Innovazione farmacologica e farmacologia clinica

Size: px
Start display at page:

Download "Innovazione farmacologica e farmacologia clinica"

Transcription

1 Innovazione farmacologica e farmacologia clinica Francesco Scaglione, MD, PhD Department of Medical Biotechnology and Translational Medicine School of medicine Postgradute School of clinical pharmacology University of Milan,Italy PostGraduate School Clinical Pharmacology

2 Milestones Achieved, Miles to Go SVR (%) % 42% 39% 54-56% 56% 20 6% 16% 0 IFN 6 m IFN 12 m IFN/RBV 6 m IFN/RBV 12 m PEG-IFN 12 m PEG-IFN /RBV 12 m Strader et al. Hepatology; 39:

3 Sustained Viral Response Rates with PEG-IFN /RBV 76%-82% 42%-46% 46% Genotype 1 Genotype Non-1 Strader et al. Hepatology; ; 39:

4 The importance of viral kinetics 8 7 Therapy Log (10) HCV RNA Non-response (NR) Slow response with relapse Early virologic response (EVR) Rapid virologic response (RVR) Time (wks) Scott J and Gretch DR. JAMA 2007.

5

6 Mechanism of Action: Interferon Biologic response modifier HCV Interferon alfa HCV virions IFN receptors JAK STAT STAT1 Assembly HCV replicative Viral RNA complex Protein Adenosine kinase R IRF9 deaminase 2',5'oligoadenylate synthetase OAS: activates antiviral RNAses PKR: inactivates viral ptn translation ADA: edits viral RNA ISG mrna ISGF3 ISRE Adapted from Hoofnagle J. NEJM 2006

7 Effect of IFN-α Average HCV RNA level reduction (log IU/ml) Group A: untreated Group C: IFN-α 3 MU tiw (Pawlotsky et al., Gastroenterology 2004;126:703-14) Days

8 inosinemonophospatedehydrogenase (IMPDH),

9 Effect of IFN-α/Ribavirin Average HCV RNA level reduction (log IU/ml) Group A: untreated Group C: IFN-α 3 MU tiw Group D: IFN-α 3 MU tiw + ribavirin g qd Days (Pawlotsky et al., Gastroenterology 2004;126:703-14) slide courtesy of JM Pawlotsky

10 e il futuro? HIV protease HIV! Abbiamo imparato tutto da qui!

11 ..il futuro è cominciato!!

12 Direct Acting Antivirals (DAAs) Specifically Targeted Antiviral Therapy for Hepatitis C (STAT-C) Telaprevir Boceprevir

13 The Hepatitis C Genome HCV Polyprotein 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

14 The protease cleaves the HCV polyprotein chain, initiating replication E1 E2 P7 NS2 NS3/4A Protease NS4B NS5A C NS5B Kwong et al. Drug Discovery Today: Therapeutic Strategies, Vol. 3, No

15 Protease inhibitors prevents cleavage of the polyprotein chain, preventing viral replication Boceprevir and Telaprevir Protease inhibitor binds to protease Downstream cleavage is halted Protease Kwong et al. Drug Discovery Today: Therapeutic Strategies, Vol. 3, No

16 Zhang J et al.hepatology 2005;42:535A. Farmacocinetica Il cuore dall azione dei farmaci BOCEPREVIR T max T 1/2 1-2,5 h 7-15 h

17 Pharmacokinetic parameters of plasma telaprevir BOCEPREVIR T max T 1/2 1-2,5 h 7-15 h Journal of Viral Hepatitis, 2012, 19, e112 e119

18 Attenzione alle interazioni!

19

20

21

22 Drug Boceprevir Telaprevir cyclosporine Tacrolimus Midazolam iv 9 os Atorvastatin !!!

23

24

25

26

27

28

29

30

31

32

33

34 Specifically Targeted Antiviral Therapies for HCV (STAT-C) Protease Inhibition Polymerase Inhibition Kwong et al. Drug Discovery Today: Therapeutic Strategies, Vol. 3, No

35 The final enzyme cleaved from the HCV polyprotein, the polymerase is critical to RNA replication NS5B Replicated RNA HCV replicase RNA template Kwong et al. Drug Discovery Today: Therapeutic Strategies, Vol. 3, No

36 Inhibition of the polymerase halts viral replication downstream NS5B Polymerase inhibitor HCV replicase RNA template Kwong et al. Drug Discovery Today: Therapeutic Strategies, Vol. 3, No

37 Evolution of HCV genotype 1 treatment 100 SVR rate (%) % IFN % IFN + RBV % Peg-IFN + RBV % DAA + Peg- IFN + RBV IFN: interferon; RBV: ribavirin Peg-IFN: peginterferon DAA: direct-acting antiviral SVR: sustained virologic response 1. McHutchison JG, et al. N Engl J Med 1998;339: ; 2. Fried M, et al. N Engl J Med 2002;347: Manns MP, et al. Lancet 2001;358:958 65; 4. Hadziyannis SJ, et al. Ann Intern Med 2004;140: Jacobson IM, et al. Hepatology 2010;52(Suppl):427A; 6. Sherman KE, et al. Hepatology 2010;52(Suppl.):401A 7. Poordad F, et al. Hepatology 2010;52(Suppl.):402A; 8. Foster GR, et al. Hepatol Int 2011;5(Suppl.1):14

38 The importance of viral kinetics 8 7 Therapy Log (10) HCV RNA Non-response (NR) Slow response with relapse Early virologic response (EVR) Rapid virologic response (RVR) Time (wks) Scott J and Gretch DR. JAMA 2007.

39 4 3 2 telaprevir PK Pharmacokinetic parameters telaprevir PK of Cmax 30 Cmin plasma telaprevir 20 AUC Days Days Journal of Viral Hepatitis, 2012, 19, e112 e119

40 No Correlation of SVR With Plasma PK No SVR (n=29) SVR (n=87) No SVR (n=29) SVR (n=87) Tx-Experienced Tx-Naive Median, Quartiles Data from RESPOND-2 and SPRINT-2. AUC=area under the concentration-time curve; Cmin=minimum observed plasma concentration; PK=pharmacokinetic; SVR=sustained virologic response.

41 Paradigm of HCV Diagnosis and Treatment Treated 1 Treated but failed 1 Diagnosed but not treated 1 Not diagnosed 2 1. Evon DM, et al. Dig Dis Sci. 2007;52(11): McHutchison JG, Bacon BR. Am J Manag Care. 2005;11(10 suppl):s286-s295.

42 Grazie per l attenzione!

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

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

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

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

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

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

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

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

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

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

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

Goals of Therapy. Treatment Options for Hepatitis C. Patterns of Response. Progress in Hepatitis C Therapy

Goals of Therapy. Treatment Options for Hepatitis C. Patterns of Response. Progress in Hepatitis C Therapy Treatment Options for Hepatitis C Helen S. Te, M.D. Center for Liver Diseases University of Chicago Hospitals Chicago, Illinois Primary: To eliminate the virus Goals of Therapy Secondary: To decrease inflammation

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

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

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

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

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

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

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

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

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

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

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

The Treatment of Hepatitis C - State of the Art -

The Treatment of Hepatitis C - State of the Art - Falk Symposium 163, March 14 15, 2008, Hangzhou, China The Treatment of Hepatitis C - State of the Art - Michael P. Manns Medical School of Hannover Department of Gastroenterology, Hepatrology and Endocrinology

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

Focus on Transplantation: Treatment Post-transplant for HBV and HCV

Focus on Transplantation: Treatment Post-transplant for HBV and HCV Focus on Transplantation: Treatment Post-transplant for HBV and HCV The Viral Hepatitis Congress, Frankfurt, 09. September 2012 Christoph Sarrazin J. W. Goethe-University Hospital Medizinische Klinik I

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

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

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

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

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

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

S. Bourgeois, G. Robaeys, P. Deltenre, C. Moreno and J. Delwaide. on behalf of the PRACTICE study group (Belgium)

S. Bourgeois, G. Robaeys, P. Deltenre, C. Moreno and J. Delwaide. on behalf of the PRACTICE study group (Belgium) Adherence but not loss to follow-up in genotype 1 and 4 chronic hepatitis C patients infected after substance use is similar in comparison with infection by other causes: data from a large real life trial.

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

Twenty-Five Years of Progress Against Hepatitis C: Setbacks and Stepping Stones

Twenty-Five Years of Progress Against Hepatitis C: Setbacks and Stepping Stones Twenty-Five Years of Progress Against Hepatitis C: Setbacks and Stepping Stones Twenty-Five Years of Progress Against Hepatitis C: Setbacks and Stepping Stones 3 Executive Summary 4 Introduction 5 The

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

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

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

Hing wars. During World War II, there was a series of hepatitis outbreaks

Hing wars. During World War II, there was a series of hepatitis outbreaks Hepatitis C: Toward a Cure and Eradication 1 CHARLES M. RICE Head, Laboratory of Virology and Infectious Disease Scientific and Executive Director Center for the Study of Hepatitis C Rockefeller University

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

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

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

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

HEPATITIS COINFECTIONS

HEPATITIS COINFECTIONS HEPATITIS COINFECTIONS Kenneth E. Sherman, MD, PhD Gould Professor of Medicine Director, Division of Digestive Diseases University of Cincinnati College of Medicine Disclosures (Activity w/i 12 months)

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

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

Hepatitis C Treatment: Tailoring Therapy To Maximize Response

Hepatitis C Treatment: Tailoring Therapy To Maximize Response PRINTER-FRIENDLY VERSION AT GASTROENDONEWS.COM Hepatitis C Treatment: Tailoring Therapy To Maximize Response PATRICK J. AMAR, MD Department of Gastroenterology and Hepatology Holy Cross Medical Group Fort

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

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 Vaccines: Are we making progress?

Hepatitis C Vaccines: Are we making progress? Hepatitis C Vaccines: Are we making progress? Second International Hepatitis Cure and Eradication Meeting. Vancouver November, 2015 Objectives: Review the need for a preventive vaccine in 2015. Identify

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

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

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

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 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

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

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. Update on Management. Hepatitis C Virus Infection Burden of Disease in United States

Hepatitis C. Update on Management. Hepatitis C Virus Infection Burden of Disease in United States Hepatitis C Update on Management Norah Terrault, MD, MPH University of California San Francisco Hawaii, 2010 Hepatitis C Virus Infection Burden of Disease in United States New infections (cases)/year 1985-89

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

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

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

HCV RNA Monitoring System Meets Critical Need to Monitor Patient Viral Loads in Hepatitis C Virus (HCV) Clinical Trials

HCV RNA Monitoring System Meets Critical Need to Monitor Patient Viral Loads in Hepatitis C Virus (HCV) Clinical Trials HCV RNA Monitoring System Meets Critical Need to Monitor Patient Viral Loads in Hepatitis C Virus (HCV) Clinical Trials Stephanie F. Finn, MS; John P. MacNeela, MSPH; Rebecca Wilgus RN, MSN; Amanda L.

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

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

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

Hepatitis C Antiviral Therapy

Hepatitis C Antiviral Therapy MEDICAL POLICY POLICY RELATED POLICIES POLICY GUIDELINES DESCRIPTION SCOPE BENEFIT APPLICATION RATIONALE REFERENCES CODING APPENDIX HISTORY Hepatitis C Antiviral Therapy Number 5.01.606 Effective Date

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

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

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

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

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

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

Commissioning Policy for Hepatitis C Treatments

Commissioning Policy for Hepatitis C Treatments Commissioning Policy for Hepatitis C Treatments Reference No: EMSCGP012V1 Version: 1 Ratified by: East Midlands Specialised Commissioning Group Date ratified: 05/06/09 Name of originator/author: Andrew

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

The Use of Protease Inhibitors for the Treatment of Hepatitis C in Liver Transplant Recipients: Is a Bird in the Hand Worth Two in the Bush?

The Use of Protease Inhibitors for the Treatment of Hepatitis C in Liver Transplant Recipients: Is a Bird in the Hand Worth Two in the Bush? The Use of Protease Inhibitors for the Treatment of Hepatitis C in Liver Transplant Recipients: Is a Bird in the Hand Worth Two in the Bush? Christina Guerra, PharmD PGY-1 Pharmacy Resident University

More information

Exploratory Study of Oral Combination Antiviral Therapy for Hepatitis C

Exploratory Study of Oral Combination Antiviral Therapy for Hepatitis C original article Exploratory Study of Oral Combination Antiviral Therapy for Hepatitis C Fred Poordad, M.D., Eric Lawitz, M.D., Kris V. Kowdley, M.D., Daniel E. Cohen, M.D., Thomas Podsadecki, M.D., Sara

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

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

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

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

Mechanisms of Interferon-associated Bone Marrow Suppression with or without Ribavirin. K. Zhdanov

Mechanisms of Interferon-associated Bone Marrow Suppression with or without Ribavirin. K. Zhdanov EASL endorsed conference White Nights of Hepatology 2012 Adverse events during antiviral therapy: how to predict, manage and monitor June 7-8 Saint-Petersburg Mechanisms of Interferon-associated Bone Marrow

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 Virus and HIV Co-infection 2015 Update. Mia N. Barnes, Pharm.D., BCPS HIV CPE Training Program for Pharmacists February 8, 2015

Hepatitis C Virus and HIV Co-infection 2015 Update. Mia N. Barnes, Pharm.D., BCPS HIV CPE Training Program for Pharmacists February 8, 2015 Hepatitis C Virus and HIV Co-infection 2015 Update Mia N. Barnes, Pharm.D., BCPS HIV CPE Training Program for Pharmacists February 8, 2015 1 Statement of Disclosure Presenter has no relevant financial

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

Dr. Abonyi Margit PhD SE 1st Medical Clinic Associate Professor. Hepatology-2014

Dr. Abonyi Margit PhD SE 1st Medical Clinic Associate Professor. Hepatology-2014 Dr. Abonyi Margit PhD SE 1st Medical Clinic Associate Professor Hepatology-2014 Other virus hepatitis Epstein-Barr vírus Cytomegalo vírus Herpes simplex vírus Coxsackie vírus Hepatitis B vírus Hepadnavírus,

More information

Managing potential drug-drug interactions to achieve success in HCV triple therapy. David Back University of Liverpool

Managing potential drug-drug interactions to achieve success in HCV triple therapy. David Back University of Liverpool Managing potential drug-drug interactions to achieve success in HCV triple therapy David Back University of Liverpool Understanding the metabolic pathways of DAAs Drug CYP 3A4 P-gp Telaprevir Boceprevir

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

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

DAA per l'epatite C: promesse e problemi. Giovanni Battista Gaeta Cattedra di Malattie Infettive UOC Epatiti Virali Seconda Università di Napoli

DAA per l'epatite C: promesse e problemi. Giovanni Battista Gaeta Cattedra di Malattie Infettive UOC Epatiti Virali Seconda Università di Napoli DAA per l'epatite C: promesse e problemi Giovanni Battista Gaeta Cattedra di Malattie Infettive UOC Epatiti Virali Seconda Università di Napoli SVR rates with telaprevir-based therapy versus PR alone in

More information

Pharmacodynamics and Drug-Drug Interactions in HCV/HIV Co-Infected Persons on Treatment with DAAs

Pharmacodynamics and Drug-Drug Interactions in HCV/HIV Co-Infected Persons on Treatment with DAAs Pharmacodynamics and Drug-Drug Interactions in HCV/HIV Co-Infected Persons on Treatment with DAAs Courtney V. Fletcher, Pharm.D. Dean, College of Pharmacy Professor, Department of Pharmacy Practice and

More information

Disclosure. Pharmacy technician objectives. Pharmacist objectives. Epidemiology. Terminology 3/3/2015. Treatment of Hepatitis C

Disclosure. Pharmacy technician objectives. Pharmacist objectives. Epidemiology. Terminology 3/3/2015. Treatment of Hepatitis C Disclosure Treatment of Hepatitis C Katerina Tagaras PGY-1 Resident Palmetto General Hospital I do not have a vested interest in or affiliation with any corporate organization offering financial support

More information

HEPATITIS C THERAPY. The Future is Now and Later

HEPATITIS C THERAPY. The Future is Now and Later HEPATITIS C THERAPY The Future is Now and Later Dilip Moonka, MD Henry Ford Health Systems Medical Director of Liver Transplantation DISCLOSURES Gilead, Bristol-Myers-Squibb, Genentech, Merck This talk

More information

Positive impact of HCV treatment initiation on health outcomes in injecting drug users

Positive impact of HCV treatment initiation on health outcomes in injecting drug users Positive impact of HCV treatment initiation on health outcomes in injecting drug users Perrine ROUX, PhD Substance Use Research Center, Columbia University, NY Inserm U912, SE4S, Marseille Introduction

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

Boceprevir: A Protease Inhibitor for the Treatment of Hepatitis C

Boceprevir: A Protease Inhibitor for the Treatment of Hepatitis C Clinical Therapeutics/Volume 34, Number 10, 2012 New Drug Review Boceprevir: A Protease Inhibitor for the Treatment of Hepatitis C Mei H. Chang, BA, PharmD, BCPS; Lori A. Gordon, PharmD; and Horatio B.

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

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

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

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