The Burden of Hepatitis C Infection

Monina Klevens, Iqbal K, Rizzo E, Thomas A, Vonderwahl C, Bryant T, Sweet K, Speers S, Sanchez M, Bornschlegel K, and Jiles R.

Objectives• Describe relevant characteristics of

hepatitis C• Describe US burden of disease• Outline challenges to state specific

burden measures

Objectives• Describe relevant characteristics of

hepatitis C• Describe US burden of disease• Outline challenges to state specific

burden measures

Features of HCV Infection

Transmission Blood

Incubation period Average, 6–7 wkRange, 2–26 wk

Acute illness (jaundice) Mild (20%–30%)

Symptoms Non specific

Immunity No protective antibodyresponse identified

Source: Marcellin J of Hepatology 1999;31:S9-16

Spectrum of Hepatitis C Infection

Elevated ALT(75%)

• Mild• Mod-severe

All Men Women0

2

4

6

8

10

12

14

16

18

HCV Ab-HCV Ab+HCV RNA+

All Cause Mortality Rates of NHANES III Participants ≥17 Years, by Hepatitis C Status

Source: El-Kamary CID 2011;53:150-7

Dea

ths

per 1

000

pers

on-y

ears

Treatment of Acute Hepatitis C Infection is Highly Effective

Source: Jaeckel et al

FDA Approved Treatments for Hepatitis C Infection

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151494.htm

Generic Names Manufacturer Name

telaprevir Vertex

boceprevir Merck & Co.

pegylated interferon Roche

ribavirin Roche

pegylated interferon alpha-2b Schering

interferon alpha-2b Schering

ribavirin Schering

interferon alpha-2a Roche

interferon aphacon-1 Three Rivers Pharma

2011

Accessed May 1, 2012

Objectives• Describe relevant characteristics of

hepatitis C• Describe US burden of disease• Outline challenges to state specific

burden measures

Prevalence of Anti-HCV, United States, 1999-2002 (NHANES)

0%1%2%3%4%5%6%7%8%

Prev

alen

ce o

f ant

i-HC

V

ALL

6-19

20-3

4

35-3

9

40-4

4

45-4

9

50-5

4

55+

Age Group (years)

MenWomen

Armstrong et al. Ann Intern Med, 2006.

Prevalence anti-HCV+ : 1.6% (4.1 million)Prevalence RNA+: 1.3% (3.2 million)

Born ~1945-1965

Forecasted Hepatitis C Mortality and Complications

Source: Rein DB, et al. Dig Liver Dis (2010), doi:10.1016/j.dld.2010.05.006

0

5000

10000

15000

20000

25000

30000

35000

40000

45000

2010

2012

2014

2016

2018

2020

2022

2024

2026

2028

2030

2032

2034

2036

2038

2040

2042

2044

2046

2048

2050

2052

2054

2056

2058

2060

Year

Num

ber DCC and HCC

DEATHS

DCC

HCC

TRANSPLANTS

DECOMPENSATED CIRRHOSIS

HEPATOCELLULAR CARCINOMA

Annual Age-Adjusted Mortality Rates of Hepatitis B, C, and HIV as Underlying or Contributing Cause of Death, United States, 1999 – 2007

1999 2000 2001 2002 2003 2004 2005 2006 20070

1

2

3

4

5

6

7

Hepatitis BHepatitis C

Year

Rat

e pe

r 100

,000

Per

sons

Source: Ly et al. Ann Intern Med 2012;156:271-278

Objectives• Describe relevant characteristics of

hepatitis C• Describe US burden of disease• Outline challenges to state specific

burden measures

Challenges at the State Level• Number of prevalent cases• Resources

– Insufficient for investigations or for preventive services

– Incidence (as notifiable diseases)• Response rates for interview low

– Supplemental sources of data• Seroprevalence - NYC• Healthcare utilization• Mortality

2010 Sites Reporting HCV Infection

Oregon

San Francisco*Colorado

Minnesota New YorkState + City*

Connecticut

New Mexico

Estimated population 31- 40 million

*Past or present only

Data Processing

Hospital, Commercial Clinical Laboratories Health Care Providers

Local Health Departments

State Health Department

CDC

• Maintain database• Investigate new

cases• Classify• Analyze

Acute hepatitis C Clinical criteria • An acute illness with discrete

onset of symptoms* and• Jaundice or elevated serum

aminotransferase (ALT) levels >400 IU/L

Laboratory criteria• Anti-HCV positive and anti-HCV

RIBA or NAT for HCV RNA, or • Positive: RIBA, NAT, genotype or• Anti-HCV positive with predictive

s/co

Laboratory criteria• Anti-HCV positive with predictive

s/co or• Positive HCV RIBA or HCV RNA

(NAT)and• IgM anti-HAV negative and• IgM anti-HBc negative

*unless seroconversion <6 months

HCV past or present

Clinical criteria • Asymptomatic or mild-severe

CLD

Evaluation of the HCV De-duplication Process2180

491

68% - duplicate/match

5% - missing s/co

2% - tests negative1% - missing demographics

Source: Klevens et al, Emerg Infect Dis 2009; 15: 1499-1502

Reports included

New cases

Rate of Incident Acute HCV Infection in Funded US Sites, 2010

Rat

e pe

r 100

,000

pop

ulat

ion

MN CO OR NM CT NYS0

0.2

0.4

0.6

0.8

1

1.2

Site

Rate of Newly Reported Cases of Past or Present HCV Infection in Funded US

Sites, 2010R

ate

per 1

00,0

00 p

opul

atio

n

Overall

Source: 2010 Surveillance Summary

MN NYS CO CT OR NYC NM SF0

50

100

150

200

250

Site

Conclusions• The burden of hepatitis C is significant

but underappreciated in the United States.– State level measurement is challenging

• New infections continue to be problematic

• Complications among the 3.2 million chronically infected persons are of great concern

Thank you.

Objectives of surveillance for chronic HCV infection

• Measure burden of disease– Estimate healthcare needs

• Characterize population for secondary prevention

• Evaluate prevention– Infected population in care– Receiving services

Courtesy: T. Bryant

Rates of Newly Reported Hepatitis C Virus Infection Among Persons <30 Years in 4

Communities, New York State, Nov 2004 - Apr 2007

Area A Area B Area C Whole County05

101520253035404550

Rat

e pe

r 100

,000

pop

ulat

ion

Laboratory results used to classify cases of past or present HCV infection,

2006/2007, 6 sites conducting enhanced hepatitis

surveillance

Figure 2. Known and Potential Exposures during the 6 months Prior to Onset of Illness Reported by Patients with Acute Hepatitis C, Sentinel Counties, United States, 1994-2006 (n=270)

Injection drug use (IDU) 47%

No risk factor identified 29%

Blood transfusion 2%

Sex with >2 partners 3%

HCV-positive household contact 1%

HCV-positive sex partner 7%

Healthcare worker with blood exposure 3%

Aggregate risk category 4%

Sex partner with suspected hepatitis C 4%

[but 14% who denied IDU during exposure period reported prior injecting (6.7%) or intranasal (7.8%) drug use]

Source: Williams et al. Arch Int Med 2011; 171:241-8

Adapted from Seef

Natural History of HCV Infection

100 People

Resolve (15)15%

Chronic (85)

85%

Cirrhosis (17)Stable (68)

80%

75%Stable (13)

Mortality (4)25%

Time

20%

Laboratory criteria• Anti-HCV positive and a confirmatory

testor • Positive: RIBA, NAT, genotype or• Anti-HCV positive with s/co predictive

HCV infection, past or present

Clinical criteria • Asymptomatic to mild-severe CLD

(2005)Characteristics• No acute infection

indicator lab test• Chronic infection

asymptomatic for decades

• High volume of anti-HCV tests• Past (resolved)• Present

• Re-infection possible