Centers for Disease Control and Prevention initiatives to prevent hepatitis C virus infection: a selective update.

Abstract

Hepatitis C virus (HCV) infection is a complex public health problem, characterized by a high prevalence of chronic infection, an increasing burden of HCV-associated disease, low rates of testing and treatment, and the prospect of increasing incidence associated with the epidemic of injection drug use. Three-quarters of chronic HCV infections occur among persons born from 1945 through 1965. Prevention efforts are complicated by limited knowledge among health care professionals, persons at risk and in the public at large. At the Centers for Disease Control and Prevention, efforts to improve primary and secondary prevention effectiveness center on policy development, education and training initiatives, and applied research. This report provides a brief overview of some of these efforts, including the development of testing recommendations for the 1945-1965 birth cohort, research and evaluation studies in settings where persons who inject drugs receive services, and a national viral hepatitis education campaign that targets health care professionals, the public, and persons at risk.

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S U P P L E M E N T A R T I C L E
Centers for Disease Control and Prevention
Initiatives to Prevent Hepatitis C Virus
Infection: A Selective Update
Bryce D. Smith, Cynthia Jorgensen, Jon E. Zibbell, and Geoff A. Beckett
Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia
Hepatitis C virus (HCV) infection is a complex public health problem, characterized by a high prevalence of
chronic infection, an increasing burden of HCV-associated disease, low rates of testing and treatment, and the
prospect of increasing incidence associated with the epidemic of injection drug use. Three-quarters of chronic
HCV infections occur among persons born from 1945 through 1965. Prevention efforts are complicated by
limited knowledge among health care professionals, persons at risk and in the public at large. At the Centers for
Disease Control and Prevention, efforts to improve primary and secondary prevention effectiveness center on
policy development, education and training initiatives, and applied research. This report provides a brief over-
view of some of these efforts, including the development of testing recommendations for the 1945–1965 birth
cohort, research and evaluation studies in settings where persons who inject drugs receive services, and a national
viral hepatitis education campaign that targets health care professionals, the public, and persons at risk.
In the United States, an estimated 3.2 million persons
are infected with hepatitis C virus (HCV) [1]. HCV-
associated liver disease is the leading indication for
liver transplantation, and chronic HCV infection is a
leading cause of hepatocellular carcinoma [2–4]. In
2007, HCV infection caused more deaths than human
immunodeficiency virus (HIV) infection in the United
States [5]. Morbidity and mortality attributable to
HCV infection is projected to increase dramatically
over the next 40–50 years such that, without treat-
ment, 1.76 million persons will develop cirrhosis,
400 000 will develop hepatocellular carcinoma, and
approximately 1 million will die from HCV-associated
complications [6]. Incident cases of HCV infection
also continue to add to the disease burden; of the
16000 persons who were newly infected with HCV in
2009, the Centers for Disease Control and Prevention
(CDC) estimates that 75%–85% (12 000–13600) will
develop chronic HCV infection [7]. Transmission
associated with injection drug use (IDU) continues to
be the leading risk for new infections with HCV [8].
Most persons who are positive for HCV antibody
(anti-HCV) [9–11] are believed to be unaware of their
HCV status because they have not been tested and/or
informed of their test results; low rates of testing and
diagnosis result in missed opportunities for medical
evaluation, care, and treatment, as well as for coun-
seling to promote behavioral changes that might re-
duce disease progression and avert transmission of
infection. There is also evidence that many HCV-
infected persons in care who have been tested and
received a diagnosis are not referred for evaluation
and possible treatment by a specialist and do not
receive other recommended clinical services. Recent
Food and Drug Administration–approved direct-acting
antivirals (DAAs) [12, 13] have increased HCV infec-
tion cure rates, and therefore improved diagnosis and
linkage to care and treatment have become increasingly
important.
HCV prevention strategies at the CDC Division of
ViralHepatitisinclude primary andsecondary
Correspondence: Geoff A. Beckett, PA-C, MPH, 1600 Clifton Rd, Mailstop G-37,
Atlanta, GA 30333 (gbeckett@cdc.gov).
Clinical Infectious Diseases2012;55(S1):S49–53
Published by Oxford University Press on behalf of the Infectious Diseases Society of
America 2012.
DOI: 10.1093/cid/cis363
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prevention approaches that have been framed by the Action
Plan for the Prevention, Care and Treatment of Viral Hepatitis,
issued by the US Department of Health and Human Services
in 2011 [14]. Presented here is a brief summary of selected
CDC prevention initiatives that address 3 problem areas: (1)
high HCV prevalence in the 1945–1965 US birth cohort, (2)
low levels of public and professional awareness, and (3) high
HCV infection incidence associated with the epidemic of
IDU.
THE HIGH PREVALENCE OF HCV INFECTION
IN THE 1945–1965 BIRTH COHORT
The CDC estimates that the overall prevalence of HCV infec-
tion is the United States is approximately 1.6%, with signifi-
cant variations in prevalence seen across many demographic
subpopulations. During the 1990s, epidemiologists first ob-
served disproportionately higher HCV infection rates among
persons who were born during the post–World War II baby
boom, from the mid-1940s through the mid-1960s [14]. An
analysis of National Health and Nutrition Examination Survey
(NHANES) data from 1999–2002 showed that 65.6% of all
persons with HCV antibody were born between 1945 and
1964 [1]. Similarly, in an analysis of 1988–1994 NHANES
data, 65% of persons with HCV antibody were 30–49 years
old (representing birth years 1939–1963) when the surveys
were conducted [15].
Epidemiological modeling has indicated that the incidence
of HCV infection rose significantly in the late 1960s and
continued to be very high before sharply decreasing after
1989 [16]. The high prevalence of HCV infection among
persons born from 1945 through 1965 is largely attributed to
exposures that occurred during this period of increased inci-
dence, and many of those exposures were associated with IDU
or blood transfusion [1, 17].
The CDC Division of Viral Hepatitis has recently com-
pleted an analysis of NHANES data for surveys conducted
during 1999–2008. From this data, the CDC estimates that
three-quarters of all persons currently living with chronic
HCV infections are in the 1945–1965 birth cohort [18], a
population that in 2012 includes persons aged 47–67 years.
The HCV infection prevalence in this cohort is 3.29%, which
represents approximately 2 million persons and is 5 times the
prevalence among persons born outside the birth cohort
(0.55%) [18].
ADDRESSING THE HIGH BURDEN OF HCV
INFECTION IN THE 1945–1965 BIRTH COHORT
Given the high HCV infection prevalence in the 1945–1965
birth cohort, it is not surprising that >70% of deaths among
HCV-infected persons occurred in this age group in 2007 [5].
Rapidly increasing HCV-related morbidity and mortality are
expected to have a significant impact on this birth cohort, as
61% of all HCV-infected persons are forecasted to develop cir-
rhosis, and 37% are expected to die from liver disease [6].
Further, studies estimate that 45%–85% of HCV-infected
persons are unaware of their status [9–11]. Without knowledge
of their status, infected persons cannot avail themselves of the
recent availability of DAAs that dramatically increase the ef-
fectiveness of therapy [12, 13]. Last, testing for and treatment
of HCV infection in the 1945–1965 birth cohort, when com-
pared with current risk-based testing and treatment, has been
determined to be cost-effective at $15700 per quality-adjusted
life year (QALY) on the basis of a regimen of pegylated
interferon with ribavirin and increases to $35700 per QALY
when more effective yet more expensive DAAs are added to
the regimen. This cost analysis also forecasts that between
80000 and 120000 lives could be saved with the implemen-
tation of birth cohort testing as compared to current risk-based
testing [17].
The CDC is responding to these findings by considering a
recommendation for 1-time HCV testing for all persons born
during 1945–1965 and subsequent linkage to care and treatment
as appropriate. In 2011, the CDC conducted an evidence-
based review of the literature related to HCV infection
prevalence in the birth cohort, as well as patient-important
outcomes related to HCV testing and treatment, using the
Grading of Recommendations Assessment, Development, and
Evaluation (GRADE) method [19]. A proposed birth cohort
testing recommendation has been drafted and is currently
under consideration. The CDC is beginning to plan for
implementation of the proposal, as well as for evaluation of its
implementation and adoption, if it becomes a formal
recommendation.
HCV KNOWLEDGE AND AWARENESS
Low levels of awareness and knowledge about HCV have
been identified as a formidable challenge to prevention and
care [20]. Many healthcare professionals lack basic knowledge
about risk factors or screening recommendations associated
with viral hepatitis. Several studies have documented limited
physician knowledge about HCV prevalence and natural
history [20–22], and fewer than half of all physicians in the
United States ask their patients sensitive questions related to
high-risk behaviors, such as IDU [21]. Knowledge about HCV
is also limited in the general public. In the 2010 HealthStyles, a
consumer marketing survey of 4071 participants, 41% of re-
spondents disagreed with the statement, “I am knowledgeable
about viral hepatitis,” and an additional 30% had a neutral
opinion [14, CDC, HealthStyles survey report, November 2010].
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This finding was supported and amplified in CDC-sponsored
focus groups, in which misconceptions about viral hepatitis
were common [CDC, unpublished data, December 2011].
Many participants assumed that they were tested for hepatitis
when blood tests were performed, as part of their routine phys-
ical examinations. In addition, some focus group participants
believed that if they were infected they would have symptoms,
and others concluded that the virus could not be detected in
their blood if they were asymptomatically infected.
THE KNOW MORE HEPATITIS NATIONAL
HEPATITIS EDUCATION CAMPAIGN
The CDC Division of Viral Hepatitis is developing the Know
More Hepatitis National Education Campaign, which will be
launched in 2012. The goals of the campaign are to raise
awareness about viral hepatitis, change perceptions associated
with the disease, and increase the identification of people who
are currently unaware of their chronic HCV infection and link
them to treatment. The campaign is designed to complement
existing hepatitis prevention efforts, leverage the CDC’s credi-
bility and expertise, capitalize on the CDC’s network of state
and local partners, and enhance public-private partnerships.
The campaign is scientifically based and rooted in behavioral
change theory and consists of 3 distinct, overlapping phases,
each targeting specific audiences. The campaign is following a
rigorous formative research and testing process designed to
maximize the potential effectiveness of the messages, and will
use multimedia strategies, including print, broadcast, digital,
and social media.
Phase I of the campaign is designed to place viral hepatitis
on the national agenda and to raise its importance as an
urgent public health issue among policy makers, opinion
leaders, healthcare professionals, and the general public. To
this end, the campaign was announced in 2011 at a White
House event on World Hepatitis Day, featuring a presidential
proclamation on viral hepatitis. The CDC has used media ad-
vocacy and social media strategies during this phase to stimu-
late discussion about viral hepatitis. Phase I is designed to
continue throughout the duration of the Know More Hepatitis
campaign, adapting messages to reflect the current news
environment and upcoming guidelines.
Phase II of the Know More Hepatitis campaign focuses on
healthcare professionals and will address perceived and real bar-
riers to screening. By using findings from the CDC’s formative
research with primary care professionals, strategies will include
educational components designed to increase knowledge about
chronic viral hepatitis and to build health care professionals’
capacity to conduct risk assessments and test patients at risk. If
professionals are knowledgeable and comfortable with screen-
ing, testing of patients at risk may increase. More importantly,
professionals will be prepared as patients respond to the direct-
to-consumer part of the campaign, which encourages patients
to be aware of their risk, talk with their physicians, and get
tested. The launch of the second phase will be in conjunction
with the release of the CDC’s birth cohort HCV testing rec-
ommendation, anticipated to be in 2012.
The CDC will launch phase III, the third and final phase of
the national campaign, in conjunction with Hepatitis Aware-
ness Month in May 2012. A combination of strategies will be
used to disseminate the message, including print and broad-
cast media, online tools, and social media. This phase will
target the same groups specified in the CDC’s expanded
guidelines for HCV testing. Another major component of this
phase will be activities to promote National Viral Hepatitis
Testing Day on 19 May. The CDC is developing an interactive
risk assessment tool designed to determine an individual’s risk
for viral hepatitis. The tool asks questions based on CDC’s
guidelines for testing and vaccination for viral hepatitis and
allows individuals to privately answer questions in either their
home or in a healthcare setting. Once the assessment is com-
pleted, individualized recommendations for testing and/or
vaccination will be produced, which can be printed and
shared with a healthcare professional.
HCV INFECTION AMONG PERSONS WHO
INJECT DRUGS (PWID): BACKGROUND
IDU continues to be the leading risk factor for HCV incidence
in the United States, and PWID have the highest prevalence of
HCV infection of any population, ranging from 40%–70% in
most studies [23–27]. Public health strategies to reduce the
burden of IDU-associated HCV infection include primary and
secondary prevention efforts and improvements in linkage of
infected PWID to care and treatment services [14].
There is increasing evidence that multicomponent pro-
grams, which provide a combination of substance abuse treat-
ment and support for safe injection practices that decrease the
shared use of injection equipment, are most likely to be effec-
tive in preventing new HCV infections among PWID. There is
a critical need for research and program evaluation to deter-
mine the best designs for these interventions [14]. Because the
highest incidence rates of HCV infection occur in persons
who recently initiate IDU, primary prevention interventions
must be able to reach new injectors and noninjectors who are
at risk of initiating IDU [26, 28, 29]. As heroin injection and
the illicit use of prescription opiates are increasing in the
United States, IDU-associated HCV infection may be increas-
ing in some areas, especially among adolescents and young
adults. Efforts to identify and provide prevention services to
young PWID and to users of noninjection drugs who may
transition to IDU are critical [30, 31].
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HCV testing rates among PWID are low, and many HCV-
infected PWID are unaware of their infection status; knowledge
about HCV infection may be low among drug addiction treat-
ment staff, and HCV educational resources for PWID receiving
services are underused in drug treatment programs [32–34].
Because >90% of PWID who receive a diagnosis of acute HCV
infection have a history of incarceration or previous drug treat-
ment at the time of diagnosis, both correctional facilities and
drug treatment programs provide important opportunities for
primary prevention efforts, testing, and care associated with
HCV infection [27].
HCV INFECTION PREVENTION FOR PWID: CDC
ACTIVITIES
At the CDC, there has been considerable expansion of the re-
search agenda for HCV infection prevention issues related to
PWID over the past 2 years. The Division of Viral Hepatitis
has been actively involved in research and evaluation of anti-
HCV rapid tests in laboratory and field settings [35, 36]. One
HCV rapid test was approved for the US market by the Food
and Drug Administration in June 2011 and was granted a
Clinical Laboratory Improvement Amendment waiver for use
in nonlaboratory settings. The CDC expects HCV rapid tests
to become a significant tool in providing point-of-care test
results to PWID, a population that has significantly limited
access to healthcare services and may be lost to follow-up if
immediate test results are not available.
The CDC and research partners are currently planning a study
aimed at providing clinical management and prevention services
to persons with HCV infection who are participating in opiate
substitution treatment yet still engaging in high-risk activities (ie,
drug use). In addition to receiving disease- and treatment-related
education, participants can receive a medical evaluation for poss-
ible HCV therapy and can enroll in prevention services, such as
individual and group behavioral interventions.
The CDC Division of Viral Hepatitis is also exploring com-
munity-level interventions and the feasibility of using structur-
al interventions at syringe services programs to reach this
underserved and often hidden population. Prevention strat-
egies that can reach neophyte injectors before they become in-
fected must include development of effective techniques for
PWID to discontinue IDU and ways to avoid high-risk prac-
tices for those unable to cease IDU. Syringe services programs
are the most capable of reaching this population, and their
focus on harm reduction education creates an ideal setting to
design and field-test education interventions meant to reduce
the transmission of HCV associated with IDU. Development
of partnerships for research and evaluation with community-
based organizations and health departments providing preven-
tion services is a CDC priority.
CONCLUSION
The CDC is pursuing multiple HCV infection prevention
efforts to reduce the disease burden and incident infection in
parallel with a broad education campaign targeting both pro-
fessionals and consumers. Primary prevention strategies center
on efforts to reach more PWID, in settings where they receive
services, such as drug treatment and syringe services pro-
grams. Secondary prevention initiatives are intended to in-
crease HCV testing to identify the large numbers of persons
with undiagnosed and untreated chronic HCV infection and
to help ensure that they are linked to appropriate and effective
care. In 2012, the CDC will continue its systematic review of
HCV screening and testing recommendations and will issue
updated guidance when this review is completed. The identifi-
cation and implementation of effective models of HCV care is
a necessary complement to enhanced screening policies, and
the CDC will be working closely with its sister health agencies
and with medical societies, clinical researchers, payors, and
other health policy makers in these efforts, as well.
Notes
Financial support.
Centers for Disease Control and Prevention Foundation receives support
from the following corporate sponsors: Abbott Laboratories, Boehringer
Ingelheim, Bristol-Myers Squibb, Genentech (Roche), Gilead Sciences,
GlaxoSmithKline, Janssen Therapeutics, Merck Sharp & Dohme, OraSure
Technologies, and Vertex Pharmaceuticals.
Supplement sponsorship.
This article was published as part of a supple-
ment entitled “The Evolving Paradigm of Hepatitis C,” sponsored byan unrest-
ricted grant from the Viral Hepatitis Action Coalition of the CDC Foundation.
Potential conflicts of interest.
All authors: No reported conflicts.
All authors have submitted the ICMJE Form for Disclosure of Potential
Conflicts of Interest. Conflicts that the editors consider relevant to the
content of the manuscript have been disclosed.
The Viral Hepatitis Action Coalition of the
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