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