Comprehensive Resistance Testing in Patients Who Did Not Achieve SVR
|
|
- Gwendolyn Montgomery
- 6 years ago
- Views:
Transcription
1 Comprehensive Resistance Testing in Patients Who Did Not Achieve SVR after Treatment with Sofosbuvir (GS- 7977)-Containing Regimens in Five Phase 2 Studies ES Svarovskaia 1, H Dvory-Sobol 1, V Gontcharova 1, S Chiu 1, C Hebner 1, J Perry 1, R Hyland 1, K Kowdley 2, E Lawitz 3, E Gane 4, B Symonds 1, J McHutchison 1, MD Miller 1, and Hongmei Mo 1 1 Gilead Sciences, Foster City, CA; 2 Digestive Disease Institute, Virginia Mason Medical Center, Seattle, WA; 3 Alamo Medical Research, San Antonio, TX; 4 Auckland City Hospital, Auckland, New Zealand HCV Resistance Workshop 2013
2 Introduction Sofosbuvir (SOF, formerly GS-7977), a novel prodrug of an HCV NS5B nucleotide inhibitor, demonstrated potent antiviral activity with broad HCV genotype coverage with high sustained virologic response (SVR) rates in patients In vitro selection studies show that NS5B S282T is the primary mutation selected by SOF in GT1a, 1b, 2a, 2b, 3a, 4a, 5a and 6a replicon cells
3 Objective To evaluate the selection of the S282T NS5B resistance mutant by deep sequencing in patients from all sofosbuvir-containing treatment arms who did not achieve SVR24 To evaluate the selection of other NS5B variants at the relapse time point To evaluate any change in susceptibility to SOF and RBV
4 SOF Phase 2 Studies and Samples Analyzed by Deep Sequencing Study Treatment regimen Total Subjects Treated Subjects Qualified for Sequencing Subjects with Deep Sequencing Data P PROTON P ATOMIC P ELECTRON P wks SOF followed by 44 wks PEG+RBV SOF+PEG+RBV 12 wks GT 1/2/3 SOF+PEG+RBV 12 wks GT1/4/6 SOF, SOF+RBV, SOF+PEG+RBV 12 wks GT1/2/ Quantum P (Arm C & G) SOF+RBV GT1/2/ Total * 74 * All subjects qualified due to relapse or early discontinuation, no on-sof treatment breakthrough
5 Summary of Population and Deep Sequencing Analysis at NS5B Position 282 Across Phase 2 Studies at Relapse GT Number of Patients with Relapse Samples Sequenced Population Deep NS5B 282 Variants >1% 1a All WT S282 1b All WT S N=1 S282T All WT S282 Total All WT S282
6 Phenotypic Data for NS5B Amino Acid Changes Developed in >2 SubjectS by Population Sequencing at Relapse NS5B Variant # Subject s AA Change from BL Observed Polymorphic Site? SOF Fold Change from Baseline RBV Fold Change from Baseline 11I 4 V11I, V/I11I, V11V/I Polymorphic N 5 S/N62N, S62S/N Polymorphic S 130N 206K 5 N/S110S Polymorphic S130S/N, T130N, T/N130N Q/K206K, Q206Q/K/R Polymorphic Polymorphic Q 4 R/Q300Q, R300R/Q Polymorphic
7 Structural Location of NS5B Substitutions Observed in >2 Subjects Thumb SOF 110S 206K 300Q Fingers Palm 62N 11I 130N
8 Susceptibility of Relapse Patient Isolates to SOF N=64 Significant EC 50 /EC 90 fold-change from reference (FCRF) or baseline (FCBL) only observed from SOF monotherapy subject with detectable S282T at relapse (a)
9 Clonal Phenotyping of S282T Relapse Patient Sample Population Sequence Change From BL: NS5B Replication Capacity (%) SOF Fold Change from Baseline SOF Fold Change from Reference Clone #1 Clone #1 Revertant Clone #2 T53T/P, V67A/V, S79N, V/I147I, S282T, T/I309T, T/I/A/V312T, V405A/V T53T/P, V67A/V, S79N, V/I147I, T/I309T, T/I/A/V312T, V405A/V S79N, V/I147I, S282T, T/I309T, T/I/A/V312T 1.4 ± ± ± Clone #2 Revertant S79N, V/I147I, T/I309T, T/I/A/V312T 9.6 ± Clone #3 Clone #3 Revertant S79N, V/I147I, S282T, T/I309T, T/I/A/V312T, T438A/T S79N, V/I147I, T/I309T, T/I/A/V312T, T438A/T 1.9 ± ± Susceptibility to SOF restored when S282T patient clones reverted to S282S
10 Population and Deep Sequencing Results for the Genotype 2b Subject with Detectable S282T after SOF Monotherapy Visit (confirmation) Follow-up week 8 Population Sequence Change From BL: NS5B S79N V/I147I S282T I/T309T T/A/I/V312T S79N V/I147I S282T I/T309T T/A/I/V312T S79N V/I147I S282S/T I/T309T T/A/I/V312T Deep Sequencing: S282T 1% >99% S282T 97.3% S282T 27.6% S282T Follow-up week 12 S79N V/I147I I/T309T T/A/I/V312T >99% WT S282 Follow-up week 24 S79N V/I147I I/T309T T/A/I/V312T >99% WT S282 8 S79N V/I147I I/T309T T/A/I/V312T >99% WT S282
11 HCV RNA Kinetics in the Subject Who Developed S282T at Relapse after SOF Monotherapy AGC 43% AGT 57% S282S ACT 0.05% S282T HCV RNA (IU/mL) BL sample AGC 43% AGT 57% ACT 97% S282T AGT 2.4% S282S ACT 99% S282T ACT 0.5% S282T AGT 91% TCT 7.2% ACT 27% S282T AGT 68% TCT 4% S282S S282S AGT 60% TCT 40% S282S 2 LOD=15 IU/mL 1 0 SOF Weeks Follow-up sample S282S ACT 0.1% S282T Relapse sample ACT (S282T) reversion TCT (S282S) AGT (S282S)
12 Population and Deep sequencing for Week 24 and 48 post-sof samples Deep seq: A G T (S282S, WT, 59.4%) T C T (S282S, WT, 40.2%) Pop seq Interpretation: Y R T A G T (S282S, WT) T C T (S282S, WT) A C T (S282T) T G T (S282C) S282C/S/T The detection of S282T/C was due to limitation of population sequencing
13 Conclusions Sofosbuvir (GS-7977) has a high HCV resistance barrier from pooled phase 2 analyses No virologic breakthrough on therapy Among relapsers, S282T resistance mutation not detected by deep sequencing in any patient following SOF + RBV +/- PEG treatment and detected in only 1 patient after SOF monotherapy No other NS5B genotypic or phenotypic resistance to SOF identified S282T had reduced fitness in patient and decreased replication capacity in vitro These results support the use of SOF-containing regimens for the initial treatment of HCV and possibly as a retreatment option among relapse patients.
New Therapeutic Strategies: Polymerase Inhibitors
New Therapeutic Strategies: Polymerase Inhibitors 6th Paris Hepatitis Conference 14 th - 15 th January, 2013 Stefan Zeuzem Goethe University Hospital Frankfurt, Germany Direct antiviral targets C E1 E2
More informationWhat is the Optimized Treatment Duration? To Overtreat versus Undertreat. Nancy Reau, MD Associate Professor of Medicine University of Chicago
What is the Optimized Treatment Duration? To Overtreat versus Undertreat Nancy Reau, MD Associate Professor of Medicine University of Chicago Learning Objectives: 1. Discuss patient populations appropriate
More informationWhat do we need to know about RAVs clinically?
14 th European HIV & Hepatitis Workshop Rome, 25-27 May, 2016 What do we need to know about RAVs clinically? Stefan Zeuzem, MD University of Frankfurt Germany Background Resistance associated variants
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 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 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 informationInfrequent Development of Resistance in Genotype 1 6 Hepatitis C Virus Infected Subjects Treated With Sofosbuvir in Phase 2 and 3 Clinical Trials
MAJOR ARTICLE Infrequent Development of Resistance in Genotype 1 6 Hepatitis C Virus Infected Subjects Treated With Sofosbuvir in Phase 2 and 3 Clinical Trials Evguenia S. Svarovskaia, 1,a Hadas Dvory
More informationAbstract LB-12. POLARIS-2: Pangenotypic Single Tablet Regimen with Inhibitors of HCV NS5B (Nucleotide) + NS5A + NS3
A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 1 Weeks in DAA-Naïve Genotype 1 6 HCV Infected Patients: The POLARIS- Study Ira M. Jacobson,
More informationEmerging Therapies for HCV: Highlights from AASLD 2012 (Part 2)
Emerging Therapies for HCV: Highlights from AASLD 2012 (Part 2) PegIFN and RBV remain vital components of HCV therapy-- selected presentations from: Program Disclosure This activity has been planned and
More informationCase 4: A 61-year-old man with HCV genotype 3 with cirrhosis. Ira M. Jacobson, M.D. Weill Cornell Medical College New York, New York USA
Case 4: A 61-year-old man with HCV genotype 3 with cirrhosis Ira M. Jacobson, M.D. Weill Cornell Medical College New York, New York USA 1 Genotype 3 case 61-year-old man with HCV genotype 3 Cirrhosis on
More informationICVH 2016 Oral Presentation: 28
Ledipasvir/Sofosbuvir Is Safe and Effective for the Treatment of Patients with Genotype 1 Chronic HCV Infection in Both HCV Mono- and HIV/HCV Coinfected Patients A Luetkemeyer 1, C Cooper 2, P Kwo 3, K
More informationBaseline and acquired viral resistance to DAAs: how to test and manage
Baseline and acquired viral resistance to DAAs: how to test and manage Round table discussion by Marc Bourliere, Robert Flisiak, Vasily Isakov, Mark Sulkowsky & Konstantin Zhdanov Prevalence of baseline
More informationEmerging Therapies for HCV: Highlights from AASLD 2012 (Part 2)
Emerging Therapies for HCV: Highlights from AASLD 2012 (Part 2) Goals for Hepatitis C Therapy Compared to PegIFN α/rbv, new treatment regimens for chronic hepatitis C should offer: Improved efficacy Efficacy
More informationPhase 3. Treatment Experienced. Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2. Afdhal N, et al. N Engl J Med. 2014;370:
Phase 3 Treatment Experienced Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2 Afdhal N, et al. N Engl J Med. 2014;370:1483-93. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Experienced HCV
More informationFailure after treatment with DAAs: What to do? Marseille France 2-3 th June 2016
Failure after treatment with DAAs: What to do? Marc Bourliere, MD White Nights of Hepatology Hôpital Saint Joseph Saint Petersburg Marseille France 2-3 th June 16 Disclosures Board member for : Schering-Plough,
More informationEvolution of Therapy in HCV
Hepatitis C: Update on New Therapies and AASLD 13 David Bernstein, MD, FACP, AGAF, FACP Professor of Medicine Hofstra North Shore-LIJ School of Medicine Evolution of Therapy in HCV 199 1999 1 13 (%) SVR
More informationHCV Drug Resistance: Regulatory Perspective
HCV Drug Resistance: Regulatory Perspective Patrick Harrington, PhD Senior Clinical Virology Reviewer Division of Antiviral Products, FDA/CDER 2016 HIV and Hepatitis Clinical Pharmacology Workshop Washington,
More informationUpdate on chronic hepatitis C treatment: current trends, new challenges, what next?
Update on chronic hepatitis C treatment: current trends, new challenges, what next? Matti Maimets 12.06.2015 MMaimets15 Disclosure this presentation is sponsored by Gilead Sciences MMaimets15 MMaimets15
More informationNew developments in HCV research and their implications for front-line practice
New developments in HCV research and their implications for front-line practice Dr. Curtis Cooper Associate Professor, University of Ottawa Director, Ottawa Hospital Viral Hepatitis Program June 17, 2013
More informationStudy Design - GT 1 Retreatment
Retreatment of Patients Who Failed 8 or 12 Weeks of Ledipasvir/Sofosbuvir-Based Regimens With Ledipasvir/Sofosbuvir for 24 Weeks Eric Lawitz, Steven Flamm, Jenny C. Yang, Phillip S. Pang, Yanni Zhu, Evguenia
More information5/12/2016. Learning Objectives. Management of Hepatitis C Virus Genotype 2 or 3 Infected Treatment-Naive or Experienced Patients
5/12/216 Management of Hepatitis C Virus Genotype 2 or 3 Infected Treatment-Naive or Experienced Patients Alexander Monto, MD Professor of Clinical Medicine University of California San Francisco San Francisco,
More informationExperience with pre-transplant antiviral treatment: PEG/RBV and DAA. Xavier Forns, MD Liver Unit Hospital Clínic IDIBAPS and CIBREHD Barcelona
Experience with pre-transplant antiviral treatment: PEG/RBV and DAA Xavier Forns, MD Liver Unit Hospital Clínic IDIBAPS and CIBREHD Barcelona Interferon-free regimens G1b nulls Asunaprevir (PI) + Daclatasvir
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 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 informationHCV Resistance Associated variants: impact on chronic hepatitis C treatment
HCV Resistance Associated variants: impact on chronic hepatitis C treatment Dr. Stéphane Chevaliez Associate Professor of Medicine at the University of Paris-Est. History of Resistance in HCV Concern Only
More informationDavid L. Wyles, MD Chief, Division of Infectious Disease Denver Health Medical Center Denver, Colorado
FORMATTED: 1/3/16 Drug Resistance-Associated Variants in Hepatitis C Virus Infection: Hype or Help? Atlanta, Georgia: October 2, 216 David L. Wyles, MD Chief, Division of Infectious Disease Denver Health
More informationEASL and The Future of HCV Treatment
EASL and The Future of HCV Treatment Douglas T. Dieterich, M.D Professor of Medicine Division of Liver Diseases, Gastroenterology and Infectious Diseases Department of Medicine Mount Sinai School of Medicine
More informationLatest Treatment Updates for GT 2 and GT 3 Patients
Latest Treatment Updates for GT 2 and GT 3 Patients Eric Lawitz, MD, AGAF, CPI Vice President, Scientific and Research Development The Texas Liver Institute Clinical Professor of Medicine University of
More informationVII CURSO AVANCES EN INFECCIÓN VIH Y HEPATITIS VIRALES
VII CURSO AVANCES EN INFECCIÓN VIH Y HEPATITIS VIRALES REGIMENES TERAPÊUTICOS DE LA HEPATITIS C, INTERFERÓN FREE A Coruña 2 Febrero 2013 Rui Sarmento e Castro Centro Hospitalar do Porto HJU ECS Universidade
More informationEASL 2013 Interferon Free, All Oral Regimens for Hepatitis C. Maria Buti Hospital Universitario Valle Hebron Barcelona Spain
EASL 2013 Interferon Free, All Oral Regimens for Hepatitis C Maria Buti Hospital Universitario Valle Hebron Barcelona Spain The first Results with Oral therapy: a Protease Inhibitor and NS5A inhibitor
More informationFelizarta, Bo Fu, Teresa Ng, Chih-Wei Lin, Federico Mensa Abstract 253. Pibrentasvir (formerly ABT-530) pangenotypic NS3/4A protease inhibitor
ENDURANCE-1: A Phase 3 Evaluation of the Efficacy and Safety of 8- versus 12-week Treatment with Glecaprevir/ Pibrentasvir (formerly ABT-493/ABT-53) in HCV Genotype 1 Infected Patients with or without
More informationSofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6 POLARIS-4
Phase 3 Treatment Experienced Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6 POLARIS-4 Bourlière M, et al. N Engl J Med. 217;376:2134-46. POLARIS-4: Study Features POLARIS-4 Trial Design:
More informationFDA ANTIVIRAL DRUGS ADVISORY COMMITTEE MEETING OCTOBER 25, 2013 BACKGROUND PACKAGE SOFOSBUVIR (GS-7977) FOR NDA FOOD AND DRUG ADMINISTRATION
FDA ANTIVIRAL DRUGS ADVISORY COMMITTEE MEETING OCTOBER 25, 2013 BACKGROUND PACKAGE FOR NDA 204671 SOFOSBUVIR (GS-7977) FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION RESEARCH OFFICE OF ANTIMICROBIAL
More informationCURRENT TREATMENTS. Mitchell L Shiffman, MD Director Liver Institute of Virginia. Richmond and Newport News, VA, USA
CURRENT TREATMENTS FOR HCV Mitchell L Shiffman, MD Director Liver Institute of Virginia Bon Secours Health System Richmond and Newport News, VA, USA Liver Institute of Virginia Education, Research and
More informationPopulation Viral Kinetic Modeling: SVR Prediction in HCV GT-3 Cirrhotic Patients With 24 Weeks of Daclatasvir + Sofosbuvir Administration
Population Viral Kinetic Modeling: SVR Prediction in HCV GT-3 Cirrhotic Patients With 24 Weeks of Daclatasvir + Sofosbuvir Administration Emi Tafoya, Yasong Lu, Melody Luo, Premkumar Narasimhan, Neelima
More informationSVR Updates from the 2013 EASL
Updates from the 2013 EASL By Tracy Swan, Treatment Action Group Streamlining HCV Treatment Treatment for hepatitis C virus (HCV) is becoming simpler, shorter, and more effective. All-oral combinations
More informationProgram Disclosure. Provider is approved by the California Board of Registered Nursing, Provider #13664, for 1.5 contact hours.
Program Disclosure This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint-sponsorship
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 informationEmerging Therapies for HCV: Highlights from AASLD 2012 (Part 1)
Emerging Therapies for HCV: Highlights from AASLD 2012 (Part 1) Goals for Hepatitis C Therapy Compared to PegIFN/RBV, new products should offer: Improved efficacy Efficacy in all patient types including
More information8/5/2014. A new era of HCV clinical management. Direct-Acting Antivirals for Hepatitis C. Goal of HCV treatment is viral cure HIV HBV HCV
NS5B NS5B 8/5/214 A new era of HCV clinical management Mark Sulkowski, MD Professor of Medicine Medical Director, Viral Hepatitis Center Divisions of Infectious Disease and Gastroenterology/Hepatology
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 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 informationIs HCV drug resistance an issue?
Is HCV drug resistance an issue? 5TH ASIAN CONFERENCE ON HEPATITIS&AIDS NANJING, CHINA 28-29 MAY 2016 FROM BASIC SCIENCE TO CLINICAL PRACTIC Jürgen Kurt Rockstroh Department of Medicine I, University Hospital
More informationGlecaprevir and Pibrentasvir in HCV GT 1-6 without Cirrhosis SURVEYOR-I and SURVEYOR-II
Phase 3 Treatment-Naïve and Treatment-Experienced Glecaprevir and Pibrentasvir in HCV GT 1-6 without Cirrhosis SURVEYOR-I and SURVEYOR-II Glecaprevir and Pibrentasvir in HCV GT 1-6 without Cirrhosis SURVEYOR-I
More informationTreatment of HCV infection in daily clinical practice. Which are the optimal options for Genotypes 2 and 3? Jiannis Vlachogiannakos
Treatment of HCV infection in daily clinical practice. Which are the optimal options for Genotypes 2 and 3? Jiannis Vlachogiannakos Associate Professor of Gastroenterology Academic Department of Gastroenterology
More informationHCV In 2015: Maximizing SVR
HCV In 2015: Maximizing SVR Alnoor Ramji Gastroenterology & Hepatology Clinical Associate Professor Division of Gastroenterology University Of British Columbia ramji_a@hotmail.com Disclosures (within Last
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 informationTreatments of Genotype 2, 3,and 4: Now and in the future
Treatments of Genotype 2, 3,and 4: Now and in the future THERAPY FOR THE TREATMENT OF GENOTYPE 2 1 GT 2 and GT 3 Treatment-Naïve: SOF+RBV vs PEG-IFN+RBV FISSION Study Design HCV GT 2 and GT 3 Treatment-naïve
More informationPIB. Next Generation Direct-Acting Antivirals. Collectively: G/P. Pibrentasvir (formerly ABT-530) pangenotypic NS5A inhibitor
Surveyor-II, Part 3: Efficacy and Safety of Glecaprevir/Pibrentasvir (Abt-493/Abt-53) in Patients with Hepatitis C Virus Genotype 3 Infection with Prior Treatment Experience and/or Cirrhosis David L. Wyles,
More informationTreatement Experienced patients without cirrhosis. Rafael Esteban Hospital Universitario Valle Hebron Barcelona
Treatement Experienced patients without cirrhosis Rafael Esteban Hospital Universitario Valle Hebron Barcelona Agenda With IFN PegIFN+ Ribavirin + Simeprevir PegIFN+ Ribavirin+ Sofosbuvir Without IFN Sofosbuvir
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 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 informationLedipasvir-Sofosbuvir (Harvoni)
HEPATITIS WEB STUDY HEPATITIS C ONLINE Ledipasvir-Sofosbuvir (Harvoni) Robert G. Gish MD Professor, Consultant, Stanford University Medical Center Senior Medical Director, St Josephs Hospital and Medical
More informationRome, February nd Riunione Annuale AISF th AISF ANNUAL MEETING
Rome, February 20-21 nd 2014 Riunione Annuale AISF 2014 14 th AISF ANNUAL MEETING Present and future treatment strategies for patients with HCV infection: chronic hepatitis and special populations IFN
More informationVirological tools for hepatitis C: re-treatment and resistance. Joop Arends Will Irving. by author
Virological tools for hepatitis C: re-treatment and resistance Joop Arends Will Irving Disclosures Joop Arends Advisory board: Gilead, Abbvie, Janssen, MSD, BMS (research) grants: Abbvie, BMS, MSD and
More informationChronic hepatitis C virus (HCV) infection is a. The Emergence of NS5B Resistance Associated Substitution S282T after Sofosbuvir-Based Treatment
HEPATOLOGY COMMUNICATIONS, VOL. 1, NO. 6, 2017 The Emergence of NS5B Resistance Associated Substitution S282T after Sofosbuvir-Based Treatment Edward J. Gane, 1 Sophie Metivier, 2 Ronald Nahass, 3 Michael
More informationHIV and Hepatitis C: Advances in Treatment
NORTHWEST AIDS EDUCATION AND TRAINING CENTER HIV and Hepatitis C: Advances in Treatment John Scott, MD, MSc Asst Professor University of Washington Presentation prepared & presented by: John Scott, MD,
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 informationThe nonstructural (NS)5B polymerase inhibitor,
RAPID COMMUNICATION Ledipasvir-Sofosbuvir Plus Ribavirin for Patients With Genotype 1 Hepatitis C Virus Previously Treated in Clinical Trials of Sofosbuvir Regimens David Wyles, 1 Paul Pockros, 2 Giuseppe
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 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 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 informationUpdates on the AASLD/IDSA HCV Guidance
Updates on the AASLD/IDSA HCV Guidance Susanna Naggie, MD, MHS Associate Professor of Medicine Duke University School of Medicine Durham, North Carolina Learning Objectives After attending this presentation,
More informationEmerging Therapies for HCV: Highlights from AASLD 2012 (Part 1)
Emerging Therapies for HCV: Highlights from AASLD 2012 (Part 1) Emerging Therapies for HCV: Highlights from AASLD 2012 (Part 1) Robert S. Brown, Jr., MD, MPH Frank Cardile Professor of Medicine Chief,
More informationIndividual Optmizaton of therapy. Graham R Foster Professor of Hepatology QMUL
Individual Optmizaton of therapy Graham R Foster Professor of Hepatology QMUL Conflicts of Interest Speaker and consultancy fees received from AbbVie, BI, BMS, Gilead, Janssen, Roche, Merck, Novarts, Springbank,
More informationHow to optimize current therapy for GT1 patients Shortened therapy with IFNa-based therapy
How to optimize current therapy for GT1 patients Shortened therapy with IFNa-based therapy Thomas Berg Sektion Hepatologie Klinik und Poliklinik für Gastroenterologie und Rheumatologie Leber- und Studienzentrum
More informationHepatitis C Treatment 2014
Hepatitis C Treatment 214 Brendan M. McGuire, MD UAB Liver Center Outline Epidemiology/National History Terminology for Treatment Treatment Considerations Current Treatment Options Genotype 1 (GT 1) Genotype
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 informationProtease inhibitor based triple therapy in treatment experienced patients
Protease inhibitor based triple therapy in treatment experienced patients Universitätsklinikum Leipzig Thomas Berg Sektion Hepatologie Klinik und Poliklinik für Gastroenterologie und Rheumatologie Leber
More informationClinical Applications of Resistance Stuart C. Ray, MD
Clinical Applications of Resistance Stuart C. Ray, MD Professor of Medicine and Oncology Director, Infectious Diseases Fellowship Training Program Johns Hopkins University School of Medicine Disclosures
More informationHCV: The next 18 months. David L. Wyles, M.D. Associate Professor of Medicine UCSD
HCV: The next 18 months David L. Wyles, M.D. Associate Professor of Medicine UCSD FIRST, A LOOK BACK WHAT DID I SAY LAST YEAR? My predictions for genotype 1: Multiple highly efficacious, well-tolerated,
More informationThe Dawn of a New Era: Hepatitis C
The Dawn of a New Era: Hepatitis C Naudia L. Jonassaint Assistant Professor of Medicine and Surgery University Pittsburgh School of Medicine December 1, 2015 Objectives After presentation the learner should
More informationNS5A inhibitors: ideal candidates for combination?
NS5A inhibitors: ideal candidates for combination? Professor Vasily Isakov, MD, PhD, AGAF Dep.Gastroentrology & Hepatology, ION, Russian Academy of Sciences, Moscow Structure and function of NS5A Meigang
More informationVirological assessment of patients candidate to DAA
Virological assessment of patients candidate to DAA Patients characteristics Italian male patient Diagnosis of chronic HCV infection in 1994 Genotype 1b defined in 1998 Non-responder to IFN+RBV He developed
More informationOral combination therapy: future hepatitis C virus treatment? "Lancet Oct 30;376(9751): Oral combination therapy with a nucleoside
Author manuscript, published in "Journal of Hepatology 2011;55(4):933-5" DOI : 10.1016/j.jhep.2011.04.018 Oral combination therapy: future hepatitis C virus treatment? Commentary article on the following
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 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 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 informationTreating HCV Genotype 2 & 3
Treating HCV Genotype 2 & 3 3rd Workshop on HCV Therapy Advances, Rome 14.12.2013 Christoph Sarrazin Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany HCV Genotypes 2 & 3 Laurel and Hardy
More informationTreatment of Unique Populations Raymond T. Chung, MD
Treatment of Unique Populations Raymond T. Chung, MD Director of Hepatology and Liver Center Vice Chief, Gastroenterology Kevin and Polly Maroni Research Scholar Mass General Hospital Disclosures Research
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 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 informationFeeling right at home
Feeling right at home Getting to Cure From Cure to Eradication Jordan J. Feld MD MPH Toronto Centre for Liver Disease Sandra Rotman Centre for Global Health University of Toronto SVR Dramatic Improvements
More informationUtility of Virological Assays at the DAA Era
Utility of Virological Assays at the DAA Era Prof. Jean-Michel Pawlotsky, MD, PhD National Reference Center for Viral Hepatitis B, C and delta Department of Virology & INSERM U955 Henri Mondor Hospital
More informationAntivirals for the treatment of chronic HCV infection: Bench to Bedside and beyond
Antivirals for the treatment of chronic HCV infection: Bench to Bedside and beyond Mark Sulkowski, MD Professor of Medicine Johns Hopkins University School of Medicine Baltimore, Maryland Disclosures for
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 informationIntroduction to the Impact of Resistance in Hepatitis C
Introduction to the Impact of Resistance in Hepatitis C Sponsored by AbbVie 2/1/2017 Presented by Sammy Saab, MD, MPH, FACG, AGAF, FAASLD February 1 st, 2017 1 AbbVie disclosures This is an Abbvie sponsored
More information2017 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 1146-7 Program Prior Authorization/Notification Medication Harvoni (ledipasvir/sofosbuvir) P&T Approval Date 10/2014, 2/2015,
More informationGlecaprevir-Pibrentasvir in Non-Cirrhotic Genotype 2 ENDURANCE-2
Phase 3 Treatment Naïve or Experienced Glecaprevir-Pibrentasvir in Non-Cirrhotic Genotype 2 ENDURANCE-2 *ENDURANCE-2: Study Features ENDURANCE-2 Trial Design: Randomized, double-blind, placebo-controlled
More informationThe role of triple therapy with protease inhibitors in hepatitis C virus genotype 1na «ve patients
The role of triple therapy with protease inhibitors in hepatitis C virus genotype 1na «ve patients David R. Nelson Clinical and Translational Science Institute, University of Florida, FL, USA Liver International
More information10/21/2016. Susanna Naggie, MD, MHS Associate Professor of Medicine Duke University Durham, North Carolina. Learning Objectives
A Crash Course on the AASLD/IDSA Hepatitis C Virus Infection Treatment Guidelines: What s New Susanna Naggie, MD, MHS Associate Professor of Medicine Duke University Durham, North Carolina FORMATTED: 1/3/16
More informationInterferon-based and interferon-free new treatment options
Interferon-based and interferon-free new treatment options White Nights of Hepatology St. Petersburg, 7. June 2013 Christoph Sarrazin Klinikum der J. W. Goethe-Universität Medizinische Klinik I Frankfurt
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 informationHCV-G3: Sofosbuvir with ledipasvir or daclatasvir?
HCV-G3: Sofosbuvir with ledipasvir or daclatasvir? Ioannis Goulis, MD Aristotelian University of Thessaloniki XXIII International Hepatitis B & C Meeting of Athens Hadziyannis HCV genotype 3 therapy Chronic
More informationAzienda ULSS12 Veneziana
Azienda ULSS12 Veneziana Risultati del trattamento dei monoinfetti con Sofosbuvir, Simeprevir nella coorte veneziana. Confronto di esito con la coorte del trattamento con Boceprevir e Telaprevir Dr.ssa
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 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 informationMany promising small molecule inhibitors directed
GASTROENTEROLOGY 2012;142:1351 1355 Will Interferon-Free Regimens Prevail? Christoph Welsch Stefan Zeuzem Department of Internal Medicine I, J. W. Goethe University Hospital, Frankfurt/Main, Germany Many
More informationSTATE OF THE ART Update: Treatment Options 2016 Mark Sulkowski, MD
Housekeeping Please turn off or silence cell phones. Restrooms are located on this floor. Make a left out of the ballroom foyer and the men s room is on your left. The ladies room is across from the elevators
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 information