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The Future of the HCV Workforce: Lessons Learned from HIV
Marissa TonelliSenior Manager, HealthHCV
HIV/Hep C Surveillance Comparison
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
– Prevalence: 2%
• Chronic HCV cases not included in NHANES (CDC health statistics survey) estimate
– Homeless (n=142,761-337,6100)
– Incarcerated (n=372,754-664,826)
– Veterans (n=1,237,461-2,452,006)
– Active military (n=6,805)– Healthcare workers
(n=64,809-259,234)– Nursing home residents
(n=63,609) Total Not Included NHANES
NHANES0
1
2
3
4
5
6
7
8
5.19
1.9
7.1
3.8
3.27
Estimated HCV Cases
Conservative estimate
Num
ber o
f Cas
es (i
n m
illio
ns)
Chak E, et al. Liver Int. 2011; 31:1090-1101; http://www.cdc.gov/hepatitis/HCV/HCVfaq.htm#section2.
Davis GL. Rev Gastroenterol Disord 2004;4:7-17.
Disease Burden of Patients Infected 20 Years or More is Peaking Now
Patients infected
Infected >20 yrs
Pre
vale
nce
(%)
1960 1970 1980 1990 2000 2010 2020 2030
4.0
3.0
2.0
1.0
0.0
People living with HCV for over 20 years in relation to all infected patients is increasing.
2000 2010 2020 2030 2040
HCV infection 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.
Morbidity and Complications Increase as Infected Population Ages
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
Adapted from Volk ML et al. Hepatology 2009;50:1750-1755.
49%Aware of their
infection
51%Unaware of
theirinfection
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 HCV-
infected 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)
• 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)
Reasons for Failure to Identify Chronic HCV Infection
Adapted from Volk ML et al. Hepatology 2009;50:1750-1755.
42%
22%
36%
Availability of Surveillance Data on Risk Exposures/Behaviors Associated with
Acute Hepatitis C
Risk IdentifiedNo Risk IdentifiedRisk Data Missing
States States that Report Acute HCV Infection
to CDC
States that Report
Chronic HCV Infection to
CDC
States/Cities that Report Advanced
Surveillance to CDC
States that Report HCV
Prevelance to CDC
0
5
10
15
20
25
30
35
40
45
50
50
42
34
8
0
Gaps in HCV Surveillance Infra-structure
Undiagnosed/Untreated HCV May Lead to Chronic Liver Disease and Liver Cancer
Fibrosis1
Chronic HCV infection can lead to the development of fibrous scar tissue within the liver
Fibrosis Cirrhosis Hepatocellular Carcinoma
(with cirrhosis)
Cirrhosis1,2
Over time, fibrosis can progress, causing severe scarring of the liver, restricted blood flow, impaired liver function, and eventually liver failure
HCC3
Cancer of the liver can develop after years of chronic HCV infection
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.
Decompensated cirrhosis:AscitesBleeding gastroesophageal varicesHepatic encephalopathyJaundice
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 co-infection
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 Peg-IFN/RBV + TVR or BOC1
(DAAs)
Prior Response
Mean Cost per SVR
Naïve (n=57) $125,915Relapse (n=61) $164,840Partial or Null Responders (n=82)
$302,070
Willingness-to-pay threshold for new
regimens
• Need payer data, real-world clinical effectiveness data, and models
Cirrhosis (n=82) $266,670
1Sethi, AASLD 2013; #1847
$-
$20,000
$40,000
$60,000
$80,000
$100,000
$5,870 $5,330
$27,845
$43,671
$93,609
The Rising Costs of Untreated Hepatitis C
Per Patient Per Year Estimated Costs
McAdam-Marx C, McGarry LJ, Hane CA, Biskupiak J, Deniz B, Brixner CI. All-Cause 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 cost-sharing
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
Respondent BreakdownRespondent
sProfessional 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)
Prescribing Providers (MD, DO, NP, PA), Pharmacists, Dentists,
Researchers, Health Administrators, Social Workers/Case Managers,
Consumers
50 US States and Puerto Rico
371(of 2,531)
Prescribing Providers (MD, DO, NP, PA) working in the scope of primary
care45 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 co-manage 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 co-infection 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 NWWashington, DC 20009
202.232.6749
www.healthhiv.org