Update on hepatitis C: treatment and care and future directions

Size: px
Start display at page:

Download "Update on hepatitis C: treatment and care and future directions"

Transcription

1 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 South Wales; St Vincent s Hospital, Darlinghurst

2 Hepatitis C update Liver disease progression Staging of liver disease Current therapeutic issues Future directions in therapy

3 Hepatitis C natural history Determinants of liver disease progression Prior evidence ALT level Alcohol intake Age at infection Co-infection (HIV or HBV) Gender Stage of fibrosis New evidence Obesity/hepatic steatosis Smoking Cannabis No/limited evidence HCV genotype HCV viral load

4 Hepatitis C liver disease staging Methods Clinical examination Serum transaminases (ALT, AST) Poor correlation with fibrosis Normal in 25% (of whom 30-35% progress to significant fibrosis) Surrogate markers Albumin, prothrombin time, bilirubin Liver biopsy (current gold standard)

5 Hepatitis C liver disease staging Viral - HBV and HCV Cause Immune - Autoimmune, PBC, PSC Toxic - Alcohol Metabolic - Nonalcoholic fatty liver disease (NAFLD) Genetic - Haemochromatosis Stage - fibrosis F1 F2 F3 F4 cirrhosis

6 Hepatitis C liver disease staging

7 Hepatitis C liver disease staging Alternative methods Biochemical surrogate markers APRI (AST/platelet ratio) FIB-4 (age, AST, platelet, bilirubin) Fibrotest Hepascore Transient Elastography (Fibroscan)

8 Hepatitis C liver disease staging: fibroscan

9 Hepatitis C liver disease staging: fibroscan 2.5 cm Explored volume 1 cm 4 cm

10 Hepatitis C liver disease staging: fibroscan Range 2.5 kpa 75 kpa Depth (mm) Depth (mm) Depth (mm) Time (ms) Time (ms) Time (ms) V S = 1.1 m/s V S = 1.6 m/s V S = 3.0 m/s E ~ 3 kpa E ~ 8 kpa E ~ 27 kpa F0 F1 F2 F3 F4 Multiple measurements : success rate should be at least 60% IQR should not be >30% of median value

11 Hepatitis C liver disease staging: fibroscan

12 Hepatitis C liver disease staging: fibroscan 711 subjects 95 with cirrhosis kpa No varices (2/3) No Child-Pugh B or C No past history ascites No hepatocellular carcinoma No past history variceal bleeding >90% NPV for above complications Foucher et al 2006

13 Hepatitis C treatment Sustained Virological Response? PEG-IFN+RBV weeks IFN-α2b+RBV 48 weeks 61%-65% PEG-IFN 48 weeks 41% IFN-α2b 48 weeks 25%-29% IFN-α2b 24 weeks 15%-22% 8%-12% 15 years

14 Hepatitis C treatment HCV treatment through HSD: Removal of mandatory liver biopsy NCHECR 2009

15 Hepatitis C treatment Issues Positive Curative potential (50 80%) Improving response rates and clinical experience Government-subsidized Some expansion of access removal of liver biopsy Negative Toxicity: flu-like symptoms, depression, anaemia, lethargy Requirement for contraception during and 6 months following Tertiary hospital focused

16 Hepatitis C treatment HCV treatment response definitions NR Relapse Viral load RVR EVR ETR SVR post-rx Treatment weeks

17 Hepatitis C treatment SVR in RVR HCV genotype 1: PEG-IFN2a/RBV % RVR non-rvr 800 mg x 24 wks 1000/1200 mg x 24 wks 800 mg x 48 wks 1000 / 1200 mg x 48 wks Jensen et al Hepatology 2006 RVR = < 50 IU/ml at week 4; 20%

18 Hepatitis C treatment Time to respond and SVR: genotype Null 20% Week 4 15% Partial 15% Week 12 35% Week 24 15% Ferrenci et al. J Hepatology 2005 SVR (%) Week HCV RNA (-)

19 Hepatitis C treatment Factors associated with poorer SVR HCV genotype 1 HCV viral load (genotype 1) Severe fibrosis cirrhosis High body weight Insulin resistance Age > 40 years African American ethnicity HIV coinfection < 80% adherence (RBV > PEG-IFN)

20 Hepatitis C treatment SVR rates by fibrosis stage: CHARIOT study (genotype 1) Peg IFN alfa 2a 180 g/wk +RBV Peg IFN alfa 2a 360 g/wk + RBV 100 Virological response (%) % 71% 58% 62% 50% 51% 29% 33% 17/25 20/28 60/104 66/107 57/113 62/121 15/51 15/46 1/16 2/14 69/129 65/117 F0 F1 F2 F3 F4 N/A Metavir Stage of Fibrosis 6% 14% 53% 56% Cheng et al. EASL 2009

21 Hepatitis C treatment Relapse rates by fibrosis stage: CHARIOT study (genotype 1) Peg IFN alfa 2a 180 g/wk +RBV Peg IFN alfa 2a 360 g/wk + RBV Relapse rate (%) F0 F1 F2 F3 F4 Fibrosis score by METAVIR Cheng et al. EASL 2009

22 Hepatitis C treatment Re-treatment considerations Factors associated with non-response: - Unable to alter: genotype, HCV viral load, disease stage - Some ability to alter: obesity, alcohol intake, adherence Prior virological response best predictor of future response: - Relapsers > Non-responders (<2 log) > Null responders (<0.5 log) Some indications: - prior therapy with IFN monotherapy or IFN/RBV - PEG-IFN/RBV genotype 2/3 relapsers (if treated for 24 weeks) - heavy alcohol intake or poor adherence Staging of liver disease: - crucial to determine ongoing management strategy - stronger consideration for re-treatment if F3/4 - HCC screening if F4

23 Hepatitis C treatment REPEAT study: genotype 1 NR to PEG-IFN-2b/RBV Peg IFN alfa 2a 180 g/wk +RBV Peg IFN alfa 2a 360 g/wk + RBV SVR (%) % 7% 14% 16% 0 N=313 N= week duration N=156 N= weeks duration Jensen DM et al. AIM 2009

24 Hepatitis C treatment HCV enzymes are targets for new therapies C E1 E2 p7 NS2 NS3 NS4A NS4B NS5A NS5B NS3 Protease domain NS3 Helicase domain NS3 Bifunctional protease / helicase NS5B RNA-dependent RNA polymerase

25 Hepatitis C treatment Preclinical Phase I Phase II Phase III Protease inhibitors BILN 2061 VX-950 (Telaprevir) X (mitochondrial-cardiac toxicity) SCH (Boceprevir) BI MK-7009 TMC ITMN 191 Polymerase inhibitors HCV-796 R1626 NM-283 (Valopcitibine) X (hepatotoxicity) X (haematological toxicity) X (git toxicity) R7128 PF GS-9190

26 PROVE 1: Telaprevir Study design: Phase II, genotype 1, treatment naive PR48 (control) (n=80) Placebo + Peg-IFN + RBV Peg-IFN + RBV Follow-up T12/PR12 (n=20) TVR + Peg-IFN + RBV Follow-up T12/PR24 (n=80) TVR + Peg-IFN + RBV Peg-IFN + RBV Follow-up T12/PR48 (n=80) TVR + Peg-IFN + RBV Peg-IFN + RBV Follow-up Weeks Dosing: Peg-IFN = Peg-IFN alfa-2a 180 µg/week, RBV = RBV 1,000 or 1,200 mg/day, TVR = TVR 750 mg q8h McHutchison EASL 2008

27 PROVE 1 Early virological responses Week 4 (RVR) Week 12 (HCV RNA undetectable) 100 Subjects with undetectable HCV RNA (%) /75 PR48 34/75 10/17 12/17 T12/PR12 64/79 54/79 T12/PR24 64/79 63/79 T12/PR48 McHutchison EASL 2008

28 PROVE 1 Sustained virological response 100 SVR rate (%) * 67* /75 PR48 6/17 T12/PR12 48/79 T12/PR24 53/79 T12/PR48 McHutchison EASL 2008

29 PROVE 3: Telaprevir Study design: Phase II, PEG-IFN/RBV NRs or relapsers A (n=114) PEG/RBV B (n=113) C (n=115) D (n=111) PEG/RBV TPV PEG/RBV TPV PEG TPV Week

30 PROVE-3 Sustained virological response SVR % % 52% % 23% 0 PEG/RBV48 T24/P24 T12/PR24 T24/PR48 Manns et al EASL 2009

31 PROVE-3 Sustained virological response SVR % PEG/RBV48 T24/P24 T12/PR24 T24/PR48 NR Relapsers Manns et al EASL 2009

32 Polymerase Inhibitor (R7128): phase II Week 4 RVR (Gen 2/3, Rx experienced) RVR % % PEG/RBV 90% PEG/RBV/R7128 (1500bd) Gane et al AASLD 2008

33 Hepatitis C treatment Dosing regimens for STAT-C agents Phase Dosing Protease inhibitors Telaprevir III 750 mg q 8 hrly (1250 mg q 12 hrly phase II) Boceprevir III 800 mg tds MK 7009 II mg bd BI II mg daily TMC II mg daily Polymerase inhibitors R7128 II mg bd PF II mg bd

34 Hepatitis C update Conclusions Lifestyle factors important to potentially modify: alcohol, diet, smoking Liver disease staging crucial for treatment-decision making HCV genotype 1 response rates remain sub-optimal, particularly in context of advanced disease, high HCV viral load, HIV coinfection Many people should defer to await new therapies, particularly those with genotype 1 (esp high VL) and early liver disease Initial protease inhibitors will have significant additional toxicity, but 2 nd generation should be much more tolerable

Management of non response or relapse following HCV therapy. Greg Dore Darrell Crawford

Management of non response or relapse following HCV therapy. Greg Dore Darrell Crawford Management of non response or relapse following HCV therapy Greg Dore Darrell Crawford Learning objectives To understand importance of characterisation of prior HCV therapy response To explore options

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

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

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

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

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

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

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

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

New IDSA/AASLD Guidelines for Hepatitis C

New IDSA/AASLD Guidelines for Hepatitis C NORTHWEST AIDS EDUCATION AND TRAINING CENTER New IDSA/AASLD Guidelines for Hepatitis C John Scott, MD, MSc Associate Professor, UW SoM Asst Director, Liver Clinic, Harborview Medical Center Presentation

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

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

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

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

Peg-IFN and ribavirin: what sustained virologic response can be achieved by using HCV genotyping and viral kinetics?

Peg-IFN and ribavirin: what sustained virologic response can be achieved by using HCV genotyping and viral kinetics? Peg-IFN and ribavirin: what sustained virologic response can be achieved by using HCV genotyping and viral kinetics? Prof. I. Bakulin Gastroenterology Department Key Questions Background Worldwide prevalence

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

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

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

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

Innovazione farmacologica e farmacologia clinica

Innovazione farmacologica e farmacologia clinica Innovazione farmacologica e farmacologia clinica Francesco Scaglione, MD, PhD Department of Medical Biotechnology and Translational Medicine School of medicine Postgradute School of clinical pharmacology

More information

HCV Treatment Failure

HCV Treatment Failure بسم االله الرحمن الرحيم HCV Treatment Failure Gamal Esmat PROF.OF HEPATOLOGY&TROPICAL MEDICINE CAIRO UNIVERSITY Director of Viral Hepatitis Treatment Centers (VHTCs( VHTCs) MOH-EGYPT www.gamalesmat.com

More information

HIV and Hepatitis Co-infection. Martin Fisher Brighton and Sussex University Hospitals, UK

HIV and Hepatitis Co-infection. Martin Fisher Brighton and Sussex University Hospitals, UK HIV and Hepatitis Co-infection Martin Fisher Brighton and Sussex University Hospitals, UK Useful References British HIV Association 2010 http://www.bhiva.org/documents/guidelines/hepbc/2010/ hiv_781.pdf

More information

Sovaldi (sofosbuvir) Prior Authorization Criteria

Sovaldi (sofosbuvir) Prior Authorization Criteria INITIAL REVIEW CRITERIA Sovaldi (sofosbuvir) Prior Authorization Criteria 1. Adult patient age 18 years old; AND 2. Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, transplant

More information

Efficacy of lead-in silibinin and subsequent triple therapy in difficult-to-treat HIV/hepatitis C coinfected patients

Efficacy of lead-in silibinin and subsequent triple therapy in difficult-to-treat HIV/hepatitis C coinfected patients Second Silibinin Workshop, Cologne, 23 rd May 2014 Efficacy of lead-in silibinin and subsequent triple therapy in difficult-to-treat HIV/hepatitis C coinfected patients Dominique L Braun, MD Division of

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

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

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

Ledipasvir/Sofosbuvir (Harvoni) for Treatment of Hepatitis C

Ledipasvir/Sofosbuvir (Harvoni) for Treatment of Hepatitis C Ledipasvir/Sofosbuvir (Harvoni) for Treatment of Hepatitis C Policy Number: Original Effective Date: MM.04.034 12/1/2014 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST Integration 12/1/2014

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

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

The following should be current within the past 6 months:

The following should be current within the past 6 months: EVALUATION Baseline Labs Obtain at time or prior to initial evaluation CBC with diff PT/INR CMP HCV Genotype (obtained PRIOR TO consult visit) HCV RNA (obtained PRIOR TO consult visit) Hep A IgG Hep BsAg,

More information

NEW APPROACHES TO THE MANAGEMENT OF HEPATITIS C IN HEMOPHILIA

NEW APPROACHES TO THE MANAGEMENT OF HEPATITIS C IN HEMOPHILIA TREATMENT OF HEMOPHILIA December 2012 No. 54 NEW APPROACHES TO THE MANAGEMENT OF HEPATITIS C IN HEMOPHILIA Fabien Zoulim François Bailly Hepatology Department Hospices Civils de Lyon, Université de Lyon

More information

What to Do with the Patient With Abnormal Liver Enzymes? Nizar N. Zein, M.D. The Cleveland Clinic

What to Do with the Patient With Abnormal Liver Enzymes? Nizar N. Zein, M.D. The Cleveland Clinic What to Do with the Patient With Abnormal Liver Enzymes? Nizar N. Zein, M.D. The Cleveland Clinic Introduction Elevated liver enzymes is often not a clinical problem by itself. However it is a warning

More information

Hepatitis C Diagnose, Therapie und Verlaufskontrolle

Hepatitis C Diagnose, Therapie und Verlaufskontrolle Hepatitis C Diagnose, Therapie und Verlaufskontrolle Molekulare Diagnostik 2010 Weiter- und Fortbildungs-Sympsium 3.-4. März 2010 B. Müllhaupt Gastroenterology and Hepatology Swiss HPB-Center University

More information

HCV/HIVCo-infection A case study by. Dominic Côté, Nurse Clinician B.Sc Chronic Viral Illness Services McGill University Health Centre

HCV/HIVCo-infection A case study by. Dominic Côté, Nurse Clinician B.Sc Chronic Viral Illness Services McGill University Health Centre HCV/HIVCo-infection A case study by Dominic Côté, Nurse Clinician B.Sc Chronic Viral Illness Services McGill University Health Centre Objectives By sharing a case study of a patient co-infected with HIV/HCV

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

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

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

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

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

HIV/HCV Co-infection. HIV/HCV Co-infection. Epidemiology. Dr Ranjababu Kulasegaram Guy s & St Thomas Hospital London. Extrahepatic manifestations

HIV/HCV Co-infection. HIV/HCV Co-infection. Epidemiology. Dr Ranjababu Kulasegaram Guy s & St Thomas Hospital London. Extrahepatic manifestations HIV/HCV Co-infection Dr Ranjababu Kulasegaram Guy s & St Thomas Hospital London HIV/HCV Co-infection Epidemiology Impact of HIV on HCV Epidemiology Impact of HCV on HIV Management issues Future Extrahepatic

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

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

Transmission of HCV in the United States (CDC estimate)

Transmission of HCV in the United States (CDC estimate) Transmission of HCV in the United States (CDC estimate) Past and Future US Incidence and Prevalence of HCV Infection Decline among IDUs Overall incidence Overall prevalence Infected 20+ years Armstrong

More information

Emerging Direct-Acting Antivirals for Treatment of Chronic Hepatitis C

Emerging Direct-Acting Antivirals for Treatment of Chronic Hepatitis C Emerging Direct-Acting Antivirals for Treatment of Chronic Hepatitis C Debra Birnkrant, MD Director, DAVP DILI Conference March 20, 2013 1 HCV in the United States 3 to 4 million people have chronic HCV

More information

Boehringer Ingelheim- sponsored Satellite Symposium. HCV Beyond the Liver

Boehringer Ingelheim- sponsored Satellite Symposium. HCV Beyond the Liver Boehringer Ingelheim- sponsored Satellite Symposium HCV Beyond the Liver HCV AS A METABOLIC MODIFIER: STEATOSIS AND INSULIN RESISTANCE Francesco Negro University Hospital of Geneva Switzerland Clinical

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

Non-invasive evaluation of liver fibrosis: current clinical use and next perspectives (chronic hepatitis C)

Non-invasive evaluation of liver fibrosis: current clinical use and next perspectives (chronic hepatitis C) Non-invasive evaluation of liver fibrosis: current clinical use and next perspectives (chronic hepatitis C) Paul Calès Liver and Gastroenterology department, University hospital & HIFIH laboratory, Angers

More information

Patterns of abnormal LFTs and their differential diagnosis

Patterns of abnormal LFTs and their differential diagnosis Patterns of abnormal LFTs and their differential diagnosis Professor Matthew Cramp South West Liver Unit and Peninsula Schools of Medicine and Dentistry, Plymouth Summary liver function / liver function

More information

Management of hepatitis C: pre- and post-liver transplantation. Piyawat Komolmit Bangkok

Management of hepatitis C: pre- and post-liver transplantation. Piyawat Komolmit Bangkok Management of hepatitis C: pre- and post-liver transplantation Piyawat Komolmit Bangkok Liver transplantation and CHC Cirrhosis secondary to HCV is the leading cause of liver transplantation in the US

More information

PREVENTION OF HCC BY HEPATITIS C TREATMENT. Morris Sherman University of Toronto

PREVENTION OF HCC BY HEPATITIS C TREATMENT. Morris Sherman University of Toronto PREVENTION OF HCC BY HEPATITIS C TREATMENT Morris Sherman University of Toronto Pathogenesis of HCC in chronic hepatitis C Injury cirrhosis HCC Injury cirrhosis HCC Time The Ideal Study Prospective randomized

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

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

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

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

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

EVALUATION OF LIVER FIBROSIS BY FIBROSCAN

EVALUATION OF LIVER FIBROSIS BY FIBROSCAN EVALUATION OF LIVER FIBROSIS BY FIBROSCAN M. Beaugrand Service d Hépatologied Hopital J. Verdier BONDY 93143 et Université Paris XIII DRESDEN 13.10.2007 ASSESSMENT OF FIBROSIS : WHY? Management of individual

More information

Protease inhibitors based triple therapy in patients with advanced fibrosis/cirrhosis

Protease inhibitors based triple therapy in patients with advanced fibrosis/cirrhosis Protease inhibitors based triple therapy in patients with advanced fibrosis/cirrhosis Michael P. Manns Department of Gastroenterology, Hepatology and Endocrinology White Nights of Hepatology, St. Petersburg,

More information

Treatment Options for Hepatitis C in the Post Transplant Patient

Treatment Options for Hepatitis C in the Post Transplant Patient Treatment Options for Hepatitis C in the Post Transplant Patient Caroline Rochon, MD, FACS,FRCSC Transplant and Hepatobiliary Surgery Hartford Hospital Assistant Professor of Surgery, University of Connecticut

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

Management of HCV/HIV co-infection in the era of DAA-based therapy

Management of HCV/HIV co-infection in the era of DAA-based therapy Management of HCV/HIV co-infection in the era of DAA-based therapy Jürgen K. Rockstroh Department of Internal Medicine I University Hospital Bonn Germany Conflict of interest I have received honoraria

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

Request for Prior Authorization HEPATITIS C TREATMENTS

Request for Prior Authorization HEPATITIS C TREATMENTS IA Medicaid Member ID # Patient name DOB FAX Completed Form To 1 (800) 574-2515 Provider Help Desk 1 (877) 776-1567 Patient address Patient phone Provider NPI Prescriber name Phone Prescriber address Fax

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

Protease Inhibitors for Chronic Hepatitis C Infection: The New Kids on the Block, But do they have The Right Stuff for all patients?

Protease Inhibitors for Chronic Hepatitis C Infection: The New Kids on the Block, But do they have The Right Stuff for all patients? Protease Inhibitors for Chronic Hepatitis C Infection: The New Kids on the Block, But do they have The Right Stuff for all patients? Lindsey M. Childs, PharmD, MPH PGY2 Infectious Diseases Pharmacy Resident

More information

Acute HCV was defined as (3 out of 4 within the preceding 4 months):

Acute HCV was defined as (3 out of 4 within the preceding 4 months): Christoph Boesecke, Patrick Ingiliz, Hans-Jürgen Stellbrink, Mark Nelson, Sanjay Bhagani, Marguerite Guiguet, Marc-Antoine Valantin, Thomas Reiberger, Martin Vogel, Jürgen K. Rockstroh, and the NEAT study

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

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

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

EASL Clinical Practice Guidelines: Management of hepatitis C virus infection

EASL Clinical Practice Guidelines: Management of hepatitis C virus infection EASL Clinical Practice Guidelines: Management of hepatitis C virus infection European Association for the Study of the Liver 1 1. Introduction Hepatitis C virus (HCV) infection is one of the main causes

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 - STATE OF THE ART -

HEPATITIS C - STATE OF THE ART - HEPATITIS C - STATE OF THE ART - Steven J. Ayres, M.D. January 23, 2015 11 th Annual Northcentral Montana Rural Physicians and Advanced Practitioners Conference Disclosures Dr. Ayres has no disclosures

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

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

Optimising therapy in chronic hepatitis B: Switch or add treatment

Optimising therapy in chronic hepatitis B: Switch or add treatment Optimising therapy in chronic hepatitis B: Switch or add treatment Teerha Piratvisuth NKC Institute of Gastroenterology and Hepatology Prince of Songkla University,Thailand NA + NA Percent with resistance

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

Hepatitis C Treatment Criteria Commercial & Minnesota Health Care Programs

Hepatitis C Treatment Criteria Commercial & Minnesota Health Care Programs Last update: February 23, 2015 Hepatitis C Treatment Criteria Commercial & Minnesota Health Care Programs Please see healthpartners.com for Medicare coverage criteria. Table of Contents 1. Harvoni 2. Sovaldi

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

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

A New Era in Hepatitis C Therapy: A Public Health Problem with Solutions

A New Era in Hepatitis C Therapy: A Public Health Problem with Solutions A New Era in Hepatitis C Therapy: A Public Health Problem with Solutions Hemant Shah MD MScCH HPTE Clinic and Education Director Francis Family Liver Clinic @ TWH University of Toronto Disclosures Consulting

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

Virological Monitoring of Hepatitis C Therapy

Virological Monitoring of Hepatitis C Therapy Virological Monitoring of Hepatitis C Therapy Stéphane Chevaliez French National Reference Center for Viral Hepatitis B, C and delta Department of Virology & INSERM U955 Henri Mondor Hospital University

More information

INTRODUCTION ABSTRACT

INTRODUCTION ABSTRACT March-April, Vol. 12 Suppl.2, 2013: s3-s35 s3 An update on the management of hepatitis C: guidelines for protease inhibitor-based triple therapy from the Latin American Association for the Study of the

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

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

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

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

HCV treatment today: pegylated interferons and ribavirin

HCV treatment today: pegylated interferons and ribavirin HCV treatment today: pegylated interferons and ribavirin Other special patient populations Patients with cirrhosis Higher SVR rates are achieved in patients without cirrhosis Patients without bridging

More information

REVIEW CLINICAL AND SYSTEMATIC REVIEWS

REVIEW CLINICAL AND SYSTEMATIC REVIEWS CLINICAL AND SYSTEMATIC S nature publishing group 1 Update on the Management and Treatment of Hepatitis C Virus Infection: Recommendations from the Department of Veterans Affairs Hepatitis C Resource Center

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

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

Hepatitis C Virus Direct-Acting Antivirals Prior Authorization Request Form

Hepatitis C Virus Direct-Acting Antivirals Prior Authorization Request Form Hepatitis C Virus Direct-Acting Antivirals Prior Authorization Request Form For assistance, please call 1-855-552-6028 or fax completed form to 570-271-5610. Medical documentation may be requested. This

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

NP/PA Clinical Hepatology Fellowship Summary of Year-Long Curriculum

NP/PA Clinical Hepatology Fellowship Summary of Year-Long Curriculum OVERVIEW OF THE FELLOWSHIP The goal of the AASLD NP/PA Fellowship is to provide a 1-year postgraduate hepatology training program for nurse practitioners and physician assistants in a clinical outpatient

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium peginterferon alfa-2a, 135 microgram/ml and 180 microgram/ml pre-filled injections of solution for subcutaneous injection (Pegasys ) No. (561/09) Roche Products Limited 10

More information

LIVER FUNCTION TESTS AND STATINS

LIVER FUNCTION TESTS AND STATINS LIVER FUNCTION TESTS AND STATINS Philippe J. Zamor and Mark W. Russo Current Opinion in Cardiology 2011,26:338 341 SUMMARY Purpose of review: To discuss recent data on statins in patients with elevated

More information

Prior Authorization Policy

Prior Authorization Policy Prior Authorization Policy http://www.paramounthealthcare.com/providers Ribavirin Rebetol (ribavirin capsule or oral solution) Copegus (ribavirin tablet), Moderiba (ribavirin tablet), Ribasphere (ribavirin

More information

Coinfezione HIV-HCV. Raffaele Bruno, MD. Department of Infectious Diseases, University of Pavia Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Coinfezione HIV-HCV. Raffaele Bruno, MD. Department of Infectious Diseases, University of Pavia Fondazione IRCCS Policlinico San Matteo, Pavia, Italy Coinfezione HIV-HCV Raffaele Bruno, MD This program is supported by educational grants from Department of Infectious Diseases, University of Pavia Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

More information