Management of adverse effects of triple therapy
|
|
- Cynthia Cunningham
- 5 years ago
- Views:
Transcription
1 Management of adverse effects of triple therapy Giovanni Battista Gaeta Cattedra di Malattie Infettive UOC Epatiti Virali Seconda Università di Napoli
2 Disclosures Advisory board: BMS, Gilead, Janssen Speaker: BMS, Gilead, Roche, Janssen, Merck
3 Factors influencing the safety profile of a drug Number of treated patients More frequent ADR/AE (both serious and trivial) are usually detected in premarket studies conducted for drug approval. There are not enough subjects to reliably detect a type of ADR that occurs only once in 2,500-5,000 or more exposures Registrative trials are sized to detect efficacy not safety Once a drug is approved, it may be administered to millions of people Circumstances of use Once a drug is marketed, its use is quite different from the premarket testing. Drugs may be used in different populations i.e. in patients with comorbiditiesor in combinations of different drugs Learning curve
4 Telaprevir placebo-controlled Phase II/III studies: summary of AEs during telaprevir/placebo phase Patients, % T12/PR (750 mg q8h) N=1346 Skin and subcutaneous tissue disorders Placebo/PR48 N=764 Leading to discontinuation of all study drugs*(%) Pruritus (SSC) % Rash (SSC) % Gastrointestinal disorders Nausea <0.5 Diarrhea <0.5 Hemorrhoids 12 3 <0.5 Anorectal discomfort 8 2 <0.5 Anal pruritus 6 1 <0.5 Blood and lymphatic system disorders Anemia (SSC) % *Discontinuation of all study drugs in the T12/PR arms (analyzed within SSC for rash and anemia) SSC: special search category Materials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM pdf
5 Boceprevir Phase III studies: summary of AEs over course of therapy Patients, % BOC RGT BOC44/PR48 PR SPRINT-2 (naïve) 1 N=368 N=366 N=363 Anemia* Dysgeusia* Grade 3-4 neutropenia (500 to <750/mm 3 and <500/mm 3 ) RESPOND-2 (experienced) 2 N=162 N=161 N=80 Anemia* Dysgeusia* Dry skin** Grade 3-4 neutropenia (500 to <750/mm 3 and <500/mm 3 ) Rash *p<0.001 for boceprevir arms versus PR **p=0.009 (BOC RGT) and p=0.004 (BOC44/PR48) versus PR p=0.01 (BOC RGT) and p=0.05 (BOC44/PR48) versus PR 1. Poordad F, et al. N Engl J Med 2011;364: Bacon BR, et al. N Engl J Med 2011;364:
6 Summary of anemiadata TELAPREVIR Hemoglobin <10 g/dl Hemoglobin <8.5 g/dl Patients (%) T12/PR Placebo/ PR48 T12/PR Placebo/ PR48 Patients (%) Hemoglobin <10 to 8.5 g/dl BOCEPREVIR Hemoglobin <8.5 g/dl BOC RGT BOC44/ PR48 Control BOC RGT BOC44/ PR48 Control Poordad F, et al. Hepatology 2010;52(Suppl.):402A; Telaprevir EU SmPC
7 How to handle anemia? Erythropoetin Regulatory limits Possible side effects Ribavirin dose reduction Risk of lower SVR? Blood transfusions Patients refusal Transfusion-related risks 1. Telaprevir EU SmPC; 2. Boceprevir EU SmPC
8 Management of anemia observed with telaprevir and boceprevir Ribavirin dose reductions due to anemia EPO use Transfusions Discontinuation clinical Telaprevir trials Phase II/III placebo-controlled trials % (telaprevir arms) vs 9.4% (control) Not permitted (1% use) Telaprevir/placebo dosing phase: 2.5% (telaprevir arms) vs 0.7% (control) Overall study period: 4.6% (telaprevirarms) vs 1.6% (control) Telaprevir alone: 1.9% vs 0.5% control All treatment at the same time: 0.9% (telaprevir arm) vs 0.5% (control) Boceprevir trials % (boceprevir arms) vs 13% (control) 43% (boceprevir arms) vs 24% (control) 3% (boceprevir arms) vs <1%(control) 0 3% (boceprevir arms) vs 0 1% (control) 3,4 1. Telaprevir EU SmPC; 2. Boceprevir EU SmpC 3. Poordad F, et al. N Engl J Med 2011;364: ; 4. Bacon BR, et al. N Engl J Med 2011;364:
9 Telaprevir studies: SVR rates by anemia status and RBV dose reduction 100 Anemia No anemia RBV dose reduction No RBV dose reduction SVR (%) PR T12PR PR T12PR PR T12PR PR T12PR n/n= 46/92 267/ / /524 37/69 243/ / /565 ADVANCE and ILLUMINATE pooled data; Erythropoietin alfa (EPO) was not allowed Sulkowski M, et al. J Hepatol 2011;54(Suppl. 1):S195
10 Boceprevir: SVR rates by EPO use and RBV dose reduction No anemia Anemia SVR (%) n/n= 212/363 95/129 29/37 109/153 30/44 SPRINT-2 Study; Data of pooled boceprevir arms Sulkowski M, et al. J Hepatol 2011;54(Suppl. 1):S194
11 Gestione dell anemia Cosa NON fare: ridurre dose di telaprevir o boceprevir Cosa fare: considerare riduzione dose ribavirina nei pazienti già HCV-RNA negativi EPO in casi selezionati Trasfusione
12 Anemia in a patient treated with telaprevir-based therapy OC, woman, age 56, no cirrhosis, naive HCV-RNA (log) 6.1 Undetectable 16 Hb g/dl T= transfusion RBV dose reduction Stop telaprevir DAYS Stop all drugs 6.6 T T Malattie Infettive, Napoli
13 Incidence of rash during telaprevir phase vs. standard therapy
14 Patient: grading of skin eruption severity Mild: localized skin eruption and/or a skin eruption with limited distribution (up to several isolated sites on the body) Moderate: diffuse rash 50% of body surface area Severe: Extent of rash >50% of body surface area or associated with significant systemic symptoms, mucous membrane ulceration, target lesions, epidermal detachment SCAR*: generalized bullous eruption, drug rash with eosinophilia and systemic symptoms (DRESS), Stevens- Johnson Syndrome/toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme *systemic cutaneous adverse reaction Telaprevir EU SmPC
15
16 Rash in 5 giornata di terapia con telaprevir Malattie Infettive, Napoli
17 Estensione al dorso in 6 giornata Malattie Infettive, Napoli
18 Estimatingbody surface area (BSA) 9% 9% Front 18% Back 18% 9% Adult body BSA Perineum 1% Arm 9% Head (front and back) 9% 18% 18% Leg 18% Chest 18% Back 18% Hettiaratchy S, et al. BMJ 2004;329:101 3
19 Checking list for criteria of rash severity Rash 50% of body surface area No prolonged fever No facial edema No mucosal involvement No enlarged lymph nodes No dyspnea No need to check for biological alterations (eosinophilia, raised ALT, Alk Ph, creatinine) MONITOR Bocquet H, et al. Semin Cutan Med Surg 1996;15:250 57
20 Treating Patients with Mild or Moderate Rash Limitexposuretosun Topical corticosteroids Systemic antihistaminic* Systemic steroids not allowed Regular follow-up is mandatory * diphenhydramine; hydroxyzine; levocetirizine; desloratadine
21 Administrationoftopicalsteroids The fingertip rule A fingertip= 0.5 g ofsteroid Sufficient to treat an area equivalent to two palms From: CacoubP etal. J Hepatolo2012; 56:455-63
22 Summary of rash data from placebo-controlled Phase II/III trials: telaprevir treatment phase Incidence of rash (%) T12/PR (N=1346) 33 Placebo/PR48 (N=764) >90% of all rash = mild/moderate Features: Typically pruritic and eczematous, and involving <30% BSA Progression was infrequent (<10% of cases) Incidence of rash (%) T12/PR arm Reported within a special search category Telaprevir EU SmPC Materials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM pdf
23 Anorectal signs and symptoms First reported with telaprevir in PROVE1 as hemorrhoids Subsequently reported under various terms such as anal pruritus, anorectal discomfort as well as hemorrhoids Onset is most commonly in the first 2 weeks of treatment Mechanism is unknown Telaprevir is extensively metabolized and metabolites primarily excreted in the feces No rectal findings in any of the toxicology studies No evident association with either generalized pruritus or skin rash Treatment: local corticosteroids, anaesthetics McHutchison JG, et al. New Engl J Med 2009;360:
24 CUPIC cohort: HCV gen1, cirrhosis 430 patients included; in this analysis Hezode, HepDart 2011
25
26 Hezode, HepDart 2011
27 Summary& Conclusions Triple therapy for HCV is associated with significant adverse events. An intense on-therapy monitoring is required Adherence to updated management plans is important Post-marketing surveillance and cohort studies will design the safety profileofdaasin realworld settings
28
29 Boceprevir Phase III studies: summary of AEs over course of therapy BOC RGT BOC44/ PR48 PR SPRINT-2 (naïve) 1,2 N=368 N=366 N=363 Deaths N=1 N=1 N=4 Serious AEs 11% 12% 9% Discontinued due to AEs 12% 16% 16% RESPOND-2 (experienced) 3 N=162 N=161 N=80 Deaths N=1 N=0 N=0 Serious AEs 10% 14% 5% Discontinued due to AE 8% 12% 2% 1. Poordad F, et al. N Engl J Med 2011;364: ; 2. Poordad F, et al. N Engl J Med 2011;364: (supplementary appendix); 3. Bacon BR, et al. N Engl J Med 2011;364:
30 Anorectal disorders* during the telaprevir treatment period in Phase II and III studies Proportion (%) of patients with: 1 T12/PR (750 mg q8h) N=1346 Placebo/PR48 N=764 AE AE of at least Grade AE leading to permanent discontinuation of telaprevir/placebo In clinical trials, the majority of these events (e.g., haemorrhoids, anorectal discomfort, anal pruritus, and rectal burning) were mild to moderate, very few led to treatment discontinuation and resolved after completion of telaprevir dosing 2 *Reported within a special search category 1. Materials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM pdf 2. Telaprevir EU SmPC
31 Telaprevir placebo-controlled Phase II/III studies: summary of AEs during telaprevir/placebo phase T12/PR (750 mg q8h) N=1346 Placebo/PR48 N=764 Deaths N=0 a N=1 a,b Serious AEs 7% 3% AEs leading to permanent discontinuation of Telaprevir/Placebo AEs leading to permanent discontinuation of all study drugs at same time 14% 4% 8% 4% a Refers to the number of patients who died as a result of an AE with onset during the telaprevir/placebo treatment phase b This includes 1 patient who had a life-threatening AE that was not resolved at his last study visit. The patient died afterwards due to this AE Materials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM pdf
32 Severe rash and SCAR* Rash Severe Discontinue telaprevir immediately. Consultation with a specialist in dermatology is recommended Monitor for progression or systemic symptoms until the rash is resolved. If no improvement within 7 days of stopping telaprevir (or earlier if rash worsens), sequential or simultaneous interruption or discontinuation of ribavirin and/or peginterferon should be considered SCAR? Permanent and immediate discontinuation of telaprevir, peginterferon and ribavirin is required Consult with a specialist in dermatology TELAPREVIR must not be restarted if discontinued *systemic cutaneous adverse reaction Telaprevir EU SmPC
Massimo Puoti Dept. of Infectious Diseases AO Ospedale Niguarda Cà Granda Milan, Italy. Side effects of new and old HCV medications
Massimo Puoti Dept. of Infectious Diseases AO Ospedale Niguarda Cà Granda Milan, Italy Side effects of new and old HCV medications The O.pe.r.a. Study Safety of PEG IFN and Ribavirin in 1523 HIV/HCV patients
More informationHCV treament with DAA Side effects: Anemia, Skin Manifestations Pr Patrice CACOUB
HCV treament with DAA Side effects: Anemia, Skin Manifestations Pr Patrice CACOUB Service de Médecine Interne, CNRS UMR 7211, INSERM UMR 959 Université Pierre et Marie Curie Centre National de Référence
More informationClinical Cases Hepatitis C Naïve Patients. Rafael Esteban Liver Unit. Hospital General Universitari Vall Hebron. Barcelona.
Clinical Cases Hepatitis C Naïve Patients Rafael Esteban Liver Unit. Hospital General Universitari Vall Hebron. Barcelona. Case study 1 27 year old woman, Diagnosed with Chronic Hepatitis C 3 years ago
More informationTreatment with the New Direct Acting Antivirals for Hepatitis C
Treatment with the New Direct Acting Antivirals for Hepatitis C Mary Olson, DNP, ANP-BC Clinical Trials Program Director Weill Cornell Medical College The Center for the Study of Hepatitis C Objectives
More informationLes Inhibiteurs de Protéase du VHC
Les Inhibiteurs de Protéase du VHC Pr Jean-Michel Pawlotsky National Reference Center for Viral Hepatitis B, C and delta Department of Virology & INSERM U955 Henri Mondor Hospital University of Paris-Est
More informationPersonalised Treatment with Telaprevir in Graham R Foster Professor of Hepatology Queen Marys University of London
Personalised Treatment with Telaprevir in 2014 Graham R Foster Professor of Hepatology Queen Marys University of London Telaprevir in 2014 Disclaimers I have received funds from: BI, BMS, Janssen, Novarts,
More informationHepatitis C: Management of Previous Non-responders with First Line Protease Inhibitors
Hepatitis C: Management of Previous Non-responders with First Line Protease Inhibitors Fred Poordad, MD The Texas Liver Institute Clinical Professor of Medicine University of Texas Health Science Center
More informationTriple therapy with telaprevir or boceprevir: management of side effects
Triple therapy with telaprevir or boceprevir: management of side effects Universitätsklinikum Leipzig Thomas Berg Sektion Hepatologie Klinik und Poliklinik für Gastroenterologie und Rheumatologie Leber
More informationCURRENT TREATMENTS. Mitchell L Shiffman, MD Director Liver Institute of Virginia. Richmond and Newport News, VA, USA
CURRENT TREATMENTS FOR HCV Mitchell L Shiffman, MD Director Liver Institute of Virginia Bon Secours Health System Richmond and Newport News, VA, USA Liver Institute of Virginia Education, Research and
More informationPierluigi Toniutto Clinica di Medicina Interna Azienda Ospedaliero Universitaria Udine
Pierluigi Toniutto Clinica di Medicina Interna Azienda Ospedaliero Universitaria Udine Il sottoscritto dichiara di non aver avuto negli ultimi 12 mesi conflitto d interesse in relazione a questa presentazione
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 14 December 2011
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 14 December 2011 INCIVO 375 mg, film-coated tablet B/4 bottles of 42 tablets (CIP code: 217 378-5) B/1 bottle of 42
More informationEmerging Approaches for the Treatment of Hepatitis C Virus
Emerging Approaches for the Treatment of Hepatitis C Virus Gap Analysis 1 Physicians may not be sufficiently familiar with the latest guidelines for chronic HCV treatment, including the initiation and
More informationTreatment Targets HCV Genotype 1 & PIs Treating HCV G2&3 Future Therapies. Advances in treatment of HCV Dr John F Dillon
Treatment Targets HCV Genotype 1 & PIs Treating HCV G2&3 Future Therapies Advances in treatment of HCV Dr John F Dillon Disclosure slide I have received consulting fees and Honoraria from MSD, Abbott,
More informationABCs of Hepatitis C: What s New. The Long-Awaited New Era: Protease Inhibitors for HCV Genotype 1
ABCs of Hepatitis C: What s New ACG Postgraduate Course Washington, DC October 30, 2011 Ira M. Jacobson, M.D. Vincent Astor Professor of Medicine Chief, Division of Gastronterology and Hepatology Medical
More information47 th Annual Meeting AISF
47 th Annual Meeting AISF Rome, 21 February 2014 Present and future treatment strategies for patients with HCV infection: chronic hepatitis and special populations (HCV/HIV coinfection, advanced cirrhosis,
More informationProtease inhibitor based triple therapy in treatment experienced patients
Protease inhibitor based triple therapy in treatment experienced patients Universitätsklinikum Leipzig Thomas Berg Sektion Hepatologie Klinik und Poliklinik für Gastroenterologie und Rheumatologie Leber
More informationThe role of triple therapy with protease inhibitors in hepatitis C virus genotype 1na «ve patients
The role of triple therapy with protease inhibitors in hepatitis C virus genotype 1na «ve patients David R. Nelson Clinical and Translational Science Institute, University of Florida, FL, USA Liver International
More informationHepatitis C: Management of Treatment Naïve Patients with First Line Protease Inhibitors
Hepatitis C: Management of Treatment Naïve Patients with First Line Protease Inhibitors Eric Lawitz, MD, AGAF, CPI The Texas Liver Institute Clinical Professor of Medicine University of Texas Health Science
More informationSAVINO BRUNO, MD Director Internal Medicine and Hepatology Unit AO Fatebenefratelli e Oftalmico, Milano
SAVINO BRUNO, MD Director Internal Medicine and Hepatology Unit AO Fatebenefratelli e Oftalmico, Milano Market wheretelaprevir has not yet launched Victrelis is still launching January 29 th 214 Developed
More informationManagement of CHC G1 patients who are relapsers or non-responders to Peg IFN and RBV therapy: Wait or Triple Therapy?
Management of CHC G1 patients who are relapsers or non-responders to Peg IFN and RBV therapy: Wait or Triple Therapy? Prof. Teerha Piratvisuth NKC Institute of Gastroenterology and Hepatology Prince of
More informationNew developments in HCV research and their implications for front-line practice
New developments in HCV research and their implications for front-line practice Dr. Curtis Cooper Associate Professor, University of Ottawa Director, Ottawa Hospital Viral Hepatitis Program June 17, 2013
More informationTratamiento de la Hepatitis C Rafael Esteban Hospital General Universitario Valle de Hebrón Barcelona
Tratamiento de la Hepatitis C Rafael Esteban Hospital General Universitario Valle de Hebrón Barcelona rrent HCV Therapy 8% % sustained response 6% 4% 2% % 54-61% 41% 34% 25% 16% 6% IFN 24w IFN 48w Peg
More informationAntiviral agents in HCV
Antiviral agents in HCV : Upcoming Therapeutic Options Su Jong Yu, M.D., Ph.D. Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine Estimated 170 Million
More informationEfficacy and safety of protease inhibitors for sever hepatitis C recurrence after liver transplantation: a first multicentric experience
Efficacy and safety of protease inhibitors for sever hepatitis C recurrence after liver transplantation: a first multicentric experience A. Coilly, B. Roche, J. Dumortier, D. Botta-Fridlund, V. Leroy,
More informationTreatment of chronic hepatitis C in drug-naïve patients
Treatment of chronic hepatitis C in drug-naïve patients 8th International Workshop on HIV & Hepatitis Co-infection Madrid, 31. May 2012 Christoph Sarrazin J. W. Goethe-University Hospital Medizinische
More informationSimeprevir + PEG + RBV in Treatment-Naïve Genotype 1 QUEST-1 Trial
Phase 3 Treatment Naïve Simeprevir + in Treatment-Naïve Genotype 1 QUEST-1 Trial Jacobson IM, et al. Lancet. 2014;384:403-13. Simeprevir + PEG + Ribavirin for Treatment-Naïve HCV GT1 QUEST-1 Trial QUEST-1
More informationEmerging Therapies for HCV: Highlights from AASLD 2012 (Part 2)
Emerging Therapies for HCV: Highlights from AASLD 2012 (Part 2) Goals for Hepatitis C Therapy Compared to PegIFN α/rbv, new treatment regimens for chronic hepatitis C should offer: Improved efficacy Efficacy
More informationOptimal Treatment with Boceprevir. Michael Manns
Optimal Treatment with Boceprevir Michael Manns 6th Paris Hepatitis Conference, 14th January 2013 Acknowledgements Benjamin Maasoumy Optimal Patient Selection Defining the Ideal Candidate Treatment Urgency
More informationHepatitis C Virus Treatments: Present and Future
Hepatitis C Virus Treatments: Present and Future Charles D. Howell, M.D., A.G.A.F Professor of Medicine University of Maryland School of Medicine Baltimore, MD Charles Howell Disclosures Boehringer Ingelheim,
More informationCurrent Treatments for HCV
Current Treatments for HCV Mitchell L. Shiffman, MD, FACG Advisory Committee/Board Member: Achillion, Anadys, Boehringer-Ingelheim, BMS, Conatus, Genentech, Gen-Probe, Gilead, Globeimmune, GSK, Janssen,
More informationBOCEPREVIR (BOC): EVIDENCE FROM TRIALS
BOCEPREVIR (BOC): EVIDENCE FROM TRIALS ROME, FEBRUARY 22 nd -25 th, 212 Savino Bruno, MD Department of Internal Medicine A.O. Fatebenefratelli e Oftalmico Milan, Italy Savino Bruno, MD Director of InternalMedicine,
More informationInfection with hepatitis C virus (HCV) is a global health concern,
Advances in the Treatment of Hepatitis C Virus Infection Arun B. Jesudian, MD, Maya Gambarin-Gelwan, MD, and Ira M. Jacobson, MD Dr. Jesudian is a Clinical Fellow, Dr. Gambarin-Gelwan is an Assistant Professor
More informationOral combination therapy: future hepatitis C virus treatment? "Lancet Oct 30;376(9751): Oral combination therapy with a nucleoside
Author manuscript, published in "Journal of Hepatology 2011;55(4):933-5" DOI : 10.1016/j.jhep.2011.04.018 Oral combination therapy: future hepatitis C virus treatment? Commentary article on the following
More informationHow to optimize current therapy for GT1 patients Shortened therapy with IFNa-based therapy
How to optimize current therapy for GT1 patients Shortened therapy with IFNa-based therapy Thomas Berg Sektion Hepatologie Klinik und Poliklinik für Gastroenterologie und Rheumatologie Leber- und Studienzentrum
More informationFor the RESPOND-2 Investigators
HCV RESPOND-2 Final Results High Sustained Virologic Response Among Genotype 1 Previous Non-Responders and Relapsers to Peginterferon/Ribavirin when Re- Treated with Boceprevir Plus PEGINTRON (Peginterferon
More informationSkin Manifestations of Drug Reactions
Skin Manifestations of Drug Reactions Dr Carol Hlela, Division of Dermatology Department of Medicine, University of Cape Town and Red Cross Children s Hospital What are the Skin Manifestations of Drug
More informationIntroduction. The ELECTRON Trial
63rd AASLD November 9-13, 12 Boston, Massachusetts Faculty Douglas T. Dieterich, MD Professor of Medicine and Director of CME Department of Medicine Director of Outpatient Hepatology Division of Liver
More information46th EASL Congress, Berlin, Germany March 30 April 3, 2011 Abstract 66
SILEN-C2: Sustained Virologic Response (SVR) and Safety of BI21335 Combined with Peginterferon Alfa-2a and Ribavirin (P/R) in Chronic HCV Genotype-1 Patients with Non-response To P/R M.S. Sulkowski, M.
More informationPharmacological management of viruses in obese patients
Cubist Pharmaceuticals The Shape of Cures to Come Pharmacological management of viruses in obese patients Dr. Dimitar Tonev, Medical Director UKINORD 1 Disclosures } The author is a pharmaceutical physician
More informationCurrent Standards in the Treatment of Chronic Hepatitis C
REVIEW ARTICLE Current Standards in the Treatment of Chronic Hepatitis C Wolf Peter Hofmann, Christoph Sarrazin, Stefan Zeuzem SUMMARY Background: In Germany, 0 000 to 500 000 people are chronically infected
More informationEASL 2013 Interferon Free, All Oral Regimens for Hepatitis C. Maria Buti Hospital Universitario Valle Hebron Barcelona Spain
EASL 2013 Interferon Free, All Oral Regimens for Hepatitis C Maria Buti Hospital Universitario Valle Hebron Barcelona Spain The first Results with Oral therapy: a Protease Inhibitor and NS5A inhibitor
More informationQuestion for the audience. 11/7/2012. Monique J. Carasso, MSN, ANP-C. Weill Cornell Medical College Center for Liver Diseases New York, New York
ANAC Pre-Conference November 14, 2012 Monique J. Carasso, MSN, ANP-C Weill Cornell Medical College Center for Liver Diseases New York, New York Question for the audience. Peglylated Interferon/Ribavirin
More informationHepatitis C Treatment 2014
Hepatitis C Treatment 214 Brendan M. McGuire, MD UAB Liver Center Outline Epidemiology/National History Terminology for Treatment Treatment Considerations Current Treatment Options Genotype 1 (GT 1) Genotype
More informationNew Therapies on the Horizon in Hepatitis C Patients Paul Y. Kwo, MD
Viral Targets for HCV New Therapies on the Horizon in Hepatitis C Patients Paul Y. Kwo, MD Sites for development of inhibitors Metalloproteinase Serine protease (trans) Core E E2 NS2 NS3 NS4a/NS4b NS5a/NS5b
More informationASSAYS UTILZIED TO MONITOR HCV AND ITS TREATMENT
ASSAYS UTILZIED TO MONITOR HCV AND ITS TREATMENT Mitchell L Shiffman, MD Liver Institute of Virginia Bon Secours Health System Richmond and Newport News, VA Liver Institute of Virginia Education, Research
More informationHCV Treatment: Why to Wait
HCV Treatment: Why to Wait Prof. Jean-Michel Pawlotsky, MD, PhD National Reference Center for Viral Hepatitis B, C and delta Department of Virology & INSERM U955 Henri Mondor Hospital University of Paris-Est
More informationRBV DR (n=249) EPO (n=251)
Eric Lawitz, Stefan Zeuzem, Lisa Nyberg, David Nelson, Lorenzo Rossaro, Luis Balart, K. Rajender Reddy, Timothy Morgan, Weiping Deng, Ken Koury, Katia Alves, Frank Dutko, Janice Wahl, Lisa D. Pedicone,
More informationPredictors of Response to Hepatitis C Therapy in the DAA Era. Pablo Barreiro Servicio de Enfermedades Infecciosas Hospital Carlos III, Madrid
Predictors of Response to Hepatitis C Therapy in the DAA Era Pablo Barreiro Servicio de Enfermedades Infecciosas Hospital Carlos III, Madrid Why Predicting HCV Response? Select candidates for therapy Prioritizing
More informationTreatement Experienced patients without cirrhosis. Rafael Esteban Hospital Universitario Valle Hebron Barcelona
Treatement Experienced patients without cirrhosis Rafael Esteban Hospital Universitario Valle Hebron Barcelona Agenda With IFN PegIFN+ Ribavirin + Simeprevir PegIFN+ Ribavirin+ Sofosbuvir Without IFN Sofosbuvir
More informationHIV and Hepatitis C: Advances in Treatment
NORTHWEST AIDS EDUCATION AND TRAINING CENTER HIV and Hepatitis C: Advances in Treatment John Scott, MD, MSc Asst Professor University of Washington Presentation prepared & presented by: John Scott, MD,
More informationExpress Scripts, Inc. monograph dated 5/25/2011; selected revision 6/1/2011
BENEFIT DESCRIPTION AND LIMITATIONS OF COVERAGE ITEM: PRODUCT LINES: COVERED UNDER: DESCRIPTION: CPT/HCPCS Code: Company Supplying: Setting: Coverage Criteria: Approval Period: Victrelis (boceprevir capsules)
More informationBackground: Narlaprevir (SCH )
Once Daily Narlaprevir (SCH 9518) in Combination with Peginterferon alfa-2b/ Ribavirin for Treatment-Naive Patients with Genotype-1 Chronic Hepatitis C: Interim Results from the NEXT-1 Study Vierling J,
More informationIFN-free for Genotype 1 HCV: the current landscape. Prof. Graham R Foster
IFN-free for Genotype 1 HCV: the current landscape Prof. Graham R Foster Wonderful new drugs are coming Poordad F, et al. New Engl J Med 2014; online DOI: 10.1056/NEJMoa1402869. 2 The New Drugs Two treatment
More informationBible Class: HCV Infection
Bible Class: HCV Infection PD Dr. Dr. med. Nasser Semmo UVCM, Hepatology What is the HCV prevalence and incidence? 2 HCV Prevalence Worldwide about 120-210 Mio. infected with HCV, about 9 Mio. in Europe,
More informationHepatitis C en 2013 Tratar o Esperar? Vicente Soriano Servicio de Enfermedades Infecciosas Hospital Carlos III Madrid
Hepatitis C en 2013 Tratar o Esperar? Vicente Soriano Servicio de Enfermedades Infecciosas Hospital Carlos III Madrid Caveats on hepatitis C therapy decision making We treat persons with a liver. They
More informationCASE STUDY. Adverse Events in treatment chronic hepatitis C patients with PegInterferon and Ribavirin What would your management decision be?
Adverse Events in treatment chronic hepatitis C patients with PegInterferon and Ribavirin What would your management decision be? CASE STUDY Pham Thi Thu Thuy MD, PhD Ho Chi Minh City Vietnam Serious Adverse
More informationCase #1. Case #1. Case #1: Audience vote VS. The Great Debate: When to Treat HCV in our HIV coinfected patients
Case #1 The Great Debate: When to Treat HCV in our HIV coinfected patients Medical Management of AIDS December, 2012 Moderated by George Beatty,MD 35 year old African American man, CD4 + 450, HIV RNA
More informationEmerging Therapies for HCV: Highlights from AASLD 2012 (Part 2)
Emerging Therapies for HCV: Highlights from AASLD 2012 (Part 2) PegIFN and RBV remain vital components of HCV therapy-- selected presentations from: Program Disclosure This activity has been planned and
More informationHCV Case Study. Treat Now or Wait for New Therapies
HCV Case Study Treat Now or Wait for New Therapies This program is supported by educational grants from Kadmon and Merck Pharmaceuticals. Program Disclosure This activity has been planned and implemented
More informationPivotal New England Journal of Medicine papers 2014 Phase 3 Trial data
4 th HCV Therapy Advances Meeting Paris, December 12-13, 14 Pivotal New England Journal of Medicine papers 14 Phase 3 Trial data Stefan Zeuzem, MD University of Frankfurt Germany Disclosures Consultancies:
More informationPegylated Interferon Alfa-2b (Peg-Intron) Plus Ribavirin (Rebetol)in the Treatment of Chronic Hepatitis C: A Local Experience
Pegylated Interferon Alfa-2b (Peg-Intron) Plus Ribavirin (Rebetol)in the Treatment of Chronic Hepatitis C: A Local Experience E L Seow, PH Robert Ding Island Hospital, Penang, Malaysia. Introduction Hepatitis
More informationTreatment of genotype 4 patient. with cirrhosis. Vincent LEROY Clinique Universitaire d Hépato-Gastroentérologie INSERM U823 CHU de Grenoble
Treatment of genotype 4 patient with cirrhosis Vincent LEROY Clinique Universitaire d Hépato-Gastroentérologie INSERM U823 CHU de Grenoble Clinical case 52 year-old patient Intra-venous drug user 1987-1989
More informationBest of AASLD 2010 For IAGH. April 2011 Reza Malekzadeh M.D. AGAF Professor of Medicne DDRC/TUMS
Best of AASLD 2010 For IAGH April 2011 Reza Malekzadeh M.D. AGAF Professor of Medicne DDRC/TUMS DAAs Direct-Acting Antivirals Understanding of HCV life cycle Identification of potential targets of antivirals
More informationLatest Treatment Updates for GT 2 and GT 3 Patients
Latest Treatment Updates for GT 2 and GT 3 Patients Eric Lawitz, MD, AGAF, CPI Vice President, Scientific and Research Development The Texas Liver Institute Clinical Professor of Medicine University of
More informationProgram Disclosure. Provider is approved by the California Board of Registered Nursing, Provider #13664, for 1.5 contact hours.
Program Disclosure This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint-sponsorship
More informationةي : لآا ةرقبلا ةروس
سورة البقرة: اآلية HCV RELAPSERS AND NONRESPONDERS: How to deal with them? BY Prof. Mohamed Sharaf-Eldin Prof. of Hepatology and Gastroenterology Tanta University Achieving SVR The ability to achieve a
More informationClinical Management: Treatment of HCV Mono-infection
Clinical Management: Treatment of HCV Mono-infection Curtis Cooper, MD, FRCPC Associate Professor-University of Ottawa The Ottawa Hospital- Infections Diseases Viral Hepatitis Program- Director Industry
More informationBoceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection: a US-based cost-effectiveness modeling study
Ferrante et al. BMC Infectious Diseases 2013, 13:190 RESEARCH ARTICLE Open Access Boceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection: a US-based cost-effectiveness
More informationHCV: Racial Disparities. Charles D. Howell, M.D., A.G.A.F Professor of Medicine University of Maryland School of Medicine Baltimore, MD
HCV: Racial Disparities Charles D. Howell, M.D., A.G.A.F Professor of Medicine University of Maryland School of Medicine Baltimore, MD Charles Howell Disclosures Research Grants Boehringer Ingelheim, Inc.
More informationUpdates on Current Status of HCV Therapy
Updates on Current Status of HCV Therapy K. Rajender Reddy, MD Professor of Medicine, Professor of Medicine in Surgery, Director of Hepatology and Medical Director of Liver Transplantation University of
More informationStick or twist management options in hepatitis C
Stick or twist management options in hepatitis C Dr. Chris Durojaiye & Dr. Matthijs Backx SpR Microbiology and Infectious Diseases University Hospital of Wales, Cardiff Patient history 63 year old female
More informationSafety of Treatment in Cirrhotics in the Era of New Antiviral Therapies for Hepatitis C Virus
Safety of Treatment in Cirrhotics in the Era of New Antiviral Therapies for Hepatitis C Virus JEFFREY NADELSON MD, ALAN EPSTEIN MD, THOMAS SEPE MD BOSTON UNIVERSITY SCHOOL OF MEDICINE ROGER WILLIAMS MEDICAL
More informationMonth/Year of Review: November 2011 End date of literature search: 4 th Quarter alone
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: November 2011 End date of literature
More informationHighlights of AASLD 2012 CCO Official Conference Coverage of the 2012 Annual Meeting of the American Association for the Study of Liver Diseases
Highlights of AASLD 12 CCO Official Conference Coverage of the 12 Annual Meeting of the American Association for the Study of Liver Diseases November 9-13, 12 Boston, Massachusetts In partnership with
More informationTrends in Hepatitis C Virus Infection Therapy: Protease Inhibitors a Step Forward in the Era of Direct Acting Antivirals
Trends in Hepatitis C Virus Infection Therapy: Protease Inhibitors a Step Forward in the Era of Direct Acting Antivirals CRISTINA POPESCU 1, 2, SMARANDA GLIGA 1, VICTORIA ARAMĂ 1, 2 1 Matei Bals National
More informationGlecaprevir-Pibrentasvir in Cirrhotic Genotype 1, 2, 4, 5, and 6 EXPEDITION-1
Phase 3 Treatment-Naïve and Treatment-Experienced Glecaprevir-Pibrentasvir in Cirrhotic Genotype 1, 2, 4, 5, and 6 EXPEDITION-1 EXPEDITION-1: Study Features EXPEDITION-1 Trial Design: Open-label, single-arm,
More informationDevelopments in the Treatment of Hepatitis C: A New Era
Developments in the Treatment of Hepatitis C: A New Era Nancy Love, PharmD, BCPS Memorial Medical Center, Johnstown, PA October 17, 2014 Pharmacist Objectives Summarize the results of clinical trials for
More informationPRAC recommendations on signals
25 November 2013 EMA/PRAC/693228/2013 Pharmacovigilance Risk Assessment Committee Adopted at the PRAC meeting of 4-7 November 2013 This document provides an overview of the recommendations adopted by the
More informationSHOULD EVERYONE WITH HCV/HIV COINFECTION BE TREATED NOW?
SHOULD EVERYONE WITH HCV/HIV COINFECTION BE TREATED NOW? Kenneth E. Sherman, MD, PhD Gould Professor of Medicine Director, Division of Digestive Diseases University of Cincinnati College of Medicine Disclosures
More informationTreatment of Hepatitis C in HIV-Coinfected Patients. Vincent Soriano Department of Infectious Diseases Hospital Carlos III Madrid, Spain
Treatment of Hepatitis C in HIV-Coinfected Patients Vincent Soriano Department of Infectious Diseases Hospital Carlos III Madrid, Spain Estimated no. of persons infected with HIV and hepatitis viruses
More information5/12/2016. Learning Objectives. Management of Hepatitis C Virus Genotype 2 or 3 Infected Treatment-Naive or Experienced Patients
5/12/216 Management of Hepatitis C Virus Genotype 2 or 3 Infected Treatment-Naive or Experienced Patients Alexander Monto, MD Professor of Clinical Medicine University of California San Francisco San Francisco,
More informationMichael Fried, MD University of North Carolina Chapel Hill, NC. Ira Jacobson, MD Weill Cornell Medical College New York, NY
Nezam Afdhal, MD Beth Israel Deaconess Medical Center Boston, MA Kim Brown, MD Henry Ford Hospital Detroit, MI Michael Fried, MD University of North Carolina Chapel Hill, NC Jordan Feld, MD Toronto Western
More informationGlobal Hepatitis Programme. Guideline development for Hepatitis C virus Screening, Care and Treatment in low- and middle-income countries
WHO/HIV/2014.26 World Health Organization 2014 Global Hepatitis Programme Guideline development for Hepatitis C virus Screening, Care and Treatment in low- and middle-income countries WHO TECHNICAL REPORT
More informationIFN-free therapy in naïve HCV GT1 patients
IFN-free therapy in naïve HCV GT1 patients Paris Hepatitis Conference Paris, 12th January, 2015 Pr Tarik Asselah MD, PhD; Service d Hépatologie & INSERM U773 University Paris Diderot, Hôpital Beaujon,
More informationPRODUCT MONOGRAPH. Telaprevir Tablets. 375 mg. Antiviral Agent. Manufactured by: Vertex Pharmaceuticals Incorporated
PRODUCT MONOGRAPH Pr INCIVEK Telaprevir Tablets 375 mg Antiviral Agent Manufactured by: Vertex Pharmaceuticals Incorporated Distributed by: Vertex Pharmaceuticals (Canada) Incorporated 275 Armand-Frappier
More informationHepatitis C Treatment
Hepatitis C Treatment Standard of care & Managing advrse events Mohssen Nassiri Toosi, MD A s s o c i a t e P ro f e s s o r Of Internal M e d i c i n e Te h r a n U n i v e r s i t y O f M e d i c a l
More informationUnderstudied treatment populations: manage with care. Massimo Puoti Infectious Diseases Dept. AO Ospedale Niguarda Ca Granda Milan, Italy
Understudied treatment populations: manage with care Massimo Puoti Infectious Diseases Dept. AO Ospedale Niguarda Ca Granda Milan, Italy Understudied treatment populations Cirrhotics Data from registrative
More informationAccepted Manuscript. Safety & Efficacy of Boceprevir/Peginterferon/Ribavirin for HCV G1 Compensated
Accepted Manuscript Safety & Efficacy of Boceprevir/Peginterferon/Ribavirin for HCV G1 Compensated Cirrhotics: Meta-Analysis of 5 Trials John M. Vierling, Stefan Zeuzem, Fred Poordad, Jean-Pierre Bronowicki,
More informationBoceprevir for chronic HCV genotype 1 infection in treatmentexperienced patients with severe fibrosis or cirrhosis: The Greek real-life experience
ORIGINAL ARTICLE Annals of Gastroenterology (215) 28, 1-6 Boceprevir for chronic HCV genotype 1 infection in treatmentexperienced patients with severe fibrosis or cirrhosis: The Greek real-life experience
More informationReview Article Hepatitis C Virus: A Critical Appraisal of New Approaches to Therapy
Hepatitis Research and Treatment Volume 2012, Article ID 138302, 21 pages doi:10.1155/2012/138302 Review Article Hepatitis C Virus: A Critical Appraisal of New Approaches to Therapy David R. Nelson, 1
More informationHepatitis C Therapy Falk Symposium September 20, 2008
Hepatitis C Therapy Falk Symposium September 20, 2008 Ira M. Jacobson, MD Vincent Astor Professor of Clinical Medicine Chief, Division of Gastroenterology and Hepatology Medical Director, Center for the
More informationBruce A. Luxon, MD, Ph.D. Anton and Margaret Fuisz Chair in Medicine Professor and Chair Department of Medicine Georgetown University
Bruce A. Luxon, MD, PhD, FACG Bruce A. Luxon, MD, Ph.D. Anton and Margaret Fuisz Chair in Medicine Professor and Chair Department of Medicine Georgetown University Dr. Luxon is on the speakers p bureau
More informationAreas of Interest. HCV Epidemiology, Natural History HCV Treatment. HBV Epidemiology and Prevention. Monoinfected Coinfected
CROI 2011 UPDATE Kenneth E. Sherman, MD, PhD Gould Professor of Medicine Director, Division of Digestive Diseases Univ. of Cincinnati College of Medicine Areas of Interest HCV Epidemiology, Natural History
More informationBoceprevir for the treatment of genotype 1 chronic hepatitis C
MSD Hertford Road Hoddesdon Hertfordshire EN11 9BU UK Telephone +44 (0)1992 xxxxxx Facsimile +44 (0)1992 xxxxxxx Kate Moore Technology Appraisals Project Manager National Institute for Health and Clinical
More informationClinical Case Discussion of Drug-Drug Interactions: Minefield or Molehill? David Back
Clinical Case Discussion of Drug-Drug Interactions: Minefield or Molehill? David Back University of Liverpool UK David Back University of Liverpool Rome December 2012 Clinical case: patient characteristics
More informationFrom 19 February 2015
Resolution by the Federal Joint Committee on an amendment to the Pharmaceutical Directive (AM-RL): Appendix XII Resolutions on the benefit assessment pharmaceuticals with new active ingredients, in accordance
More informationSECTION 1: OLYSIO with (PEGASYS) AND RIBAVIRIN SECTION 2: OLYSIO with (PEGINTRON) AND RIBAVIRIN RATIONALE FOR INCLUSION IN PA PROGRAM
SECTION 1: OLYSIO with (PEGASYS) AND RIBAVIRIN SECTION 2: OLYSIO with (PEGINTRON) AND RIBAVIRIN RATIONALE FOR INCLUSION IN PA PROGRAM SECTION 1: OLYSIO with (PEGASYS) AND RIBAVIRIN Background Hepatitis
More informationNew product information wording Extracts from PRAC recommendations on signals
12 October 2017 EMA/PRAC/610988/2017 Pharmacovigilance Risk Assessment Committee (PRAC) New product information wording Extracts from PRAC recommendations on signals Adopted at the 25-29 September 2017
More informationExperience with pre-transplant antiviral treatment: PEG/RBV and DAA. Xavier Forns, MD Liver Unit Hospital Clínic IDIBAPS and CIBREHD Barcelona
Experience with pre-transplant antiviral treatment: PEG/RBV and DAA Xavier Forns, MD Liver Unit Hospital Clínic IDIBAPS and CIBREHD Barcelona Interferon-free regimens G1b nulls Asunaprevir (PI) + Daclatasvir
More informationHEPATITIS WEB STUDY. Treatment of Hepatitis C following Liver Transplantation
HEPATITIS WEB STUDY Treatment of Hepatitis C following Liver Transplantation Terry D. Box, MD Associate Professor of Medicine Division of Gastroenterology/Hepatology University of Utah Health Sciences
More information