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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