Emerging Direct-Acting Antivirals for Treatment of Chronic Hepatitis C

Size: px
Start display at page:

Download "Emerging Direct-Acting Antivirals for Treatment of Chronic Hepatitis C"

Transcription

1 Emerging Direct-Acting Antivirals for Treatment of Chronic Hepatitis C Debra Birnkrant, MD Director, DAVP DILI Conference March 20,

2 HCV in the United States 3 to 4 million people have chronic HCV Most unaware of their infection HCV Genotype 1 most common (~75%), followed by Genotypes 2 and 3 (~20%) Most common reason for liver transplant 15,000 deaths/year More annual deaths than related to HIV 2

3 HCV in the United States Decompensated cirrhosis Projected Peak incidence: 2020 with >145,000 cases/year Hepatocellular carcinoma Projected Peak incidence: 2019 with 14,000 cases/year CDC issued recent recommendation to screen all baby boomers Gastroenterology. 2010;138(2):

4 Sustained Virologic Response (SVR) Lack of detection of HCV RNA in blood several weeks after complete treatment (e.g., SVR12) Florian, Jeffry, Chen, Jianmeng, Jadhav, Pravin, Carter, Wendy, Murray, Jeff, Birnkrant, Debra. Consideration of new endpoints for regulatory approval and dose selection of hepatitis C therapies. In: 62nd AASLD, San Francisco, CA, 4 8 November Abstract LB- 28. (accepted for publication in Gastroenterology, 2013) Used as determination of treatment success; primary endpoint in clinical trials Correlated with improvements in development of hepatocellular carcinoma, hepatic events, fibrosis, allcause mortality Adriann van der Meer, et al., JAMA, 2012;308: Considered equal to virologic cure of chronic HCV 4

5 HCV Treatment Evolution Standard Interferon Ribavirin Pegylated Interferon Boceprevir Telaprevir % Percent Sustained Response 80% 60% 40% 20% 6% 16% 34% 42% 39% 54% 70 + % 0% IFN 6 m IFN 12 m IFN/R 6 m IFN/R 12 m PegIFN 12m Peg/R 12m Peg/R/PI 5

6 May 2011 New era of direct acting antiviral- (DAA) based treatment Two HCV protease inhibitors approved for use in HCV genotype 1-infected patients Boceprevir and Telaprevir represents a new direction in the treatment of hepatitis C and a significant improvement over the current standard of care Dr. Margaret A. Hamburg, Commissioner of the FDA 6

7 Direct-Acting Antivirals (DAAs) 7

8 Boceprevir: Treatment-Naïve SVR 38% 63% 66% Response Guided Therapy (RGT) ~60% eligible to receive a shortened 28 week duration -> ~90% SVR 8

9 Telaprevir: Treatment-Experienced SVR significantly higher in pooled T12/PR48 groups compared with PR48 % SVR Relapsers Partial Responders 32 Nulls 5 T12/PR48 PR48 9

10 Boceprevir: Safety 4 pills 3x/day Plus PEG/RBV Anemia, neutropenia Dysgeusia Drug-drug interactions CYP3A4/5 inhibitor 10

11 Telaprevir: Safety 2 pills 3x/day with high fat food Plus PEG/RBV Anemia Rash, pruritus, anorectal disorders Drug-drug interactions CYP3A inhibitor/substrate Pgp inhibitor/substrate 11

12 Approved DAA-based HCV Treatment Boceprevir and Telaprevir approvals are major advance in HCV treatment options Improved SVR rates compared to PEG/RBV alone Potential for shorter duration through RGT Limitations Still need PEG/RBV (bone marrow suppression, neuropsychiatric effects, hemolytic anemia, teratogenicity, etc.) Only for HCV GT1 Drug-drug interactions High pill burden Serious side effects, i.e. rash, anemia Intensive clinical management 12

13 Challenges for Future DAA Therapy Simple regimens Short duration, simple futility rules Easy dosing Low pill burden, limited drug interactions All oral Pan-genotypic Highly effective In challenging populations Safe and tolerable Manageable side effect profile 13

14 Future DAA-based HCV Treatment boceprevir telaprevir NS3/4A PIs simeprevir faldaprevir Vaniprevir ABT-450 MK-5172 and others sovaprevir GS-9451 asunaprevir danoprevir GS-9256 NS5B Polymerase inhibitors Nuc. Analogues NS5B Polymerase inhibitors Non-Nuc. sofosbuvir mericitabine and others BI ABT-333 tegobuvir ABT-072 VX-222 filibuvir setrobuvir BMS and others NS5A inhibitors daclatasvir ABT-267 GS-5885 and others 14 Assembled based on information included in HCV Drug ResisSS 2012 v1.2 (HCV DrAG)

15 DAA Classes NS3/4A PIs NS5B Polymerase Inhibitors NS5A Inhibitors Nucleoside /tide Non-nuc (multiple subclasses) Genotypic Coverage Limited* Pangenotypic Limited Variable Potency High Variable Intermediate High Barrier to Resistance Low* High Low Low* *Varies with the generation of the drug within the class 15 Adapted/Updated from Vachon M. and Dieterich D., Semin Liver Dis. 2011;31(4):

16 SVR Rates With 24 Wks of Daclatasvir + Sofosbuvir ± RBV: Treatment Naïve, non-cirrhotic, GT 1-3 Very high SVR24 rates with 24-wk regimens across genotypes GT1 GT2/3 HCV RNA < LLOQ (%) EOT* SVR24 EOT* Sulkowski MS, et al. AASLD Abstract LB-2. SVR24 EOT* SVR4 SOF LI + DCV SOF + DCV SOF + DCV (12 wk) SOF + DCV + RBV SOF + DCV + RBV (12 wk) *EOT includes pts who discontinued early, with last visit considered EOT. 0 16

17 AVIATOR: SVR12 Rates With ABT-450/RTV, ABT-267, ABT-333, and RBV SVR12 rates higher in pts with GT1b HCV but also high in pts with GT1a HCV 12-wk regimen with all 3 DAAs + RBV produced highest SVR12 rates Treatment-Naive Patients Null Responders SVR12 (%) n = a 1b 1a 1b 1a 1b 1a 1b 1a 1b 1a 1b 1a 1b Observed data (above bar) ITT (within bar) ABT-450 ABT-267 ABT-333 RBV ABT-450 ABT-333 RBV ABT-450 ABT-267 RBV ABT-450 ABT-267 ABT-333 ABT-450 ABT-267 ABT-333 RBV ABT-450 ABT-267 RBV ABT-450 ABT-267 ABT-333 RBV 8 wks 12 wks 12 wks Kowdley KV, et al. AASLD Abstract LB-1. 17

18 Daclatasvir/Asunaprevir Dual Regimen in GT1b Null Responders Group A1: DCV+ASV 200 mg BID SVR12 = 78% (14/18) Group A2: DCV+ASV 200 mg QD SVR12 = 65% (13/20) Bristol-Myers Squibb. Investigational Hepatitis C Dual DAA Regimen of Daclatasvir and Asunaprevir Achieved SVR12 in 78% of Difficult-to-Treat Genotype 1b Prior Null Responders In Expanded Phase II Study. Press release. November 11,

19 Fission GT2/3 Naïve Sofosbuvir NS5B nucleotide polymerase inhibitor + RBV x 12 weeks vs PEG/RBV x 24 weeks SOF+RBV N=207 SVR12 67% PEG+RBV N=243 SVR12 67% Weeks Gilead Sciences: Press release February 4,

20 FDA Guidance (DILI) Intended to assist in the evaluation of the potential for a drug to cause severe liver injury during new drug development Does not address the issue of DILI in patients with preexisting liver disease such as chronic hepatitis C who often have elevated liver enzymes at baseline 20

21 Challenges in the Evaluation of Potential DILI in HCV Drug Development Should trials have standardized entry and monitoring criteria? Concern that clinical trial inclusion or exclusion criteria are too stringent do not reflect the wide range of patients who will receive treatment in real-world setting. Which criteria should be used for suspicion of DILI in patients with elevated liver enzymes at baseline? During a clinical trial, change in ALT from a patient s own baseline or nadir value on treatment may be more informative 21

22 Future DAA-based HCV Treatment IFN-free regimens Pan-genotypic Shorter durations Once daily dosing Improved efficacy All patient subgroups Oral regimen with low pill burden Improved safety 22

23 Conclusions Chronic HCV may lead to cirrhosis, hepatocellular carcinoma, and/or hepatic decompensation if left untreated Growing at-risk population in the US PI approvals in 2011 marked a significant improvement in HCV treatment options, but many limitations remain Future IFN-free DAA options are rapidly advancing 23

HIV/Hepatitis C co-infection. Update on treatment Eoin Feeney

HIV/Hepatitis C co-infection. Update on treatment Eoin Feeney HIV/Hepatitis C co-infection Update on treatment Eoin Feeney HIV/Hepatitis C coinfection Where we are now Current treatment regimens and outcomes What s coming soon Direct acting antivirals (DAAs) What

More information

HCV Pipeline: The Next 18 Months Michael W. Fried, MD

HCV Pipeline: The Next 18 Months Michael W. Fried, MD HCV Pipeline: The Next 18 Months Michael W. Fried, MD Professor of Medicine Director, UNC Liver Center University of North Carolina at Chapel Hill Michael W. Fried, MD Commercial Disclosures Grants/Research

More information

Debate: To Treat Now or Not to Treat Now. Age, Disease Stage, Resistance, and Comorbidities

Debate: To Treat Now or Not to Treat Now. Age, Disease Stage, Resistance, and Comorbidities Debate: To Treat Now or Not to Treat Now Age, Disease Stage, Resistance, and Comorbidities Moderator: Raymond T. Chung, MD Associate Professor of Medicine, Harvard Medical School Director of Hepatology

More information

HCV in 2020: Any cases left? Rafael Esteban Hospital General Universitario Valle Hebron Barcelona. Spain

HCV in 2020: Any cases left? Rafael Esteban Hospital General Universitario Valle Hebron Barcelona. Spain HCV in 2020: Any cases left? Rafael Esteban Hospital General Universitario Valle Hebron Barcelona. Spain Yes, still too many Measures to eradicate an Infectious Disease Prevention: Vaccination Screening

More information

New Research On Direct-acting Antivirals For The Treatment Of Hepatitis C

New Research On Direct-acting Antivirals For The Treatment Of Hepatitis C New Research On Direct-acting Antivirals For The Treatment Of Hepatitis C Highlights From EASL 214, London, U.K. This report contains highlights from a selection of abstracts and posters presented during

More information

Hepatitis Update. Study 110: SVR at post-treatment week 24 (SVR24) Jürgen Rockstroh, MD. No ART EFV/TDF/FTC ART/r/TDF/FTC Total

Hepatitis Update. Study 110: SVR at post-treatment week 24 (SVR24) Jürgen Rockstroh, MD. No ART EFV/TDF/FTC ART/r/TDF/FTC Total Hepatitis Update Jürgen Rockstroh, MD Study 11: SVR at post-treatment week 24 (SVR24) Patients with Undetectable HCV RNA (Percentage) 8 7 6 5 4 3 2 1 71 No ART EFV/TDF/FTC ART/r/TDF/FTC Total 69 8 74 n/n

More information

Robert G. Knodell, M.D. Maryland Chapter, American College of Physicians Fb February 3, 2012

Robert G. Knodell, M.D. Maryland Chapter, American College of Physicians Fb February 3, 2012 Treatment of Hepatitis C:Present and Future Robert G. Knodell, M.D. Scientific Meeting Maryland Chapter, American College of Physicians Fb February 3, 2012 Presentation Objectives Appreciate the Public

More information

Objectives. Hepatitis C: The new era of screening and treatment. Distribution of HCV genotypes 11/1/2014. History of HCV diagnosis and screening

Objectives. Hepatitis C: The new era of screening and treatment. Distribution of HCV genotypes 11/1/2014. History of HCV diagnosis and screening Objectives Hepatitis C: The new era of screening and treatment David Crabb, M.D. Department of Medicine, Indiana University and Eskenazi Health Describe the natural history of HCV infection Be able to

More information

In this study, the DCV+ASV regimen had low rates of discontinuation (5%) due to adverse events, and low rates of serious adverse events (5.

In this study, the DCV+ASV regimen had low rates of discontinuation (5%) due to adverse events, and low rates of serious adverse events (5. BMS Submits First All-Oral, Interferon-Free and Ribavirin-Free Treatment Regimen for Regulatory Review in Japan for Patients with Chronic Hepatitis C Infection An overall SVR 24 rate of 84.7 percent was

More information

UPDATE ON NEW HEPATITIS C MEDICINES

UPDATE ON NEW HEPATITIS C MEDICINES UPDATE ON NEW HEPATITIS C MEDICINES Diana Sylvestre, MD 2014 AASLD/IDSA Guidelines: Gt 1 Treatment naïve Interferon eligible: sofosuvir + ribavirin + PEG-IFN x 12 weeks Interferon ineligible: sofosbuvir

More information

Newton Kendig, MD RADM, Assistant Surgeon General, USPHS Assistant Director Health Services Division, FBOP

Newton Kendig, MD RADM, Assistant Surgeon General, USPHS Assistant Director Health Services Division, FBOP Newton Kendig, MD RADM, Assistant Surgeon General, USPHS Assistant Director Health Services Division, FBOP I do not have any relevant financial relationships with any commercial interests. At the end of

More information

Back to main HCV Drug Development Section. December 2012. By Tracy Swan

Back to main HCV Drug Development Section. December 2012. By Tracy Swan Submitted by tracyswan on Wed, 12/12/2012-20:09 Back to main HCV Drug Development Section December 2012 By Tracy Swan It is difficult to be anything other than dazzled by astounding cure rates of up to

More information

A Cure is Within Reach:

A Cure is Within Reach: A Cure is Within Reach: A Review of the New HCV Medications Misty Miller, Pharm.D., BCPS, AAHIVP Clinical Assistant Professor University of Oklahoma College of Pharmacy September 11, 2015 Pre Assessment

More information

HEPATITIS C UPDATE: A Quarter-Century Dramatic Journey. Steve T. Chen M.D. FACP, FACG

HEPATITIS C UPDATE: A Quarter-Century Dramatic Journey. Steve T. Chen M.D. FACP, FACG HEPATITIS C UPDATE: A Quarter-Century Dramatic Journey Steve T. Chen M.D. FACP, FACG Hepatitis C Virus: Morphology and Characteristics Hepatitis C Virus Discovered in 1989 Nucleic Acid: 9.6 kb ssrna 40-60

More information

Clinical Criteria for Hepatitis C (HCV) Therapy

Clinical Criteria for Hepatitis C (HCV) Therapy Diagnosis Clinical Criteria for Hepatitis C (HCV) Therapy Must have chronic hepatitis C (HCV infection > 6 months), genotype and sub-genotype specified to determine the length of therapy; Liver biopsy

More information

A collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C

A collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C A collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C Q1-2013 Conference Call - Presenting team Maris Hartmanis, CEO Charlotte

More information

Hepatitis C. Eliot Godofsky, MD University Hepatitis Center Bradenton, FL

Hepatitis C. Eliot Godofsky, MD University Hepatitis Center Bradenton, FL Hepatitis C Eliot Godofsky, MD University Hepatitis Center Bradenton, FL Recent Advances in Hepatitis C Appreciation that many patients are undiagnosed Improved screening to identify infected persons Assessment

More information

Hepatitis C Virus (HCV)

Hepatitis C Virus (HCV) HFS Report to Legislative Task Force Hepatitis C Arvind Goyal MD, MPH, MBA Medical Director Illinois Department of Healthcare and Family Services Hepatitis C Virus (HCV) Slowly progressive disease 40 years-median

More information

NEW DRUGS FOR THE TREATMENT OF HEPATITIS C. Marcella Honkonen, PharmD, BCPS AzPA Annual Convention. Sunday, June 29 th, 2014 (1:15-2:15)

NEW DRUGS FOR THE TREATMENT OF HEPATITIS C. Marcella Honkonen, PharmD, BCPS AzPA Annual Convention. Sunday, June 29 th, 2014 (1:15-2:15) NEW DRUGS FOR THE TREATMENT OF HEPATITIS C Marcella Honkonen, PharmD, BCPS AzPA Annual Convention. Sunday, June 29 th, 2014 (1:15-2:15) Objectives Determine initial treatment options for patients with

More information

Management of Chronic HCV Cirrhosis: Pre and Post-Liver Transplantation

Management of Chronic HCV Cirrhosis: Pre and Post-Liver Transplantation Management of Chronic HCV Cirrhosis: Pre and Post-Liver Transplantation K.Rajender Reddy M.D., Professor of Medicine and Surgery Director of Hepatology Director, Viral Hepatitis Center Transplantation

More information

GUIDELINES FOR THE SCREENING, CARE AND TREATMENT OF PERSONS WITH CHRONIC HEPATITIS C INFECTION POLICY BRIEF

GUIDELINES FOR THE SCREENING, CARE AND TREATMENT OF PERSONS WITH CHRONIC HEPATITIS C INFECTION POLICY BRIEF NEW RECOMMENDATIONS IN THE UPDATED WHO GUIDELINES FOR THE SCREENING, CARE AND TREATMENT OF PERSONS WITH CHRONIC HEPATITIS C INFECTION POLICY BRIEF NEW RECOMMENDATIONS IN THE UPDATED WHO GUIDELINES FOR

More information

Current & New Hepatitis C Meds on the Horizon

Current & New Hepatitis C Meds on the Horizon Current & New Hepatitis C Meds on the Horizon African Americans & Clinical Trials National Black Leadership Commission on AIDS May 28, 2014 Tracy Swan, Treatment Action Group Short for.. PEG-IFN pegylated

More information

New treatment options for HCV: implications for the Optimal Use of HCV Assays

New treatment options for HCV: implications for the Optimal Use of HCV Assays New treatment options for HCV: implications for the Optimal Use of HCV Assays Hans Orlent Dept. of Gastroenterology & Hepatology AZ Sint Jan Brugge-Oostende, Brugge This program is supported by educational

More information

The Comparative Clinical Effectiveness and Value of Simeprevir and Sofosbuvir in the Treatment of Chronic Hepatitis C Infection

The Comparative Clinical Effectiveness and Value of Simeprevir and Sofosbuvir in the Treatment of Chronic Hepatitis C Infection The Comparative Clinical Effectiveness and Value of Simeprevir and Sofosbuvir in the Treatment of Chronic Hepatitis C Infection A Technology Assessment Final Report April 15, 2014 Completed by: Institute

More information

The question and answer session is not available after the live webinar.

The question and answer session is not available after the live webinar. 1 Read verbatim. 2 The Infectious Diseases Society of America (IDSA) Hepatitis C Knowledge Network offers monthly, 1 hour webinars to educate IDSA members on current recommended practices and treatments

More information

MEDICAL POLICY STATEMENT

MEDICAL POLICY STATEMENT MEDICAL POLICY STATEMENT Original Effective Date Next Annual Review Date Last Review / Revision Date 5/21/2014 3/24/2016 3/24/2015 Policy Name Policy Number Hepatitis C Oral SRx-0003 Medical Policy Statements

More information

A JOURNAL OF CURRENT TRENDS IN MEDICINE FROM IU HEALTH PHYSICIANS, A PARTNERSHIP OF IU SCHOOL OF MEDICINE AND INDIANA UNIVERSITY HEALTH

A JOURNAL OF CURRENT TRENDS IN MEDICINE FROM IU HEALTH PHYSICIANS, A PARTNERSHIP OF IU SCHOOL OF MEDICINE AND INDIANA UNIVERSITY HEALTH O C T O B E R 2 0 1 3 V O L. 1 3, I S S U E 4 ADVANCEDpraxis A JOURNAL OF CURRENT TRENDS IN MEDICINE FROM IU HEALTH PHYSICIANS, A PARTNERSHIP OF IU SCHOOL OF MEDICINE AND INDIANA UNIVERSITY HEALTH C A

More information

Preamble. Introduction. Marc G. Ghany, 1 David R. Nelson, 2 Doris B. Strader, 3 David L. Thomas, 4 and Leonard B. Seeff 5 *

Preamble. Introduction. Marc G. Ghany, 1 David R. Nelson, 2 Doris B. Strader, 3 David L. Thomas, 4 and Leonard B. Seeff 5 * An Update on Treatment of Genotype 1 Chronic Hepatitis C Virus Infection: 2011 Practice Guideline by the American Association for the Study of Liver Diseases A new section on Use and Interpretation of

More information

Safety and Efficacy of DAA + PR in HCV/HIV co-infected patients. Mark Sulkowski, MD Johns Hopkins University Baltimore Maryland USA

Safety and Efficacy of DAA + PR in HCV/HIV co-infected patients. Mark Sulkowski, MD Johns Hopkins University Baltimore Maryland USA Safety and Efficacy of DAA + PR in HCV/HIV co-infected patients Mark Sulkowski, MD Johns Hopkins University Baltimore Maryland USA Liver disease is the second leading cause of death amongst HIV-positive

More information

Hepatitis C: Eradication of a Disease? Gordon Dow, MD Oct 16 th, 2015

Hepatitis C: Eradication of a Disease? Gordon Dow, MD Oct 16 th, 2015 Hepatitis C: Eradication of a Disease? Gordon Dow, MD Oct 16 th, 2015 Disclosures: In the past two years I have participated in research 1 or received consultation/speaking fees 2 from: Astellas 2 Abbvie

More information

DE VERSCHILLENDE ANTIVIRALE MIDDELEN EN HUN WERKINGSMECHANISME

DE VERSCHILLENDE ANTIVIRALE MIDDELEN EN HUN WERKINGSMECHANISME DE VERSCHILLENDE ANTIVIRALE MIDDELEN EN HUN WERKINGSMECHANISME Johan Neyts Rega Institute for Medical Research, University of Leuven, Belgium Johan.neyts@rega.kuleuven.be www.antivirals.be Pentalfa, 28

More information

HEPATITIS C (HCV) CME ACCREDITED INTERACTIVE TRAINING SESSION: @DDW 2015

HEPATITIS C (HCV) CME ACCREDITED INTERACTIVE TRAINING SESSION: @DDW 2015 CME ACCREDITED INTERACTIVE TRAINING SESSION: HEPATITIS C (HCV) @DDW 2015 LIVER DISEASE 905 891 1900 www.careeducation.ca info@careeducation.ca Community Academic Research Education @wearecare CME ACCREDITED

More information

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

Medical Policy An independent licensee of the Blue Cross Blue Shield Association Hepatitis C Second Generation Antivirals Page 1 of 22 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Hepatitis C Second Generation Antivirals Through Preferred

More information

Technology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta364

Technology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta364 Daclatasvir for treating chronic hepatitis C Technology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta364 NICE 2015. All rights reserved. Contents 1 Guidance... 3 Table 1 Daclatasvir

More information

Treatment of Chronic Hepatitis C - September 2014 Update

Treatment of Chronic Hepatitis C - September 2014 Update Treatment of Chronic Hepatitis C - September 014 Update Swiss Association for the Study of the Liver and Swiss Society for Infectious Diseases Written by: Darius Moradpour, Andri Rauch, Jan Fehr and Beat

More information

CADTH THERAPEUTIC REVIEW Drugs for Chronic Hepatitis C Infection: Recommendations Report

CADTH THERAPEUTIC REVIEW Drugs for Chronic Hepatitis C Infection: Recommendations Report CADTH THERAPEUTIC REVIEW Drugs for Chronic Hepatitis C Infection: Recommendations Report Product Line: Therapeutic Review Version: 1.0 Volume Number: 3 Issue Number: 1d Publication Date: November 2015

More information

Post AASLD Update in HCV Torino, 10 Gennaio 2013. Fattori che possono influenzare il trattamento: RVR e Lead in

Post AASLD Update in HCV Torino, 10 Gennaio 2013. Fattori che possono influenzare il trattamento: RVR e Lead in Post AASLD Update in HCV Torino, 10 Gennaio 2013 Fattori che possono influenzare il trattamento: RVR e Lead in Alessia Ciancio Università di Torino Città della Salute e delle Scienze Will predictors usefull

More information

Viral Hepatitis Prevention Board Meeting November 2013. The Netherlands: Hepatitis C treatment guidelines

Viral Hepatitis Prevention Board Meeting November 2013. The Netherlands: Hepatitis C treatment guidelines Viral Hepatitis Prevention Board Meeting November 2013 The Netherlands: Hepatitis C treatment guidelines Floor Berden MD, PhD student Radboud university medical center Nijmegen, the Netherlands Conflicts

More information

Current Opinion in Hepatitis C Treatment

Current Opinion in Hepatitis C Treatment White Nights of Hepatology 2011 Current Opinion in Hepatitis C Treatment George V. Papatheodoridis, MD Associate Professor in Medicine & Gastroenterology 2nd Department of Internal Medicine, Athens University

More information

Treatment of Hepatitis C in Patients with Renal Insufficiency

Treatment of Hepatitis C in Patients with Renal Insufficiency HEPATITIS WEB STUDY HEPATITIS C ONLINE Treatment of Hepatitis C in Patients with Renal Insufficiency Robert G. Gish MD Professor Consultant, Stanford University Medical Center Senior Medical Director,

More information

Learning Objectives. HCV Treatment Evolution. Evolution of HCV Therapy 4/7/2014. Hepatitis C: A health problem of global importance!

Learning Objectives. HCV Treatment Evolution. Evolution of HCV Therapy 4/7/2014. Hepatitis C: A health problem of global importance! Therapy New HCV In Frontiers We have no conflict of interest to declare. How the Magic Pill Cured Hep C Spring Therapeutics Update Trana Hussaini, Pharm D Nilu Partovi, Pharm D Google Images; collage by

More information

Patients with HCV and F1 and F2 fibrosis stage: treat now or wait?

Patients with HCV and F1 and F2 fibrosis stage: treat now or wait? Liver International ISSN 1478-3223 REVIEW ARTICLE Patients with HCV and F1 and F2 fibrosis stage: treat now or wait? Mitchell L. Shiffman 1 and Yves Benhamou 2 1 Liver Institute of Virginia, Bon Secours

More information

Hepatitis C treatment update

Hepatitis C treatment update Hepatitis C treatment update Viral Hepatitis Workshop Hepatitis Foundation and Regional Public Health December 2013 Jeffrey S Wong Hepatitis C treatment Non-A non-b hepatitis History of HCV treatment Hutt

More information

PRIOR AUTHORIZATION POLICY

PRIOR AUTHORIZATION POLICY PRIOR AUTHORIZATION POLICY Harvoni (sofosbuvir/ledipasvir tablets Gilead) To initiate a Coverage Review, Call 1-800-417-1764 OVERVIEW Harvoni is a fixed-dose combination of ledipasvir, a hepatitis C virus

More information

Susan Kidger. North Manchester General Hospital. 16 th Annual Conference of the National HIV Nurses Association (NHIVNA)

Susan Kidger. North Manchester General Hospital. 16 th Annual Conference of the National HIV Nurses Association (NHIVNA) 16 th Annual Conference of the National HIV Nurses Association (NHIVNA) Susan Kidger North Manchester General Hospital 26-27 June 2014- City Hall, Cardiff 2 nd Generation Treatment for Hepatitis C and

More information

boceprevir 200mg capsule (Victrelis ) Treatment experienced patients SMC No. (722/11) Merck, Sharpe and Dohme Ltd

boceprevir 200mg capsule (Victrelis ) Treatment experienced patients SMC No. (722/11) Merck, Sharpe and Dohme Ltd boceprevir 200mg capsule (Victrelis ) Treatment experienced patients SMC No. (722/11) Merck, Sharpe and Dohme Ltd 09 September 2011 The Scottish Medicines Consortium (SMC) has completed its assessment

More information

PRIOR AUTHORIZATION PROTOCOL FOR HEPATITIS C TREATMENT

PRIOR AUTHORIZATION PROTOCOL FOR HEPATITIS C TREATMENT PRIOR AUTHORIZATION PROTOCOL FOR HEPATITIS C TREATMENT HARVONI (90mg ledipasvir/400mg sofosbuvir): tablet (PREFERRED AGENT) SOVALDI (sofosbuvir ): 400mg tablets (PREFERRED AGENT ) OLYSIO (simeprivir) PEG-INTRON

More information

Update on Hepatitis C. Sally Williams MD

Update on Hepatitis C. Sally Williams MD Update on Hepatitis C Sally Williams MD Hep C is Everywhere! Hepatitis C Magnitude of the Infection Probably 8 to 10 million people in the U.S. are infected with Hep C 30,000 new cases are diagnosed annually;

More information

Clinical Criteria for Hepatitis C (HCV) Therapy

Clinical Criteria for Hepatitis C (HCV) Therapy Diagnosis Clinical Criteria for Hepatitis C (HCV) Therapy Must have chronic hepatitis C, genotype and sub-genotype specified to determine the length of therapy; Liver biopsy or other accepted test demonstrating

More information

Daclatasvir for treating chronic hepatitis C

Daclatasvir for treating chronic hepatitis C NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Appraisal consultation document Daclatasvir for treating chronic hepatitis C The Department of Health has asked the National Institute for Health and Care

More information

Disclosure of Conflicts of Interest Learner Assurance Statement:

Disclosure of Conflicts of Interest Learner Assurance Statement: Raj Reddy, MD Ruimy Family President's Distinguished Professor of Medicine Professor of Medicine in Surgery Director of Hepatology Director, Viral Hepatitis Center Medical Director, Liver Transplantation

More information

An Action Guide for the Treatment of Chronic Hepatitis C Infection: Next Steps for Patients

An Action Guide for the Treatment of Chronic Hepatitis C Infection: Next Steps for Patients The Comparative Clinical Effectiveness and Value of Simeprevir and Sofosbuvir in the Treatment of Chronic Hepatitis C Infection An Action Guide for the Treatment of Chronic Hepatitis C Infection: Next

More information

17/01/14. What are special patient groups? Management of hepatitis C in special patient groups. Management of hepatitis C in

17/01/14. What are special patient groups? Management of hepatitis C in special patient groups. Management of hepatitis C in Management of hepatitis C in special patient groups Minisymposium Challenges in viral hepatitis 14 Lausanne 16.1.14 B. Müllhaupt Gastroenterology and Hepatology Swiss HPB- and Transplant-Center University

More information

I. What s New and Updates/Changes (Last updated: February 17, 2015; last reviewed: February 17, 2015) Summary Table

I. What s New and Updates/Changes (Last updated: February 17, 2015; last reviewed: February 17, 2015) Summary Table Chronic Hepatitis C Virus (HCV) Infection: Treatment Considerations from the Department of Veterans Affairs National Hepatitis C Resource Center Program and the Office of Public Health Contents I. What

More information

Hepatitis C Second Generation Antivirals (Harvoni, Technivie TM, Viekira Pak ) Prior Authorization - Through Preferred Agent(s) Program Summary

Hepatitis C Second Generation Antivirals (Harvoni, Technivie TM, Viekira Pak ) Prior Authorization - Through Preferred Agent(s) Program Summary Hepatitis C Second Generation Antivirals (Harvoni, Technivie TM, Viekira Pak ) Prior Authorization - Through Preferred Agent(s) Program Summary This program applies to Health Insurance Marketplace, FlexRx

More information

HEPATITIS C THERAPY PRIOR AUTHORIZATION FORM: Page 1 of 3 Patient Information. Diagnosis Acute Hep C Chronic Hep C Hepatocellular Carcinoma

HEPATITIS C THERAPY PRIOR AUTHORIZATION FORM: Page 1 of 3 Patient Information. Diagnosis Acute Hep C Chronic Hep C Hepatocellular Carcinoma HEPATITIS C THERAPY PRIOR AUTHORIZATION FORM: Page 1 of 3 Patient Information Recipient: MA#: Date of Birth: Phone #: Body Weight: Treatment Plan Sovaldi (sofosbuvir) 400mg: Take once daily for weeks Olysio

More information

PHARMACY PRIOR AUTHORIZATION

PHARMACY PRIOR AUTHORIZATION PHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline Harvoni (sofosbuvir/ledipasvir), Sovaldi (sofosbuvir), Viekira PAK (ombitsavir, paritapravir/ritonavir, dasubavir), and Olysio (simeprevir) Authorization

More information

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

Medical Policy An independent licensee of the Blue Cross Blue Shield Association Hepatitis C Second Generation Antivirals (2015) Page 1 of 14 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C Second Generation Antivirals Through

More information

HIV/HCV Co-Infection

HIV/HCV Co-Infection HIV/HCV Co-Infection 2015 Kentucky Conference on Viral Hepatitis Matt Cave, M.D. Associate Professor Department of Medicine Division of Gastroenterology, Hepatology, & Nutrition Department of Pharmacology

More information

Update on hepatitis C: treatment and care and future directions

Update on hepatitis C: treatment and care and future directions Update on hepatitis C: treatment and care and future directions Professor Greg Dore Viral Hepatitis Clinical Research Program, National Centre in HIV Epidemiology and Clinical Research, University of New

More information

Grote winst met nieuwe antivirale middelen Waar gaan we naar toe? Joost PH Drenth, MDL-arts 2de Nationale HCV symposium Amsterdam, 14 September 2014

Grote winst met nieuwe antivirale middelen Waar gaan we naar toe? Joost PH Drenth, MDL-arts 2de Nationale HCV symposium Amsterdam, 14 September 2014 Grote winst met nieuwe antivirale middelen Waar gaan we naar toe? Joost PH Drenth, MDL-arts 2de Nationale HCV symposium Amsterdam, 14 September 2014 Vragen Waar komen we vandaan? Waar staan we nu? Waar

More information

Management of HIV/HCV Co-infected Patients

Management of HIV/HCV Co-infected Patients Management of HIV/HCV Co-infected Patients David Wyles, MD Associate Professor of Medicine Division of Infectious Diseases University of California, San Diego San Diego, California Disclosures Grants/Research

More information

Hepatitis Update. HCV Cure As A Paradigm for Convergence of Interests. Evidence Based Nuts and Bolts For the Family Doc 11/5/2014

Hepatitis Update. HCV Cure As A Paradigm for Convergence of Interests. Evidence Based Nuts and Bolts For the Family Doc 11/5/2014 Evidence Based Nuts and Bolts For the Family Doc Hepatitis Update William Carey MD MACG, FAASLD Oct 25, 2014 HCV Cure As A Paradigm for Convergence of Interests Hepatitis C Cure 1 Get Ready Get SET Go

More information

Hepatitis C Monitoring and Complications (and Treatment!) Dr Mark Douglas

Hepatitis C Monitoring and Complications (and Treatment!) Dr Mark Douglas Hepatitis C Monitoring and Complications (and Treatment!) Dr Mark Douglas Hepatitis C Virus Shimizu et al., 1996 Positive single strand RNA virus Flaviviridae family, Hepacivirus genus 9.6 kbp genome ~3000

More information

HCV Case Study. Optimizing Outcomes with Current Therapies

HCV Case Study. Optimizing Outcomes with Current Therapies HCV Case Study Optimizing Outcomes with Current Therapies This program is supported by educational grants from Kadmon and Merck Pharmaceuticals. Program Disclosure This activity has been planned and implemented

More information

Interferon free hepatitis C treatment. Cynthia Solomon, RN, BS, ACNP-BS Hepatology Nurse Practitioner

Interferon free hepatitis C treatment. Cynthia Solomon, RN, BS, ACNP-BS Hepatology Nurse Practitioner Interferon free hepatitis C treatment Cynthia Solomon, RN, BS, ACNP-BS Hepatology Nurse Practitioner DISCLAIMER I have no potentially biasing relationships of a personal, financial or professional nature

More information

An Approach to the Diagnosis and Treatment of Hepatitis C Virus Infection in 2015. Matthew McMahon, MD

An Approach to the Diagnosis and Treatment of Hepatitis C Virus Infection in 2015. Matthew McMahon, MD An Approach to the Diagnosis and Treatment of Hepatitis C Virus Infection in 2015 Matthew McMahon, MD In the United States, 2.2-3.2 million people are infected with the hepatitis C virus (HCV) Half unaware

More information

boceprevir 200mg capsule (Victrelis ) Treatment naïve patients SMC No. (723/11) Merck Sharpe and Dohme Ltd

boceprevir 200mg capsule (Victrelis ) Treatment naïve patients SMC No. (723/11) Merck Sharpe and Dohme Ltd boceprevir 200mg capsule (Victrelis ) Treatment naïve patients SMC No. (723/11) Merck Sharpe and Dohme Ltd 09 September 2011 The Scottish Medicines Consortium (SMC) has completed its assessment of the

More information

Expectations for HCV Therapy with Small Molecules: An Activist Perspective

Expectations for HCV Therapy with Small Molecules: An Activist Perspective Expectations for HCV Therapy with Small Molecules: An Activist Perspective Tracy Swan, Treatment Action Group Second International Symposium on Hepatitis Care in Substance Users September 15-16, 2011 Brussels,

More information

Therapy of decompensated cirrhosis Pre-transplant for HBV and HCV

Therapy of decompensated cirrhosis Pre-transplant for HBV and HCV Therapy of decompensated cirrhosis Pre-transplant for HBV and HCV Universitätsklinikum Leipzig Thomas Berg Sektion Hepatologie Klinik und Poliklinik für Gastroenterologie und Rheumatologie Leber- und Studienzentrum

More information

Current Antiviral Treatment of HCV cirrhosis

Current Antiviral Treatment of HCV cirrhosis Current Antiviral Treatment of HCV cirrhosis Hugo R. Rosen, M.D. Waterman Endowed Chair in Liver Research Division Head, Gastroenterology & Hepatology Professor of Medicine and Immunology University of

More information

Prevalenza HIV/HCV in Italia

Prevalenza HIV/HCV in Italia Prevalence of HIV/HCV co-infection by region, 2013 WHO global systematic review of prevalence of HIV/HCV Ab co-infection based on prevalence studies in HIV+ persons stratified by risk group (where available)

More information

Hepatitis C Drug Development Catapults Onward

Hepatitis C Drug Development Catapults Onward Hepatitis C Drug Development Catapults Onward By Tracy Swan Thanks to Jules Levin The pace of, and progress in, hepatitis C virus (HCV) drug development are astonishing. In April 2011, proof-of-concept

More information

Victrelis: hints for success. Katarnya Gilbert Hepatology MSL MSD

Victrelis: hints for success. Katarnya Gilbert Hepatology MSL MSD Victrelis: hints for success Katarnya Gilbert Hepatology MSL MSD 1 Some Facts: BOC has no clinically significant activity against other HCV genotypes. Resistance with protease inhibitor monotherapy can

More information

Writing Group. Dr Mark Nelson (Vice Chair) Prof Anna Maria Geretti. Dr Ranjababu Kulasegaram. Dr Adrian Palfreeman Dr Padmasayee Papineni

Writing Group. Dr Mark Nelson (Vice Chair) Prof Anna Maria Geretti. Dr Ranjababu Kulasegaram. Dr Adrian Palfreeman Dr Padmasayee Papineni BHIVA guidelines for the management of hepatitis viruses in adults infected with HIV 2013 Update September 2014: Consensus statement on the guidelines for treating hepatitis C in patients with HIV Further

More information

Federal Government Standing Committee on Health

Federal Government Standing Committee on Health Federal Government Standing Committee on Health Inquiry into Hepatitis C in Australia Professor Gregory Dore Head, Viral Hepatitis Clinical Research Program, Kirby Institute, UNSW Australia Infectious

More information

Technology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta365

Technology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta365 Ombitasvir paritaprevir ritonavir with or without dasabuvir for treating chronic hepatitis C Technology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta365 NICE 2015. All rights reserved.

More information

Perspective Advances in the Treatment of Hepatitis C Virus Infection

Perspective Advances in the Treatment of Hepatitis C Virus Infection Advances in HCV Treatment Volume 20 Issue 1 April/May 2012 Perspective Advances in the Treatment of Hepatitis C Virus Infection Since 2007, the annual age-adjusted mortality rate in hepatitis C virus (HCV)

More information

Hepatitis C Glossary of Terms

Hepatitis C Glossary of Terms Acute Hepatitis C A short-term illness that usually occurs within the first six months after someone is exposed to the hepatitis C virus (HCV). 1 Antibodies Proteins produced as part of the body s immune

More information

Hepatitis C Class Review

Hepatitis C Class Review Hepatitis C Class Review Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-945-5220 Fax 503-947-1119 Month/Year of Review: January

More information

HEPATITIS C. Current approach and Therapeutic considerations

HEPATITIS C. Current approach and Therapeutic considerations HEPATITIS C Current approach and Therapeutic considerations Disease Burden Approximately 3.2 million people in the U.S. infected (1.3%) with HCV Responsible for 16,000 death per year in the U.S. (CDC 2010)

More information

Chronische Hepatitis C. 170 Millionen

Chronische Hepatitis C. 170 Millionen Chronische Hepatitis C 170 Millionen Natürliche Geschichte der Hepatitis C Akute Hepatitis C Chronische Hepatitis C Hepatitis Zirrhose Clearance Zeit (20 Jahre) ist sehr unterschiedlich (Host, Virus, Umwelt)

More information

APASL consensus statements and recommendation on treatment of hepatitis C

APASL consensus statements and recommendation on treatment of hepatitis C DOI 10.1007/s12072-016-9717-6 GUIDELINES APASL consensus statements and recommendation on treatment of hepatitis C Masao Omata 1,2 Tatsuo Kanda 3 Lai Wei 4 Ming-Lung Yu 5 Wang-Long Chuang 6 Alaaeldin Ibrahim

More information

CADTH Therapeutic Review

CADTH Therapeutic Review Canadian Agency for Drugs and Technologies in Health Agence canadienne des médicaments et des technologies de la santé CADTH Therapeutic Review October 2014 Volume 2, Issue 2C Recommendations for Direct-Acting

More information

AASLD PRACTICE GUIDELINE

AASLD PRACTICE GUIDELINE AASLD PRACTICE GUIDELINE An Update on Treatment of Genotype 1 Chronic Hepatitis C Virus Infection: 2011 Practice Guideline by the American Association for the Study of Liver Diseases Marc G. Ghany, 1 David

More information

Treatment of Chronic Hepatitis C - September 2015 Update

Treatment of Chronic Hepatitis C - September 2015 Update Treatment of Chronic Hepatitis C - September 2015 Update Swiss Association for the Study of the Liver and Swiss Society for Infectious Diseases Written by: Beat Müllhaupt, Andri Rauch, Jan Fehr and Darius

More information

A 55 year old man with cirrhosis due to chronic hepatitis C (CHC) genotype 3a is referred for liver transplantation.

A 55 year old man with cirrhosis due to chronic hepatitis C (CHC) genotype 3a is referred for liver transplantation. A 55 year old man with cirrhosis due to chronic hepatitis C (CHC) genotype 3a is referred for liver transplantation. Three years ago he was treated with 24 weeks of peginterferon alfa-2a (180 µg/wk, PEGIFN)

More information

PERSPECTIVES ON DRUGS Hepatitis C treatment for injecting drug users

PERSPECTIVES ON DRUGS Hepatitis C treatment for injecting drug users UPDATED 15. 5. 2015 PERSPECTIVES ON DRUGS Hepatitis C treatment for injecting drug users Transmitted through the sharing of needles, syringes and other injecting equipment, hepatitis C is the most common

More information

The new paradigm of hepatitis C therapy: integration of oral therapies into best practices

The new paradigm of hepatitis C therapy: integration of oral therapies into best practices Journal of Viral Hepatitis, 2013, 20, 745 760 doi:10.1111/jvh.12173 REVIEW The new paradigm of hepatitis C therapy: integration of oral therapies into best practices N. H. Afdhal, 1 S. Zeuzem, 2 R. T.

More information

Review: How to work up your patient with Hepatitis C

Review: How to work up your patient with Hepatitis C Review: How to work up your patient with Hepatitis C You screened your patient, and now the HCV antibody test is positive. What do you do next? The antibody test only means they have been exposed to HCV.

More information

Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis

Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis Massachusetts Medical Society, April 2014 sponsored by Gilead Sciences 23.04.2014 Marie-Luise Lauterjung 1 Zweck der Studie

More information

Managing Treatment Naive Pa/ents in the DAA Era. An Interac/ve Case study

Managing Treatment Naive Pa/ents in the DAA Era. An Interac/ve Case study Managing Treatment Naive Pa/ents in the DAA Era. An Interac/ve Case study Case Prepared by Sinēad Sheils CNC Royal Prince Alfred Hospital, Sydney Friday 17 th May 2013 Nigel 63 yrs old caucasian male HCV

More information

Hepatitis C Infection In Singapore

Hepatitis C Infection In Singapore Hepatitis C Infection In Singapore Richard Guan MBBS, MRCP(UK), FAMS(Gastro), FRCP(Edin), FRCP(Lond) Gastroenterologist & Hepatologist, Mt Elizabeth Medical Centre, Singapore Summary of HCV treatment practice

More information

Introduction. Background

Introduction. Background INFORMATION DRIVES SOUND ANALYSIS, INSIGHT PHARMACY BENEFIT ADVISORY Introduction According to the Centers for Disease Control and Prevention (CDC), the rate of new hepatitis C virus (HCV) infections in

More information

Monitoring of Treatment of viral hepatitis C

Monitoring of Treatment of viral hepatitis C Monitoring of Treatment of viral hepatitis C J.Boubaker Department of Gastroenterology La Rabta hospital Tunis-Tunisia Monitoring of Hepatitis C Treatment Aims of Monitoring : Evaluate Efficacy. Detect

More information

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES. I. Requirements for Prior Authorization of Hepatitis C Agents

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES. I. Requirements for Prior Authorization of Hepatitis C Agents MEDICAL ASSISTANCE HBOOK I. Requirements for Prior Authorization of Hepatitis C Agents A. Prescriptions That Require Prior Authorization Prescriptions for Hepatitis C Agents that meet any of the following

More information

HEPATITIS C DISCUSSION GUIDE:

HEPATITIS C DISCUSSION GUIDE: HEPATITIS C DISCUSSION GUIDE: INFORMATION AND ANSWERS TO AID YOUR COUNSELING OF PATIENTS INDICATION HARVONI is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. Warnings

More information

Guidance for Industry Chronic Hepatitis C Virus Infection: Developing Direct- Acting Antiviral Drugs for Treatment

Guidance for Industry Chronic Hepatitis C Virus Infection: Developing Direct- Acting Antiviral Drugs for Treatment Guidance for Industry Chronic Hepatitis C Virus Infection: Developing Direct- Acting Antiviral Drugs for Treatment DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

More information

THE VIRAL HEPATITIS CONGRESS 2015. 10 12 September 2015, Kap Europa, Frankfurt, Germany THE VIRAL HEPATITIS CONGRESS. Scientific Programme

THE VIRAL HEPATITIS CONGRESS 2015. 10 12 September 2015, Kap Europa, Frankfurt, Germany THE VIRAL HEPATITIS CONGRESS. Scientific Programme THE VIRAL HEPATITIS CONGRESS THE VIRAL HEPATITIS CONGRESS 2015 10 12 September 2015, Kap Europa, Frankfurt, Germany Scientific Programme PRE-CONGRESS WORKSHOP SPONSOR ACHILLION Achillion is seeking to

More information

Cirrhosis and HCV. Jonathan Israel M.D.

Cirrhosis and HCV. Jonathan Israel M.D. Cirrhosis and HCV Jonathan Israel M.D. Outline Relationship of fibrosis and cirrhosisprevalence and epidemiology. Sequelae of cirrhosis Diagnosis of cirrhosis Effect of cirrhosis on efficacy of treatment

More information