Harvoni: solution to HCV
|
|
- Leon Welch
- 6 years ago
- Views:
Transcription
1 Harvoni: solution to HCV PRESENTATION BY: PATRICK HO, USC PHARM D. CANDIDATE OF 2017 MENTOR: DR. CRAIG STERN, PHARMD, MBA, RPH, FASCP, FASHP, FICA, FLMI, FAMCP
2 Hepatitis C (HCV) Inflammation of the liver, characterized by hepatocyte necrosis An enveloped, single stranded, positive sense RNA virus The most common chronic bloodborne infection in the United States Prevalence: 1.6% (2.0*) 3.2 (5.2*) million persons live with HCV infection Genotype 1 (72%) Genotype 2 (16% to 19%) Genotype 3 (8% to 19%) Gritsenko D, Hughes G. Ledipasvir/Sofosbuvir (harvoni): improving options for hepatitis C virus infection. P T. 2015;40(4):
3 Progression of Hepatitis C
4 Goals of Pharmacological Treatment Sustained virological response (SVR) Continued absence of detectable HCV RNA at least 12 weeks after completion of therapy SVR is a marker for cure of HCV infection and has been shown to be durable in large prospective studies in more than 99% of patients followed up for > 5 years 1 Prevent complications from HCV infection Necroinflammation Fibrosis Cirrhosis Hepatocellular carcinoma Death 1 Swain MG, et al. Gastroenterology. 2010;139(5):
5 History of HCV Treatment (genotype 1) Pegylated interferon + oral ribavirin SVR 45-50% 2 Relapse 13% to 18% 1 1 st gen protease inhibitors + pegylated interferon alfa-2a + ribavirin SVR 67-75% 2 2 nd gen protease inhibitors e.g. simeprevir SVR 79.2% 3 RNA polymerase nonstructural protein (NS5B) inhibitor sofosbuvir SVR 90% Gritsenko D, Hughes G. Ledipasvir/Sofosbuvir (harvoni): improving options for hepatitis C virus infection. P T. 2015;40(4): Forns X, Lawitz E, Zeuzem S, et al. Simeprevir with peginterferon and ribavirin leads to high rates of SVR in patients with HCV genotype 1 who relapsed after previous therapy: a phase 3 trial. Gastroenterology. 2014;146(7): e3. 4 Sofosbuvir [package insert]. Foster City, CA: Gilead Sciences; 2015.
6 What is Harvoni? Fixed-dose combination in a single pill taken once daily: Sofosbuvir 400 mg NS5B Polymerase Inhibitor Ledipasvir 90 mg NS5A inhibitor Indicated for HCV genotypes 1, 4, 5, 6 SVR 96% - 8 clinical trials that demonstrate >90% efficacy One tablet taken orally once daily with or without food Recommended treatment duration for GT 1: Treatment naïve with or without cirrhosis: 12 weeks Treatment experienced without cirrhosis: 12 weeks Treatment experienced with cirrhosis: 24 weeks Recommended treatment duration for other GTs: 12 weeks Harvoni [package insert]. Gilead Sciences, Inc. Foster City, CA. Published February Accessed May 19, 2016.
7 Who is Harvoni being recommended by? Department of Veterans Affairs (VA) National Hepatitis C Resource Center Program and National Viral Hepatitis Program American Liver Foundation European Association for the Study of the Liver (EASL) 2016 AASLD/ISDA Guideline - American Association for the Study of Liver Diseases and Infectious Diseases Society of America Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) Rating: Class I, Level A Daily sofosbuvir (400 mg) and weight-based RBV for 24 weeks Rating Class IIb, Level A Chronic Hepatitis C Virus (HCV) Infection: Treatment Considerations from the Department of Veterans Affairs National Hepatitis C Resource Center Program and the National Viral Hepatitis Program in the Office of Patient Care Services. Accessed May 19,2016. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. Accessed May 19, 2016.
8 Harvoni is cost-effective! Interferon and ribavirin overall combined cost: $25,000 for 48 weeks SVR 50%, Relapse 18% Cost / (SVR - Relapse) = $ Harvoni Cost: $94,500 for 12 week course SVR 96%, Relapse 1% Cost / (SVR Relapse) = $ Cost and Medication Access: The wholesale acquisition cost (WAC) for ledipasvirsofosbuvir is $1125 per pill. 1 Cost of 8-week course of therapy = $63,000 Cost of 12-week course of therapy = $94,500 Annals of Internal Medicine cost effectiveness study - Harvoni vs. older standard of care requiring a protease inhibitor, interferon and ribavirin 83% cost effective for treatment-naïve and 81% for treatment-experienced
9 Why Harvoni? One course cure to HCV Once daily oral tablet formulation promotes patient adherence Sustained virological response 96% with low relapse 1% Pregnancy category B No need for IFN (flu-like syndrome) or ribavirin (preg cat X) Well tolerated Fatigue, headache, nausea, diarrhea 1 Cost-effective Harvoni [package insert]. Gilead Sciences, Inc. Foster City, CA. Published February Accessed May 19, 2016.
10 The end
2017 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 1146-7 Program Prior Authorization/Notification Medication Harvoni (ledipasvir/sofosbuvir) P&T Approval Date 10/2014, 2/2015,
More informationHarvoni. Harvoni (ledipasvir & sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Harvoni Page: 1 of 7 Last Review Date: June 19, 2015 Harvoni Description Harvoni (ledipasvir &
More informationHarvoni. Harvoni (ledipasvir & sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.03.32 Subject: Harvoni Page: 1 of 7 Last Review Date: December 3, 2015 Harvoni Description Harvoni (ledipasvir
More informationHarvoni. Harvoni (ledipasvir & sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.32 Subject: Harvoni Page: 1 of 9 Last Review Date: March 18, 2016 Harvoni Description Harvoni (ledipasvir
More informationHarvoni. Harvoni (ledipasvir & sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.32 Subject: Harvoni Page: 1 of 9 Last Review Date: December 2, 2016 Harvoni Description Harvoni (ledipasvir
More informationUpdate on Real-World Experience With HARVONI
Update on Real-World Experience With A RESOURCE FOR PAYERS This information is intended for payers only. The HCV-TARGET and TRIO studies were supported by Gilead Sciences, Inc. Real-world experience data
More informationThe Dawn of a New Era: Hepatitis C
The Dawn of a New Era: Hepatitis C Naudia L. Jonassaint Assistant Professor of Medicine and Surgery University Pittsburgh School of Medicine December 1, 2015 Objectives After presentation the learner should
More informationPhase 3. Treatment Experienced. Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2. Afdhal N, et al. N Engl J Med. 2014;370:
Phase 3 Treatment Experienced Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2 Afdhal N, et al. N Engl J Med. 2014;370:1483-93. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Experienced HCV
More informationClinical 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 information2017 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2052-10 Program Prior Authorization/Medical Necessity Medication Harvoni (ledipasvir/sofosbuvir) P&T Approval Date 4/2015, 8/2015,
More informationHepatitis C Genotype 1 (GT 1) Patients in the United States (US)
Hepatitis C Genotype 1 (GT 1) Patients in the United States (US) INDICATION is indicated with or without ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or
More informationHepatitis C Resistance Associated Variants (RAVs)
Hepatitis C Resistance Associated Variants (RAVs) Atif Zaman, MD MPH Oregon Health & Science University Professor of Medicine Division of Gastroenterology and Hepatology Nothing to disclose Disclosure
More informationUpdate on Real-World Experience With HARVONI
Update on Real-World Experience With A RESOURCE FOR PAYERS MAY 217 This information is intended for payers only. The HCV-TARGET study was supported by Gilead Sciences, Inc. Real-world experience data were
More informationSofosbuvir (Sovaldi) Drug Summary. Class and Mechanism. Table of Contents
Hepatitis C Online PDF created July 12, 2018, 1:44 pm Sofosbuvir (Sovaldi) Table of Contents Sofosbuvir Sovaldi Editor's Summary Drug Summary Class and Mechanism Manufacturer for United States Cost and
More informationLedipasvir-Sofosbuvir (Harvoni)
HEPATITIS WEB STUDY HEPATITIS C ONLINE Ledipasvir-Sofosbuvir (Harvoni) Robert G. Gish MD Professor, Consultant, Stanford University Medical Center Senior Medical Director, St Josephs Hospital and Medical
More informationCost effectiveness of sofosbuvir and ledipasvir (Harvoni ) in combination with other medicinal products for the treatment of hepatitis C infection
Cost effectiveness of sofosbuvir and ledipasvir (Harvoni ) in combination with other medicinal products for the treatment of hepatitis C infection The NCPE has issued a recommendation regarding the cost
More informationDaklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Daklinza Sovaldi Page: 1 of 7 Last Review Date: June 24, 2016 Daklinza Sovaldi Description Daklinza
More informationDaklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.36 Subject: Daklinza Page: 1 of 8 Last Review Date: March 18, 2016 Daklinza Description Daklinza (daclatasvir)
More informationPrimary Care Approach to Diagnosis and Management of Chronic Hepatitis C Brian Viviano, D.O.
Primary Care Approach to Diagnosis and Management of Chronic Hepatitis C Brian Viviano, D.O. Objectives Epidemiology of chronic hepatitis C CDC guidelines on screening or hepatitis C Diagnosing hepatitis
More informationTopic: Sovaldi, sofosbuvir Date of Origin: March 14, Committee Approval Date: August 15, 2014 Next Review Date: March 2015
Medication Policy Manual Policy No: dru332 Topic: Sovaldi, sofosbuvir Date of Origin: March 14, 2014 Committee Approval Date: August 15, 2014 Next Review Date: March 2015 Effective Date: October 1, 2014
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 informationDrug Class Prior Authorization Criteria Hepatitis C
Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: Interim (pending P&T approval) Effective Date: July 1, 2018 This policy has been developed through review
More informationHepatitis C Virus Management
Hepatitis C Virus Management FDA-Approved Medications Hepatitis C is caused by a virus and results in liver inflammation, which can lead to advanced liver disease and/or liver cancer. An estimated 3 to
More informationJOHNS HOPKINS HEALTHCARE
JOHNS HOPKINS HEALTHCARE Subject: Clinical Criteria for Hepatitis C (HCV) Therapy Department: Pharmacy Lines of Business: PPMCO Policy Number: MEDS92 Effective Date: 04/15/2015 Revision Date: 08/15/2015
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C First Generation Agents Page 1 of 16 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C First Generation Agents - Through Preferred
More informationGenotype 1 Treatment Naïve No Cirrhosis Options
Genotype 1 Treatment Naïve No Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) x 12 weeks 1 Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks Ledipasvir/Sofosbuvir (Harvoni ) x 8-12 weeks 2 1 If genotype
More informationPHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline
PHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline Preferred Regimen Based on Diagnosis: Mavyret (glecaprevir/pibrentasvir ) Non-Preferred: Daklinza (daclatasvir) Epclusa (sofosbuvir/velpatasvir)
More informationHepatitis C Prior Authorization Policy
Hepatitis C Prior Authorization Policy Line of Business: Medi-Cal P&T Approval Date: November 15, 2017 Effective Date: January 1, 2018 This policy has been developed through review of medical literature,
More informationDaklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Daklinza Sovaldi Page: 1 of 4 Last Review Date: September 18, 2015 Daklinza Sovaldi Description
More informationHepatitis C Agents
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.41 Subject: Hepatitis C Agents Page: 1 of 20 Last Review Date: March 16, 2018 Hepatitis C Agents Description
More informationHepatitis C Agents
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.41 Subject: Hepatitis C Agents Page: 1 of 19 Last Review Date: December 8, 2017 Hepatitis C Agents
More informationDrug Class Prior Authorization Criteria Hepatitis C
Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: Interim Criteria Pending P&T Approval Effective Date: August 16, 2018 This drug class prior authorization
More informationHCV in 2017: New Therapies and New Opportunities. Presentation prepared by: Date prepared: OBJECTIVES
Project ECHO HCV Collaborative HCV in 217: New Therapies and New Opportunities Paulina Deming, PharmD Assistant Director Hepatitis C Programs, ECHO Institute Associate Professor College of Pharmacy University
More informationNew York State HCV Provider Webinar Series. Side Effects of Therapy
New York State HCV Provider Webinar Series Side Effects of Therapy Objectives Understand the basics of HCV therapy Review the currently available regimens for treatment of HCV Appreciate side effects related
More informationPHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline
Preferred Regimen Based on Diagnosis: Mavyret (glecaprevir/pibrentasvir) PHARMACY PRI AUTHIZATION Hepatitis C Clinical Guideline Non-Preferred: Daklinza (daclatasvir) Epclusa (sofosbuvir/velpatasvir) Harvoni
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 informationRATIONALE FOR INCLUSION IN PA PROGRAM
RATIONALE FOR INCLUSION IN PA PROGRAM Background Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with
More informationDrug Class Monograph
Drug Class Monograph Class: Chronic Hepatitis C Drugs(s): Daclatasvir (Daklinza), Dasabuvir/ombitasivir/paritaprevir/ritonavir (Viekira XR), Elbasvir/grazoprevir (Zepatier), Peginterferon alfa-2a (Pegasys),
More informationChronic Hepatitis C Drug Class Monograph
Chronic Hepatitis C Drug Class Monograph Line of Business: Medi-Cal Effective Date: July 10, 2017 (Interim Guidelines; Final Review and Approval by the P&T Subcommittee Pending) This policy has been developed
More informationHepatitis C Genotypes
9/2/21 OBJECTIVES Project ECHO HCV Collaborative HCV in 21: New Therapies and New Opportunities Paulina Deming, PharmD Assistant Director Hepatitis C Programs, ECHO Institute Associate Professor College
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 informationHepatitis C Update: What s New in 2017
Hepatitis C Update: What s New in 2017 Cody A. Chastain, MD Assistant Professor of Medicine Viral Hepatitis Program Division of Infectious Diseases Vanderbilt University Medical Center Cody.a.Chastain@Vanderbilt.edu
More informationChronic Hepatitis C Drug Class Prior Authorization Protocol
Line of Business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 Chronic Hepatitis C Drug Class Prior Authorization Protocol This policy has been developed through review of medical
More informationDrug Class Monograph
Drug Class Monograph Class: Chronic Hepatitis C Drugs(s): Daclatasvir (Daklinza), Dasabuvir/ombitasivir/paritaprevir/ritonavir (Viekira Pak), Elbasvir/grazoprevir (Zepatier), Peginterferon alfa-2a (Pegasys),
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Harvoni) Reference Number: CP.CPA.175 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
More informationHepatitis C Update: Screening, Diagnosis, and Treatment
Mountain West AIDS Education and Training Center Hepatitis C Update: Screening, Diagnosis, and Treatment Brian R. Wood, MD (bwood2@uw.edu) Assistant Professor of Medicine, University of Washington Medical
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 information2017 Bruce Lucas Hepatology and Liver Transplant Symposium October 13th 2017 Management of Hepatitis C in Pre- and Post-Transplant Patients
2017 Bruce Lucas Hepatology and Liver Transplant Symposium October 13th 2017 Management of Hepatitis C in Pre- and Post-Transplant Patients Jens Rosenau, MD Associate Professor of Medicine Acting Director
More informationCriteria for Indiana Medicaid Hepatitis C Agents
Prepared for State of Indiana by OptumRx EXECUTIVE SUMMARY Purpose: Promote prudent prescribing of Setting & Population: All members Type of Criteria: Increased Risk of ADE Non-Preferred Agent Appropriate
More informationAri Bunim, M.D. Director of Hepatology New York Hospital Queens Assistant Professor of Clinical Medicine Weill Cornell Medical College
Ari Bunim, M.D. Director of Hepatology New York Hospital Queens Assistant Professor of Clinical Medicine Weill Cornell Medical College New York State Law Goes into Effect January 1, 2014 Hepatitis C Virus
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C First Generation Agents Page 1 of 18 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C First Generation Agents - Through Preferred
More informationWhy make this statement?
HCV Council 2014 10 clinical practice statements were evaluated by the Council A review of the available literature was conducted The level of support and level of evidence for the statements were discussed
More information2017 United Healthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2055-10 Program Prior Authorization/Medical Necessity Medication Olysio (simeprevir) P&T Approval Date 4/2015, 11/2015, 8/2016,
More informationObjectives. Objectives. Introduction. Hepatitis A. Hepatitis B. At the end of the presentation, pharmacy technician participants will be able to:
Objectives A Revolution in Medicine: Advances in the Treatment of Hepatitis C Infection Spencer H. Durham, Pharm.D., BCPS (AQ ID) Assistant Clinical Professor of Pharmacy Practice Auburn University Harrison
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 1231-1 Program Prior Authorization/Notification Medication Mavyret (glecaprevir/pibrentasvir) P&T Approval Date 9/2017 Effective
More informationUPDATES IN HEPATITIS C
UPDATES IN HEPATITIS C S A R A H N A I D O O, P H A R M, B C P S AP RI L 13, 2014 OBJECTIVES Be able to discuss changes in hepatitis c treatment Be able to provide recommendations to providers regarding
More informationHARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES
HARVARD PILGRIM HEALTH CARE Generic Brand HICL GCN Exception/Other DACLATASVIR DAKLINZA 41377 ELBASVIR/GRAZOPREVIR ZEPATIER 43030 GLECAPREVIR/PIBRENTASVIR MAVYRET 44453 OMBITASVIR/PARITAPREVIR/ RITONAVIR
More informationDepartment of Veterans Affairs
Department of Veterans Affairs HEPATITIS C TREATMENT : REQUEST FOR CHOICE PROGRAM FLEXIBILITY TO ADDRESS $500 MILLION SHORTFALL IN FY 2015 7/14/15 1 Veteran Hepatitis-C Treatment: Summary VA is changing
More informationHepatitis C in Correctional Facilities: Big Problem, Bigger Opportunity. Cody A. Chastain, MD
Hepatitis C in Correctional Facilities: Big Problem, Bigger Opportunity Cody A. Chastain, MD Disclosures Research supported by Gilead Sciences Inc.: Site investigator for HIV/HCV SWITCH Registry Study
More informationVosevi (sofosbuvir/velpatasvir/voxilaprevir)
Vosevi (sofosbuvir/velpatasvir/voxilaprevir) Policy Number: 5.01.646 Last Review: 10/2017 Origination: 10/2017 Next Review: 11/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide
More information29th Viral Hepatitis Prevention Board Meeting
29th Viral Hepatitis Prevention Board Meeting Madrid, November 2006 Treatment of chronic hepatitis C José M. Sánchez-Tapias Liver Unit Hospital Clínic University of Barcelona Spain CHRONIC HEPATITIS C
More informationSOFOSBUVIR/VELPATASVIR Generic Brand HICL GCN Exception/Other SOFOSBUVIR/ VELPATASVIR
Generic Brand HICL GCN Exception/Other SOFOSBUVIR/ VELPATASVIR EPCLUSA 43561 GUIDELINES FOR USE 1. Is the patient at least 18 years old? If yes, continue to #2. 2. Does the patient have a diagnosis of
More informationMassimo Puoti SC Malattie Infettive AO Ospedale Niguarda Cà Granda, Milano. Eradicazione da HCV e nuove prospettive: Prospetive Terapeutiche future
Massimo Puoti SC Malattie Infettive AO Ospedale Niguarda Cà Granda, Milano Eradicazione da HCV e nuove prospettive: Prospetive Terapeutiche future DAA classes and subclasses Drug Class Subclass Potency
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 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 informationManaging New Treatments for Hepatitis C in Primary Care
Managing New Treatments for Hepatitis C in Primary Care Christina Connel, PharmD, BCPS, AAHIVP Objectives 2 Review HCV disease burden Identify risk factors and recommended testing for HCV Describe who
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 informationHEPATITIS C. Mitchell L. Shiffman, MD, FACG Director. Liver Institute of Virginia. Richmond and Newport News, VA
NEW TREATMENTS FOR HEPATITIS C Mitchell L. Shiffman, MD, FACG Director Liver Institute of Virginia Bon Secours Health System Richmond and Newport News, VA Liver Institute of Virginia Education, Research
More informationImpatto della clearance virale e rischio di carcinoma epatocellulare
EPATITE CRONICA DA HCV: Impatto della clearance virale e rischio di carcinoma epatocellulare Rodolfo Sacco, M.D., PhD Direttore U.O.C. Gastroenterologia ed Endoscopia Digestiva A.O.U. Ospedali Riuniti"
More informationUpdate in the Management of Hepatitis C: What Does the Future Hold
Update in the Management of Hepatitis C: What Does the Future Hold Paul Y Kwo, MD, FACG Professor of Medicine Mdi Medical ldirector, Liver Transplantation tti Gastroenterology/Hepatology Division Indiana
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2132-1 Program Prior Authorization/Medical Necessity Medication Mavyret (glecaprevir/pibrentasvir) P&T Approval Date 9/2017 Effective
More information2018 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2018 P 1127-9 Program Prior Authorization/Notification Medication Sovaldi (sofosbuvir) P&T Approval Date 2/2014, 4/2014, 5/2014, 8/2014,
More informationHarvoni (sofosbuvir/ledipasvir
Market DC Override(s) Prior Authorization Quantity Limit (sofosbuvir/ledipasvir) Approval Duration Based on Genotype, Treatment status, Baseline HCV RNA status, Cirrhosis status, Transplant status, or
More informationTreatment of Hepatitis C with simeprevir (Olysio ) PLUS sofosbuvir (Sovaldi ) Archived Medical Policy
Treatment of Hepatitis C with simeprevir (Olysio ) PLUS sofosbuvir (Sovaldi ) Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana,
More informationHepatitis C in Dr. Michael Bays D.O.
Hepatitis C in 2015 Dr. Michael Bays D.O. HCV Virology Member of the Flavivirus family (Yellow Fever, Dengue) Hepacivirus genus Enveloped, positive, singlestranded RNA virus 9.6 Kb genome encodes a single
More informationAustralasian Professional Society on Alcohol and other Drugs, Annual Conference 2016 Sydney Australia
Efficacy and safety of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic HCV genotype 1 infection receiving opioid substitution therapy: Analysis of Phase 3 ION trials J Grebely
More informationClinical Policy: Simeprevir (Olysio) Reference Number: CP.CPA.289 Effective Date: Last Review Date: Line of Business: Commercial
Clinical Policy: (Olysio) Reference Number: CP.CPA.289 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C Second Generation Antivirals Page 1 of 30 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C Second Generation Antivirals Through
More informationClinical Criteria for Hepatitis C (HCV) Therapy
Clinical Criteria for Hepatitis C (HCV) Therapy Pre-Treatment Evaluation o Must have chronic hepatitis C and HCV genotype and sub-genotype documented; o Patients who have prior exposure to DAA therapy
More informationSelecting HCV Treatment
Selecting HCV Treatment Caveats Focus on treatment selection for genotypes 1, 2, and 3. Majority of US population infected with GT 1, 2, or 3 GT 4 treatment closely reflects GT 1 treatment GT 5 and 6 are
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 informationClinical Policy: Daclatasvir (Daklinza) Reference Number: CP.CPA.283 Effective Date: Last Review Date: Line of Business: Commercial
Clinical Policy: (Daklinza) Reference Number: CP.CPA.283 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for
More informationDr. Siddharth Srivastava
Dr. Siddharth Srivastava MD, DM (Gastroenterology) Associate Professor GIPMER, New Delhi Rashtriya Gaurav Award 2013 for work on hepatitis B and C Set up Liver clinic at GIPMER and in charge EUS laboratory.
More informationSovaldi Ribavirin. Sovaldi (sofosbuvir) with Ribavirin (Copegus, Moderiba, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Sovaldi Ribavirin Page: 1 of 7 Last Review Date: December 3, 2015 Sovaldi Ribavirin Description
More informationPEARL-I. Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4. Treatment Naïve and Treatment Experienced
Phase 2b Treatment Naïve and Treatment Experienced Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4 PEARL-I Hézode C, et al. Lancet. 2015 March 30. [Epub ahead of print] PEARL-I: Study Design
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 informationSovaldi (sofosbuvir) with PegIntron (peginterferon alfa-2b) and Ribavirin (Copegus, Moderiba, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.24 Subject: Sovaldi PegIntron Ribavirin Page: 1 of 6 Last Review Date: November 30, 2018 Sovaldi PegIntron
More informationTreatment of Hepatitis C with sofosbuvir/ledipasvir (Harvoni )
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationHepatitis C Management and Treatment
Hepatitis C Management and Treatment Kaya Süer Near East University Faculty of Medicine Infectious Diseases and Clinical Microbiology 1 Discovery of Hepatitis C Key facts Hepatitis C: the virus can cause
More informationUpdates in the Treatment of HCV
Updates in the Treatment of HCV Misty Miller, Pharm.D., BCPS, AAHIVP Associate Professor University of Oklahoma College of Pharmacy September 21 st, 2018 Overview HCV Review and Definitions HCV Genotypes
More informationEliminating Hepatitis C from New Zealand
Eliminating Hepatitis C from New Zealand Catherine Stedman Associate Professor of Medicine, University of Otago, Christchurch Gastroenterology Department, Christchurch Hospital Disclosures I have the following
More informationGeneral Statement for Drugs for the Treatment of Hepatitis C
General Statement for Drugs for the Treatment of Hepatitis C Use the following criteria to determine patient eligibility for subsidisation under the PBS for hepatitis C treating agents. By writing a PBS
More informationUpdates in the Management of HCV: What Clinicians Who Care for Patients With HCV Need to Know Today
Updates in the Management of HCV: What Clinicians Who Care for Patients With HCV Need to Know Today The treatment paradigm for hepatitis C virus (HCV) is changing very rapidly. In the short time since
More informationSeyed Moayed Alavian Professor of Gastroenterology and Hepatology Editor in-chief of Hepatitis Monthly E mail:
Sofosbuvir and Ledipasvir Combination with and without Ribavirin in Patients with Hepatitis C Virus Infection; Preliminary Report of an Experience from Iran Seyed Moayed Alavian Professor of Gastroenterology
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Epclusa) Reference Number: CP.CPA.286 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
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 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 informationCENTENE PHARMACY AND THERAPEUTICS DRUG REVIEW 3Q17 July August
BRAND NAME Technivie GENERIC NAME Ombitasvir/paritaprevir/ritonavir MANUFACTURER AbbVie, Inc. DATE OF APPROVAL February 27, 2017 PRODUCT LAUNCH DATE Already available on the market REVIEW TYPE Review type
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 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 information