Universal HCV treatment: Strategies for simplification

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1 Universal HCV treatment: Strategies for simplification PARIS HEPATOLOGY CONFERENCE 3 January 217 Tarik Asselah (MD, PhD) 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

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7 Universal HCV treatment: Strategies for simplification The goal of this lecture will be to understand directacting antivirals (DAAs) revolution and to propose a rational approach to simplify therapy, to achieve HCV elimination.

8 Universal HCV treatment: Strategies for simplification Direct-acting antivirals (DAAs) Treatment simplification Universal treatment Take home messages

9 HCV viral cycle Asselah et al. Liver Int. 215;35 S1:56-64.

10 Direct-acting antivirals : a Revolution Structural proteins 5 NTR Capsid C Envelope glycoproteins E1 E2 Protease Inhibitors «previr» Telaprevir Boceprevir Simeprevir Paritaprevir Glecaprevir Grazoprevir Voxilaprevir Sovaprevir ACH-2684 NS1 NS2 Nonstructural proteins Metalloprotease Serine protease RNA helicase Cofactors NS3 NS4A NS4B NS5A Inhibitors «.asvir» Daclatasvir Ledipasvir Velpatasvir (GS-5816) Ombitasvir Pibrentasvir Elbasvir MK-848 Samatasvir Odalasvir (ACH-312) 3 NTR RNA polymerase NS5A NS5B Polymerase Inhibitors «..buvir» Nucs Non-Nucs Sofosbuvir MK 3682 ACH-3422 ALS-335 Dasabuvir GS-9669 MK-8876 Asselah et al. Liver Int 216; 36; S1:47-57.

11 Goals obtained by achieving Sustained Virological Response (SVR) cure Eradicate the virus (HCV clearance) Reduce necroinflammation Stop fibrosis progression Schinazi & Asselah. From HCV to HBV cure. Liver Int. 217;37 S1:73-8.

12 Goals obtained by achieving Sustained Virological Response (SVR) cure Eradicate the virus (HCV clearance) Reduce necroinflammation Stop fibrosis progression Prevent cirrhosis & complications Prevent hepatocellular carcinoma Reduce extra-hepatic manifestations Increase survival Schinazi & Asselah. From HCV to HBV cure. Liver Int. 217;37 S1:73-8.

13 ANRS CO22 HEPATHER: Outcomes in patients treated with DAAs 2156 patients (63% with cirrhosis at baseline) were followed-up for a median of 18 months Outcome incidence rates over the first 24 months after initiating DAA therapy* Carrat F, et al. EASL 216; Poster #LBP55

14 ANRS CO22 HEPATHER: Outcomes in patients treated with DAAs 2156 patients (63% with cirrhosis at baseline) were followed-up for a median of 18 months Outcome incidence rates over the first 24 months after initiating DAA therapy* Rate per 1 per 6-month period P=.256 All Cirrhotic Non Cirrhotic Decompensation of cirrhosis (DC) Months since initiation of therapy Carrat F, et al. EASL 216; Poster #LBP Rate per 1 per 6-month period Hepatocellular Carcinoma (HCC) P= HCC incidence rates decreased by 43% after 12 months from initiation of therapy (P=.256) Months since initiation of therapy DC incidence rates decreased by 77% after 6 months from initiation of therapy (P=.4) *SOF RBV (n=283); SOF PEG-IFN RBV (n=228); SOF DCV ± RBV (n=148) or SOF SMV ± RBV (n=597); Number of events per period

15 ANRS CO22 HEPATHER: Outcomes in patients treated with DAAs 2156 patients (63% with cirrhosis at baseline) were followed-up for a median of 18 months Outcome incidence rates over the first 24 months after initiating DAA therapy* Hepatocellular Carcinoma (HCC) Rate per 1 per 6-month period P=.256 All Cirrhotic Non Cirrhotic Months since initiation of therapy Months since initiation of therapy Carrat F, et al. EASL 216; Poster #LBP55 Rate per 1 per 6-month period Rate per 1 per 6-month period * DC incidence rates decreased by 77% after 6 months from initiation of therapy (P=.4) All Cause Death Months since initiation of therapy Liver-related Death 1 HCC incidence rates decreased by 43% after 12 months from initiation of therapy (P=.256) P=.4 Rate per 1 per 6-month period 36 Decompensation of cirrhosis (DC) Major HCV-related outcomes decreased after DAA-based therapy Months since initiation of therapy *SOF RBV (n=283); SOF PEG-IFN RBV (n=228); SOF DCV ± RBV (n=148) or SOF SMV ± RBV (n=597); Number of events per period

16 Top Priorities for Direct-Acting Antiviral Agents Potency (SVR) Genotype Coverage Resistance Barrier Safety/Tolerability Schinazi & Asselah. From HCV to HBV cure. Liver Int. 217;37 S1:73-8.

17 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. 217;37 S1:73-8.

18 Universal HCV treatment: Strategies for simplification Direct-acting antivirals (DAAs) Treatment simplification Universal treatment Take home messages

19 Treatment simplification No ribavirin Shorten treatment duration Pan-genotypic efficacy Reduce pill burden

20 LDV/SOF for 8 or 12 weeks in HCV mono- and HIV/HCV co-infected patients (German Hepatitis C-Registry) Analysis of 2485 HCV GT 1 patients treated with LDV/SOF for 8 weeks or 12 weeks under real-world conditions Virological response (per protocol) LDV/SOF 8 weeks LDV/SOF 12 weeks / 138/ / 77 92/ 95 8 SVR12 (%) / 1289/ Overall 73/ 158/ HIV Age >7 co-infection Patients on OST Buggisch P, et al. AASLD 216; Poster #883

21 Garnet : 8 weeks 3D in GT1b non cirrhotic patients ITT: tous les patients ayant reçu au moins une dose de traitement mitt-gt: ITT modifiée: exclusion des 3 patients non G1b mitt-gt-vf: mittgt exclusion des échecs non virologiques Asselah et al. AFEF 216

22 Available and future DAAs (high efficacy and good tolerance) provide a unique opportunity to establish a program for HCV elimination

23 POLARIS : sofosbuvir/velpastasvir/voxilaprevir SOF/VEL/VOX SOF/VEL Experienced Patients (DAAs) POLARIS-1 G POLARIS-4 n = 415 n = 333 En échec d inhibiteurs NS5A En échec d inhibiteurs Non NS5A Naïve Patients (DAAs) G POLARIS-2 POLARIS-3 n = n = 219 Cirrhose G G SVR12 12 weeks Placebo 96 % 12 weeks 97 % 8 weeks 12 weeks 9 % 12 weeks Bourlière et al, AASLD 216, A194 Zeuzem et al, AASLD 216, A19 95 % 98 % 8 weeks 96 % 12 weeks 96 % Jacobson et als, AASLD 216, LB-12 Foster et al, AASLD 216, A258

24 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 EXPEDITION Trials GT1, 2, 4-6 cirrhotic GT1-6 all stages of renal impairment MAGELLAN Trials GT1,4-6 prior DAA failures: 12 vs 16 weeks SURVEYOR Trials GT2, 4-6 non-cirrhotic: 8 weeks GT3 cirrhotic: 12 vs 16 weeks

25 EBR/GZR: Efficacy in Different Patient Populations16 Phase 3 studies vs placebo 9 9 Overall mfasa SVR12 rates from the Phase 3 clinical trial program Patients Achieving SVR12, % 9 6 Comorbidity Genotypes Treatment Experience Treatmentexperienced Stage 4-5 CKD OAT/PWI D ± HIV IBLD ± HIV HIV ± HIV ± HIV 1,4,6 1 1,4,6 1,4 1,4,6 1,4,6 1,4,6 TN TN/PRPTF TN TN/PRPTF TN PR-PTF PR-PTF 12 Weeks EBR/GZR Without RBV 16 Weeks EBR/GZR RBV amfas 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; TE = treatment experienced; RBV = ribavirin; PR = peginterferon ribavirin; PTF = prior-treatment failure; mfas= modified full analysis set. 1. Roth D et al. Lancet. 215;386: Dore GJ et al. EASL 216, SAT Hezode C et al. EASL 216, SAT Zeuzem S et al. Ann intern Med. 215;163: Rockstroh JK et al. Lancet HIV. 215;2:e319 e Kwo P et al. Gastroenterology. 217;152:

26 Current Therapies G1,4 G1,4 Paritaprevir/r Simeprevir Ombitasvir Sofosbuvir Dasabuvir G1,2 3,4, 5, 6 ± RBV IFN-free Daclatasvir G1,4, 5, 6 Sofosbuvir Sofosbuvir G2,3, 4 Ledipasvir Sofosbuvir ± RBV RBV Jan Jun Jul Dec Jan Jun 215 With IFN 214 Sofosbuvir (G1,3,4,5,6) Simeprevir (G1, 4) Jul Dec Daclatasvir (G4) Protease Inhibitors «previr» NS5A Inhibitors «.asvir» Polymerase Inhibitors «..buvir»

27 Current and Future Therapies Sofosbuvir G1,4 G1,4 Paritaprevir/r Simeprevir Ombitasvir Sofosbuvir Dasabuvir G1,2 3,4, 5, 6 ± RBV Daclatasvir IFN-free G1,2 3,4, 5, 6 Velpatasvir Sofosbuvir Velpatasvir G1,4, 5, 6 Sofosbuvir Sofosbuvir G2,3, 4 Voxilaprevir Glecaprevir Pibrentasvir G1,4 Grazoprevir Elbasvir Grazoprevir MK-848 MK-3682 Ledipasvir Sofosbuvir Simeprevir ± RBV RBV Odalasvir Jan Jun Jul Dec Jan Jun 215 With IFN 214 Sofosbuvir (G1,3,4,5,6) Simeprevir (G1, 4) Daclatasvir (G4) ACH-3422 Jul Dec 216/ :218 Protease Inhibitors «previr» NS5A Inhibitors «.asvir» Polymerase Inhibitors «..buvir» Asselah et al. Liver Int 216; 36; S1:47-57.

28 Universal HCV treatment: Strategies for simplification Direct-acting antivirals (DAAs) Treatment simplification Universal treatment Take home messages

29 Strategies for HCV elimination Test & Treat Universal Universal HCV HCV screening screening Linkage Linkage to to care care :: Treat Treat all all diagnosed diagnosed with with optimal optimal DAAs DAAs Schinazi & Asselah. From HCV to HBV cure. Liver Int. 217;37 S1:73-8.

30 Strategies for HCV elimination Test & Treat Prevention Universal Universal HCV HCV screening screening Linkage Linkage to to care care :: Treat Treat all all diagnosed diagnosed with with optimal optimal DAAs DAAs Harm Harm reduction reduction Infection Infection control control Blood Blood safety safety Schinazi & Asselah. From HCV to HBV cure. Liver Int. 217;37 S1:73-8.

31 Strategies for HCV elimination Test & Treat Universal Universal HCV HCV screening screening Linkage Linkage to to care care :: Treat Treat all all diagnosed diagnosed with with optimal optimal DAAs DAAs Prevention Harm Harm reduction reduction Infection Infection control control Blood Blood safety safety Awareness Increase Increase awareness awareness Fights Fights barriers barriers and and stigma stigma Advocacy Advocacy Schinazi & Asselah. From HCV to HBV cure. Liver Int. 217;37 S1:73-8.

32 HCV re-infection Re-infection rate in total population and among PWID (Canada) Incidence rate (/1 patients-year) 2,5 2, 1,88 1,59 1,14 1,5 1,,48,5, Population Spontaneous Clearance PWID Population PWID Cure after treatment (SVR) Islam et al. AASLD 216, A6

33 DAAs therapies: Increase Prescribers Prospective study ASCEND (USA) : 6 patients treated with SOF/LDV by 6 Hepato-Gastroenterologists, 5 GP, 5 nurses after a SPECIFIC EDUCATION SVR 12 ( PP) % 1 93,6 95, 94,5 92,3 % Tous All IDE Nurses MG GP Spécialiste Specialists 2 SVR 12 patients with cirrhosis ( PP) 9, All Tous 86, IDE Nurses 92,6 92, GPMG Spécialiste Specialists Emmanuel et al, AASLD 216, A22

34 Therapeutic Patient Education: a multidisciplinary team Doctors Psychologi st Hepatolo gist Pharmacist PATIEN TS Dietician Nurses Secretary Addiction specialists Boyer et al, Hepato-Gastro 217

35 Hepatitis plans for HCV elimination National action plans and strategies: (all accessed January 217)

36 Hepatitis plans for HCV elimination France : universal access to HCV treatment National action plans and strategies: (all accessed January 217)

37 Universal HCV treatment: Strategies for simplification Direct-acting antivirals (DAAs) Treatment simplification Universal treatment Take home messages

38 Universal HCV treatment: Strategies for simplification Take Home Messages HCV cure Combining DAAs results in high SVR (> 95%) and short duration (8-12weeks). HCV elimination requires improvment in: Screening (linkage to care) Prevention Access to treatment

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