Universal HCV treatment: Strategies for simplification
|
|
- David Stone
- 6 years ago
- Views:
Transcription
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
3
4
5
6
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
Current trends in CHC 1st genotype treatment
Current trends in CHC 1st genotype treatment Tarik Asselah MD, PhD Professor of Medicine Hepatology, Chief INSERM UMR 1149, Hôpital Beaujon, Clichy, France Disclosures Employee of Paris Public University
More informationTreatment of HCV : 100 % cure?
Treatment of HCV : % cure? PHC 8 PARIS January 5th, 8 Tarik Asselah (MD, PhD) Professor of Medicine Hepatology, Chief ISERM UMR 49, Hôpital Beaujon, Clichy, France. PHC 8 - www.aphc.info Disclosures Employee
More informationHCV therapy : Clinical case
HCV therapy : Clinical case PHC 2018 Paris January 14th, 2018 Tarik Asselah (MD, PhD) Professor of Medicine Hepatology, Chief INSERM UMR 1149, Hôpital Beaujon, Clichy, France. Disclosures Professor Asselah
More informationIFN-free therapy in naïve HCV GT1 patients
IFN-free therapy in naïve HCV GT1 patients Paris Hepatitis Conference Paris, 12th January, 2015 Pr Tarik Asselah MD, PhD; Service d Hépatologie & INSERM U773 University Paris Diderot, Hôpital Beaujon,
More informationHepatitis C Update: What s New in 2017
Hepatitis C Update: What s New in 2017 Cody A. Chastain, MD Assistant Professor of Medicine Viral Hepatitis Program Division of Infectious Diseases Vanderbilt University Medical Center Cody.a.Chastain@Vanderbilt.edu
More informationHepatitis C Resistance Associated Variants (RAVs)
Hepatitis C Resistance Associated Variants (RAVs) Atif Zaman, MD MPH Oregon Health & Science University Professor of Medicine Division of Gastroenterology and Hepatology Nothing to disclose Disclosure
More information2017 Bruce Lucas Hepatology and Liver Transplant Symposium October 13th 2017 Management of Hepatitis C in Pre- and Post-Transplant Patients
2017 Bruce Lucas Hepatology and Liver Transplant Symposium October 13th 2017 Management of Hepatitis C in Pre- and Post-Transplant Patients Jens Rosenau, MD Associate Professor of Medicine Acting Director
More informationHepatitis C Introduction and Overview
Hepatitis C Introduction and Overview Michael S. Saag, MD Professor of Medicine Associate Dean of Global Health Director, Center for AIDS Research University of Alabama at Birmingham Birmingham, Alabama
More informationViva La Revolución: Options to Combat Hepatitis C
Viva La Revolución: Options to Combat Hepatitis C David L. Wyles, MD Professor of Medicine University of Colorado Chief, Division of Infectious Disease Denver Health Learning Objectives After attending
More informationDebate: Do We Need More HCV Drugs Con Standpoint
Debate: Do We Need More HCV Drugs Con Standpoint 18 th Antivirals PK Workshop, Friday 16 th June 2017, Chicago Jürgen Rockstroh Department of Medicine I University Hospital Bonn, Bonn, Germany Conflict
More informationDirect-acting Antiviral (DAA) Regimens in Late-stage Development: Which Patients Should Wait? Fred Poordad, MD
Direct-acting Antiviral (DAA) Regimens in Late-stage Development: Which Patients Should Wait? Fred Poordad, MD The HCV Lifecycle: Multiple Targets Polymerase Inhibitors Protease Inhibitors NS5A Inhibitors
More informationHepatitis C Genotypes
9/2/21 OBJECTIVES Project ECHO HCV Collaborative HCV in 21: New Therapies and New Opportunities Paulina Deming, PharmD Assistant Director Hepatitis C Programs, ECHO Institute Associate Professor College
More informationHCV in 2017: New Therapies and New Opportunities. Presentation prepared by: Date prepared: OBJECTIVES
Project ECHO HCV Collaborative HCV in 217: New Therapies and New Opportunities Paulina Deming, PharmD Assistant Director Hepatitis C Programs, ECHO Institute Associate Professor College of Pharmacy University
More informationHCV Treatment Failure: What Next? Dr Ashley Brown, Imperial College Healthcare NHS Trust, London
HCV Treatment Failure: What Next? Dr Ashley Brown, Imperial College Healthcare NHS Trust, London European HIV Hepatitis Co-infection Conference QEII Conference Centre 10 th December 2015 Dr Ashley Brown
More informationShorter Durations and Pan-genotypic Regimens The Final Frontier. Professor Greg Dore
Shorter Durations and Pan-genotypic Regimens The Final Frontier Professor Greg Dore Disclosures Funding and speaker fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences and Merck Efficacy Evolution
More informationUpdate on Hepatitis C. Francesco Negro Hôpitaux Universitaires de Genève Berne, November 15, 2017
Update on Hepatitis C Francesco Negro Hôpitaux Universitaires de Genève Berne, November 15, 2017 The global prevalence of HCV was 1 0% (95% uncertainty interval 0 8 1 1) in 2015: 71 1 million (62 5 79
More informationHCV eradication with direct acting antivirals (DAAs)?
HCV eradication with direct acting antivirals (DAAs)? Emilie Estrabaud Service d Hépatologie et INSERM UMR1149, AP-HP Hôpital Beaujon, Paris, France. emilie.estrabaud@inserm.fr HCV eradication with direct
More informationCurrent HCV Treatment by Genotype
Current HCV Treatment by Genotype Ari Bunim, MD Assistant Professor Clinical Medicine Weill Cornell Medical College Clinical Director of Hepatology New York-Presbyterian/Queens Objectives To understand
More informationTREATMENT OF GENOTYPE 2
Treatment of Genotype 2, 3,and 4 David E. Bernstein, MD, FACG Advisory Committee/Board Member: AbbVie Pharmaceuticals, Gilead, Merck, Janssen Consultant: AbbVie Pharmaceuticals, Bristol-Myers Squibb, Gilead,
More informationKristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, New York
Newly Approved Hepatitis C Virus Drugs: Approach to Initial Therapy Kristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, New York Learning Objectives After attending this presentation,
More informationManagement of HCV in Prior Treatment Failure
Management of HCV in Prior Treatment Failure Arthur Y. Kim, MD Associate Professor of Medicine Harvard Medical School Boston, Massachusetts Learning Objectives After attending this presentation, learners
More informationHEPATITIS C: UPDATE AND MANAGEMENT
HEPATITIS C: UPDATE AND MANAGEMENT José Franco, MD Professor of Medicine Associate Dean for Educational Improvement Associate Director, Kern Institute STAR Center Director José Franco, MD Disclosures I
More informationHCV Resistance Clinical Aspects. Sanjay Bhagani Royal Free Hospital/UCL London
HCV Resistance Clinical Aspects Sanjay Bhagani Royal Free Hospital/UCL London DAAs in 2018, and beyond % patients % patients Changing characteristics of patients treated with DAA over time Prospective,
More informationHCV Treatment Options in 2017/2018: What s Here and What s Coming Soon
HCV Treatment Options in 2017/2018: What s Here and What s Coming Soon Supported by educational grants from AbbVie; Bristol-Myers Squibb; Gilead Sciences; Janssen Therapeutics; Merck & Co., Inc; and ViiV
More informationCase. 63 year old woman now with:
Case 63 year old woman now with: HCV GT 1b, HCV RNA 6.2 x 10 6 IU/mL Asymptomatic except for fatigue Normal exam ALT 72 IU/mL, Bili 0.9 mg/dl, INR 1.1, Albumin 3.9 g/dl, Creatinine 0.7 mg/dl Normal EGD
More informationHepatitis C in Special Populations
Hepatitis C in Special Populations David E. Bernstein, MD, FACG Vice Chairman of Medicine for Clinical Trials Chief, Division of Hepatology and Sandra Atlas Bass Center for Liver Diseases Northwell Health
More informationNeed to Assess HCV Resistance to DAAs: Is it Useful and When?
Need to Assess HCV Resistance to DAAs: Is it Useful and When? Stéphane Chevaliez French National Reference Center for Viral Hepatitis B, C and delta Department of Virology & INSERM U955 Henri Mondor Hospital
More informationHepatitis B and Hepatitis C Virus in non-liver Transplant Recipients. Karim Qumosani MD, FRCPC, ABIM, MdMEd Multi-organ Transplant Unit, London
Hepatitis B and Hepatitis C Virus in non-liver Transplant Recipients Karim Qumosani MD, FRCPC, ABIM, MdMEd Multi-organ Transplant Unit, London Financial Disclosures Research Grants Merck, Gilead, Abbvie,
More informationCurrent HCV Treatment by Genotype Ira M. Jacobson, MD
Current HCV Treatment by Genotype Ira M. Jacobson, MD Director of Hepatology NYU School of Medicine Objectives To understand the prevalence of HCV and distribution of HCV genotypes Describe the HCV lifecycle
More informationMassimo Puoti SC Malattie Infettive AO Ospedale Niguarda Cà Granda, Milano. Eradicazione da HCV e nuove prospettive: Prospetive Terapeutiche future
Massimo Puoti SC Malattie Infettive AO Ospedale Niguarda Cà Granda, Milano Eradicazione da HCV e nuove prospettive: Prospetive Terapeutiche future DAA classes and subclasses Drug Class Subclass Potency
More informationHCV Treatment of Genotype 1: Now and in the Future
HCV Treatment of Genotype 1: Now and in the Future Bruce R. Bacon, MD, FACG James F. King, MD Endowed Chair in Gastroenterology Professor of Internal Medicine Co-Director of the Abdominal Transplant Program
More informationDisclosures. Advanced HCV management. Overview. Renal failure 1/10/2018. Research Grant support to UCSF from AbbVie Gilead Merck Proteus NIH
Disclosures Advanced HCV management Annie Luetkemeyer, MD Division of HIV, ID and Global Medicine ZSFG, UCSF Research Grant support to UCSF from AbbVie Gilead Merck Proteus NIH Overview Renal failure Acute
More informationWhy make this statement?
HCV Council 2014 10 clinical practice statements were evaluated by the Council A review of the available literature was conducted The level of support and level of evidence for the statements were discussed
More informationSelecting HCV Treatment
Selecting HCV Treatment Caveats Focus on treatment selection for genotypes 1, 2, and 3. Majority of US population infected with GT 1, 2, or 3 GT 4 treatment closely reflects GT 1 treatment GT 5 and 6 are
More informationExpert Perspectives: Best of HCV from EASL 2015
Best of HCV from EASL 2015 Expert Perspectives: Best of HCV from EASL 2015 Saeed Hamid, MD Alex Thompson, MD, PhD This activity is supported by educational grants from AbbVie, Bristol-Myers Squibb, and
More informationNew Antivirals for Hep C in Context of HIV: Vosevi and Mavyret
New Antivirals for Hep C in Context of HIV: Vosevi and Mavyret John Scott, MD, MSc, FIDSA November 16, 2017 This presentation is intended for educational use only and does not in any way constitute medical
More informationDrug Class Prior Authorization Criteria Hepatitis C
Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: Interim Criteria Pending P&T Approval Effective Date: August 16, 2018 This drug class prior authorization
More informationHARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES
HARVARD PILGRIM HEALTH CARE Generic Brand HICL GCN Exception/Other DACLATASVIR DAKLINZA 41377 ELBASVIR/GRAZOPREVIR ZEPATIER 43030 GLECAPREVIR/PIBRENTASVIR MAVYRET 44453 OMBITASVIR/PARITAPREVIR/ RITONAVIR
More informationHepatitis C: Difficult-to-treat Patients 11th Paris Hepatology Conference 16th January 2018 Stefan Zeuzem, MD University Hospital, Frankfurt, Germany
Hepatitis C: Difficult-to-treat Patients 11th Paris Hepatology Conference 16th January 2018 Stefan Zeuzem, MD University Hospital, Frankfurt, Germany PHC 2018 - www.aphc.info Disclosures Advisory boards:
More informationInitial Treatment of HCV G Hugo E. Vargas, MD Professor of Medicine Medical, Director Office of Clinical Research Mayo Clinic Arizona
Initial Treatment of HCV G1 2016 Hugo E. Vargas, MD Professor of Medicine Medical, Director Office of Clinical Research Mayo Clinic Arizona Disclosure Information Disclosure Information Dr. Vargas receives
More informationUpdate on the Treatment of HCV
Update on the Treatment of HCV K. Rajender Reddy, MD Professor of Medicine Director of Hepatology Director, Viral Hepatitis Center University of Pennsylvania Philadelphia, USA 1 K. Rajender Reddy, MD Disclosure
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C Second Generation Antivirals Page 1 of 32 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C Second Generation Antivirals Through
More informationGenotype 1 HCV in 2016: Clinical Decision Making in a Time of Plenty
Genotype 1 HCV in 216: Clinical Decision Making in a Time of Plenty Ira M. Jacobson, MD Chair, Department of Medicine Mount Sinai Beth Israel Senior Faculty and Vice-Chair, Department of Medicine Icahn
More informationSaeed Hamid, MD Alex Thompson, MD, PhD
Saeed Hamid, MD Alex Thompson, MD, PhD 1 We will review some top line data from EASL Majority of the time discussing how the data affects daily practice 2 Grazoprevir (GZR; MK-5172) + Elbasvir (EBR; MK-
More informationHepatitis C Prior Authorization Policy
Hepatitis C Prior Authorization Policy Line of Business: Medi-Cal P&T Approval Date: November 15, 2017 Effective Date: January 1, 2018 This policy has been developed through review of medical literature,
More informationAssociate Professor of Medicine University of Chicago
Nancy Reau, MD Associate Professor of Medicine University of Chicago Management of Hepatitis C: New Drugs and New Paradigms HCV is More Lethal than HIV Infection HCV superseded HIV as a cause of death
More information10/21/2016. David L. Wyles, MD Chief, Division of Infectious Disease Denver Health Medical Center Denver, Colorado
Drug Resistance-Associated Variants in Hepatitis C Virus Infection: Hype or Help? David L. Wyles, MD Chief, Division of Infectious Disease Denver Health Medical Center Denver, Colorado FORMATTED: 1/3/16
More informationHCV Infection: EASL Clinical Practice Guidelines Francesco Negro University Hospital Geneva Switzerland
HCV Infection: EASL Clinical Practice Guidelines 2016 Francesco Negro University Hospital Geneva Switzerland Panel Codinat: Jean-Michel Pawlotsky Panel: Alessio Aghemo David Back Geoffrey Dusheiko Xavier
More informationTHE THERAPEUTIC REVOLUTION THAT TRANSFORMED CHRONIC HEPATITIS C TO A CURABLE DISEASE
THE THERAPEUTIC REVOLUTION THAT TRANSFORMED CHRONIC HEPATITIS C TO A CURABLE DISEASE MARIA SCHINA CONSULTANT PHYSICIAN INTERNAL MEDICINE AND HEPATOLOGY ATHENS EUROCLINIC 10 th INTERNATIONAL CONGRESS OF
More informationOn Target for Hepatitis C Elimination: Direct Acting Antiviral Agents in 2018
On Target for Hepatitis C Elimination: Direct Acting Antiviral Agents in 2018 Trana Hussaini, PharmD Pharmacotherapy Specialist in Liver Transplantation, VGH Clinical Assistant Professor, Faculty of Pharmaceutical
More informationTreating Hepatitis C in Patients with Advanced Renal Disease
Treating Hepatitis C in Patients with Advanced Renal Disease Seyed Moayed Alavian M.D. Professor of Medicine, Hepatologist alavian@thc.ir Hemodialysis Patients hemodialysis Preventive Strategies Strict
More informationTreating Hepatitis C Virus (HCV) Infection
Slide 1 of 42 Treating Hepatitis C Virus (HCV) Infection Susanna Naggie, MD, MHS Associate Professor of Medicine Duke Clinical Research Institute Durham, North Carolina Slide 3 of 42 Learning Objectives
More informationHepatitis C in Correctional Facilities: Big Problem, Bigger Opportunity. Cody A. Chastain, MD
Hepatitis C in Correctional Facilities: Big Problem, Bigger Opportunity Cody A. Chastain, MD Disclosures Research supported by Gilead Sciences Inc.: Site investigator for HIV/HCV SWITCH Registry Study
More informationHCV Update from AASLD 2016
HCV Update from AASLD 2016 Ahmed Elsharkawy Consultant Hepatologist QE Birmingham Secretary and Chair-Elect of BVHG BHIVA/BVHG Feedback Meeting November 2016 Speaker Name Ahmed Elsharkawy Statement Speaking
More informationCCO Official Conference Coverage: Clinical Impact of New Data From AASLD 2015
CCO Official Conference Coverage: Clinical Impact of New Data From AASLD 2015 CCO Official Conference Coverage of the 2015 Annual Meeting of the American Association for the Study of Liver Diseases, November
More informationMavyret (glecaprevir/pibrentasvir)
(glecaprevir/pibrentasvir) Override(s) Prior Authorization Quantity Limit Medication (glecaprevir/pibrentasvir) Approval Duration Based on Genotype, Treatment Status, or Cirrhosis Status. Quantity Limit
More informationHepatitis C: a treatment revolution
Sunday, 10th July 2016 Michaelmas Cay 2 Room Concurrent 11 Health Innovation Hepatitis C: a treatment revolution Dr. Heather McNamee Hepatitis C a treatment revolution Dr Heather McNamee Medical Director
More informationHIV/HCV Coinfection: Why It Matters and What To Do About It. Cody A. Chastain, MD 10/26/16
HIV/HCV Coinfection: Why It Matters and What To Do About It Cody A. Chastain, MD 10/26/16 Disclosures I have no relevant financial disclosures. Objectives At the end of this lecture, the learner will be
More informationA treatment revolution: current management for chronic HCV
A treatment revolution: current management for chronic HCV Ray Chung, M.D. Director of Hepatology and Liver Center Kevin and Polly Maroni Research Scholar Massachusetts General Hospital Disclosures Research
More informationManagement of Chronic HCV 2017 and Beyond
Management of Chronic HCV 2017 and Beyond Blaire E Burman, MD Virginia Mason Gastroenterology & Hepatology Relevant Disclosures No financial disclosures to report Leaning Objectives Burden of HCV Prevalence
More informationNew York State HCV Provider Webinar Series. Treatment of HCV/HIV Co-Infection
New York State HCV Provider Webinar Series Treatment of HCV/HIV Co-Infection Objectives Review the epidemiology of HCV and HIV/HCV co-infection Discuss the burden of HIV/HCV co-infection Discuss the treatment
More informationCases: Management of Hepatitis C in Prior Treatment Failure
Cases: Management of Hepatitis C in Prior Treatment Failure David L. Wyles, MD Professor of Medicine University of Colorado Chief, Division of Infectious Disease Denver Health Learning Objectives After
More informationUpdate in the Management of Hepatitis C: What Does the Future Hold
Update in the Management of Hepatitis C: What Does the Future Hold Paul Y Kwo, MD, FACG Professor of Medicine Mdi Medical ldirector, Liver Transplantation tti Gastroenterology/Hepatology Division Indiana
More informationManagement of HCV in Decompensated Liver Disease
Management of HCV in Decompensated Liver Disease Michael P. Manns Hannover Medical School (MHH) Department of Gastroenterology, Hepatology and Endocrinology Helmholtz Center for Infection Research (HZI),
More informationTreating HCV Prior to Liver Transplantation. What Are the Treatment Options? Xavier Forns Liver Unit Hospital Clinic, CIBEREHD, IDIBAPS Barcelona
Treating HCV Prior to Liver Transplantation What Are the Treatment Options? Xavier Forns Liver Unit Hospital Clinic, CIBEREHD, IDIBAPS Barcelona Disclosures Unrestricted Grant Support: Janssen and Abbvie
More informationDrug Class Prior Authorization Criteria Hepatitis C
Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: Interim (pending P&T approval) Effective Date: July 1, 2018 This policy has been developed through review
More informationAri Bunim, M.D. Director of Hepatology New York Hospital Queens Assistant Professor of Clinical Medicine Weill Cornell Medical College
Ari Bunim, M.D. Director of Hepatology New York Hospital Queens Assistant Professor of Clinical Medicine Weill Cornell Medical College New York State Law Goes into Effect January 1, 2014 Hepatitis C Virus
More informationPHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline
PHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline Preferred Regimen Based on Diagnosis: Mavyret (glecaprevir/pibrentasvir ) Non-Preferred: Daklinza (daclatasvir) Epclusa (sofosbuvir/velpatasvir)
More informationHepatitis C Agents
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.41 Subject: Hepatitis C Agents Page: 1 of 19 Last Review Date: December 8, 2017 Hepatitis C Agents
More informationHepatitis C Agents
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.41 Subject: Hepatitis C Agents Page: 1 of 20 Last Review Date: March 16, 2018 Hepatitis C Agents Description
More informationHCV Treatment in 2016: Genotypes 1, 2, and 3. Cody A. Chastain, MD October 12, 2016
HCV Treatment in 2016: Genotypes 1, 2, and 3 Cody A. Chastain, MD October 12, 2016 Disclosures I have no financial disclosures. Caveats I will only discuss treatment of GT 1-3. Majority of US population
More informationImpatto della clearance virale e rischio di carcinoma epatocellulare
EPATITE CRONICA DA HCV: Impatto della clearance virale e rischio di carcinoma epatocellulare Rodolfo Sacco, M.D., PhD Direttore U.O.C. Gastroenterologia ed Endoscopia Digestiva A.O.U. Ospedali Riuniti"
More informationDr Janice Main Imperial College Healthcare NHS Trust, London
BHIVA AUTUMN CONFERENCE 2014 Including CHIA Parallel Sessions Dr Janice Main Imperial College Healthcare NHS Trust, London 9-10 October 2014, Queen Elizabeth II Conference Centre, London BHIVA AUTUMN CONFERENCE
More informationManagement of HIV/HCV Coinfection. Kristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, NY
Management of HIV/HCV Coinfection Kristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, NY Disclosure Dr. Marks has received grants and research support from Gilead Sciences
More informationNew Hepatitis C Antivirals
New Hepatitis C Antivirals Kris Stewart, BSP, MD, FRCPC Drug Therapy Conference College of Medicine, University of Saskatchewan September 23, 2016 Disclosures I have received research and program support
More informationPan-Genotypic Diret-Acting Antivirals: Opportunity to Achieve HCV Elimination
Pan-Genotypic Diret-Acting Antivirals: pportunity to Achieve HCV Elimination HEPDART 2017 USA December 6 th, 2017 Tarik Asselah (MD, PhD) Professor of Medicine Hepatology, Chief ISERM UMR 1149, Hôpital
More informationClinical Management: Treatment of HCV Mono-infection
Clinical Management: Treatment of HCV Mono-infection Curtis Cooper, MD, FRCPC Associate Professor-University of Ottawa The Ottawa Hospital- Infections Diseases Viral Hepatitis Program- Director Industry
More informationLength of Authorization: 8-16 weeks. Requires PA: All direct-acting antivirals for treatment of Hepatitis C. Approval Criteria
Hepatitis C Direct-Acting Antivirals Goals: Approve use of cost-effective treatments supported by the medical evidence. Provide consistent patient evaluations across all hepatitis C treatments. Ensure
More informationHIV-HCV Co-Infection in Shobha Swaminathan, MD Associate Professor of Medicine Rutgers New Jersey Medical School
HIV-HCV Co-Infection in 2018 Shobha Swaminathan, MD Associate Professor of Medicine Rutgers New Jersey Medical School AASLD/IDSA and DHHS Guidance: HIV/HCV Coinfection All pts with HIV should be screened
More informationWhat Should We Do With Difficult to Treat HCV Populations?
What Should We Do With Difficult to Treat HCV Populations? Norah Terrault, MD Professor of Medicine and Surgery Director, Viral Hepatitis Center University of California San Francisco Disclosures Norah
More informationHepatitis C Elimination: Screening, Linkage and Treatment. Eric Lawitz, MD The Texas Liver Institute San Antonio, Texas
Hepatitis C Elimination: Screening, Linkage and Treatment Eric Lawitz, MD The Texas Liver Institute San Antonio, Texas Hepatitis C: Worldwide Presence Worldwide prevalence: 130-150 million Viral hepatitis
More informationOptimizing HCV Treatment Continuity and Outcomes
Optimizing HCV Treatment Continuity and Outcomes Empowering Pharmacists to Take Action Faculty Michelle T. Martin, PharmD, BCPS, BCACP Clinical Pharmacist University of Illinois Hospital and Health Sciences
More informationMonitoring Patients Who Are Starting HCV Treatment, Are On Treatment, Or Have Completed Therapy
Monitoring Patients Who Are Starting HCV Treatment, Are On Treatment, Or Have Completed Therapy WV ECHO August 10, 2017 Selection of patients for HCV treatment Despite current guidance to treat everyone,
More informationHepatitis C in Disclosures
Hepatitis C in 2018 Sandeep Mukherjee, MD CHI Health and Creighton University Medical Center Division of Gastroenterology Grant support: Abbvie Disclosures Speaker: Abbvie, Gilead, Merck Section editor
More informationHBV/HCV Eradication. Prof. Jean-Michel Pawlotsky, MD, PhD
HBV/HCV Eradication Prof. Jean-Michel Pawlotsky, MD, PhD National Reference Center for Viral Hepatitis B, C and delta Department of Virology & INSERM U955 Henri Mondor Hospital University of Paris-Est
More informationHow to optimize treatment in G3 patients? Jérôme GOURNAY, MD Hépatologie Centre Hospitalier Universitaire de Nantes France
How to optimize treatment in G3 patients? Jérôme GOURNAY, MD Hépatologie Centre Hospitalier Universitaire de Nantes France Paris Hepatitis Conference, January 12, 2016 Disclosures I have received funding
More informationHepatitis C: New Therapies in
Hepatitis C: New Therapies in 216-217 Mark Sulkowski, MD Professor of Medicine Johns Hopkins University School of Medicine Medical Director, Viral Hepatitis Center Divisions of Infectious Diseases and
More informationTransformation of Chronic Hepatitis C Treatment
Transformation of Chronic Hepatitis C Treatment UVHS, Adana, 22 May 2015 Christoph Sarrazin Goethe-University Hospital Frankfurt am Main Germany Epidemiology of HCV Infection Global Global HCV Prevalence
More informationHepatitis C in 2018: From Evolution to Revolution
Hepatitis C in 218: From Evolution to Revolution Arthur Y. Kim, MD Associate Professor of Medicine Harvard Medical School Director, Viral Hepatitis Clinic Massachusetts General Hospital Boston, Massachusetts
More informationPHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline
Preferred Regimen Based on Diagnosis: Mavyret (glecaprevir/pibrentasvir) PHARMACY PRI AUTHIZATION Hepatitis C Clinical Guideline Non-Preferred: Daklinza (daclatasvir) Epclusa (sofosbuvir/velpatasvir) Harvoni
More informationCases: Initial Treatment of Hepatitis C
Cases: Initial Treatment of Hepatitis C Kristen Marks, MD Assistant Professor of Medicine Weill Cornell Medical College New York, New York Off-Label Warning I will discuss the following off-label use in
More informationDogma: HCV treatment for eradication. Lisa Barrett MD PhD FRCPC Dept. of Infectious Diseases, Microbiology and Immunology April 18, 2015
Dogma: HCV treatment for eradication Lisa Barrett MD PhD FRCPC Dept. of Infectious Diseases, Microbiology and Immunology April 18, 2015 Disclosures Some discussion of non-hc approved compounds Industry:
More informationRapid Response from San Francisco: The Latest in the HCV Treatment Revolution
Activity presentations are considered intellectual property. These slides may not be published or posted online without permission from Vindico Medical Education (cme@vindicocme.com). Please be respectful
More informationNew York State HCV Provider Webinar Series. Side Effects of Therapy
New York State HCV Provider Webinar Series Side Effects of Therapy Objectives Understand the basics of HCV therapy Review the currently available regimens for treatment of HCV Appreciate side effects related
More informationSovaldi (sofosbuvir)
Market DC Sovaldi (sofosbuvir) Override(s) Prior Authorization Quantity Limit Approval Duration Based on Genotype, Treatment status, Cirrhosis status, or Ribavirin Eligibility status **IN, SC, WA Medicaid
More informationA One-day Scientific Conference: Updates on Hepatitis C Treatments along with Consensus on Management of Hepatitis C in Iran
A One-day Scientific Conference: Updates on Hepatitis C Treatments along with Consensus on Management of Hepatitis C in Iran Teheran, 22 July 2016 Massimo Colombo Treatment of HCV genotype 1 & 4 with DAAs
More informationEliminating Hepatitis C from New Zealand
Eliminating Hepatitis C from New Zealand Catherine Stedman Associate Professor of Medicine, University of Otago, Christchurch Gastroenterology Department, Christchurch Hospital Disclosures I have the following
More informationSpecial developments in the management of Hepatitis C. Disclosures
Special developments in the management of Hepatitis C Sandeep Mukherjee,MD Division of Gastroenterology CHI Health and Creighton University Medical Center Omaha, NE 68154 Sandeep.Mukherjee@alegent.org
More informationCurrent HCV Treatment by Genotype Empire Liver Foundation Ira M. Jacobson, MD
Current HCV Treatment by Genotype Empire Liver Foundation Ira M. Jacobson, MD Chairman, Department of Medicine Mount Sinai Beth Israel Professor of Medicine Co-Director, Liver Institute Icahn School of
More information