Case. 63 year old woman now with:
|
|
|
- Terence Stokes
- 6 years ago
- Views:
Transcription
1 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 Mild splenomegaly with few small venous collaterals Three indeterminate lesions 2 LR4, 1 LR3
2 Prior HCV Treatment In 2012: In 2015: Liver biopsy demonstrated Stage II Fibrosis Asymptomatic. Normal Lab. Imaging negative. Clinical Trial: DAC + ASV + RBV x 12 weeks Relapsed FibroScan 11.9 kpa; c/w Stage III/IV Fibrosis Asymptomatic. Normal Lab. Imaging with areas of transient hypervascularity. She was anxious about the possible stage progression and hypervascularities and wanted re-treatment. Would you have considered re-treatment in 2015?
3 Question 1 HCV GT1, treatment experienced (dual DAA protease inhibitor (Asunaprevir) + NS5a inhibitor (Daclatasvir), F3/F4 Fibrosis Stage. What would you have recommended for re-treatment? 1. Ledipasvir/sofosbuvir 2. Paritaprevir/ombitasvir/dasabuvir 3. Simiprevir/Sofosbuvir 4. Add Ribavirin 5. Lengthen Duration (from 12 to 24 Weeks) 6. Wait for other Treatment Options
4 NS3 RAVs Observed With Treatment Boceprevir, telaprevir Activity in genotype 1 Low genetic barrier of resistance Considerable cross-resistance Boceprevir NS3 Protease (180 aa) Observed in >10% and <10% of Non-SVR Achievers V36 V54 V55 R155 A156 I/V170 V107 V158 D168 M175 V36, T54, R155, A156 Telaprevir V36 V54 V55 I132 R155 A156 D168 Simeprevir, asunaprevir, paritaprevir, vaniprevir Simeprevir Q80 S122 R155 D168 I/V170 Activity in multiple genotypes Asunaprevir V36 V55 Y56 Q80 S122 R155 V158 D168 I/V170 Improved genetic barriers to resistance R155 and D168 mutations substantially reduce activity Paritaprevir Vaniprevir V36 V55 Y56 R155 R155 A156 D168 D168 Lontok E, et al. Hepatology. 2015;62:
5 NS5A RAVs Observed With Treatment Broad genotypic coverage Relatively low barriers to resistance Most common NS5A RAV in patients not achieving SVR12 Daclatasvir Genotype 1a: M28T, Q30E/H/R, L31M, H58D, Y93H/N Genotype 1b: L31M/V, Y93H Genotype 4: Q30H/S Ledipasvir Genotype 1a: Q30E/R, L31M, Y93C/H/N Genotype 1b: Y93H Ombitasvir Genotype 1a: M28T, Q30R Genotype 1b: Y93H Genotype 4d: L28V Daclatasvir Ledipasvir Ombitasvir NS5A Domain 1 (213 aa) Observed in >10% and <10% of Non-SVR Achievers M/L28 Q/R30 L31 H/P58 Y93 P29 P32 E62 A92 Q30 L31 Y93 M28 H58 M28 Q30 Y93 H58 Lontok E, et al. Hepatology. 2015;62:
6 Decision HCV GT1, treatment experienced (dual DAA protease inhibitor (Asunaprevir) + NS5a inhibitor (Daclatasvir), F3/F4 Fibrosis Stage. What we decided to do: 1. Ledipasvir/sofosbuvir 2. Paritaprevir/ombitasvir/dasabuvir 3. Simiprevir/Sofosbuvir 4. Add Ribavirin 5. Lengthen Duration (from 12 to 24 Weeks) 6. Wait for other Treatment Options
7 Case She was treated with Ledipasvir/Sofosbuvir for 24 weeks. She refused RBV initially, but requested addition of RBV around week 12 of treatment. RBV was added, and was administered from weeks 12 to 24. She relapsed 12 weeks after stopping treatment. She is upset! Treatment did not work! Have we created an HCV SuperBug? Significant co-pay of several thousand US dollars!
8 NS5B RAVs Observed With Treatment No cross-resistance across nucleotide (sofosbuvir) and non-nucleotide (dasabuvir) polymerase inhibitors High barrier to resistance (sofosbuvir) Most common RAVs detected in non-svr12 achievers Sofosbuvir Genotype 2: S282T Genotype 3: L159F and V321A Dasabuvir Genotype 1a: M414T, S556G Genotype 1b: S556G Beclabuvir Genotype 1a: A421V, P495L/S NS5B Polymerase (591 aa) Observed in >10% and <10% of Non-SVR Achievers Nucleotide Analog Sofosbuvir Non-Nucleoside Analog Dasabuvir Beclabuvir L159 S282 V321 M414 S556 C316 Y448 A554 G554 D559 A421 P495 Lontok E, et al. Hepatology. 2015;62:
9 Question 2 Failed two DAA regimens: PI inhibitor (Asunaprevir) + NS5a inhibitor (Daclatasvir) and NS5b nuc inhibitor (Sofosbuvir) + NS5a inhibitor (Ledipasvir). F3/F4 Fibrosis Stage with possible HCC. What do you recommend for the possible HCC? 1. Loco-Regional Therapy (LRT) 2. Surgical resection 3. Evaluate for Liver Transplantation A. Deceased donor B. Living donor 4. Other
10 Decision Failed two DAA regimens: PI inhibitor (Asunaprevir) + NS5a inhibitor (Daclatasvir) and NS5b nuc inhibitor (Sofosbuvir) + NS5a inhibitor (Ledipasvir). F3/F4 Fibrosis Stage with multi-centric HCC. What we have done for the HCC: 1. Loco-Regional Therapy (LRT) 2. Surgical resection 3. Evaluate for Liver Transplantation A. Deceased donor B. Living donor 4. Other Followup Imaging for LR5 HCC
11 Question 3 What do you recommend for treatment of the HCV? 1. Treat Now or Pre-transplant 2. Treat after the potential transplant 3. Other If you decide to Treat Now: What DAA regimen would you recommend? Would you use interferon? Would you use ribavirin? How long would you treat?
12 Sofosbuvir + Paritaprevir/Ombitasvir/Dasabuvir + Ribavirin
13
14
15
16 What is in the Pipeline?
17 DUAL DAA Regimens Protease Inhibitor + Inhibitor of NS5A protein Grazoprevir + Elbasvir GT 1, 4 Polymerase Inhibitor + NS5A protein inhibitor Sofosbuvir + Velpatasvir Pan-GT
18 Grazoprevir/Elbasvir (GRZ/ELB)
19 Trials of GRZ/ELB % SVR C EDGE TN C EDGE HIV C SURFER C EDGE TE C EDGE TE C SALVAGE Mixed TN C EDGE TE Genotype 1 Genotype 4
20 Impact of Baseline RAVs on SVR12 Rates: HCV Genotype 1a Treatment-Naïve, Prior PR Relapsers Elbasvir/Grazoprevir for 12 Weeks Population Sequencing Next-Generation Sequencing* No RAVs With RAVs No RAVs With RAVs 98% 98% % 98% 91% 86% 80 72% SVR12 (%) % SVR12 (%) Elbasvir RAVs NS5A RAVs Prevalence of RAVs (%): 5 20 *1% cut-off. (n=414) (n=24) (n=352) (n=86) (n=396) (n=43) (n=289) (n=150) 0 Elbasvir RAVs NS5A RAVs Prevalence of RAVs (%): Jacobson IM, et al. Hepatology. 2015;62(suppl S1):1393A-1394A. Abstract LB
21 Impact of Baseline RAVs on SVR12 Rates: HCV Genotype 1a, Prior PR Nonresponders Elbasvir/Grazoprevir + RBV for 16/18 Weeks Population Sequencing Next-Generation Sequencing* 100 No RAVs With RAVs 100% 100% 100% 100% 100 No RAVs With RAVs 100% 100% 100% 100% SVR12 (%) SVR12 (%) Elbasvir RAVs NS5A RAVs Prevalence of RAVs (%): 2 15 *1% cut-off. (n=51) (n=1) (n=44) (n=8) (n=59) (n=9) (n=47) (n=21) 0 Elbasvir RAVs NS5A RAVs Prevalence of RAVs (%): 8 27 Jacobson IM, et al. Hepatology. 2015;62(suppl S1):1393A-1394A. Abstract LB
22 Velpatasvir / Sofosbuvir (VEL/SOF)
23 ASTRAL-1 SVR GT1a GT1b GT2 GT4 GT5 GT6 Overall Astral-1 Trial: Phase 3, 624 patients, 8% Black, 19% Cirrhosis, 32% prior treatment. SVR in placebo group 0%. SVR 99% in Compensated Cirrhosis, and 99% in Treatment Experienced. SVR not affected by baseline NS5A RAVs. No on-rx and only 2 post-rx virologic failures. N Engl J Med Dec 31;373(27):
24 ASTRAL-4 (CP B Cirrhosis) SVR VEL/SOF 12 VEL/SOF 24 VEL/SOF/RBV 12 ASTRAL-4: Phase 3, 267 patients with CP B Cirrhosis. 78% GT1, 4% GT2, 15% GT3, 3% GT4, 0 GT5, <1% GT6. N Engl J Med Dec 31;373(27):
25 TRIPLE DAA Regimens Polymerase Inhibitor + NS5A Inhibitor + Protease Inhibitor Sofosbuvir + Elbasvir + Grazoprevir GT 1 Sofosbuvir + Velpatasvir + GS 9857 Pan-GT MK Elbasvir + Grazoprevir Pan-GT ACH Odalasvir + Sovaprevir GT 1 TMC r + Samatasvir + Simeprevir GT 1 Sofosbuvir + Daclatasvir + Simeprevir GT 1,3,4
26 Sofosbuvir / Elbasvir / Grazoprevir C-SWIFT study of HCV GT 1
27 Shortened Duration of Rx: GT1 SOFOSBUVIR 400 mg + ELBASVIR 50 mg + GRAZOPREVIR 100 mg 100 % SVR 4/ , , ,7 12/31 26/30 16/20 18/19 NonCirrh 4 Wk NonCirrh 6 Wk Cirrh 6 Wk Cirrh 8 Wk Lawitz E, et al. C-SWIFT: MK MK SOFOSBUVIR in Rx-Naïve Patients with HCV GT1 with and without cirrhosis. AASLD LB-33.
28 Sofosbuvir / Velpatasvir / GS 9857 POLARIS Studies 1,2,3,4
29 Anybody can jump a motorcycle. The trouble begins when you try to land it. Evel Kneivel
30 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 Mild splenomegaly with few small venous collaterals Three indeterminate lesions 2 LR4, 1 LR3
31 Question 3 What do you recommend for treatment of the HCV? Enrolled in clinical trial POLARIS.* She has been evaluated but not listed for LTx. She has potential donors for LDLT.
Hepatitis 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
HCV 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
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
Management 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
Direct-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
Resistencias & Epidemiología. Eva Poveda Division of Clinical Virology INIBIC-Complexo Hospitalario Universitario de A Coruña
Resistencias & Epidemiología Eva Poveda Division of Clinical Virology INIBIC-Complexo Hospitalario Universitario de A Coruña Rapid Evolution of HCV Regimens: Easier to take/tolerate, Short Duration, Pangenotypic,
What 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
Hepatitis 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
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
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
Saeed 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-
HCV 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
Cases: 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
Is 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
Management 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
A 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
Kristen 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,
Meet the Professor: HIV/HCV Coinfection
Meet the Professor: HIV/HCV Coinfection Vincent Lo Re, MD, MSCE Assistant Professor of Medicine and Epidemiology Division of Infectious Diseases Center for Clinical Epidemiology and Biostatistics University
Genotype 1 Treatment Naïve No Cirrhosis Options
Genotype 1 Treatment Naïve No Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) x 12 weeks 1 Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks Ledipasvir/Sofosbuvir (Harvoni ) x 8-12 weeks 2 1 If genotype
Initial 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
5/12/2016. 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,
Viva 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
Massimo 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
Study 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
Expert 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
Current 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
IFN-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,
What 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
Hepatitis C: Aplicaciones Clínicas de la Resistencia. Eva Poveda Division of Clinical Virology INIBIC-Complexo Hospitalario Universitario de A Coruña
Hepatitis C: Aplicaciones Clínicas de la Resistencia Eva Poveda Division of Clinical Virology INIBIC-Complexo Hospitalario Universitario de A Coruña DAA agents approved or in more advanced stages of clinical
HCV 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,
Evolution 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
Direct Acting Antivirals for the Treatment of Hepatitis C Infection
Hepatitis C Core Curriculum, Module 2 Direct Acting Antivirals for the Treatment of Hepatitis C Infection Jason J. Schafer, PharmD, MPH, BCPS, AAHIVP Objectives Discuss the evolution of hepatitis C treatment
Disclosures. 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
Selecting 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
Debate: 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
HCV 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
Azienda 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
VIRAL LIVER DISEASE. OAG Post DDW Course Westin Prince, Toronto, June 13-14, 2015
VIRAL LIVER DISEASE OAG Post DDW Course Westin Prince, Toronto, June 13-14, 2015 Financial Interest Disclosure (over the past 24 months) Dr. Paul Marotta Relationships related to this presentation! Research
Hepatitis 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
Universal HCV treatment: Strategies for simplification
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. Disclosures
2017 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
HEPATITIS 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
How 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
Hepatitis 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
Virological 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
Update 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
8/5/2014. 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
Dr 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
HCV 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
Update 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
Current 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
CCO 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
HCV 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
Genotype 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
EASL 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
The HCV Pipeline Ira M. Jacobson, MD, FACP, FACG, AGAF. Slide Presentation. IFN-free DAA combinations (G1)
Slide Presentation The HCV Pipeline Vincent Astor Distinguished Professor of Medicine Chief, Division of Gastroenterology and Hepatology Medical Director, Center for the Study of Hepatitis C Weill Cornell
Medical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C Second Generation Antivirals Page 1 of 30 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C Second Generation Antivirals Through
TREATMENT 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,
1/16/2019. Goals of HCV Therapy. Objectives. Treating Hepatitis C and HIV Co Infection. Cure Defined as sustained virologic response (SVR)
HCV ECHO WESTERN STATES HCV ECHO WESTERN STATES Treating Hepatitis C and HIV Co Infection Paulina Deming, Pharm D Associate Professor, College of Pharmacy Assistant Director, Viral Hepatitis Programs,
Associate 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
10/21/2016. 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
Update 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
Antiviral agents in HCV
Antiviral agents in HCV : Upcoming Therapeutic Options Su Jong Yu, M.D., Ph.D. Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine Estimated 170 Million
Hepatitis C Virus: HIV/Hepatitis C Coinfection Wednesday, August 24, 2016
Hepatitis C Virus: HIV/Hepatitis C Coinfection Debika Bhattacharya, MD, MSc Associate Clinical Professor University of California Los Angeles Los Angeles, California Washington, DC: August 24, 2016 Slide
Disclosures. I have given sponsored lectures for the following pharmaceutical companies: Gilead, Abbvie and MSD. I own shares of Gilead Sciences.
Disclosures I have given sponsored lectures for the following pharmaceutical companies: Gilead, Abbvie and MSD. I own shares of Gilead Sciences. Chronic Hepatitis C Prof CL Lai University Department of
Is Treatment cost effective HCV and Organ Transplantation
Is Treatment cost effective HCV and Organ Transplantation Dr Kosh Agarwal Institute of Liver Studies King s College Hospital Barcelona 2016 Disclosures: BoJo Pharma support: AbbVie/Achillion/ Astellas/
4/30/2015. Interactive Case-Based Presentations and Audience Discussion. Debika Bhattacharya, MD, MSc. Learning Objectives
4/3/215 Interactive Case-Based Presentations and Audience Discussion Debika Bhattacharya, MD, MSc Assistant Clinical Professor University of California Los Angeles Los Angeles, California Formatted:4-27-215
Hepatitis 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
Sovaldi (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
Virological 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
Patients with compensated cirrhosis: how to treat and follow-up
Patients with compensated cirrhosis: how to treat and follow-up Thomas Berg Sektion Hepatologie Klinik und Poliklinik für Gastroenterologie und Rheumatologie Universitätsklinikum Leipzig Leber- und Studienzentrum
Protease 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
HCV Treatment in 2016
HCV Treatment in 2016 Hugo E. Vargas, MD Professor of Medicine Mayo College of Medicine Medical Director, Clinical Trials Office Vice Chair, Department of Research Educational Goals Caveats: Cannot cover
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Harvoni) Reference Number: CP.CPA.175 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
Tough Cases in HIV/HCV Coinfection
NORTHWEST AIDS EDUCATION AND TRAINING CENTER Tough Cases in HIV/HCV Coinfection John Scott, MD, MSc Assistant Professor University of Washington Presentation prepared by: J Scott Last Updated: Jun 5, 2014
SURVEYOR-II Part 2 Study Design
HIGH SVR RATES WITH + CO-ADMINISTERED FOR 8 WEEKS IN NON-CIRRHOTIC PATIENTS WITH HCV GENOTYPE 3 INFECTION A.J. Muir, S. Strasser, S. Wang, S. Shafran, M. Bonacini, P. Kwo, D. Wyles, E. Gane, S.S. Lovell,
Clinical Сase A previously relapse to PEG IFN + RBV in HCV G3a patient. Konstantin Zhdanov
Clinical Сase A previously relapse to PEG IFN + RBV in HCV G3a patient Konstantin Zhdanov Genotype 3 in Europe Canada Norway Germany Sweden Czech Republic Poland Approximately 1/3 of HCV-infected patients
HCV 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
NS5A 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
Cases: 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
David 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
6/2/2015. Interactive Case-Based Presentations and Audience Discussion
6/2/215 Interactive Case-Based Presentations and Audience Discussion Andrew Aronsohn, MD Assistant Professor of Medicine University of Chicago Medical Center Chicago, Illinois Formatted:5-6-215 Washington,
New 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
STATE 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
Medical 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
Hepatitis C ew Medications, New Hope and New. V. Opportunities for Primary Care. Outline. HCV Disease Outcomes in the US 9/21/2016
Hepatitis C ew Medications, New Hope and New Opportunities for Primary Care Primary Care Principles and Practice October 14, 2016 Disclosures: Grant support Gilead Sciences, Inc Quality improvement Systematized
Why 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
HCV resistance testing in clinical practice. Daniel Bradshaw Virus Reference Department National Infection Service Public Health England
HCV resistance testing in clinical practice Daniel Bradshaw Virus Reference Department National Infection Service Public Health England Declaration of Interests Dan Bradshaw has received personal grants
Primary Care Approach to Diagnosis and Management of Chronic Hepatitis C Brian Viviano, D.O.
Primary Care Approach to Diagnosis and Management of Chronic Hepatitis C Brian Viviano, D.O. Objectives Epidemiology of chronic hepatitis C CDC guidelines on screening or hepatitis C Diagnosing hepatitis
Drug Class Monograph
Drug Class Monograph Class: Chronic Hepatitis C Drugs(s): Daclatasvir (Daklinza), Dasabuvir/ombitasivir/paritaprevir/ritonavir (Viekira Pak), Elbasvir/grazoprevir (Zepatier), Peginterferon alfa-2a (Pegasys),
Harvoni (sofosbuvir/ledipasvir
Market DC Override(s) Prior Authorization Quantity Limit (sofosbuvir/ledipasvir) Approval Duration Based on Genotype, Treatment status, Baseline HCV RNA status, Cirrhosis status, Transplant status, or
Hepatitis C: the 2015 Perspective for the Family Medicine Practitioner
Hepatitis C: the 2015 Perspective for the Family Medicine Practitioner Annie Luetkemeyer, MD Division of HIV,ID & Global Medicine San Francisco General Hospital Disclosures I have received research grant
HCV Case Study. Treat Now or Wait for New Therapies
HCV Case Study Treat Now or Wait for New Therapies This program is supported by educational grants from Kadmon and Merck Pharmaceuticals. Program Disclosure This activity has been planned and implemented
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Epclusa) Reference Number: CP.CPA.286 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
Need 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
5/10/2016. Management of Hepatitis C Virus Genotype 1 and 4 Treatment-Naive and Treatment-Experienced Patients. HCV life-cycle and antiviral targets
5/1/216 Management of Hepatitis C Virus Genotype 1 and 4 Treatment-Naive and Treatment-Experienced Patients David L. Wyles, MD Associate Professor of Medicine University of California San Diego La Jolla,
Chronic Hepatitis C Drug Class Prior Authorization Protocol
Line of Business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 Chronic Hepatitis C Drug Class Prior Authorization Protocol This policy has been developed through review of medical
Baseline 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
Drug Class Prior Authorization Criteria Hepatitis C
Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: November 14, 2018 Effective Date: January 1, 2019 This drug class prior authorization criteria have been
Hepatitis 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
Hepatitis 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