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Imtiaz Alam. M.D.
Why Do We Care About Hepatitis C in Ohio?
HepVu 2019
Ohio – 2013‐2016, an estimated 1,000 of every 100,000 were
living with hepatitis C
WHO Targets for HCV Elimination by 2030
Diagnose 90% and treat 80% by 2030
2016 status update*Average incidence of diagnosis: 20%
Leaders: Australia (85%), Sweden (82%), Finland (79%), Canada (71%)
Average incidence of treatment: 7%Leaders: Australia (16%), Japan (12%), Netherlands (12%), Egypt (12%), US (8%), France (8%), Spain (8%)
>5 cures/new HCV infection (n=10)Australia, Canada, Egypt, Iceland, Israel, Japan, Portugal, Spain, Qatar, USA
*Data from 91 of 210 countries.Net cure: number of (cured+HCV-related deaths) minus new infections as a percentage of the number viremic.
0
20
40
60
80
100Highest Net HCV Cure Rate in 2016
(Overall: 0.43%)
Net
Cur
e (%
)Iceland Qatar
12% 9%
Japan
35%
15%
26%
8%
Australia
The Polaris Observatory HCV Collaborators. Lancet Gastroenterol Hepatol. 2017;2:161-176.Hill AM, et al. J Virus Erad. 2017;3:117-123.WHO. Global Hepatitis Report 2017.
Egypt Netherlands
Current Treatment Rates in the United States Are Lower Than Those Needed to Meet WHO Targets
HCV=hepatitis C virus; WHO=World Health Organization.Polaris Observatory. http://cdafound.org/polaris‐hepC‐dashboard/. Accessed February 11, 2018.
0
1
2
3
2016 2018 2020 2022 2024 2026 2028 2030
Projections for United StatesTreatment and New Infections From 2016‐2030
At current treatment rates, there will still be more than 1 million people in the United States who need HCV treatment by 2030
Virem
ic HCV In
fections (M
)
Base 2016 WHO target
Year
High HCV Disease Burden in the United States:Increasing HCV Treatment Capacity is Essential
Base of HCV disease burden (2015)
Decompensated cirrhosis: 198,000
HCC: 154,000
Liver‐related death: 337,000
Liver transplants: 31,000
More patients need to be treated to overcome the continued and substantial HCV burden
Aggressive screening and treatment policies are needed
*Comprehensive analysis of patient demographics, HCV disease characteristics, disease progression, therapeutic advancesscreening policies, Affordable Care act, insurance coverage, and access to treatment.
Reduction in HCV Disease Burden (2015-2030)
Dis
ease
Pre
vent
ion
Treatment capacity: 280,000 (current) Increasing to 500,000
Chhatwal J, et al. Hepatology. 2016;64:1442-1450.
-14000
-12000
-10000
-8000
-6000
-4000
-2000
0
DecompensatedCirrhosis HCC
Liver-RelatedMortality
LiverTransplants
-8600
-12,000
-9700
-13,500
-5400
-7400
-900-1400
HCV Screening
PATIENTS SHOULD BE SCREENED FOR HCV ACCORDING TO BIRTH COHORT AND RISK FACTORS1,2
1. Smith BD, et al. MMWR Recomm Rep. 2012;61:1‐32.
2. Moyer VA; US Preventive Services Task Force. Ann Intern Med. 2013;159:349‐357.
Persons Born Between1945 and 19651,2
• The 1945‐1965 birth cohort was selected on the basis of HCV prevalence and disease burden
• One‐time screening for HCV infection in the birth cohort may identify infected patients at earlier stages of disease
Birth Cohort Screening Risk Factor–Based Screening
• Past or current injection drug use
• Receiving a blood transfusion before 1992
• Long‐term hemodialysis
• Being born to an HCV‐infected mother
• Incarceration
• Intranasal drug use
• Getting an unregulated tattoo
• Other percutaneous exposures
Important Risk Factors1,2
PATIENT SCREENING FOR HCVPATIENT SCREENING FOR HCV
Changing Trends in HCV and Acute HCV in the US
HCV in 2015 (NY State)
0
50
100
150
200MaleFemale
https://www.health.ny.gov/statistics/diseases/communicable/index.htm. CDC. National Notifiable Diseases Surveillance System.
HC
V C
ases
(num
ber)
20 300 10 60 7040 50 80 90
Age (years)
BabyBoomers
PWID
0
0.5
1
1.5
2
2.5
3
Rat
e (p
er 1
00,0
00 p
opul
atio
n)2000 2003 2006 2009 2012 2015
Year
Acute HCV Rate in USAge group (years)
20-2930-3940-4950-59≥60
*Estimated prevalence of acute HCV infections after adjusting for under‐ascertainment and under‐reporting. Latest available data.1. Campbell CA, et al. MMWR Morb Mortal Wkly Rep. 2017;66(18):465‐469. 2. CDC. Hepatitis Surveillance Report – United States. https://www.cdc.gov/hepatitis/statistics/2015surveillance/commentary.htm. Accessed May 11, 2017. 3. Litwin AH, et al. Clin Infect Dis. 2005;40(Suppl 5):S339‐S345. 4. CDC. Hepatitis Surveillance Report – United States. https://www.cdc.gov/nchhstp/newsroom/2017/hepatitis‐surveillance‐report.html. Accessed May 11, 2017.
IDU Is the Primary Risk Factor for New HCV Infections in the United States1
~3.5 million people living with chronic HCV in the United States2
are current or former PWIDs3
~60% With an estimated 34,000 new HCV infections in the United States in 2015,
new infections have nearly tripled in the past 5 years, reaching a 15‐year high.2,4,*
The greatest increases in new HCV infections, and the highest overall number of cases, were among young people aged 20‐29 years, with injection drug use as the primary
route of transmission.4
HCV Outbreaks Associated With IDU Are Occurring Throughout the United States
Injection Networks Are Driving Hepatitis C Outbreaks
*Based on data from national surveillance and supplemental case follow‐up at selected jurisdictions describing the US epidemiology of HCV infection among young persons (aged ≤30 years).SuryaprasadAG, et al.
• Higher incidence of HCV infection (especially among younger PWIDs) in 2012 than in 2006 in at least 30 states, with the largest increases occurring in nonurban counties east of the Mississippi River*
Data indicate an emerging US epidemic of HCV infection among young nonurban persons (aged ≤30 years).
Data indicate an emerging US epidemic of HCV infection among young nonurban persons (aged ≤30 years).
HCV Linkage to Care
Chronic HCV Treatment Cascade in the US (2003‐2009)
Pers
ons
With
HC
V in
the
US
(%)
Yehia BR, et al. PLoS One. 2014;9:e101554.
0
20
40
60
80
100
Chronic HCVInfection(n=3,500,000)
100%
50%
Diagnosedand Aware(n=1,743,000)
Access toOutpatient Care
(n=1,514,667)
UnderwentLiver Biopsy
(n=581,632)
HCV RNAConfirmed
(n=952,726)
AchievedSVR
(n=326,859)
PrescribedHCV Treatment
(n=655,883)
43%
27%
17% 16%9%
Systematic Review and meta-analysis: MEDLINE, EMBASE, and Cochrane Database of Systematic Reviews (n=10 eligible articles).Numbers in parentheses are number of articles assessing a step in the cascade.
TheLargest Gap
Baby Boomers Who Were HCV RNA Positive:Linkage to Care in the US (2016)
Reau N, et al. Hepatology. 2018;68(suppl S1):892A‐893A. Abstract 1567.
Propo
rtion of HCV RNA Pos
itive (%
)
0
20
40
60
80
100100%
23%
HCV RNAPositive(n=67,223)
Linked to Specialist
SawSpecialist
Received Treatment After
Specialist Visit
8%32%
Patients HCV antibody positive and administered HCV RNA test were longitudinally followed.Specialist (gastroenterology/hepatology/ infectious disease)Primary care physician (general practitioner/family medicine/internal medicine).
0
20
40
60
80
100100%
41%
HCV RNAPositive(n=67,223)
Linked to Primary Care Physician
Saw Primary Care Physician
Received Treatment After Primary Care Physician Visit
3%8%Propo
rtion of HCV RNA Pos
itive (%
)
Data from two large national laboratory companies
Young Adults Who Were HCV RNA Positive:Linkage to Care in the US (2016)
Reau N, et al. Hepatology. 2018;68(suppl S1):892A‐893A. Abstract 1567.
Linked to Specialist
Patients HCV antibody positive and administered HCV RNA test were longitudinally followed.Specialist (gastroenterology/hepatology/ infectious disease)Primary care physician (general practitioner/family medicine/internal medicine).
Linked to Primary Care Physician
0
20
40
60
80
100100%
40%
HCV RNAPositive(n=42,263)
2%5%Propo
rtion of HCV RNA Pos
itive (%
)Saw Primary Care Physician
Received Treatment After Primary Care Physician Visit
Propo
rtion of HCV RNA Pos
itive (%
)
0
20
40
60
80
100100%
9%
HCV RNAPositive(n=42,263)
SawSpecialist
Received Treatment After
Specialist Visit
2%23%
Data from two large national laboratory companies
HCV Care Cascade Among PWID
0
10
20
30
40
50
60
70
80
90
100
Anti‐HCVPositive
Tested forRNA
HCV RNAPositive
Referred toCare
Attended FirstAppointment
100
4530
203A
nti‐H
CV‐Pos
itive Participa
nts [%
]
Blackburn NA, et al. Public Health Rep. 2016;131 (2 suppl):91‐97.
What Are The Barriers To Linkage of Care for Hepatitis C Patients?
– Fragmentation of HCV services– Medicaid health insurance restrictions– Denial or lack of understanding about the importance of care
– Concerns about costs of care– Conditions that make it harder for patients to enter care, like substance abuse and mental health issues
– Difficulties arranging transportation, childcare, time away from work, or other logistics related to keeping appointments
– Fear of stigma
C‐SCOPE Study: Perceived Barriers Related to HCV Management Among Physicians Treating PWID (2017)
Litwin AH, et al. Hepatology. 2017;66(suppl S1):568A-569A. Abstract 1064.
5-point Likert scale (1: not a barrier; 2: minor barrier; 3: moderate barrier; 4: major barrier; 5: extreme barrier).
Perceived Barriers to HCV Testing, Evaluation, and Treatment (n=203)
0
1
2
3
4
5
Mea
n B
arrie
r Rat
ing
2.78
Lack Funding for Non-Invasive
Liver Testing
Health System Barriers Clinic Barriers Patient Barriers
Lack Funding for New
HCV Therapy
AbstinenceRequired forTreatment
Access
Long Patient Wait Lines to
See HCV Specialist
Lack of Case Managers for
Linkage to Care
Need for Off-SiteReferral forAssessment
and Treatment
Lack of PeerSupport
Programs for Testing
Do not Attend Referral
Appointment for Testing
Difficulty Navigating
Health System
Fear ofSide Effects
Not Motivatedto be Treated
for HCV
2.76 2.73 2.712.36 2.31 2.27
3.05 3.01 2.99 2.90
HCV Access to Treatment
IFN6 Mos
PegIFN/ RBV
12 Mos
IFN12 Mos
IFN/RBV12 Mos
PegIFN12 Mos
2001
1998
2011StandardInterferon
RibavirinPeginterferon
1991
PegIFN/RBV +DAA
IFN/RBV6 Mos
616
3442 39
55
70+
0
20
40
60
80
100
DAA + RBV ±PegIFN
90+2013
All–OralDAA±RBV
Current95+
All‐Oral Therapy
Direct‐Acting Antivirals
Very high SVR rates; therapies highly tolerable All‐oral therapy for every patient Treatment generally just 8‐12 weeks
Approved GenotypesGrazoprevir/elbasvir 1, 4Ombitasvir/paritaprevir/ritonavir 4Ombitasvir/paritaprevir/ritonavir + dasabuvir 1
Sofosbuvir + daclatasvir 1, 3Sofosbuvir/ledipasvir 1, 4, 5, 6Simeprevir + sofosbuvir 1, 4Sofosbuvir/velpatasvirGlecaprevir/PibrentasvirSofosbuvir/velpatasvir/Voxilaprevir
1, 2, 3, 4, 5, 6
Single‐pill formulations or2‐3‐pill combinations
Effective for all genotypes
HCV Treatment Access Based on Insurance Status(2011‐2017)
Predictors of receiving HCV treatment versus commercial insurance (adjusted odds ratio)
Medicare: 0.79Medicaid: 0.21
Continuing restrictions by payer status, particularly Medicaid reimbursement, continue to contribute to persisting inequities in receipt of DAA therapies
Wong RJ, et al. Hepatology. 2017;66(suppl S1):307A. Abstract 561.
0
5
10
15
20
25
30
2011 2012 2013 2014 2015 2016 2017
HCV Treatmen
t (%
)
Commercial
Medicare
Medicaid
HCV Treatment by Payer
21%
79%
NVHR Report: 2017 Medicaid Access to HCV Therapy and Prescriber Restriction
Medicaid Access Prescriber Restriction
https://stateofhepc.org/wp‐content/uploads/2017/10/State‐of‐Access‐Infographic.pdf. https://stateofhepc.org/wp‐content/uploads/2017/10/Prescriber‐Infographic.pdf.
Best WorseAccess
AK, CT,MA, NV, WA
AR, LA,MT, OR, SD
Prescriber Restrictions
None By or inConsultation
With Specialist
SpecialistMust
Prescribe
UnknownNVHR: National Viral Hepatitis roundtable.
OHIOBy or in Consultation with
Specialist
NVHR Report: 2017 Medicaid Fee‐for‐Service Liver DamageRestrictions for HCV Treatment
Liver Damage Restrictions
https://stateofhepc.org/wp‐content/uploads/2017/10/Liver‐Damage‐Infographic.pdf.
Liver Damage Restrictions
No restrictions
F1
F2
F3
NVHR: National Viral Hepatitis roundtable.
OHIONo Fibrosis Restrictions
NVHR Report: 2017 Medicaid Fee‐for‐Service SobrietyRestrictions for HCV Treatment
Sobriety Restrictions
Sobriety Restrictions
No restrictions
Screening/counseling
Abstain (1 month)
Abstain (3 months)
Abstain (6 months)
Abstain (12 months)
https://stateofhepc.org/wp‐content/uploads/2017/10/Sobriety‐Infographic.pdf.
NVHR: National Viral Hepatitis roundtable.
OHIO6 months Abstinence
HCV Care Model
Treat to Prevent: Strategies To Identify and Advance HCV Patient Care
30
PATIENT IDENTIFICATION
MEDICAL PROVIDERREFERRAL
MANAGEMENT
Outreach & Awareness: First Contact:• Recovery Treatment Center – Short
& Long Term Residential Treatment Centers
• Sober Living Homes• FQHC
Diagnosis:• HCV Testing ‐Antibody• HCV Confirmation – PCR RNA
Quantification• HCV Genotyping• Fibrosis Determination ‐ FibroScan• Urine Drug Toxicology Testing• HAV and HBV Testing –Vaccination• Liver Cancer Screening – Abdominal U/S
Clinical Care Coordination:Appropriate link to quality care –“Linkage To Care” [LTC]• Care Specialist/Navigator• Research Specialist• Website Portal ‐To submit and
communicate information • Improved information sharing &
communication between treatment center & medical provider
HCV Therapy:• Medication – Pharmacy• Care – Face‐to‐Face In Office +/‐
Telemedicine• Support Adherence to therapy• Monitor Patient Related Outcome to
Therapy• Prevent Post‐Cure Reinfection
HARM Reduction:• Opioid substitution therapy [OST] –
Buprenorphine/Methadone• Needle Exchange Programs• Behavioral Health Therapy• Relapse Prevention – Naltrexone
Integrated and Sustainable Care of HCV Patients
Linkage to C Care ProgramCHOOSE WISELY TO ACHIEVE GREATEST CERTAINITY OF CARE AND HIGHEST CERTAINITY
OF CURE
LINKAGE TO C CARE PROGRAM –A COLLABORATIVE CARE MODEL
EDUCATION LINKAGE TO CARE CARE CO‐ORDINATION RESEARCH
Public
Website
www.linkagetocare.com
Medical Provider
HCV Screening in PWID Population
Finding A Provider –“Choose Wisely”
• Navigation Team
• Care Coordination Team
• HARM Reduction Team
Individual Counselling
“Encourage the patient to follow the treatment care plan”
Education
“Listening to my story”
Behavior Modification
Acceptance of HCV Treatment
Adherence to HCV Treatment
HCV Treatment Effectiveness
Real World SVR12
Post‐Therapy Viral Re‐infection
Patient Related Outcomes [PRO]
Adherence to Treatment
Adherence to Provider Care PlanCME HCV
Screening and
Treatment Training Program
HCV Patient Self Referrals
Linkage to Care
Reduce HCV Reinfection post SVR
Rx CARE PLAN
In Office Based Care
Telemedicine
Project ECHO
Access to DAA Rx
340b Revenue
www.linkagetocare.com
LTC PDMS Training Program Manual & On Line
Linkage to Care [LTC]www.linkagetocare.com
Hub and Spoke Model – Centralizes Multi‐Site CommunicationPWID HCV PATIENT IDENTIFIED
Patient Information Sent to Linkage to Care ProgramWeb‐Based Program[HIPPA Compliant]
Linkage to Care Specialist/Navigator
Community Clinic
Project ECHO HCVTelemedicine
UninsuredPatient
Local Private ProviderNetwork
• GI/Hepatology• Addiction Medicine• Primary Care• Telemedicine
InsuredPatient
HARM Reduction
Adherence To Clinical Program
Post Therapy IDU Relapse & HCV Reinfection
0
200
400
600
800
1000
1200
1400
1600
1800
2000
Referred toLTC
HCV RNA [+] Contacted byLTCS
Referred toMedicalProvider
Made it toFirst
Appointment
Initiated HCVRx
Finished Rx orAchievedSVR12
1838
855680
470
172 83 62
Num
ber o
f Patient
s
LTC Cascade of Care for HCV Patients
AASLD HCV Special Conference Miami Feb 2019 – Poster #21
80% Contacted by LTCS69% Referred to Medical Provider37% Made it to First Appointment48% Initiated HCV RX75% Finished Rx or Achieved SVR12
Improving Hepatitis C Care Cascade Through Electronic Health Engagement
Linkage to C Care Educational Material
A New Life ‐Testimonials from LTC Patients
ECHO Model: HCV Treatment With DAA Regimens by Primary Care Providers
ECHO program: retrospective analysis of use with DAA regimens (2012‐2015)Regimens
Genotype 1Ledipasvir/sofosbuvir + RBV (8 and 12 weeks)Simeprevir + sofosbuvir + RBV (12 weeks)
Genotype 2: sofosbuvir + RBV (12 weeks)Genotype 3: sofosbuvir + RBV (24 weeks)
Georgie F, et al. J Hepatol. 2016;64(suppl 2):S818‐S819. Abstract SAT‐260.
• Telehealth PCP training, advice, and support to manage HCV
• Academic/specialty sites (n=6)
• Multiple ECHO sites in Arizona, New Mexico, Oklahoma, Texas, Utah, Washington
• Successful in HCV treatment using IFN‐based regimens
ECHO Model: Baseline Characteristics and SVR12 Rates in HCV Genotype 1 (2012‐2015)
Number 40 65 69 155 7 24 18 106 7 17Age (years) 53 56 55 59 55 61 57 60 53 60White/black (%) 40/0* 89/5 56/1* 81/8 100/0 83/13 79/4 79/6 14/0* 88/0Treatment-naïve (%) 95 97 93 68 43 42 67 37 57 41Prior IFN-based regimen (%) 5 3 7* 32 57 58 33* 63 43 59Cirrhosis (%) 5 12 41 43 100* 54 46 57 43 65ALT >1.5x ULN (%) 23 23 26 28 71 38 29 27 29 47
Georgie F, et al. J Hepatol. 2016;64(suppl 2):S818‐S819. Abstract SAT‐260.
ECHO Specialty
SVR12 Rates (mITT)
LDV/SOF8 Weeks
0
20
40
60
80
100
SVR12 (%
)
86%
100% 100%100%
88%82%
93%99%95%
94%
LDV/SOF12 Weeks
LDV/SOF + RBV8 Weeks
SIM/SOF12 Weeks
SIM/SOF + RBV12 Weeks
*P<0.05 versus speciality care.
Pts (N = 600) from 13 urban, FQHCs in DC, all treated with LDV/SOF per FDA prescribing information; all providers given 3‐hr training in AASLD/IDSA HCV guidance
Kattakuzhy S, et al. Ann Intern Med. 2017;167:311‐318.
SVR12 (%
)
100
80
60
40
20
0NP/PA Primary MD Specialist MD Overall
89 87 84 86
Refer According to Provider Experience ReferNo Need to Refer
No advanced fibrosis
Compensated cirrhosis
Decompensated cirrhosis (any ascites)
Hepatitis C reinfection
Renal impairment If required by insurance
Prior treatment with peginterferon/RBV
HIV coinfection (refer to provider with experience treating HIV)
Active substance use
Recurrent hepatitis C infection after liver transplantation
Identify undiagnosed HCV› HCV rapid testing› PWID Testing – “Next Wave”› Age Cohort Testing
Preventing infection and reinfection› Outreach and education› Safer injection counseling› Reinfection prevention counseling
Treatment access and delivery
› Linkage to HCV care› Access to HCV drugs› Primary care–based therapy› Methadone‐based directly
observed therapy› Access to specialty care Telemedicine
Electronic Health Engagement
Screening and Linkage to Care Can Help Lead to Curing HCV for Our HCV‐Positive FQHC Patients
Screen
Patient should be screened whether
or not symptoms are present
Provide HCV Care
Assist withscheduling the appointment
Treat hepatitis C patient at the FQHC
Follow Up With Patients and HCV Care Provider
Call to checkthat your patient followed through
Follow up screening for liver cancer
Diagnose
Explain to your patient what a diagnosis of HCV means and that HCV is curable
DISCUSSION
