HCV Disease Outcomes in the US. Hepatitis C New Medications, New Hope and New Opportunities for Primary Care. Learning Objectives 10/13/17
|
|
- Hugo Carr
- 6 years ago
- Views:
Transcription
1 Hepatitis C New Medications, New Hope and New Opportunities for Primary Care Disclosures: Grant for quality improvement Gilead In this talk, 10 drugs will be discussed, 4 of which are manufactured by Gilead. Learning Objectives 1. Review the evidence based and guideline recommended screening for hepatitis C virus (HCV) infection for primary care 2. Understand how new HCV antivirals work and review the current treatment options and success rates HCV Disease Outcomes in the US 3. Recognize which patients can be treated in primary care and which patients should be referred. 4. Understand the need for adherence on HCV treatment 5. Recognize the need for cirrhosis and HCC monitoring after patients achieve HCV cure 1
2 Decompensated Cirrhosis and HCC Projected Prevalence Rises Through 2020 HCV mortality higher than from top 60 other infections combined From , number of HCV deaths surpassed the major 60 other nationally notifiable infectious conditions combined Although the overall prevalence of HCV infection is decreasing, the prevalence of cirrhosis is increasing Decompensated cirrhosis more common after 1995 HCC rose steeply after 1990, predicted to peak in 2019 at 14,000/year Davis GL et al. Gastro. 2010; 138 (2): Mortality from other conditions (eg TB, pneumococcal disease) is declining while HCV mortality rising HCV deaths mainly among ages yo Ly K et al. Clin Infect Dis; 2016;62: Deaths from liver cancer increased at the highest rate of all cancers HCC has second highest rise in incidence second only to thyroid cancer Rising Number of New Infections Death rates from HCC highest of all cancer sites During same time, death rates decline from all cancers combined HCV associated liver cancer death rates highest among persons born Ryerson AB et al. Cancer 2016 May 1;122(9): Estimated Actual New Cases of HCV ,500 24,700 29,700 30,
3 Screening Recommendations from the CDC and USPSTF Birth Year Screening: Born Screening and Initial Evaluation Risk Based Screening: 1 or more Risk Factors IDU Transfusion before 1992 Clotting factors before 1987 HIV or HBV Chronic Hemodialysis Elevated ALT Smith BD, et al. MMWR Morb Mortal Wkly Rep. 2012;61(RR04);1-18. HCV RNA (viral load) HCV Genotype Primary Care Evaluation of HCV Baseline Every 6 mos *if cirrhosis* Annually CBC/Platelet PT/ INR BMP / LFTs HIV Ab HAV IgG HBsAg, HBsAb, HBcAb Fibrosis assessment Cryoglobulins Abdominal US Immunizations As needed Staging and Assessment of Fibrosis Why test for fibrosis? Determine treatment urgency Assess need for additional care Cirrhosis requires additional management How to test for fibrosis? Gold standard: liver biopsy Serum markers Fibrosure, APRI, Fib-4 Elastography (FibroScan, MRE) Imaging may detect cirrhotic features 3
4 Calculators for Fibrosis APRI FIB-4 HCV Treatment Chou R, et al. Ann Intern Med. 2013;158: Viral Cure (SVR) Associated With Reduced Risk of Death,Transplant and HCC Meta-analysis of over 23,000 patients from 129 studies Achieving SVR vs. no SVR was associated with substantial benefits 62% to 84% reduction in all-cause mortality, 90% reduction in liver transplantation, 68% to 79% reduction in HCC 60% 50% US HCV Treatment During Interferon-Ribavirin Era 50% Pts Dead After 5 Yrs (%) Yr Risk of All-Cause Death by SVR SVR No SVR General Cirrhotic Pts HIV- Coinfected Pts Hill AM, et al. AASLD Abstract Pts With HCC After 5 Yrs (%) General 5-Yr Risk of HCC by SVR SVR No SVR Cirrhotic Pts HIV- Coinfected Pts 40% 30% 20% 10% 0% 32-38% 7-11% 5-6% Diagnosed Referred to care Treated Successfully Treated Holmberg SD, et al. New Eng J Med. 2013;368:
5 Direct Acting Antivirals (DAAs) Against specific HCV targets Sites: NS3 NS4a NS5A NS5B DAA Regimens and Abbreviations Sofosbuvir SOF Sofosbuvir + Simeprevir+ Ledipasvir++/Sofosbuvir SOF + SIM LDV/SOF Paritaprevir+/ritonavir/Ombitasvir++ + Dasabuvir PrOD Paritaprevir+/ritonavir/Ombitasvir++ Elbasvir++/Grazoprevir+ Daclatasvir++ + Sofosbuvir Sofosbuvir/Velpatasvir++ Sofosbuvir/Velpatasvir++/Voeliprevir+ * Glecaprevir+/Pibrentasvir++ ** * FDA approved July 2017; ** FDA approved August 2017; + NS3/4A protease inhibitor; ++ NS5A Inhibitor PrO EBR/GZR DCV + SOF SOF/VEL SOF/VEL/VOX GLE/PIB Sofosbuvir DAA Regimens and Trade Names Sofosbuvir + Simeprevir+ Ledipasvir++/Sofosbuvir Sovaldi Sovaldi + Olysio Harvoni Paritaprevir+/ritonavir/Ombitasvir++ + Dasabuvir Viekira Pak Paritaprevir+/ritonavir/Ombitasvir++ Elbasvir++/Grazoprevir+ Daclatasvir++ + Sofosbuvir Sofosbuvir/Velpatasvir++ Sofosbuvir/Velpatasvir++/Voeliprevir+ * Glecaprevir+/Pibrentasvir++ ** * FDA approved July 2017; ** FDA approved August 2017; + NS3/4A protease inhibitor drug; ++ NS5A Inhibitor drug Technivie Zepatier Daklinza +Sovaldi Epclusa Vosevi Mavyret 3 Major Factors in Choosing HCV Treatment Regimen Cirrhosis Genotype/subtype Treatment history 5
6 SVR Efficacy of GLE/PIB 12 Weeks in GT 1-6 Patients with Cirrhosis Treatment Naïve and Peg/SOF treatment eperienced N= 47/48 39/39 34/34 16/16 1/1 7/7 39/40. 45/47 GT1A GT1B GT2 GT4 GT5 GT6 GT3 TN 12 wks EXPEDITION-1 12 weeks GT3 TE 16 wks SURVEYOR 2 Forns X, Lancet Infect Dis 2017; Wyles D. Hepatology 2017 Summary of Glecaprevir/Pibrentasvir Label For Treatment Naïve and Retreatment Without Cirrhosis With Compensated Cirrhosis HCV Genotype Prior Treatment Eperience Duration 1, 2, 3, 4, 5, 6 Naïve 8 Weeks 12 Weeks 1, 2, 4, 5, 6 PRS 8 Weeks 12 Weeks 3 PRS 16 Weeks 16 Weeks NS5A inhibitor (NS3/4A PI naive) 16 Weeks 16 Weeks Dosage 1 and durations NS3/4A PI are (NS5A applicable inhibitor naive) to patients * 12 with: Weeks 12 Weeks HCV mono-infection and HCV/HIV-1 co-infection Any stage of renal impairment, including patients receiving dialysis GLE/PIB not recommended with moderate hepatic impairment (CPT-B) GLE/PIB is contraindicated with severe hepatic impairment (CPT-C) PRS: regimens containing interferon, pegylated interferon, ribavirin and/or sofosbuvir (but no eperience with NS3/4A PI or NS5A inhibitors); CP: Child-Pugh classification MAVYRET US Prescribing Information; Accessed August SOF/VEL/VOX FDA Approved for Retreatment Genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an NS5A inhibitor Eamples of regimens containing NS5A inhibitors: 1. Ledipasvir/Sofosbuvir 2. Elbasvir/Grazoprevir 3. Sofosbuvir + Daclatasvir 4. Paritaprevir/ritonovir/ Ombitasvir + Dasabuvir SOF/VEL/VOX FDA Approved for Retreatment, cont d Genotype 1a or 3 previously treated with Sofosbuvir, without an NS5A inhibitor Eamples of regimens containing SOF without NS5A inhibitor 1. Sofosbuvir + Ribavirin 2. Peginterferon + Ribavirin + Sofosbuvir 3. Sofosbuvir + Simeprevir 6
7 Genotype 1a Treatment Naive LDV/SOF 8 weeks SVR 93%-97% Only if HCV RNA < 6 mill AND F0-F2 AND HIV neg GLE/PIB 8 or 12 weeks SVR 99% 12 weeks if cirrhosis SOF/VEL 12 weeks SVR % LDV/SOF 12 weeks SVR 94-96% if HCV RNA > 6 mill OR F3-4 OR HIV pos PrOD + Ribavirin 12 weeks SVR 96% 24 weeks if cirrhosis EBR/GZR 12 weeks SVR 95-99% if no baseline NS5A RAV EBR/GZR + Ribavirin 16 weeks SVR 97% if baseline NS5A RAV Genotype 1b Treatment Naive LDV/SOF 8 weeks SVR 93%-97% if HCV RNA < 6 mill AND F0-F2 AND HIV neg GLE/PIB 8 or 12 weeks SVR 99% 12 weeks if cirrhosis SOF/VEL 12 weeks SVR % LDV/SOF 12 weeks SVR 94-96% if HCV RNA > 6 mill OR F3-4 OR HIV pos PrOD 12 weeks SVR 99% EBR/GZR 12 weeks SVR 95-98% Genotype 2 Treatment Naive Genotype 3 Treatment Naive GLE/PIB 8 or 12 weeks SVR % 12 weeks if cirrhosis SOF/VEL 12 weeks SVR % DAC + SOF 12 weeks SVR 100% GLE/PIB 8 or 12 weeks SVR 95-98% 12 weeks if cirrhosis SOF/VEL 12 weeks SVR 93-99% If cirrhosis and baseline RAV, add ribavirin DAC + SOF 12 weeks SVR 97% Add ribavirin if cirrhosis 7
8 Genotype 4 - Treatment Naive GLE/PIB 8 or 12 weeks SVR % 12 weeks if cirrhosis EBR/GZR 12 weeks SVR 97% SOF/VEL 12 weeks SVR % LDV/SOF 12 weeks SVR 93% Add ribavirin PrO 12 weeks SVR 95% Genotype 5,6 - Treatment Naive GLE/PIB 8 or 12 weeks SVR 100% 12 weeks if cirrhosis SOF/VEL 12 weeks SVR % LDV/SOF 12 weeks SVR 93-96%% Resistance Associated Variants (RAVs) Drug resistance mutations in HCV, usually to specific - NS3/4 Protease inhibitor drugs - NS5A inhibitor drugs Genotype 3 patients with RAVs, especially if have cirrhosis, have much lower SVR rates Genotype 1a patients with RAVs also have lower SVR rates. Patients Who Failed DAA Need RAV Testing Before Retreatment Test for NS3/4A RAV if treated previously with: 1. SOF + SIM 2. PrOD 3. EBR/GZR Test for NS5A RAV if treated previously with: 1. LDV/SOF 2. PrOD 3. EBR/GZR 4. DCV + SOF 5. SOF/VEL Pre-Treatment Considerations 8
9 Whom to treat Everyone should be considered for treatment Most urgent for patients at increased risk of: Decompensation and death Morbidity, symptoms Transmitting virus to others Rapid progression Barriers to Optimizing Treatment Patient Factors Not offered linkage to care with an HCV treater Alcohol/drug use Missed appointments Fear of side effects due to previous information about interferon Contraindications to treatment (eg, medical or psychiatric comorbidity) 1 Provider Factors Under-diagnosis of HCV Knowledge gaps about new HCV treatments and recommendations Hesitation to treat past substance abusers Lack of access to specialist help Cultural inertia Time constraints AASLD = American Association of for the Study of Liver Diseases; IDSA = Infectious Diseases Society of America. Other Lack of awareness of infection Access to care/loss of insurance Payer restrictions Cost concerns 1. AASLD/IDSA. Sept 16, 2016;. Accessed February 9, McGowan CE, et al. Hepatol. 2013:57: ; 3. Rein DB, et al. Ann Intern Med. 2015;156: ; 4. Spach DH. HCV Incidence and Prevalence. In: Hepatitis C Online. Updated Sep 5, Morrill JA, et al. J Gen Intern Med. 2005;20: ; 6. Fo R. Dig Dis Sci September 12. [Epub ahead of print]; 7. Thomson M, et al. Dig Dis Sci. 2016;61: ; 8. Kattakuzhy S, et al. 51st EASL; Barcelona, Spain; April 13-17, Abstract LBP524. Viral Factors Influencing HCV Treatment Decisions Genotype Subtype Viral load Treatment History Naïve or eperienced Ribavirin eligibility Resistance mutations Prior treatments Fibrosis stage Comorbidities Payor requirements Financial Fibrosis stage (F0-F4) If cirrhosis, Childs score A, B or C Pre- or Post-Transplant HIV coinfection Etrahepatic manifestations (cryoglobulinemia, etc) Renal function Drug-drug interactions Insurance approval Adherence is crucial Patient adherence Note the factors that may complicate adherence: active substance use, depression, neurocognitive disorders, and lack of social support Address issues of adherence before initiating medications. Incorporate strategies for measuring and supporting adherence within your clinics. 9
10 Whole Sale Costs Regimen Total Ledipasvir/Sofosbuvir 8 wks-12 wks $63,000 - $94,500 Elbasvir/Grazoprevir 12 wks $54,600 Daclatasvir + Sofosbuvir 12 wks $147,000 Sofosbuvir/Velpatasvir 12 wks $74,760 Sof/Vel/Vo 12 weeks $74,760 Glecaprevir/Pibrentasvir 8wks-12 wks $26,400 - $39,600 Whole Sale Costs Patients with HCV $9681 per patient per year HCV with decompensated cirrhosis $27,845 per patient per year HCV with hepatocellular carcinoma $43,671 per patient per year HCV with liver transplant $93,609 per patient per year McAdam-Mar C, et al. J Manag Care Pharm. 2011;17(7): Treatment is Cost-Effective Price of sofosbuvir in selected countries 1. Real world SVR rates comparable to clinical trials 2. HCV treatment for genotype 1 patients at all fibrosis stages, Ledipasvir/Sofosbuvir was cost effective. 3. Cost-effective yes, but affordable no. 4. Advanced fibrosis no longer always required by payors Chahal M et al. JAMA Intern Med Nov 23:1-9 Hill et al. Journal of Virus Eradication 2016; 2:
11 Managing Medication Authorization Denial ü Don t give up after first prior authorization denied ü Carefully read reason for denial q Mild fibrosis q Not the preferred drug q Missing data ü Payor creates eligibility criteria and drug preference ü Appeal or peer to peer available ü Access pt assistance programs ü Often the pharmaceutical will cover the pt s copay Genotype Monitoring on HCV Treatment Pre-Treat X 4 wks On T 12 wks After T = SVR Notes HCV RNA X X X Or every 2 weeks until undetectable. Stop treatment if not undetectable by 6 wks CBCD X X Every 2 weeks if on RBV LFTs X X Stop if AST/ALT 10 GFR X X Every 2 weeks if abnl or drug interactions INR X Source: hcvguidelines.org After SVR: Long-term Monitoring Patients with advanced fibrosis should be screened for liver cancer every 6 months Patients who are active IV drug users should be screened for reinfection and receive counseling Adverse Events Discuss most common adverse events and management strategies in pre-education session Headaches, Fatigue, Nausea, Insomnia less than 10% Anemia still a concern with Ribavirin 11
12 HBV Reactivation During HCV Treatment FDA Drug Safety Communication 24 cases of HBV reactivation (including 3 cases of acute liver failure) over a 31 month period, Boed Warning requirement issued All patients should be tested before treatment for HBsAg, HBsAb, HBcAb If HBsAg positive, refer for HBV treatment while on HCV treatment Opportunities for Primary Care FDA. FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. Oct 4, Accessed Feb 2, 2016; 2. ISMP. QuarterWatch. Jan 25, Accessed Feb 2, 2017; 3. Grady D. Are New Drugs for Hepatitis C Safe? A Report Raises Concerns. The New York Times. Jan 24, Accessed Feb 2, Primary Care can provide most of the spectrum of HCV care Such as: Screening and diagnosis Performing initial evaluation after diagnosis Caring for patient with chronic liver disease Performing pre-treatment assessment Prescribing and managing DAA treatment of uncomplicated cases Managing compensated cirrhosis Linkage to Care Any patient with HCV RNA should be referred to a medical provider who can further evaluate and manage the patient s HCV infection, such as: 1) A primary care clinician (physician, nurse practitioner, or physician assistant) with interest and eperience evaluating and treating HCV patients 2) An infectious diseases specialist with HCV evaluation and treatment competence 3) A hepatology or gastroenterology specialist 12
13 Why Gaps Occur in Linkage of Care Provider failure to offer follow-up appointment Patient failure to follow-up on the referral Lack of medical insurance Substance abuse problems that interfere with making or keeping the appointment Untreated HCV From The Interferon Era Many patients diagnosed in the interferon era were ineligible or were counseled not to undergo treatment Many patients in the interferon era failed or didn t tolerate treatment These patients should be re-evaluated for DAA treatment now Recommended for Referral Decompensated cirrhosis (Child Pugh B or C) Etrahepatic manifestations HIV-HCV coinfection DAA treatment failure Renal insufficiency Drug-Drug interactions Conclusions Compelling evidence for use of DAAs - etremely high cure rates, short duration, few side effects Ease of regimen - many regimens are one pill per day and ribavirin-free regimens now eist Resistance testing is required for some genotypes with some regimens, and some retreatment situations Major barriers are access to an HCV prescriber and insurance coverage yet coverage is very dynamic Goal of eliminating HCV needs participation from specialists and generalists Systems need to be in place to make HCV screening and linkage to care more reliable 13
Hepatitis C ew Medications, New Hope and New. V. Opportunities for Primary Care. Outline. HCV Disease Outcomes in the US 9/21/2016
Hepatitis C ew Medications, New Hope and New Opportunities for Primary Care Primary Care Principles and Practice October 14, 2016 Disclosures: Grant support Gilead Sciences, Inc Quality improvement Systematized
More informationOutline. HCV Disease Outcomes in the US. Hepatitis C: The New Landscape 5/24/16. Advances in Internal Medicine May 24, I have no disclosures
5/24/16 Hepatitis C: The New Landscape Advances in Internal Medicine May 24, 2016 I have no disclosures Rena K. Fo, MD Professor of Clinical Medicine, UCSF Outline I. Current HCV outcomes in the US II.
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 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 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 informationLength of Authorization: 8-16 weeks. Requires PA: All direct-acting antivirals for treatment of Hepatitis C. Approval Criteria
Hepatitis C Direct-Acting Antivirals Goals: Approve use of cost-effective treatments supported by the medical evidence. Provide consistent patient evaluations across all hepatitis C treatments. Ensure
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 information1/16/2019. Goals of HCV Therapy. Objectives. Treating Hepatitis C and HIV Co Infection. Cure Defined as sustained virologic response (SVR)
HCV ECHO WESTERN STATES HCV ECHO WESTERN STATES Treating Hepatitis C and HIV Co Infection Paulina Deming, Pharm D Associate Professor, College of Pharmacy Assistant Director, Viral Hepatitis Programs,
More informationHCV Treatment in 2016: Genotypes 1, 2, and 3. Cody A. Chastain, MD October 12, 2016
HCV Treatment in 2016: Genotypes 1, 2, and 3 Cody A. Chastain, MD October 12, 2016 Disclosures I have no financial disclosures. Caveats I will only discuss treatment of GT 1-3. Majority of US population
More informationLength of Authorization: 8-16 weeks. Requires PA: All direct-acting antivirals for treatment of Hepatitis C. Approval Criteria
Hepatitis C Direct-Acting Antivirals Goals: Approve use of cost-effective treatments supported by the evidence. Provide consistent patient evaluations across all hepatitis C treatments. Ensure appropriate
More informationLength of Authorization: 8-12 weeks. Requires PA: All direct-acting antivirals for treatment of Hepatitis C. Approval Criteria
Hepatitis C Direct-Acting Antivirals Goals: Approve use of cost-effective treatments supported by the medical evidence. Provide consistent patient evaluations across all hepatitis C treatments. Ensure
More informationHepatits C Criteria Direct Acting Antiviral Medications
Hepatits C Criteria Direct Acting Antiviral Medications Harvoni-Formulary PA required 1. Is the patient being treated for a funded condition by the Oregon Health Plan? 2. Does the member have a diagnosis
More informationManagement of Chronic HCV 2017 and Beyond
Management of Chronic HCV 2017 and Beyond Blaire E Burman, MD Virginia Mason Gastroenterology & Hepatology Relevant Disclosures No financial disclosures to report Leaning Objectives Burden of HCV Prevalence
More informationHepatitis C Direct-Acting Antivirals
Hepatitis C Direct-Acting Antivirals Goals: Approve use of cost-effective treatments supported by the medical evidence. Provide consistent patient evaluations across all hepatitis C treatments. Ensure
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 informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C Second Generation Antivirals Page 1 of 32 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C Second Generation Antivirals Through
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 informationHepatitis C Infection: Updated Information for Front Line Workers in Primary Care Settings MAMTA K. JAIN, MD, MPH 2/14/18
Hepatitis C Infection: Updated Information for Front Line Workers in Primary Care Settings MAMTA K. JAIN, MD, MPH 2/14/18 Overview Hepatitis C Virus Prevalence Effects of Hepatitis C Prevention Diagnosis
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 informationLength of Authorization: 8-16 weeks. Requires PA: All direct-acting antivirals for treatment of Hepatitis C. Approval Criteria
Hepatitis C Direct-Acting Antivirals Goals: Approve use of cost-effective treatments supported by the evidence. Provide consistent patient evaluations across all hepatitis C treatments. Ensure appropriate
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 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 informationHEPATITIS C: UPDATE AND MANAGEMENT
HEPATITIS C: UPDATE AND MANAGEMENT José Franco, MD Professor of Medicine Associate Dean for Educational Improvement Associate Director, Kern Institute STAR Center Director José Franco, MD Disclosures I
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 informationMonitoring Patients Who Are Starting HCV Treatment, Are On Treatment, Or Have Completed Therapy
Monitoring Patients Who Are Starting HCV Treatment, Are On Treatment, Or Have Completed Therapy WV ECHO August 10, 2017 Selection of patients for HCV treatment Despite current guidance to treat everyone,
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 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 informationHepatitis C Update on New Treatments
Hepatitis C Update on New Treatments Kevork M. Peltekian, MD, FRCPC 44th Annual Dalhousie Spring Refresher Course - Therapeutics April 5 - April 7, 2018 Halifax Convention Centre Disclosures Conflicts
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 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 informationMolina Healthcare of Texas Hepatitis C Drugs (Medicaid)
Texas Standard Prior Authorization Form Addendum Molina Healthcare of Texas Hepatitis C Drugs (Medicaid) This fax machine is located in a secure location as required by HIPAA Regulations. Complete / Review
More informationCurrent HCV Treatment by Genotype
Current HCV Treatment by Genotype Ari Bunim, MD Assistant Professor Clinical Medicine Weill Cornell Medical College Clinical Director of Hepatology New York-Presbyterian/Queens Objectives To understand
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 informationSpecial developments in the management of Hepatitis C. Disclosures
Special developments in the management of Hepatitis C Sandeep Mukherjee,MD Division of Gastroenterology CHI Health and Creighton University Medical Center Omaha, NE 68154 Sandeep.Mukherjee@alegent.org
More information10/4/2016. Management of Hepatitis C Virus Genotype 2 or 3 Infection
Management of Hepatitis C Virus Genotype 2 or 3 Infection Kenneth E. Sherman, MD, PHD Gould Professor of Medicine Director, Division of Digestive Diseases University of Cincinnati Cincinnati, Ohio FORMATTED:
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 informationCurrent Issues in Hepatitis B and C
Current Issues in Hepatitis B and C Rena Fox, MD Professor of Clinical Medicine Division of General Internal Medicine May-June 2018 Disclosures: Quality improvement project funded by Gilead Sciences, completed
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 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 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 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 informationPegylated Interferon Agents for Hepatitis C
Applicable X X X X X X X Pegylated Interferon Agents for Hepatitis C Override(s) Prior Authorization Quantity Limit Initial for Monotherapy or Combination with Ribavirin based on Genotype, Status, or Co-Infection
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 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 information10/10/18. Hepatitis B and C: New Medications, New Hope and New Opportunities for Primary Care. Hepatitis B. Hepatitis B and C. I have no disclosures
Hepatitis B and C: New Medications, New Hope and New Opportunities for Primary Care I have no disclosures Rena Fox, MD Professor of Clinical Medicine Division of General Internal Medicine Hepatitis B and
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 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 informationHepatitis C in Disclosures
Hepatitis C in 2018 Sandeep Mukherjee, MD CHI Health and Creighton University Medical Center Division of Gastroenterology Grant support: Abbvie Disclosures Speaker: Abbvie, Gilead, Merck Section editor
More informationUpdates in the Treatment of Hepatitis C
Disclosures Updates in the Treatment of Hepatitis C Arslan Kahloon M.D Assistant Professor of Medicine University of Tennessee, Chattanooga I have no conflicts of interest or financial sponsorship to disclose
More informationHepatitis C Policy Discussion
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationSovaldi (sofosbuvir)
Market DC Sovaldi (sofosbuvir) Override(s) Prior Authorization Quantity Limit Approval Duration Based on Genotype, Treatment status, Cirrhosis status, or Ribavirin Eligibility status **IN, SC, WA Medicaid
More informationHepatitis C Medications Prior Authorization Criteria
Hepatitis C Medications Authorization Criteria Epclusa (/velpatasvir), Harvoni (ledipasvir/), Sovaldi (), Daklinza (daclatasvir), Zepatier (elbasvir/grazoprevir), Olysio (simeprevir), Viekira Pak (ombitasvir/paritaprevir/ritonavir;
More informationHepatitis C. No disclosures. 1. The USPSTF recommends Hepatitis C screening in which patient populations?
Hepatitis C Jennifer Acosta PA-C No disclosures 1. The USPSTF recommends Hepatitis C screening in which patient populations? a. All adults at least once b. Immigrants to the US and those over age 65 c.
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 informationAddress: City: State: ZIP code: Inferferon Product Requested (Include Strength):
Please complete this entire form and fax it to: 866-940-7328. If you have questions, please call 800-310-6826. This form contains multiple pages. Please complete all pages to avoid a delay in our decision.
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 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 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 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 information10/21/2016. Susanna Naggie, MD, MHS Associate Professor of Medicine Duke University Durham, North Carolina. Learning Objectives
A Crash Course on the AASLD/IDSA Hepatitis C Virus Infection Treatment Guidelines: What s New Susanna Naggie, MD, MHS Associate Professor of Medicine Duke University Durham, North Carolina FORMATTED: 1/3/16
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 informationUpdate in hepatitis C virus infection
Update in hepatitis C virus infection Eoin Feeney Consultant in Infectious Diseases St. Vincent s University Hospital Overview Natural history Diagnosis, screening, staging Management Barriers going forward
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 informationNew York State HCV Provider Webinar Series. Side Effects of Therapy and Drug-Drug Interactions
New York State HCV Provider Webinar Series Side Effects of Therapy and Drug-Drug Interactions Case Presentation Case 56 year-old lady with Genotype 1A Hepatitis C, Treatment-naive Noninvasive fibrosis
More informationClass Update with New Drug Evaluations: Hepatitis C Direct-acting Antivirals
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationDrug Class Prior Authorization Criteria Hepatitis C
Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: November 14, 2018 Effective Date: January 1, 2019 This drug class prior authorization criteria have been
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 informationHIV/HCV Coinfection: Why It Matters and What To Do About It. Cody A. Chastain, MD 10/26/16
HIV/HCV Coinfection: Why It Matters and What To Do About It Cody A. Chastain, MD 10/26/16 Disclosures I have no relevant financial disclosures. Objectives At the end of this lecture, the learner will be
More informationHCV Case Studies (and Special Populations)
HCV Case Studies (and Special Populations) Case 1: Alfred 58 y/o man presents to clinic for primary care f/u. PMH: Hypertension, diabetes Medications: lisinopril, glipizide Allergies: NKDA Family History:
More informationManagement of HIV/HCV Coinfection. Kristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, NY
Management of HIV/HCV Coinfection Kristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, NY Disclosure Dr. Marks has received grants and research support from Gilead Sciences
More informationThe New World of HCV Therapy
HCV: Assessing the Patient Prior to Treatment: Diagnostic Testing and Strategy JORGE L. HERRERA M.D., MACG UNIVERSITY OF SOUTH ALABAMA COLLEGE OF MEDICINE, MOBILE, AL The New World of HCV Therapy Interferon-free
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 informationNew Antivirals for Hep C in Context of HIV: Vosevi and Mavyret
New Antivirals for Hep C in Context of HIV: Vosevi and Mavyret John Scott, MD, MSc, FIDSA November 16, 2017 This presentation is intended for educational use only and does not in any way constitute medical
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 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 informationDescription of Antivirals for Hepatitis C. LCDR Dwayne David, PharmD, BCPS, NCPS Cherokee Nation Infectious Diseases
Description of Antivirals for Hepatitis C LCDR Dwayne David, PharmD, BCPS, NCPS Cherokee Nation Infectious Diseases Dwayne-David@cherokee.org Objectives Compare the different classes of direct-acting antiviral
More informationSASKATCHEWAN FORMULARY BULLETIN Update to the 62nd Edition of the Saskatchewan Formulary
April 1, 2017 Bulletin #165 ISSN 1923-0761 SASKATCHEWAN FORMULARY BULLETIN Update to the 62nd Edition of the Saskatchewan Formulary Related Information for Prescribers: Only prescribers who have completed
More informationNew Hepatitis C Antivirals
New Hepatitis C Antivirals Kris Stewart, BSP, MD, FRCPC Drug Therapy Conference College of Medicine, University of Saskatchewan September 23, 2016 Disclosures I have received research and program support
More informationHepatitis C: the 2015 Perspective for the Family Medicine Practitioner
Hepatitis C: the 2015 Perspective for the Family Medicine Practitioner Annie Luetkemeyer, MD Division of HIV,ID & Global Medicine San Francisco General Hospital Disclosures I have received research grant
More informationClinical Policy: Glecaprevir/Pibrentasvir (Mavyret) Reference Number: HIM.PA.SP36 Effective Date: Last Review Date: 06.18
Clinical Policy: (Mavyret) Reference Number: HIM.PA.SP36 Effective Date: 08.01.17 Last Review Date: 06.18 Line of Business: HIM Revision Log See Important Reminder at the end of this policy for important
More informationClinical Policy: Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) Reference Number: GA.PMN.25 Product: Medicaid Effective Date: 9/17
Clinical Policy: Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) Reference Number: GA.PMN.25 Product: Medicaid Effective Date: 9/17 Last Review Date: 9/17 Revision Log See Important Reminder at the end of
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 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 informationNew York State HCV Provider Webinar Series. Side Effects of Therapy and Drug-Drug Interactions
New York State HCV Provider Webinar Series Side Effects of Therapy and Drug-Drug Interactions Case Presentation Case 56 year-old lady with Genotype 1A Hepatitis C, Treatment-naive Noninvasive fibrosis
More informationClinical Policy: Daclatasvir (Daklinza) Reference Number: ERX.SPA.131 Effective Date:
Clinical Policy: (Daklinza) Reference Number: ERX.SPA.131 Effective Date: 10.01.16 Last Review Date: 08.18 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
More informationBrief Review of HIV and Hepatitis C Virus (HCV) Infection (with focus on HCV)
Brief Review of HIV and Hepatitis C Virus (HCV) Infection (with focus on HCV) James Morrill, MD, PhD MGH Charlestown HealthCare Center Massachusetts General Hospital www.mghcme.org Disclosures Neither
More informationHepatitis C Update: A Growing Challenge With Evolving Management Solutions
Pts (%) Hepatitis C Update: A Growing Challenge With Evolving Management Solutions A Growing Challenge With Evolving Management Solutions Introduction Magda Houlberg, MD Chief Clinical Officer Howard Brown
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 informationCurrent trends in CHC 1st genotype treatment
Current trends in CHC 1st genotype treatment Tarik Asselah MD, PhD Professor of Medicine Hepatology, Chief INSERM UMR 1149, Hôpital Beaujon, Clichy, France Disclosures Employee of Paris Public University
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 informationHepatitis C Medications Hawaii PRIOR AUTHORIZATION REQUEST FORM
Please complete this entire form and fax it to: 866-940-7328. If you have questions, please call 800-310-6826. This form contains multiple pages. Please complete all pages to avoid a delay in our decision.
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 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 informationNew York State HCV Provider Webinar Series
New York State HCV Provider Webinar Series Treatment of HCV/HIV Co-Infection Dost Sarpel, MD Division of Infectious Disease Viral Hepatology Milford Regional Medical Center Objectives Review the epidemiology
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 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 informationHCV In 2015: Maximizing SVR
HCV In 2015: Maximizing SVR Alnoor Ramji Gastroenterology & Hepatology Clinical Associate Professor Division of Gastroenterology University Of British Columbia ramji_a@hotmail.com Disclosures (within Last
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 informationHCV Screening, Management and Guidelines
HCV ECHO WESTERN STATES HCV Screening, Management and Guidelines Paulina Deming, PharmD, PhC Associate Professor of Pharmacy-College of Pharmacy Project ECHO University of New Mexico Health Sciences Center
More information