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

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

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

Transcription

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

2 Moderator: Raymond T. Chung, MD Associate Professor of Medicine, Harvard Medical School Director of Hepatology and the Liver Center, Massachusetts General Hospital Discussant: Robert S. Brown, Jr., MD, MPH Frank Cardile Professor of Medicine and Pediatrics Columbia University College of Physicians & Surgeons Director, Center for Liver Disease and Transplantation New York-Presbyterian Hospital Discussant: John F. Reinus, MD Professor of Clinical Medicine Albert Einstein College of Medicine Chief of Clinical Hepatology Montefiore Medical Center

3 Preamble º In 2013, we ve witnessed substantial improvements in treatment for genotype 1 HCV, with SVR rates 30% higher than seen previously and the ability to shorten therapy: PEG/RBV/TVR PEG/RBV/BOC º There have been corresponding increases in AEs, SAEs, and overall intolerability º SVR rates have diminished in those with advanced fibrosis, particularly cirrhosis, and those with prior null response to PEG-IFN/RBV º Tolerability concerns are heightened for those with cirrhosis

4 Preamble º Dramatic data regarding the success of all oral DAAs further promises to change the landscape, with e90% SVR rates possible º So...

5 Do We Treat Now or Do We Not Treat Now? º Whom do we treat now, if we do treat at all? º Importance of disease stage in decision making º Utility of biopsy vs. noninvasive staging º Do we confine treatment to patients with cirrhosis or bridging fibrosis? º What about treatment-experienced patients? º If we treat, what about a lead-in approach to stratify? º What about other baseline factors age, race, VL, IL28B?

6 Do We Treat Now or Do We Not Treat Now? º What about the specter of resistance? º Should we push clinical trials as a third way? Is this feasible? º What about genotypes 2 or 3? Do we treat now or wait on them, too? º What do our patients want? Does SVR rate matter most? Or avoidance of IFN? How much do duration, pill burden, and DDIs matter? º Given current time lines for approvals, can we justify much more widespread deferrals? º What about use of approved agents in unapproved combinations?

7 Treatment of HCV Now Git-R-Done! Robert S. Brown, Jr., MD, MPH Frank Cardile Professor of Medicine and Pediatrics Columbia University College of Physicians & Surgeons Director, Center for Liver Disease and Transplantation New York-Presbyterian Hospital

8 HCV Treat Now Cure today is always better than cure tomorrow Benefits of waiting Higher cure rate Lower side effects So the question is always how much better and how much longer is the wait The answer is better and soon but the benefit is not equal for all

9 SVR Improves Long-Term Outcomes = 80% SVR rate = 60% SVR rate = 40% SVR rate % cirrhosis % liver-related death proportion of population treated proportion of population treated Davis GL, et al. Gastroenterol. 2010;138(2):

10 Predictors of Response Viral Factors HCV genotype HCV G1 subtype HCV RNA levels Based on these factors a group of patients can be selected who have ~90% cure rate with 24 weeks of therapy Host Factors Adherence BMI Age Fibrosis Race Sex IL28B genotype Response to therapy

11 SPRINT-2: Influence of Patient and Virus Characteristics on SVR with BOC SVR (%) Genotype HCV RNA (IU/mL) Fibrosis* IL28B *Using the Metavir fibrosis score. Poordad F, et al. N Engl J Med. 2011;364(13): ; Poordad F, et al. Gastroenterol. 2012;143:

12 ADVANCE: Influence of Baseline Patient and Virus Factors on SVR with TVR SVR (%) Genotype HCV RNA (IU/mL) Fibrosis a IL28B b a Using the Metavir fibrosis score; b IL28B testing was in Caucasians only. Jacobson IM, et al. N Engl J Med. 2011;364(25): ; Jacobson IM, et al. EASL Abstract 1369.

13 REALIZE Study: TVR for Retreatment of HCV SVR (%) T12PR48 = TVR + PR administered for 12 weeks followed by 36 weeks PR for 12 weeks followed by PR for 32 weeks; SOC = PR administered for 48 weeks; LI-T12PR48 = patients assigned to the lead-in group received PR for 4 weeks, followed by TVR for 12 weeks, and PR for a total of 48 weeks. Zeuzem S, et al. N Engl J Med. 2011;364(25):

14 RESPOND-2: SVR in Relapsers and Non-Responders with BOC SVR (%) *Patients with detectable HCV RNA level at Week 8 received placebo and PR for an additional 12 weeks. All 3 groups received PR 4 weeks (lead-in period). BOC/PR = boceprevir + pegifn/rbv; Control = received placebo + PR for 44 weeks. Bacon BR, et al. N Engl J Med. 2011;364(13):

15 OPTIMIZE Phase III: TVR BID vs TVR Q8h in Treatment-Naïve GT1 OPTIMIZE: SVR12 rates with TVR 1,125 mg BID noninferior to TVR 750 mg every 8 hours (q8h) Similar safety and tolerability profile in both treatment arms Outcome (%) TVR BID + PR (n = 369) TVR q8h + PR (n = 371) All Patients (n = 740) SVR12 (ITT) SVR12 (per protocol) Relapse a On-Treatment Virologic Failure b a Patients with HCV RNA < 25 IU/mL at planned treatment end assessed for relapse. b Patients who experienced virologic breakthrough or met virologic stopping rule. Buti M, et al. AASLD Abstract LB-8.

16 What s Coming? ~1 year Interferon Sparing regimens + DAA with ~90% SVR weeks Fewer side effects, easier dosing IFN-free fo easy to treat GT2,? 3, 2+ years Interferon-free multiple DAA s with ~90% SVR Multiple regimens based on GT and other factors Fewer side effects?ribavirin

17 Limitations of Emerging Trials Several agents from different classes discontinued due to AEs Phase 3 for IFN-free not done for most drugs Trials on patients with cirrhosis and other special populations needed Time line and costs issues remain unknown, particularly for IFN-free Rx

18 Patients with Good Outcome: Characteristics of a Easy-to-Treat Patient Naïve or prior relapse to IFN Mild Fibrosis HCV genotype 1b IL-28B CC Low viral load Under 40 years old No NAFLD Risk factors (Thin, nondiabetic) These patients need to wait 1 year to save 12 weeks of IFN and longer for the last 12!

19 New and Emerging Strategies: Clinical Considerations Recent recommendations from the CDC emphasize the importance to screen and early diagnosis of HCV infection Newly diagnosed patients with chronic HCV infection still require comprehensive counseling For patients who are candidates for therapy Initiate treatment with currently available therapy easy or advanced disease naïve or relapse Defer treatment until availability of new antiviral agents with the potential for increased efficacy, decreased adverse events, and shorter duration of therapy over existing regimens

20 To Treat or Not to Treat : DON T John F. Reinus, MD Professor of Clinical Medicine Albert Einstein College of Medicine Chief of Clinical Hepatology Montefiore Medical Center

21

22 When planning therapy of a disease Goal: What is the desired result in this patient? Effectiveness: Can the desired result be achieved? Disease prognosis: What is the prognosis without therapy? Benefit: Will the desired result benefit the patient? Safety: What are the risks of treating? Contraindications: Is the patient able to receive treatment? Tolerability: Can the patient tolerate therapy? Alternative treatment: Is there another more suitable therapy?

23 HCV genotype 1 treatment response rates Genotype 1 SVR IFN 12% IFN/RBV 35% Peg-IFN RBV 44% Protease Peg-IFN RBV 70% 2nd Generation DAAs >90% Schaefer EA, et al. Gastroenterology 2012;142:1340 Ghany MG, et al. Hepatology 2009;49:1335 Ghany MG, et al. Hepatology 2011;54:1433

24 When planning therapy of a disease Goal: What is the desired result in this patient? Effectiveness: Can the desired result be achieved? Disease prognosis: What is the prognosis without therapy? Benefit: Will the desired result benefit the patient? Safety: What are the risks of treating? Contraindications: Is the patient able to receive treatment? Tolerability: Can the patient tolerate therapy? Alternative treatment: Is there another more suitable therapy?

25 5- and 20-year probabilities of progression to different stages of fibrosis in HCV infection Terrault, et al. Clinical Gastroenterology and Hepatology 2008;6: YEAR PROGRESSION 20-YEAR PROGRESSION Estimated median time of progression from F0 to cirrhosis was 79 years!

26 Will the patient benefit from treatment? What is the prognosis with liver disease? What is the prognosis without liver disease?

27 When planning therapy of a disease Goal: What is the desired result in this patient? Effectiveness: Can the desired result be achieved? Disease prognosis: What is the prognosis without therapy? Benefit: Will the desired result benefit the patient? Safety: What are the risks of treating? Contraindications: Is the patient able to receive treatment? Tolerability: Can the patient tolerate therapy? Alternative treatment: Is there another more suitable therapy?

28 Adverse events in 157 patients treated with telaprevir at Montefiore and Mt. Sinai Bichoupan K, et al. AASLD 2012; Abstract 1755 Hgb < 8.5 g/dl 35 (20%) RBC transfusion 18 (11%) Severe rash 15 (9%) Severe fatigue 54 (31%) Skin burning 24 (14%) Anorectal burning 39 (24%) Hypokalemia 30 (17%) AKI 27 (16%) Depression 10 (6%) Hospital admission 28 (16%) Other* 18 (10%) Early telaprevir discontinuation due to adverse event: MMC + MSMC Advance + Realize (n=157) (n=629) P 21% 13% 0.01 *Other: diarrhea, dehydration, infection, arrhythmia, decompensation

29 BCP: pharmacokinetic interactions Data courtesy of Dr. Mark S. Sulkowski, Johns Hopkins School of Medicine Effect on ART Effect on BCP ART AUC C MIN AUC C MIN Recommendation Efavirenz 20% 19% 44% Do not prescribe ETR;NVP;RPV Do not prescribe Atazanavir/r 35% 49% No Change Do not prescribe Darunavir/r 44% 59% 29% 35% Do not prescribe Lopinavir/r 34% 43% 44% 35% Do not prescribe Raltegravir No Change No Change Standard BCP dose

30 When planning therapy of a disease Goal: What is the desired result in this patient? Effectiveness: Can the desired result be achieved? Disease prognosis: What is the prognosis without therapy? Benefit: Will the desired result benefit the patient? Safety: What are the risks of treating? Contraindications: Is the patient able to receive treatment? Tolerability: Can the patient tolerate therapy? Alternative treatment: Is there another more suitable therapy?

31 HCV drugs in late-stage clinical development NS3/4A Nucleotide NS5B NS5A Protease Polymerase Replication-Complex Inhibitors Inhibitors Inhibitors FDA Approved Telaprevir Boceprevir Phase III ABT-450 Sofosbuvir Daclatasvir (Clinical Trial) (ABT450/r + ABT267 (Sof + GS RBV) (Dac + P/RBV) + ABT333 + RBV) (Sof + RBV) (Dac + Asunaprevir) Asunaprevir (Asun +Daclatasvir) Faldaprevir (Fal + P/RBV) Simeprevir (Sim + P/RBV)

32 Oral 12-week therapy of geno-1 HCV: efficacy Sofosbuvir, Ledipasvir, Ribavirin Treatment Naive (n=25) Null Responder (n=9) Week 1 11/25 (44%) 0/9 (0%) Week 2 22/25 (88%) 4/9 (44%) Week 4 25/25 (100%) 8/9 (89%) Week 12 25/25 (100%) 9/9 (100%) SVR 4 25/25 (100%) 9/9 (100%) SVR 12 25/25 (100%) 9/9 (100%) Gane E, et al. AASLD, EASL

33 Oral 12-week therapy of geno-1 HCV: safety Sofosbuvir, Ledipasvir, Ribavirin Treatment Naive (n=25) Null Responder (n=9) Anemia 5/25 (20%) 0/9 (0%) Depression 2/25 (8%) 0/9 (0%) Headache 1/25 (4%) 0/9 (0%) URI 0/25 (0%) 0/9 (0%) Fatigue 0/25 (0%) 2/9 (22%) Sprain 0/25 (0%) 0/9 (0%) Gane E, et al. AASLD, EASL

34 Oral 12-week therapy of geno-1 HCV: safety Sofosbuvir, Ledipasvir, Ribavirin Treatment Naive (n=25) Null Responder (n=9) PT > 3X ULN 0/25 (0%) 0/9 (0%) PT 1.5-3X ULN 2/25 (8%) 0/9 (0%) Hematuria? 9/25 (36%) 0/9 (0%) Hgb 7-9 g/dl 5/25 (20%) 2/9 (22%) ALT > 5X ULN 0/25 (0%) 0/9 (0%) TB > 2.6X ULN 0/25 (0%) 0/9 (0%) Gane E, et al. AASLD, EASL

35 Just say NO to drugs Goal and Effectiveness: While the goal is cure, many patients still cannot be treated successfully with currently available drugs. Prognosis and Benefit: Most patients have a benign shortterm prognosis and do not need to be treated immediately. Safety and Tolerability: Current therapy has many severe side effects that make it difficult for patients to complete treatment. Alternative Therapy: Numerous new, vastly superior drugs will be available in the near future.

36

37

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

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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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

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

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

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

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

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

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

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

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

SCIENTIFIC DISCUSSION

SCIENTIFIC DISCUSSION London, 13 October 2005 Product name: PEGINTRON Procedure No. EMEA/H/C/280/II/54 SCIENTIFIC DISCUSSION 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86

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

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

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

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

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

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

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 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

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

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

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

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

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

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

A Proposal for Managing the Harvoni Wave June 22, 2015

A Proposal for Managing the Harvoni Wave June 22, 2015 A Proposal for Managing the Harvoni Wave June 22, 2015 Clinical Background Hepatitis C is an infectious disease caused by the Hepatitis C Virus (HCV) that damages the liver over time. The disease affects

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

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

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

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

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

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

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

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

New Hepatitis C Wonder Drugs: Who Is Worth the Cost?

New Hepatitis C Wonder Drugs: Who Is Worth the Cost? New Hepatitis C Wonder Drugs: Who Is Worth the Cost? Riddle me this, riddle me that, your HCV treatment, who will pay for that? Rachel Rogers, PharmD PGY2 Infectious Diseases Pharmacy Resident South Texas

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

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

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

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

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

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

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

Prior Authorization Conditions for Approval of Hepatitis C Agents

Prior Authorization Conditions for Approval of Hepatitis C Agents Prior Authorization Conditions for Approval of Hepatitis C Agents All requests for Hepatitis C Agents require a prior authorization and will be screened for medical necessity and appropriateness using

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

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

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

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

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

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