Hepatitis C Epidemiology

and Disease Burden

Presented by:

Robert Brown, MD

Frank Cardile Professor of Medicine

Columbia University Medical Center

New York, NY

This program is supported by educational

grants from: AbbVie, Bristol-Myers Squibb,

Gilead Sciences, and Janssen Therapeutics

Chronic Hepatitis C is a

Serious Health Problem

• Chronic Hepatitis C (CHC) is a global problem

– ~ 180 million infected worldwide1

• CHC is a serious problem in the United States

– CDC estimated that ~ 4 million of the US population is

chronically infected2

– Incidence of infection in US is decreasing but CHC related

complications are increasing: cirrhosis, HCC3

• With aging of infected population, more liver related complications are

expected in the next 10 – 20 years

• CHC is the most common reason for liver transplant4

1. Hadigan C e al. JAMA 2011; 306: 294-301.

2. Armstrong GL et al. Ann Intern Med. 2006; 144:705-714.

3. Davis GL. Rev Gastroenterol Disord 2004;4:7-17.

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

The Increasing Burden of Chronic

Hepatitis C in the US

• Despite declines in estimated incidence of HCV

infections, the size of the population living with

chronic viral hepatitis C is considerable

• National serum surveys indicate that 3.2

million individuals in the US have chronic

hepatitis C

– 66% of those infected were born between 1945 and

1964 and are now entering a period of risk for HCV-

related diseases and premature death

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

Pre

va

len

ce

(N

)

715,000

385,000

231,000

869,000 825,000

2,475,000

~1,100,000 ~1,100,000

~3,300,000 Aware of Infection

Unaware of Infection

Adapted from Colvin HM, Mitchell AE. Hepatitis and liver cancer: A national strategy for

prevention and control of hepatitis B and C. Washington, DC: The National Academies

Press; 2010.

Hepatitis C is the Most Common

Blood-Borne Chronic Viral Infection in US

Characteristic

(Participants tested, n)

Prevalence of

Antibodies to HCV,

% (95% CI)

Estimated Persons Ever

Infected Nationwide,

N (95% CI)

All participants

(n=15,079) 1.6 (1.3-1.9)

4,060,000

(3,410,000 – 4,850,000)

Non-Hispanic white

(n=5,991) 1.5 (1.1-1.9)

2,610,000

(2,020,000 – 3,380,000)

Non-Hispanic black

(n=3,530) 3.0 (2.4-3.9)

920,000

(720,000 – 1,170,000)

Mexican American

(n=4,422) 1.3 (0.8-2.1)

260,000

(150,000 – 430,000)

Armstrong GL et al. Ann Intern Med. 2006;144:705-714.

Prevalence of Antibody to HCV Varies by

Race/Ethnicity in the United States

Population

Reported

Prevalence

Range

Estimated

Number in US

Estimated Range of

HCV Cases

Homeless 22.2 - 52.5% 643,067 142,761 - 337,610

Incarcerated 23.1 - 41.2% 1,613,656 372,754 - 664,826

Veterans 5.4 - 10.7% 22,915,943 1,237,461 - 2,452,006

Active Military Duty 0.48% 1,417,747 680,519

Healthcare Workers 0.9-3.6% 7,200,950 64,809 - 259,234

An estimated 1,921,748 - 3,821,668 persons living in the

USA were not accounted for in the NHANES survey

Chak E et al. Liver Int 2011;31:1090-1101.

The Prevalence of Hepatitis C Infection in

the US May be Underestimated

Population

Reported

Prevalence

Range

Estimated

Number in US

Estimated Range

of HCV Cases

Nursing Home

Residents 4.5% 1,413,540 63,609

Chronic

Hemodialysis 7.8% 263,820 20,578

Hemophiliacs with

Transfusions

before 1992

76.3 - 100% 17,000 12,971 - 17,000

Unaccounted number of HCV positive 1,921,748 - 3,821,668

NHANES* 3,270,000

Total 5,191,748 - 7,091,668

*Original NHANES estimate minus HCV cases attributed to veterans (4,060,000 total -

790,000 veterans).

Chak E et al. Liver Int 2011;31:1090-1101.

The Prevalence of Hepatitis C Infection in

the US May be Underestimated (cont)

Adapted from Colvin HM, Mitchell AE. Hepatitis and liver cancer: A national strategy for

prevention and control of hepatitis B and C. Washington, DC: The National Academies

Press; 2010.

825,000

AWARE

(25%)

2,475,000

UNAWARE

(75%)

• ~3,300,000 individuals

are infected

• Only 825,000 are

aware of their infection

• 2,475,000 are unaware

of their infection

Most Patients with Chronic Hepatitis C In the

US Are Unaware that They Are Infected

Disease Burden of Patients Infected More

Than 20 Years Will Peak Around 2015

Patients infected

Infected > 20 y

Pre

vale

nce (

%)

1960 1970 1980 1990 2000 2010 2020 2030

4.0 3.0 2.0 1.0 0.0

Davis GL. Rev Gastroenterol Disord 2004;4:7-17.

Acute Hepatitis C

Chronic Hepatitis 50 – 85%

Cirrhosis 20 – 30%

Decompensation 6 – 10%

HCC 5 – 10%

Death 5 – 10%

(~12,000 Annually)

10 – 30 years

Liver Transplant (1,915 transplants

due to CHC in 2007)

Alberti A et al. Aliment Pharmacol Ther 2005;22(Suppl 2):74-78.

Gallegos-Orozco JF, Vargas HE. Med Clin North Am 2009;93:931-950.

Centers for Disease Control and Prevention.

Available at http://www.cdc.gov/hepatitis/HCV/StatisticsHCV.htm. Accessed 12/4/14.

Chronic Hepatitis C Progression

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

Projected Disease Burden of CHC, Cirrhosis,

and Complications as Infected Population Ages

Davis GL et al. Liver Transpl 2003;9:331-338.

Annual Age-Adjusted Mortality Rates from HCV

Compared to HBV and HIV, US, 1999-2007

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

Annual Age-Adjusted Mortality Rates

from HCV Are Increasing

Other, non-

Hispanic, 0.4%

n=15,106

*Contributing or underlying cause

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

Deaths from HCV According to

Race/Ethnicity, 2007*

• Abdominal pain (right upper abdomen)

• Abdominal swelling (due to ascites)

• Clay-colored or pale stools

• Dark urine

• Fatigue

• Fever

• Itching

• Jaundice

• Loss of appetite

• Nausea

• Vomiting

Available at http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001329/. Accessed 12/4/14.

Symptoms of Chronic

Hepatitis C Infection

• In many cases, there may be no symptoms until

cirrhosis develops

• Symptoms that can occur include:

HCV Patients

(n=306)

Non-HCV Controls

(n=306) P value

Mean age (years) 52.6 54.3 ---

Male (%) 64% 60% ---

Presenteeism (%)* 23.16% 13.06% <0.001

Overall Work Impairment (%) 26.16% 14.91% <0.001

Activity Impairment (%) 42.16% 27.29% <0.001

HRQoL PCS 40.20 44.89 <0.001

HRQoL MCSǂ 43.72 48.62 <0.001

SF6D Utility Score 0.65 0.73 <0.001

*Impairment experienced while at work; Physical Component Summary;

ǂMental Component Summary

El Koury AC et al. J Hepatol 2012;56(Suppl 2):S345.

Burden of Illness in Treatment Naïve

HCV Patients in the US

HCV Patients

(n=306)

Non-HCV Controls

(n=306) P value

Outpatient visits 12.24 8.22 <0.001

ER Visits 0.76 0.54 0.023

Mean Indirect Costs $10,316.00 $5,468.56 <0.001

Total Healthcare

Related Direct Costs $22,818.48 $15,361.64 0.001

El Koury AC et al. J Hepatol 2012;56(Suppl 2):S345.

Burden of Illness in Treatment Naïve

HCV Patients in the US

• Differences in absenteeism and hospitalizations

for the two groups were not statistically significant

Davis GL et al. Gastroenterology 2010;138:513-521.

Can We Reduce the Impact of

Chronic Hepatitis C?

• “Prevalence of hepatitis C cirrhosis and its

complications will continue to increase through

the next decade and will mostly affect those

older than 60 years of age.”

• “Current treatment patterns will have little effect

on these complications, but wider application of

antiviral treatment and better responses with

new agents could significantly reduce the impact

of this disease in coming years.”

Breakthroughs in the Management

of Hepatitis C

• The approval of the direct acting antiviral agents (DAAs)

has markedly changed treatment options for individuals

who are infected with genotype 1 HCV, including both

treatment naïve and previously treated patients

• The AASLD/IDSA/IAS–USA hepatitis C Guidance has

made management recommendations that include

testing and linkage to care, the crucial first steps toward

improving health outcomes for HCV-infected persons

• The CDC has also augmented previous

recommendations for HCV testing

Endpoint Benefit of SVR

Longevity of response Rate of late relapse extremely low (<1%)

Histology Compared to pre-treatment liver biopsies,

improved inflammation and fibrosis

Clinical events and survival

Compared to non-responders, less frequent

hepatic complications, liver-related mortality,

and incidence of HCC

Pearlman BL, Traub N. Clin Infect Dis 2011;52:889-900.

Benefits of a Sustained Virologic

Response (SVR) Following Treatment

“---SVR should no longer be considered to be a surrogate

end point, but a clinically meaningful end point of successful

therapy for hepatitis C infection; SVR represents a cure---”

60

70

80

90

100

0 Current 25% 50% 75% 100%

A

Pe

rce

nt

cir

rho

sis

Vs

. n

o t

rea

tmen

t

Proportion of population treated

0 Current 25% 50% 75% 100%

B

Pe

rce

nt

live

r-re

late

d

dea

th v

s.

no

tre

atm

en

t

Proportion of population treated

20

40

60

80

100

80% SVR rate

60% SVR rate

40% SVR rate

Davis GL et al. Gastroenterology 2010;138:513-521.

Can We Reduce the Impact of

Chronic Hepatitis C?

Thank you for participating in

Hep C Linkage to Care

Update on

Hepatitis C Epidemiology

and Disease Burden