The Future of the HCV Workforce:
Lessons Learned from HIV
Marissa Tonelli
Senior Manager, HealthHCV
HIV/Hep C Surveillance Comparison
AK
HI
HIV Prevalence
by State
33 - 68
69 - 116
117 - 228
229 - 338
339 - 488
489 - 810
CA
OR
WA
NV
ID
AZ
MT
WY
CO
ND
SD
NE
KS
OK
MN
IA
LA
AR
MO
WI
MS
IL
AL
TN
IN
MI
2011 State HIV Prevalence Rates
UT
NM
TX
Data was adapted from the Centers for Disease Control
and Prevention's 2011 HIV Surveillance Report.
Prevalence rates are calculated per 100,000 people.
April 19, 2013
KY
OH
GA
WV
SC
FL
PA
VA
NC
NY
CT
MA
RI
VT NH
NJ
MD DE
ME
PR
Puerto Rico
Purpose
•
Education & Training: deliver medical and consumer
education and training programs to improve the ability
of organizations, professionals, and individuals to address
HCV
•
Research & Evaluation: conduct health services research
to identify trends across HCV, HIV, and the broader
health care landscape
•
Advocacy: develop sound public health policy
responsive to the shifting landscape of HCV and health
care
Chronic HCV Infection in the US
•
More than 5.2 million living with
chronic HCV in US
Estimated HCV Cases
8
– Prevalence: 2%
Chronic HCV cases not
included in NHANES (CDC
health statistics survey)
estimate
– Homeless (n=142,761-337,6100)
– Incarcerated (n=372,754664,826)
– Veterans (n=1,237,4612,452,006)
– Active military (n=6,805)
– Healthcare workers
(n=64,809-259,234)
– Nursing home residents
(n=63,609)
Number of Cases (in millions)
•
7.1
7
Conservative estimate
Upper limit of estimate
6
5.19
5
3.8
4
3.27
3
1.9
2
1
0
Total
Not Included
NHANES
Chak E, et al. Liver Int. 2011; 31:1090-1101; http://www.cdc.gov/hepatitis/HCV/HCVfaq.htm#section2.
NHANES
Disease Burden of Patients Infected 20 Years or
More is Peaking Now
People living with HCV for over 20 years in relation to all infected
patients is increasing.
4.0
Patients infected
Prevalence (%)
3.0
Infected >20 yrs
2.0
1.0
0.0
1960
1970
1980
1990
Davis GL. Rev Gastroenterol Disord 2004;4:7-17.
2000
2010
2020
2030
Morbidity and Complications Increase as Infected
Population Ages
2000
HCV infection
2010
2020
2030
2040
2,940,678 2,870,391 2,281,556 2,433,709 2,177,089
Cirrhosis
472,103
720,807
858,788
879,747
828,134
Decompensated
Cirrhosis
65,294
103,117
134,743
146,408
142,732
Hepatocellular
Carcinoma
7,271
11,185
13,183
13,390
12,528
Liver-related
death
13,000
27,732
36,483
39,875
39,064
Davis GL et al. Liver Transpl 2003;9:331-338.
Baby Boomers
• 5x more likely to be
infected with HCV
• 3 out of every 4 people
living with HCV are
born between these
years
• 73% of HCV-related
deaths are among
baby boomers
CDC Know More Hepatitis Campaign. http://www.cdc.gov/knowmorehepatitis/media/pdfs/infographic-paths.pdf
Increasing Burden of Disease
• Large pool of surviving patients remains at risk of
progressive disease as the duration of their
infection increases
• A dramatic increase will occur in the number
patients with liver failure, HCC (cancer), and death
caused by liver disease
• Identification and treatment of a larger proportion
of infected patients may decrease morbidity and
mortality from this disease
Davis GL et al. Liver Transpl 2003;9:331-338.
The Problem: Only One-Half of Those Infected with
HCV Are Aware of Their Infection
49%
Aware of their
infection
51%
Unaware of
their
infection
Adapted from Volk ML et al. Hepatology 2009;50:1750-1755.
Who Should Be Screened for HCV
• Everyone born from 1945
through 1965 (one-time)
• Persons with abnormal ALT
levels
• HIV positive persons
• Past or present injection drug
use
• Sex with an IDU; other high-risk
sex
• Incarceration
• Intranasal drug use
• Receiving an unregulated
tattoo
• Children born to an HCVinfected mother
• Recipients of blood transfusion
or organ transplant prior to
1992
• Persons who received clotting
factor concentrates produced
before 1987 (such as persons
with hemophilia)
• Chronic (long-term)
hemodialysis
• Occupational percutaneous
exposure (needle stick)
• Surgery before
implementation of universal
precautions
Smith at al. Ann Intern Med 2012; 157:817-822. Moyer et al. Ann Intern Med epub 25 June 2013
USPSTF/CDC Guidelines
• Recommends screening for hepatitis C
virus (HCV) infection in persons at high
risk for infection (Grade B)
• Recommends offering 1-time screening
for HCV infection to adults born
between 1945 and 1965 (Grade B)
Reasons for Failure to Identify Chronic HCV Infection
• Asymptomatic patients without any other
medical problems may not seek medical
attention
• Many primary care physicians lack knowledge
about risk factors and testing for hepatitis C
• Patients may be reluctant to reveal risk factors
• Patients may be outside healthcare system
(young, poor, drug addicts)
Adapted from Volk ML et al. Hepatology 2009;50:1750-1755.
Availability of Surveillance Data on Risk
Exposures/Behaviors Associated with Acute
Hepatitis C
36%
42%
Risk Identified
No Risk Identified
Risk Data Missing
22%
Gaps in HCV Surveillance Infrastructure
50
50
45
40
42
35
34
30
25
20
15
10
8
5
0
0
States
States that Report States that Report States/Cities that States that Report
Acute HCV
Chronic HCV Report Advanced HCV Prevelance
Infection to CDC Infection to CDC Surveillance to
to CDC
CDC
Undiagnosed/Untreated HCV May Lead to
Chronic Liver Disease and Liver Cancer
Fibrosis
Cirrhosis
Hepatocellular Carcinoma
(with cirrhosis)
HCC3
Cancer of the liver
can develop after
years of chronic
HCV infection
Fibrosis1
Chronic HCV
infection can
lead to the
development of
fibrous scar
tissue within
the liver
Cirrhosis1,2
Over time, fibrosis can
progress, causing severe
scarring of the liver,
restricted blood flow,
impaired liver function,
and eventually liver failure
Decompensated
cirrhosis:
Ascites
Bleeding gastroesophageal
varices
Hepatic encephalopathy
Jaundice
Chronic liver disease includes fibrosis, cirrhosis, and hepatic decompensation; HCC=hepatocellular carcinoma.
1. Highleyman L. Hepatitis C Support Project. http://www.hcvadvocate.org/hepatitis/factsheets_pdf/Fibrosis.pdf. Accessed August 18, 2011; 2. Bataller
R et al. J Clin Invest. 2005;115:209-218;
3. Medline Plus. http://www.nlm.nih.gov/medlineplus/enxy.article/000280.htm. Accessed August 28, 2012; 4. Centers for Disease Control and
Prevention. http://www.cdc.gov/hepatitis/HCV/HCVfaq.htm. Accessed May 8, 2012.
HIV/HCV Co-infection Epidemiology
• 20-30% of people with HIV are co-infected with
HCV
• HIV/HCV co-infection is more common in people
with high exposures to blood and blood products
•
•
60-90% of HIV positive hemophiliacs have HCV
50-70% of HIV positive IDUs have HCV
• Increasing incidence of HCV in HIV+ MSM
• Liver disease (mostly related to HCV) is the second
leading cause of death in people with HIV infection
• Over 80% of people with HIV/HCV have genotype 1
infection (harder to treat)
Maier, World Zj Gastro 2002; Sherman, CID 2002; Smith, AIDS 2012;
Comparing HIV/HCV Co-infection to HCV
Mono-infection
Positives:
• Higher rate of HCV diagnosis
• Better coverage and services for HCV infection
(sometimes) through ADAP/Ryan White
Negatives:
• Faster progression to cirrhosis
• Fewer diagnosed people treated for HCV (due to coinfection complications)
• Delayed inclusion in clinical trials for HCV
Neither:
• Cure rates with DAA-containing regimens (has not been
determined)
• Clinical benefits of cure
Graham CID 2001; Davies, PLoS ONE 8(2): e55373. doi:10.1371/journal.pone.0055373
Who is Providing HCV Treatment?
Primarily
• Hepatologists
• Gastroenterologists
• Infectious Diseases
Specialists
Secondarily
• PCPs
• Physician extenders
– NP, PA
Costs of HCV Treatment
• Standard cost of HCV treatment (Peg-INF &
RBV)= about $35k
• Plus DAA (telaprevir/boceprevir)= about $90k
• Estimated cost of new market treatments
(sofosbuvir)= additional $84k
• Over the next 20 years, total medical costs
for patients with HCV infection are expected
to increase from $30 billion in 2009 to over $85
billion in 2024
FDA Approves 'Game Changer' Hepatitis C Drug Sofosbuvir. Medscape. Dec 06, 2013.
NVHR 2014
Don’t Assume Regimens That Cost Less Are Actually
Cheaper
Actual Costs of PegIFN/RBV + TVR or BOC1
Willingness-to-pay
threshold for new
(DAAs)
regimens
Prior
Response
Naïve (n=57)
Relapse (n=61)
Partial or Null
Responders
(n=82)
Cirrhosis (n=82)
1Sethi,
AASLD 2013; #1847
Mean Cost
per SVR
$125,915
$164,840
$302,070
$266,670
• Need payer data, realworld clinical
effectiveness data, and
models
The Rising Costs of Untreated Hepatitis C
$100,000
$93,609
$90,000
$80,000
$70,000
$60,000
$50,000
$43,671
$40,000
$27,845
$30,000
$20,000
$10,000
$5,870
$5,330
$-
HCV patients
without liver
disease
HCV patients with HCV patients with HCV patients with HCV patients with
compensated
decompensated
hepatocellular
liver transplant
cirrhosis
cirrhosis
carcinoma
Per Patient Per Year Estimated Costs
McAdam-Marx C, McGarry LJ, Hane CA, Biskupiak J, Deniz B, Brixner CI. AllCause and Incremental Per Patient Per Year Cost Associated with Chronic
Hepatitis C Virus and Associated liver Complications in the United States: A
Managed Care Perspective. J Manag Care Pharm. 2011 Sep;17(7): 531-46.
Implications of ACA
• USPSTF recommendations for HCV screening for
at-risk and baby boomers
• Private Insurance: Only exceptions are grandfathered
plans that existed before ACA implementation
o Medicaid (Traditional): Elected independently on a
state-by-state basis
o Medicaid (Expanded): Required to cover without costsharing
o Medicare: No finalized NCD for baby boomers, but
covers screening at “increased risk”
• All forms of insurance are required to provide
one drug per class to treat HCV
HealthHIV’s 3rd Annual
State of HIV Primary Care
Survey Findings
OR
WA
NV
ID
AZ
UT
MT
WY
NM
CO
ND
SD
NE
TX
KS
OK
MN
IA
MO
AR
LA
WI
IL
MS
MI
IN
TN
AL
KY
OH
GA
WV
SC
FL
PA
VA
NC
NY
CT
MA
RI
VT NH
NJ
MD DE
ME
September 4, 2013
Puerto Rico
PR
Third Annual State of HIV Primary Care Provider Survey Respondents
and 2011 State HIV Prevalence Rates
AK
HI
CA
Provider Survey Respondents
State HIV Prevalence
33 - 68
69 - 116
117 - 228
229 - 338
339 - 488
489 - 810
Map shows the location of provider respondents to HealthHIV's
Third Annual State of HIV Primary Care Survey. HIV Prevelance
Data was adapted from the Centers for Disease Control
and Prevention's 2011 HIV Surveillance Report.
Prevalence rates are calculated per 100,000 people.
Respondent Breakdown
Respondents
Professional Designation
Location
2,531
Prescribing Providers (MD, DO, NP,
PA), Pharmacists, Dentists,
Researchers, Health Administrators,
Social Workers/Case Managers,
Consumers
50 US States,
4 US territories,
28 Countries
2,494
(of 2,531)
371
(of 2,531)
Prescribing Providers (MD, DO, NP,
PA), Pharmacists, Dentists,
Researchers, Health Administrators,
Social Workers/Case Managers,
Consumers
Prescribing Providers (MD, DO, NP,
PA) working in the scope of primary
care
50 US States and
Puerto Rico
45 US States and
Puerto Rico
Methods
• Fifty-five question instrument
(51 quantitative, 4 qualitative)
• Distributed online using Survey
MonkeyTM (March 7 – June 17, 2013)
• Recruited using email lists, monthly
newsletters, and website postings
• Convenience sample; no incentive
provided
HIV PCP Profile Comparison
Gaps in HCV Care Capacity
• 89% of PCPs treating HIV also provide HCV screening
• 97% provide HCV screening to all patients born
between 1945 and 1965, or based on identified risk
factors
Gaps in HCV Care Capacity
Survey Implications
• Highlights need for HCV education among both
PCPs treating HIV and those who are not
• Leverage specialists working in primary care as
mentors to train other PCPs on treating HIV/HCV
• Correlation between mental health/substance
abuse and poor health outcomes for people
living with HIV/HCV suggests services have yet to
be integrated fully into primary care settings
• PCPs must be trained more thoroughly on ACA,
especially changes to service delivery and
reimbursement (i.e. treatment costs)
HCV Provider Survey
HealthHIV surveyed 64 providers at
AASLD’s Liver Meeting on Nov 1-4th, 2013:
• Over half of respondents (56%) were
MDs
• 11% of respondents were NPs
• 5% of respondents were PAs
• Half of respondents (48%) practice in
the US
HCV Survey Findings
• Half (51%) believe capacity of healthcare system is
insufficient to diagnose/treat HCV
• Roughly one-third (36%) believe PCPs should comanage HCV care/treatment with specialist
-
Only 16% believe PCPs should provide comprehensive HCV
care
• Over half (62%) believe low patient awareness on HCV
risk factors is a barrier to providing HCV testing
• Clear majority (80%) expressed strong interest in
receiving medical education on new HCV therapies
• HCV treatment algorithms was the most requested
CME topic
Best Practices for Screening
• Testing needs to be implemented in settings with
high HCV prevalence such as prisons, substance
abuse programs, and STD clinics
• Prevention efforts are needed for the younger
population in high-risk settings such as substance
abuse programs
• Routinize HCV screening: Consider EMR reminders
help to prompt providers to test patients born
between 1945-1965
MedScape Hot Topics, Nov 2013
Education for Patients
• Educate patients on:
o Transmission of HCV
o Need to be screened for HCV
o Importance of adherence and engagement in
care
o Screening and treatment coverage/availability
that result from the ACA and new treatment
development
MedScape Hot Topics, Nov 2013
Education for Advocates
• Advocates need to be aware of:
o Burden of disease and surveillance
o Need for increase in surveillance mechanisms
o At-risk populations (in order to advocate for appropriate
allocation of resources)
o Best methods to translate educational initiatives to at-risk
populations
o What treatment is available to patients depending on
insurance to ensure treatment access for all patients regardless
of socioeconomic or insurance status
o How PCPs can increase adherence to treatment and reduce
risk factors for cirrhosis, etc in primary care settings
MedScape Hot Topics, Nov 2013
Education and Training for PCPs
• Expanding HVC patient population creates a need for
PCPs to initiate and provide HCV treatment
• PCPs need information on:
o Screening guidelines (at-risk populations and birth cohort)
o Newest treatment methods and side effects of those
methods
o Determining treatment options for patients, including special
populations, to ensure SVR
• Implement team approach with PCP, physician
extenders (NP/PA), support staff, specialist, and patient
• PCPs (and physician extenders) are responsible for
educating patients about their disease, drug regime,
side effects, the importance of adherence to
treatment, and the consequences of non-adherence
to treatment
MedScape Hot Topics, Nov 2013
• Provides HIV expert mentoring to clinicians in
primary care practices, community health
centers, health clinics, and residency program
• Matches MD, NP, PA to HIV clinical experts for
coaching and training on HIV care
• Offers expansive educational resources to
mentors and mentees
Lessons Learned from Workforce Initiative
• PCPs have the skills to treat complex infectious
diseases (such as HIV/HCV), but lack
confidence
• There is an increased need for PCP integration
in HIV/HCV care in rural areas with fewer
specialists
• As PCPs became more advanced in HIV
treatment, they asked more about HCV coinfection and mono-infection
• PCPs are overburdened and need incentives
for completing training programs
HealthHIV’s HIV Primary Care
Training and Certificate Program
2000 S Street NW
Washington, DC 20009
202.232.6749
www.healthhiv.org