towards the goal of hcv elimination: ucsf echonorah terrault, md professor of medicine and surgery...
TRANSCRIPT
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Towards the Goal of HCV Elimination:
UCSF Project ECHO
Norah Terrault, MDProfessor of Medicine and Surgery
University of California San Francisco
Direct acting antiviral drugs (DAAs) have been transformative
NOW
3’UTR5’UTR Core E1 E2 NS2 NS4BNS3 NS5A NS5Bp 7
NS5BNUC
Inhibitors
NS3Protease Inhibitors
NS5AReplication Complex Inhibitors
NS5BNon‐NUC Inhibitors (NNI)
4 A
HCV
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Treatment is EasyFor 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!
ScreenScreen
•Baby boomers
•Risk factors
Confirmation of InfectionConfirmation of Infection
•HCV RNA testing
Staging and Readiness of Treatment
Staging and Readiness of Treatment
• Fibrotest/Fibroscan
•Comorbidities
•Adherence
Prescribe HCV therapyPrescribe
HCV therapy
•Authorization
•Monitoring
• Insure adherence
Cure
The Path to Cure:Multiple steps multiple opportunities to “get lost”
At least 750,000 Californians with chronic HCV need to successfully navigate this pathway
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The HCV Care Cascade in 2014: Biggest gap lies in screening>750,000 in California
& Disease Evaluated
Among Screened Patients
Bourgi K, et al. PLoS One. 2016;11:e0161241.
CDC and USPSTOne time screening of all persons born 1945‐65
PLUS
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 positive MSM
Increasing Burden of Patients with Advanced Fibrosis Among Baby Boomers
• 1990 77.6% F0/1; cirrhosis =5%
• 2010 41.8% F0/1; cirrhosis =25%
• 2020 cirrhosis = 37.2% (predicted cirrhosis peak 2010‐2030)
Davis GL, Gastroenterology. 2010;138:513‐521.
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Prevalence of HCV By Year of Birth
NHANES Data, 1988–1994 and 1999–2002
• Anti‐HCV prevalence among persons born 1945–1965: 3.25%
– 5‐times higher than among adults born in other years
Armstrong GL, et al. Ann Internal Med. 2006;144:705‐714.
HCV Screening of Birth Cohort Increased After CDC Call to Action; Screening Rate Fell in Non‐
Boomers
Smyth C, et al. Abstract 1447 AASLD 2014
Nationwide Medivo Lab Exchange Database
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Surveillance of Acute HCV Infection ‐ 2013
Estimated 29,000 new HCV infections
150% increase since 2010
28 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 20‐29 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
Regional doubling of first time heroin users 3 of 4 had history of prescription opioid abuse
MMWR 2015Suryaprasad AG, Clin Infect Dis 2014:15;59:1411-9
CDC. Viral Hepatitis Surveillance --- United States, 2013
• ≤30 years of age•White•Non‐urban
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The HCV Care Cascade in 2016: Biggest gap lies in screening
Bourgi K, et al. PLoS One. 2016;11:e0161241.
& Disease Evaluated
Among Screened Patients
Integrated Health System in Southeast Michigan 2014‐2015
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. 2009 Jun;23(6):421‐4.
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• 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
ECHO HUBTeam of Specialists
Hepatologists, NP/PAs, Pharmacists, Psychiatrist, Addiction Medicine
ECHO SPOKESPrimary Care and Other Providers
PATIENT REACH
What is UCSF Project ECHO?(Extension for Community Healthcare Outcomes)
[email protected]: 415‐353‐4994 Fx: 415‐353‐2562 400 Parnassus Ave., Ste. 331 San Francisco, CA 94143
The “Spokes”
N=52
20 California Counties
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HOW IT WORKSECHO clinic
ECHO clinics are held on the 1st and 3rd and 5th
Wednesdays of every month from 11:30am‐1:00pm.
A 15‐20 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)
Didactics*
Key Areas:
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
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• 1‐800 access to liver/treatment specialists for “between clinic”questions
ECHO SPOKES
Wrap‐Around Support for Spokes
HCV 101 introduction to HCV In‐Person Immersion
held quarterly
UCSF HCV ECHO clinics
twice monthly
Goal: Longitudinal Mentoring of Spokes
HCV Voice
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ECHO HCV Provider Evaluation (≥5 clinics)
1=novice5=expert
ECHO HCV Provider Evaluation (≥5 clinics) 1=novice ‐‐ 5=expert
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The HCV Care Cascade in 2016: 2nd biggest gap lies in getting treatment
Bourgi K, et al. PLoS One. 2016;11:e0161241.
& Disease Evaluated
Among Screened Patients
Integrated Health System in Southeast Michigan 2014‐2015
50% of patients seeing HCV
provider are not treated
Improvements in the Care Cascade
% HCV RNA test % Referred to HCV Specialist % Attended Appt % Started Treatment
(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.
Howes N, Open Forum Infect Dis. 2016 Jan 6;3(1):ofv218.
%
~50% drop off
WHY?
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Barriers to Treatment
Contraindications
Adherence
Undervalued Physicians
Payers
Patients
Access
Contraindications Were Frequent Reason for Lack of Treatment in Interferon Era
Kramer JR, et al. J Hepatol. 2012;56(2):320‐325.
Type ofComorbidity
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 Abuse
Alcohol Use 55%
Illicit Drug Use 39%
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C‐EDGE CO‐STAR: Efficacy of EBV/GZR for 12 Wks in Persons Who Inject Drugs on Opioid Agonist Therapy
Data demonstrate support for treating HCV among subjects receiving Opiate Agonist Therapy
5 patients reinfected different viral detected at time of relapse based on phylogenetic analysis (PW8)
Dore G, Ann Intern Med. 2016 Aug 9.
Efficacy of DAA Therapy in Persons Who Inject Drugs on Opioid Agonist Therapy
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. 2016 Aug 9.
C‐EDGE CO‐STAREBR/GZP X 12 wks
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Treating All Stages of Disease is Cost‐Effective and Averts Liver Complications
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.
COST PER SVR LIFETIME COSTS
Chahal HS, JAMA Intern Med. 2016;176:65‐73
Younossi ZM , APT, 2016
Restricted Access to HCV Drugs is Barrier in HCV Care Cascade
Do A, PLoS One 2015;10:e0135645
Cirrhosis 21.6%Decompensated cirrhosis 7.7%Liver transplant 17.7%
Initial Rates of Un‐approved by Disease Status
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HOW IT WORKSECHO clinic
Pharmacist: Key to ECHO Team
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 supportHCV providers in every California county, urban and rural
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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!
It is a great opportunity to
grow as a provider – acquire new knowledge
and skills
HCV therapy saves lives –your patients need you to be an expert!
The UCSF ECHO team is really keen to support you in your care of patients!
It yields improved efficiency in
managing HCV patients, including
medication authorization