Towards the Goal of HCV Elimination: UCSF Project ECHO
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1 Towards the Goal of HCV Elimination: UCSF Project ECHO Norah Terrault, MD Professor of Medicine and Surgery University of California San Francisco Direct acting antiviral drugs (DAAs) have been transformative NOW HCV 5 UTR Core E1 E2 NS2 NS3 NS4B NS5A NS5B p 7 4 A 3 UTR NS3 Protease Inhibitors NS5A Replication Complex Inhibitors NS5B NUC Inhibitors NS5B Non NUC Inhibitors (NNI) 1
2 Treatment is Easy For Most patients: Regimens of low complexity Monitoring simple Side effects infrequent and easily managed Finite treatment duration typically 12 weeks, can be as little as 8 weeks Also easy for providers: Decisions regarding selection of regimens is getting simpler Monitoring simple Side effects infrequent and easily managed Biggest hurdle: getting insurance approval! Screen Baby boomers Risk factors Confirmation of Infection HCV RNA testing The Path to Cure: Multiple steps multiple opportunities to get lost Staging and Readiness of Treatment Fibrotest/Fibroscan Comorbidities Adherence Prescribe HCV therapy Authorization Monitoring Insure adherence At least 750,000 Californians with chronic HCV need to successfully navigate this pathway Cure 2
3 The HCV Care Cascade in 2014: Biggest gap lies in screening >750,000 in California CDC and USPST One time screening of all persons born Among Screened Patients PLUS Bourgi K, et al. PLoS One. 2016;11:e CDC: Risk based screening: Illicit drug use History of blood transfusion prior to 1990 Percutaneous exposures via injections/infusions Unprofessional tattoos Children of anti HCV positive mothers HIV & Disease positive MSM Evaluated Increasing Burden of Patients with Advanced Fibrosis Among Baby Boomers % F0/1; cirrhosis =5% % F0/1; cirrhosis =25% 2020 cirrhosis = 37.2% (predicted cirrhosis peak ) Davis GL, Gastroenterology. 2010;138:
4 Prevalence of HCV By Year of Birth NHANES Data, and Anti HCV prevalence among persons born : 3.25% 5 times higher than among adults born in other years Armstrong GL, et al. Ann Internal Med. 2006;144: HCV Screening of Birth Cohort Increased After CDC Call to Action; Screening Rate Fell in Non Boomers Nationwide Medivo Lab Exchange Database Smyth C, et al. Abstract 1447 AASLD
5 Surveillance of Acute HCV Infection 2013 Estimated 29,000 new HCV infections 150% increase since of 34 states reported increases 66% of cases reported from 12 states CA, FL, IN, KY, MA, MI, NJ, NY, NC, OH, PA, TN) KY has highest rate Case Rates 61% report IDU Equal Male (0.8): Female (0.7) Highest rate By age years (2.0) By race American Indian (1.7) and whites (0 82) 2.5 fold Increase in New HCV Infections in the US Epidemic Among Young Heroin Users 30 years of age White Non urban Regional doubling of first time heroin users 3 of 4 had history of prescription opioid abuse MMWR 2015 Suryaprasad AG, Clin Infect Dis 2014:15;59: CDC. Viral Hepatitis Surveillance --- United States,
6 The HCV Care Cascade in 2016: Biggest gap lies in screening Integrated Health System in Southeast Michigan Among Screened Patients & Disease Evaluated Bourgi K, et al. PLoS One. 2016;11:e Improving Access Among Those Who Screen Positive Improve patient education Referral Self-referral options Low wait times Point-of-Care testing Expanding Provider Pool PA/NP Telemedicine Project ECHO Eliminating Provider Bias Education regarding risk/benefit Increased treatment rates Can J Gastroenterol Jun;23(6):
7 What is UCSF Project ECHO? (Extension for Community Healthcare Outcomes) ECHO HUB Team of Specialists Hepatologists, NP/PAs, Pharmacists, Psychiatrist, Addiction Medicine ECHO SPOKES Primary Care and Other Providers PATIENT REACH Project ECHO empowers front line primary care professionals to provide the right care, in the right place, at the right time One to Many A proven model to significantly increase access to specialty care Hubs & Spokes ECHO links expert specialist teams at an academic hub with primary care providers in local communities the spokes of the model The Spokes N=52 20 California Counties HCVECHO@ucsf.edu Ph: Fx: Parnassus Ave., Ste. 331 San Francisco, CA
8 HOW IT WORKS ECHO clinic ECHO clinics are held on the 1 st and 3 rd and 5 th Wednesdays of every month from 11:30am 1:00pm. A minute didactic presentation at the beginning of each ECHO clinic. Case presentations are given by the Spokes. Each case is discussed and treatment recommendations are offered by the Hub panel. Cases are also presented for follow up. Wrap up take home messages. ZOOM Video Teleconference (VTC) Key Areas: Didactics* Screening and diagnostics HCV natural history and anticipated complications HCV treatment algorithms Managing treatment related complications Treatment of special populations Chronic liver disease management Other concurrent liver diseases Alcohol Fatty liver Iron overload *CME credit offered 8
9 Wrap Around Support for Spokes HCV 101 introduction to HCV In Person Immersion held quarterly UCSF HCV ECHO clinics twice monthly access to liver/treatment specialists for between clinic questions ECHO SPOKES Goal: Longitudinal Mentoring of Spokes HCV Voice 9
10 ECHO HCV Provider Evaluation ( 5 clinics) 1=novice 5=expert ECHO HCV Provider Evaluation ( 5 clinics) 1=novice 5=expert 10
11 The HCV Care Cascade in 2016: 2 nd biggest gap lies in getting treatment Integrated Health System in Southeast Michigan Among Screened Patients 50% of patients seeing HCV provider are not treated & Disease Evaluated Bourgi K, et al. PLoS One. 2016;11:e Improvements in the Care Cascade (1) reflex testing of anti HCV positive samples for HCV RNA; (2) annotation of laboratory results recommending referral to specialist clinics; (3) educational programs for primary care physicians and nurses; (4) the establishment of needs driven community clinics in substance misuse services. % HCV RNA test % Referred to HCV Specialist % Attended Appt % Started Treatment % ~50% drop off WHY? Howes N, Open Forum Infect Dis Jan 6;3(1):ofv
12 Barriers to Treatment Contraindications Adherence Undervalued Physicians Payers Patients Access Contraindications Were Frequent Reason for Lack of Treatment in Interferon Era Type of Comorbidity Comorbid Condition % Ever with Diagnosis * Medical HTN 63% Diabetes 26% Cirrhosis 12% HIV 4% Psychiatric Depression 56% Anxiety 33% PTSD 26% Bipolar 12% Schizophrenia 10% Substance Alcohol Use 55% Abuse Illicit Drug Use 39% Kramer JR, et al. J Hepatol. 2012;56(2):
13 C EDGE CO STAR: Efficacy of EBV/GZR for 12 Wks in Persons Who Inject Drugs on Opioid Agonist Therapy 5 patients reinfected different viral detected at time of relapse based on phylogenetic analysis (PW8) Data demonstrate support for treating HCV among subjects receiving Opiate Agonist Therapy Dore G, Ann Intern Med Aug 9. Efficacy of DAA Therapy in Persons Who Inject Drugs on Opioid Agonist Therapy C EDGE CO STAR EBR/GZP X 12 wks Urine Drug Screens During Treatment Despite drug use during treatment, 96.5% of patients missed 3 doses of therapy over 12 wks Dore G, Ann Intern Med Aug 9. 13
14 Treating All Stages of Disease is Cost Effective and Averts Liver Complications COST PER SVR LIFETIME COSTS Initiating LDV / SOF treatment in F0-F1 or F2 as opposed to F3-F4 results in substantial savings per successfully treated patient (cost per SVR) and in lifetime costs. Younossi ZM, APT, 2016 Chahal HS, JAMA Intern Med. 2016;176:65 73 Restricted Access to HCV Drugs is Barrier in HCV Care Cascade Initial Rates of Un approved by Disease Status Cirrhosis 21.6% Decompensated cirrhosis 7.7% Liver transplant 17.7% Do A, PLoS One 2015;10:e
15 Pharmacist: Key to HOW ECHO ITTeam WORKS ECHO clinic List of what the insurers preferred HCV drugs are Check lists of what is needed for prior authorization Template language for appeals Knowing eligibility for PAP (patient assistance programs) Experts on drug drug interactions (and best web sites to use) Next Steps in HCV Elimination Identify, train and support HCV providers in every California county, urban and rural 15
16 Summary HCV can be eliminated goal is to do so by 2030 Many barriers along the cascade of care but screening is a major one Some urgency in undertaking screening of baby boomers Access to knowledgeable experts in HCV care is another barrier UCSF HCV ECHO is building a community of HCV experts who can provide high quality care locally Barriers to treatment remain but are diminishing Few contraindications and adherence is high Treatment is cost effective across stages of disease Authorization is time consuming find ways to streamline Be the HCV Champion in Your Practice, Your Community, Your County! HCV therapy saves lives your patients need you to be an expert! It is a great opportunity to grow as a provider acquire new knowledge and skills It yields improved efficiency in managing HCV patients, including medication authorization The UCSF ECHO team is really keen to support you in your care of patients! HCVecho@ucsf.edu 16
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