Hepatitis C virus prevention, care, and treatment: from policy to practice.
ABSTRACT The prevention of hepatitis C virus (HCV) infection and associated health conditions (eg, cirrhosis and hepatocellular carcinoma) is a public health priority in the United States. Hepatitis C virus-related morbidity and mortality is increasing at a time when the advent of highly effective therapies greatly increases opportunities to prevent HCV transmission and disease. In 2010, the Institute of Medicine recommended that national action be taken to address this "underappreciated health concern for the nation." In response, in 2011, the US Department of Health and Human Services (HHS) published a viral hepatitis action plan that guides response to the viral hepatitis epidemic by providing explicit steps to be undertaken by specific HHS agencies to improve provider training and community education; expand access to testing, care, and treatment; strengthen public health surveillance; improve HCV preventive services for injection drug users; develop a hepatitis C vaccine; and prevent HCV transmission in healthcare settings. For all aspects of the action plan, infectious disease specialists and other clinicians assume a key role in efforts to reduce HCV-related morbidity and mortality. With successful collaboration of the public and private sectors, the hepatitis C epidemic can be forever silenced.
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ABSTRACT: Although injection drug use (IDU) and blood transfusions prior to 1992 are well-accepted risk factors for hepatitis C virus (HCV) infection, many prior studies that have evaluated tattooing as a risk factor for HCV infection did not control for a history of IDU or transfusion prior to 1992. In this large, multicenter case-control study we analyzed demographic and HCV risk factor exposure history data from 3,871 patients, including 1,930 with chronic HCV infection (HCV RNA positive) and 1,941 HCV negative (HCV antibody negative) controls. Crude and fully adjusted odds ratios of tattoo exposure by multivariate logistic regression in HCV infected versus controls were determined. As expected, injection drug use (65.9% vs. 17.8%, p < 0.001), blood transfusions prior to 1992 (22.3% vs. 11.1%, p < 0.001), and history of having one or more tattoos (OR = 3.81; 95% CI 3.23 - 4.49, p<0.001) were more common in HCV-infected patients than in control subjects. After excluding all patients with a history of ever injecting drugs and those who had a blood transfusion prior to 1992, a total of 1,886 subjects remained for analysis (465 HCV positive and 1,421 controls). Among these individuals without traditional risk factors, HCV positive patients remained significantly more likely to have a history of one or more tattoos after adjustment for age, sex, and race/ethnicity (OR = 5.17; 95% CI 3.75 - 7.11, p<0.001). Conclusion: Tattooing is associated with HCV infection, even among those without traditional HCV risk factors such as injection drug use and blood transfusion prior to 1992. (HEPATOLOGY 2013.).Hepatology 01/2013; · 12.00 Impact Factor
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ABSTRACT: Prevention of cancer remains the most promising strategy for reducing both its incidence and the mortality due to this disease. For more than four decades, findings from epidemiology, basic research and clinical trials have informed the development of lifestyle and medical approaches to cancer prevention. These include selective oestrogen receptor modulators and aromatase inhibitors for breast cancer, the 5-α-reductase inhibitors finasteride and dutasteride for prostate cancer, and the development of vaccines for viruses that are associated with specific cancers. Future directions include genetic, proteomic and other molecular approaches for identifying pathways that are associated with cancer initiation and development, as well as refining the search for immunologically modifiable causes of cancer.Nature Reviews Cancer 11/2012; · 29.54 Impact Factor
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ABSTRACT: The US Centers for Disease Control and Prevention recently issued new recommendations to screen persons born between 1945 and 1965 for hepatitis C virus. Federal facilities in the US Indian Health Service were surveyed on knowledge and support for the hepatitis C virus recommendations, as well as barriers and concerns.Journal of public health management and practice: JPHMP 07/2013; · 0.96 Impact Factor
S U P P L E M E N T A R T I C L E
Hepatitis C Virus Prevention, Care, and
Treatment: From Policy to Practice
John W. Ward,1Ron O. Valdiserri,2and Howard K. Koh2
1Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta,
Georgia; and2US Department of Health and Human Services, Washington, D.C.
The prevention of hepatitis C virus (HCV) infection and associated health conditions (eg, cirrhosis and hepa-
tocellular carcinoma) is a public health priority in the United States. Hepatitis C virus–related morbidity and
mortality is increasing at a time when the advent of highly effective therapies greatly increases opportunities
to prevent HCV transmission and disease. In 2010, the Institute of Medicine recommended that national
action be taken to address this “underappreciated health concern for the nation.” In response, in 2011, the
US Department of Health and Human Services (HHS) published a viral hepatitis action plan that guides
response to the viral hepatitis epidemic by providing explicit steps to be undertaken by specific HHS agencies
to improve provider training and community education; expand access to testing, care, and treatment;
strengthen public health surveillance; improve HCV preventive services for injection drug users; develop a
hepatitis C vaccine; and prevent HCV transmission in healthcare settings. For all aspects of the action plan,
infectious disease specialists and other clinicians assume a key role in efforts to reduce HCV-related morbid-
ity and mortality. With successful collaboration of the public and private sectors, the hepatitis C epidemic
can be forever silenced.
Recently, the US Department of Health and Human
Services (HHS) unveiled a new strategic plan to align
with and recognize the rising public health priority of
hepatitis C virus (HCV), the changing epidemiology
of this infectious disease, and steady advances in pre-
vention, care, and treatment. In an era of improved
therapy, publication of this plan has created a unique
opportunity to rally the nation to advance clinical and
public health practices and decrease HCV-related suf-
fering and disease.
The changing epidemiology of HCV is reflected in
the rising morbidity and mortality among the 2.7–3.9
million persons living with the virus . Hepatitis C
virus greatly raises risk for hepatocellular carcinoma
(HCC) and cirrhosis, and HCV-associated disease is
the leading indication for liver transplantation [2–5].
In contrast to most other forms of cancer, rates of
HCC are increasing , with at least 50% of the in-
crease attributable to HCV . The high rates of
HCV-related morbidity and mortality are expected to
continue for several decades. Without access to
therapy, an estimated 1.76 million persons (61% of
HCV-infected persons) will develop cirrhosis, 418 000
persons (14% of HCV-infected persons) will develop
liver cancer, and 1071 000 persons (37% of HCV-in-
fected persons) will die from HCV-related diseases
over the next 50 years . Indeed, from 1999 to 2007,
HCV-associated deaths increased 50%, superseding
deaths associated with human immunodeficiency virus
(HIV) . The burden of HCV-related morbidity and
mortality disproportionately impacts baby boomers
(persons born during 1945–1965), most of whom
have been infected for several decades and are at in-
creased risk for HCV-associated cirrhosis and HCC as
they age. This large population currently accounts for
81% of all HCV infection in the United States .
Received 26 January 2012; accepted 23 March 2012.
Correspondence: John W. Ward, MD, Division of Viral Hepatitis, Centers for
Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333 (firstname.lastname@example.org).
Clinical Infectious Diseases2012;55(S1):S58–63
Published by Oxford University Press on behalf of the Infectious Diseases Society of
S58 • CID 2012:55 (Suppl 1) • Ward et al
at Emory University on July 25, 2012
Annual declines in new HCV infections over the last several
decades reflect improvements in blood safety and infection
control. Nevertheless, an estimated 16000 persons were infected
with HCV in 2009. Approximately half of these cases occurred
among persons with a history of injection drug use; in some
states, HCV has increased among adolescents and young adults,
many of whom reported engaging in this behavior .
Although recent advances have been made in preventing
and treating HCV, as many as 75% of persons living with
HCV have not been tested  and remain unaware of their
infection status. Fortunately, a new point-of-care test is avail-
able that can increase access to testing, presenting an opportu-
marginalized populations with limited access to routine clini-
cal care. To be effective, this intervention must be followed by
receipt of care and treatment, as appropriate; however, of
persons who are tested and found to be infected with HCV,
many never receive appropriate therapy.
To ensure that more persons are tested and linked to care
and treatment, the Centers for Disease Control and Prevention
(CDC) is considering expanding current HCV screening guide-
lines to include a birth-cohort approach to testing . Identi-
fying baby boomers and other HCV-infected persons is the first
step to receiving new medications that can improve treatment
response and shorten the duration of therapy for infected
patients. In May 2011, the first generation of HCV NS3/4A pro-
tease inhibitors, telaprevir and boceprevir, were licensed for
clinical use in the United States. Compared with peginterferon/
ribavirin therapy alone, the addition of boceprevir or telaprevir
to this standard regimen increased sustained virologic response
rates from 38% to 63% and 46% to 79%, respectively [13, 14].
The pipeline of promising HCV therapies is robust, making an
all-oral regimen to eradicate HCV after a short course (ie, 12
weeks) of therapy an achievable goal in the coming years .
In January 2010, the Institute of Medicine (IOM) summar-
ized these new developments and recommended national
action in its report “Hepatitis and Liver Cancer: a National
Strategy for Prevention and Control of Hepatitis B and C”
(http://www.iom.edu/viralhepatitis) . In its report, the
IOM identified viral hepatitis as an “underappreciated health
concern for the nation” and recommended ways for the
federal government to improve prevention of HCV trans-
mission and disease, prompting HHS to develop a new stra-
tegic plan and strengthen HCV-related policies.
VIRAL HEPATITIS ACTION PLAN: A ROADMAP
FOR IMPROVING HCV PREVENTION, CARE,
In 2011, HHS published “Combating the Silent Epidemic of
Viral Hepatitis: US Department of Health and Human
Services Action Plan for the Prevention and Treatment of
Viral Hepatitis” (the action plan) . The action plan pro-
vides a roadmap for guiding the nation’s public health
response to viral hepatitis, presenting explicit steps for im-
proving prevention and enhancing the care and treatment pro-
vided to infected persons. When fully implemented, the action
plan can increase the proportion of persons who are aware of
their HCV from 45% to 66% and reduce the number of new
HCV infections by 25%.
Reducing HCV transmission and improving health out-
comes for persons living with hepatitis C infection requires
three things: (1) recognizing existing barriers to HCV testing
and referral to care, (2) identifying strategies for overcoming
these barriers, and (3) creating public policies, guidance, and
resources to support implementation of these strategies. In
order to achieve these goals, it will be necessary to
improve community awareness and provider education;
improve testing, care, and treatment;
strengthen public health surveillance;
improve HCV preventive services for injection drug users
develop a hepatitis C vaccine; and
prevent HCV transmission in healthcare settings.
To reach these goals, the action plan assigns specific actions
to the appropriate HHS agencies. Further, the action plan
highlights opportunities for improving the coordination of
viral hepatitis activities across HHS operating divisions, sets
priorities for developing an effective public health and
primary care infrastructure, and provides a framework for en-
gaging other governmental and nongovernmental partners
(eg, medical specialty associations) in efforts to improve viral
hepatitis prevention and care.
Improving Community Awareness and Provider Education
Along with the general public, many hard-to-reach commu-
nities and populations remain uninformed about viral hepa-
titis and the benefits of prevention and treatment. Providers
also have inadequate knowledge about viral hepatitis ,
often failing to provide at-risk patients with viral hepatitis–
related services [18–21]. Because the opinion of a medical pro-
vider is one of the strongest motivators for a patient to accept
an intervention or change behaviors , increasing provider
awareness of viral hepatitis is pivotal.
The action plan activities for improving education include:
creating an educational curriculum for HCV prevention,
care, and treatment to be used by multiple disciplines of
integrating viral hepatitis into the curricula of all HHS
healthcare provider training programs; and
HCV Prevention, Care, and Treatment: From Policy to Practice • CID 2012:55 (Suppl 1) • S59
at Emory University on July 25, 2012
collaborating with professional, medical, and other organ-
izations to build a workforce capable of providing HCV-
related prevention, care, and treatment.
Many of these actions are already underway. The CDC is
developing a medical school curriculum and a national edu-
cation campaign to increase public awareness called “Know
More Hepatitis,” and the Federal Bureau of Prisons (BOP) is
training regional hepatitis pharmacists on new direct acting
antivirals (DAAs). Both the Veterans Health Administration
and the American Association for the Study of Liver Diseases
are developing national treatment guidelines and criteria for
use of DAAs .
Improving Testing, Care, and Treatment
Identifying persons infected with HCV and referring them to
appropriate care and treatment can greatly reduce the public
health and economic consequences of HCV. Increasing the
number of patients who know their infection status can lead
to better health outcomes by providing opportunities to
prevent cirrhosis, HCC, and mortality from undetected liver
disease and other causes [23–25]. Rates of viral hepatitis
testing also can be improved by eliminating existing barriers
(eg, testing policies that inadvertently pose impediments to
the timely diagnosis of HIV and cost-related deterrents to
screening for both providers and patients).
Once tested, persons found to be infected with HCV must
receive ongoing care (eg, alcohol counseling, hepatitis A and
hepatitis B vaccination, assessment of liver disease, manage-
ment of comorbidities) and treatment services (eg, antiviral
therapy, monitoring of therapeutic response) to improve
health outcomes. Care coordination is critical to linking in-
fected persons to these needed services after diagnosis.
The action plan strategies for improving HCV testing, care,
and treatment include:
creating standard recommendations to guide HCV testing
and referral to care;
implementing routine HCV testing and linkage to care as
standard practice in healthcare systems;
promoting health information technology to improve
testing and enhance referral to viral hepatitis care; and
developing care models to optimize management of the
diverse populations living with HCV.
Several HHS agencies have already begun implementing
these strategies. The Health Resources and Services Adminis-
tration (HRSA) is funding 29 demonstration projects to inte-
grate HCV care into HIV primary care, the Agency for
Healthcare Research and Quality is reviewing the comparative
effectiveness of HCV treatment in adults, and the National In-
stitutes of Health (NIH) is conducting research on HCV
therapy. In addition, the US Preventive Services Task Force, an
independent group of national experts, is in the process of up-
dating its previous recommendations on HCV screening .
Finally, because approximately 3 of every 4 HCV-infected
persons in the United States were born during 1945–1965, the
CDC is reviewing evidence for recommending HCV testing as
a cost-effective preventive service for this population .
Strengthening Public Health Surveillance
National surveillance for viral hepatitis is underresourced, re-
sulting in vast underreporting. The CDC estimates that only
10% of new cases of viral hepatitis are reported through the
National Notifiable Diseases Surveillance System; further, only
two-thirds of states report cases of chronic HCV, and among
those that do, substantial backlogs of cases exist because
capacity issues make it difficult for states to enter relevant
information into surveillance systems in a timely manner.
Surveys may also underrepresent priority populations (eg,
Asian Pacific Islanders) and lack the key data needed for state
and local planning.
The action plan proposes to improve surveillance through
strategies that include, but are not limited to
integrating electronic laboratory and medical records as
components of HCV surveillance;
collecting data at the community level to help state and
local programs identify and address HCV-related health
documenting and monitoring provision and impact of
testing, care, and treatment services.
Activities to improve public health surveillance capacity in
the United States have already begun. For instance, the CDC
has funded 5 health departments to begin integration of elec-
tronic lab reporting as a component of viral hepatitis case sur-
veillance, and the HRSA is reporting on HCV testing and
prevalence in community health centers.
Improving HCV Services for IDUs
In the United States, injection drug use is the most common
mode of transmission among persons with acute HCV infec-
tion. IDUs are more likely to have adverse hepatitis-related
health outcomes than other infected populations, primarily
because of comorbidities and inadequate access to and receipt
of needed health services [27, 28]. Still, it has been shown that
IDUs can successfully adhere to a full course of HCV therapy
, reducing their risk for chronic infection and possibly low-
ering the risk of transmission to partners; new HCV treatments
can serve as valuable prevention tools for reducing HCV trans-
mission in this population. According to one modeling study,
treating 10 HCV infections per 1000 IDUs per year could
result in a relative decrease in HCV prevalence over 10 years of
7%–31% . Because HCV prevalence among incarcerated
S60 • CID 2012:55 (Suppl 1) • Ward et al
at Emory University on July 25, 2012
persons is high (23.1%–39.4%), representing an estimated 373
000–665000 infected persons , prevention and treatment is
particularly needed for current inmates. Further, continued
prevention and care services are needed for HCV-infected
persons after they return to their communities because these
persons have been shown to re-engage in risk behaviors follow-
ing incarceration .
The action plan identifies the following strategies for pre-
venting HCV among IDUs and improving health outcomes
among those already infected:
integrating viral hepatitis prevention and care services as
standard components of substance abuse and treatment
integrating HCV prevention services with HIV prevention
enhancing substance abuse treatment;
increasing access to state and local syringe service pro-
grams as part of a comprehensive approach that includes
access to substance abuse prevention and treatment ser-
promoting integrated approaches for managing HCV-in-
fected patients who have comorbid health conditions.
Many of these actions are underway. The Substance Abuse
and Mental Health Services Administration is not only updat-
ing its Opioid Treatment Program accreditation guidelines to
include a hepatitis testing standard but is developing curricula
on integrating drug treatment and hepatitis treatment and
care. The Veterans Administration is educating providers
caring for persons with substance-use disorders about the risk
of viral hepatitis in these populations, and the BOP has incor-
porated information on viral hepatitis prevention, care, and
treatment into the drug education program they provide to
Developing a Hepatitis C Vaccine
Vaccines to prevent infection with hepatitis A virus and hepa-
titis B virus have been available in the United States since
1995 and 1981, respectively. Although effective treatment
options exist for HCV-infected persons, no effective vaccines
have been developed; hence, without antiviral treatment, >75%
of acute HCV infections will become chronic, often leading to
serious, progressive, and fatal liver disease.
The action plan stresses the urgency of developing such a
vaccine. The NIH, the CDC, and the US Food and Drug
Administration (FDA) are tasked to facilitate development of
candidate hepatitis C vaccines designed to induce protective
immune responses and to evaluate indications for hepatitis C
vaccination in the United States and globally. The NIH has
begun to implement these activities by supporting a portfolio
of HCV vaccine research.
Preventing HCV Transmission in Healthcare Settings
Reports of healthcare-associated outbreaks of HCV infection
attributed to unsafe injection practices and inadequate infec-
tion control are unacceptably high , compromising patient
safety and requiring local health departments, many of which
already face substantial resource constraints, to investigate in-
cidents and offer testing to possibly exposed patients. Several
actions can further protect patients and providers, including
increased infection control education for all healthcare provi-
ders, enhanced professional and institutional accountability,
and improved practice oversight. Also needed are efforts to
better protect patients receiving blood, tissue, and organs.
The action plan strategies for protecting patients and
workers from healthcare-associated HCV include efforts to
improve surveillance and detection of outbreaks in
lower the risk of HCV transmission associated with im-
proper handling and use of point-of-care devices, reusable
equipment, and syringes;
improve provider education regarding basic infection
control and improve infection control oversight at long-
term care and outpatient facilities;
reduce device-related percutaneous exposures; and
update existing guidelines for management of HCV
exposures in healthcare settings.
Progress toward preventing healthcare-associated infection
is being made. For instance, the CDC is expanding partici-
pation of healthcare facilities in the National Healthcare Safety
healthcare-associated outbreaks of HCV . The NIH is con-
ducting research on tests to improve detection of transfusion-
transmissible infections, and the FDA has issued draft
guidance for industry on the reprocessing of reusable medical
devices in healthcare settings that addresses the validation of
device cleaning, disinfection, and sterilization
The 2011 HHS report “Combating the Silent Epidemic of
Viral Hepatitis: US Department of Health and Human Ser-
vices Action Plan for the Prevention and Treatment of Viral
Hepatitis” can help strengthen public and provider awareness
of HCV as a significant public health problem, identify unmet
needs, spur the development of partnerships and collaborative
initiatives, and provide a framework and impetus for action.
Further, these directives can be integrated with other HHS
health initiatives (eg, Healthy People 2020, the National HIV/
AIDS Strategy, the National Prevention Strategy, and the HHS
Action Plan to Reduce Racial and Ethnic Health Disparities)
to leverage existing efforts to improve the health of the nation.
HCV Prevention, Care, and Treatment: From Policy to Practice • CID 2012:55 (Suppl 1) • S61
at Emory University on July 25, 2012
For all aspects of the action plan, infectious disease special-
ists and other clinicians assume a key role in efforts to reduce
HCV-related morbidity and mortality. Infectious disease
clinicians must remain knowledgeable about how HCV is
transmitted, understand which populations are at risk for
transmission and disease, and be prepared to offer HCV
testing and to counsel patients regarding their test results. For
patients found to be infected with HCV, clinicians should
provide care to help patients protect their liver (eg, vaccination
for hepatitis A and hepatitis B and counseling about alcohol
use) and evaluate and manage comorbidities (eg, HIV) and
risk behaviors that can result in exposure or transmission (eg,
injection drug use). To increase access to therapy, a greater
number of clinicians must become HCV treatment providers,
staying abreast of changes in the field to incorporate new
therapies and new treatment recommendations into their
practices. Beyond providing HCV services to their patients,
clinicians play a critical role in disease surveillance, helping
public health entities identify outbreaks, emerging modes of
transmission, and the sequelae of chronic liver disease. They
can also reduce healthcare-associated infection by implement-
ing practices to protect their patients from HCV infection in
the healthcare setting.
Public health authorities have an equally important obli-
gation to help clinicians by developing and promoting evi-
dence-based policies for HCV testing that are readily
implemented at the provider level, providing public education
to help patients and communities understand the value of pre-
ventive services, developing models of care that improve the
effectiveness and efficiency of medical management, and pro-
viding surveillance and program evaluation data to policy
makers to build support for a comprehensive continuum of
HCV-related preventive and clinical services. Furthermore, the
success of HCV prevention hinges on a fully functional health
infrastructure. The HHS is committed to promoting changes
in the health system that will help clinicians better deliver
needed services to their patients. With successful collaboration
of the public and private sectors, the hepatitis C epidemic can
be forever silenced.
Action Coalition (VHAC) of the CDC Foundation, which receives support
from the following corporate sponsors: Abbott Laboratories; Boehringer
Ingelheim; Bristol-Myers Squibb; Genentech (Roche); Gilead Sciences,
Inc.; GlaxoSmithKline; Janssen Therapeutics; Merck Sharp & Dohme;
OraSure Technologies, Inc.; and Vertex Pharmaceuticals.
This article was published as part of the
supplement, “The Evolving Paradigm of Hepatitis C,” sponsored by an
unrestricted grant from the Viral Hepatitis Action Coalition of the CDC
Potential conflicts of interest.
All authors: No reported conflicts.
This work was supported by the Viral Hepatitis
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.
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