclatasvir Ledipasvir Velpatasvir (GS-5816) Ombitasvir Pibrentasvir Elbasvir MK-8408 Samatasvir Odalasvir (ACH-3102) Nucs Polymerase Inhibitors «..buvir» Sofosbuvir MK 3682 ACH-3422 ALS-335 Non-Nucs Dasabuvir GS-9669 MK-8876 Asselah et al. Liver Int 2016; 36; S1:47-57.
8 With IFN IFN-free Current Therapies G1,4 G1,4 Simeprevir + Sofosbuvir G2,3, 4 Sofosbuvir + RBV G1,2 3,4, 5, 6 Daclatasvir + Sofosbuvir Paritaprevir/r + Ombitasvir + Dasabuvir ± RBV G1,4, 5, 6 Sofosbuvir ± RBV + Ledipasvir Protease Inhibitors «previr» NS5A Inhibitors «.asvir» Polymerase Inhibitors «..buvir» Jan Jun 2014 Jul Dec Jan Jun 2015 Jul Dec 2016 Sofosbuvir (G1,3,4,5,6) Simeprevir (G1, 4) Daclatasvir (G4) Narlaprevir (G1)
9 AASLD/IDSA: Treatment Recommendations for GT1 HCV Infection HCV GT SOF + SIM SOF/LDV SOF + DCV OMB/PTV/ RTV + DSV GRZ/ELB SOF/VEL Without cirrhosis 1a 1b With compensated cirrhosis 1a 1b Alternative Recommended AASLD/IDSA HCV Guidance. 2016
10 EASL recommendations ALL patients must be considered for treatment of HCV Achieving HCV elimination will require national plans Treatment must be considered without delay F0 1 F2 F3 CTP A CTP B CTP C Additional population that should be prioritised: HIV co-infection HBV co-infection Clinically significant extrahepatic manifestations High transmitters: Active injection drug users MSM Prisoners Post- Transplant EASL. J Hepatol 2017;66: CTP: Child Turcotte Pugh; EASL: European Association for the Study of the Liver; F: fibrosis stage; MSM: men who have sex with men
11 HCV treatment regimens available in NS3 NS5A Non- Nuc NS5B Nuc NS5B RBV IFN Narlaprevir/ritonavir Paritaprevir/ritonavir/Ombitasvir + dasabuvir Asunaprevir/Daclatasvir/ Beclabuvir 1a only Grazoprevir/Elbasvir Glecaprevir/Pibrentasvir Sofosbuvir +Ledipasvir Sovosbuvir+Velpatasvir Sofosbuvir +Daclatasvir Simeprevir+Sofosbuvir MK-3682/Ruzasvir/Grazoprevir Sofosbuvir/Ledipasvir/Voxilaprevir
12 Patients Achieving SVR12, % Efficacy of EBR/GZR : Comorbidities 1-5 Phase 3 studies vs placebo FAS mfas a Comorbidity Stage 4-5 CKD (C-SURFER) OAT/PWID ± HIV (C-EDGE CO-STAR) IBLD ± HIV HIV Genotypes 1 1,4,6 1,4 1,4,6 Treatment Experience TN/PR-PTF TN TN/PR-PTF TN 12 Weeks EBR/GZR Without RBV a mfas, excludes patients who failed for reasons unrelated to study medication. EBR/GZR = elbasvir/grazoprevir; SVR12 = sustained virologic response 12 weeks after the cessation of treatment; CKD = chronic kidney disease; OAT = opioid agonist therapy; PWID = people who inject drugs; IBLD = inherited blood disorders; TN = treatment naive; HIV = human immunodeficiency virus; RBV = ribavirin; PR = peginterferon + ribavirin; PTF = prior-treatment failure; mfas= modified full analysis set. 1. Roth D et al. Lancet. 2015;386: Dore GJ et al. EASL 2016, SAT Dore GJ et al. Ann Intern Med. 2016;165: Hezode C et al. EASL 2016, SAT Rockstroh JK et al. Lancet HIV. 2015;2:e319 e327.
13 POLARIS : sofosbuvir/velpastasvir/voxilaprevir SOF/VEL/VOX SOF/VEL Experienced Patients (DAAs) POLARIS-1 POLARIS-4 POLARIS-2 POLARIS-3 n = 415 n = 333 n = 941 n = 219 En échec d inhibiteursn S5A En échec d inhibiteurs Non NS5A Naïve Patients (DAAs) Cirrhose G G G G SVR12 12 weeks 96 % 12 weeks 97 % 8 weeks 95 % 8 weeks 96 % Placebo 12 weeks 90 % 12 weeks 98 % 12 weeks 96 % Bourlière et al, AASLD 2016, A194 Zeuzem et al, AASLD 2016, A109 Jacobson et als, AASLD 2016, LB-12 Foster et al, AASLD 2016, A258
14 Glecaprevir/Pibrentasvir: Program ENDURANCE Trials GT1 non-cirrhotic including HIV co-infection: 8 vs 12 weeks GT2 placebo-controlled: 12 weeks GT3 active comparator: 12 weeks GT4-6: 12 weeks MAGELLAN Trials GT1,4-6 prior DAA failures: 12 vs 16 weeks EXPEDITION Trials GT1, 2, 4-6 cirrhotic GT1-6 all stages of renal impairment SURVEYOR Trials GT2, 4-6 non-cirrhotic: 8 weeks GT3 cirrhotic: 12 vs 16 weeks
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