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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”

  


 

Hepatitis C Among Offenders--Correctional Challenge and Public
Health Opportunity.
Author(s): Allen, Scott A.

Rich, Josiah D.

Schwartzapfel, Beth

Friedmann, Peter D.
Source: Federal Probation; Sep2003, Vol. 67 Issue 2, p22, 5p

CHRONIC INFECTION WITH hepatitis C virus (Hepatitis C Virus) is the most common
blood-borne illness in the United States, affecting nearly 2 percent of
all Americans, or an estimated 4-5 million individuals (Alter et al.,
1999). While most individuals with chronic infection are not expected to
progress to end-stage liver disease or death, hepatitis C is the most
common indication for liver transplantation in the U.S., and it is
responsible for 10,000 deaths annually (NIH Consensus Statement on
Management of Hepatitis C, 2002). Although Hepatitis C Virus can be transmitted
through blood and blood product transfusions, hemodialysis and high-risk
sexual practices, the leading risk factor for Hepatitis C Virus infection is injection
drug use (IDU) (Alter, 1997).

While the hepatitis C epidemic is substantial in the country as a whole,
it has become a major concern in correctional settings. Prevalence of
Hepatitis C Virus infection in prisons is 8- to 20-fold higher than in the community,
with infection rates between 16-41 percent and evidence of chronic
infection in 12-35 percent (Centers for Disease Control and Prevention,
2003). An estimated one out of three Americans with chronic hepatitis C
infection rotate through correctional facilities annually (Hammett, et
al., 1997). Despite slow progression of most infections, illness and
death within correctional systems is already substantial, likely
explained by a large number of infections acquired decades ago.
Hepatitis C infection is a leading cause of illness and death among
in-custody inmates in some correctional facilities (Allen, 2003; D.
Reiger, personal communication, 2002) and an emerging cause in others
(J. Paris, personal communication, 2003).


Natural History of the Disease and Treatment Options


Hepatitis C virus primarily affects the liver. Over time, the virus can
cause inflammation, which can lead to scarring (fibrosis or cirrhosis),
and in some cases, liver cancer or end-stage liver failure.

The hepatitis C virus was only identified a little over a decade ago.
Consequently, accurate information regarding the natural progression of
untreated disease is limited to a number of epidemiologic retrospective
analyses. The most widely accepted models state that between 15-20
percent of individuals initially infected will spontaneously clear the
virus without any treatment. The majority of those infected, 80-85
percent, will go on to have chronic infection (Alter, 2000).

Fortunately for those with chronic infection, progression occurs slowly
over years--typically decades. In a well respected model, in a 25-year
period following initial infection, 20 percent of individuals exposed to
hepatitis C will develop late-stage scarring of the liver (or cirrhosis)
and only 3-5 percent will develop fatal complications such as
decompensated liver disease of liver cancer (hepatocellular carcinoma)
(Alter, 2000). Co-infection with HIV can cause acceleration of this
process, as can regular heavy alcohol use.

While the disease can be staged (determining how advanced the disease
is) by means of blood work and a liver biopsy, current experience with
the disease does not allow clinicians to accurately predict who will
progress to end-stage complications. For that reason, most patients with
established disease and evidence of scarring on liver biopsy are
potential candidates for anti-viral therapy.

Over the past decade, anti-viral treatments have become available, and
have steadily improved. Initially, standard interferon regimens resulted
in successful eradication of virus in roughly 20 percent of those
treated. With the addition of ribavarin, treatment response increased to
roughly 40 percent. With the current therapy, pegylated interferon plus
ribavarin has been associated with a response rate in excess of 60
percent, with a response rate as high as 80 percent for some strains of
the virus. No effective vaccine is currently available.

Unfortunately, despite improvements in response to therapy, significant
side effects limit the utility of treatment. Unlike HIV, where treatment
may continue for an indefinite period, current hepatitis C treatments
are either 24 or 48 weeks, depending on the strain of the virus and
initial response to treatment. Side effects of ribavirin may include
significant drops in blood counts, resulting in anemia, fatigue and
shortness of breath. In addition, pegylated interferon can cause
flu-like symptoms including fever, muscle aches, headache and malaise,
plus a host of possible reactions including eye problems, thyroid
dysfunction and lung abnormalities. Significant psychiatric adverse
effects of the treatment include irritability, depression and
suicidality. Therapy for hepatitis C is contraindicated in a number of
conditions, including pregnancy, advanced liver disease, autoimmune
disease (such as Lupus) and uncontrolled psychiatric illness, among
others.

In combination with the slow smoldering course of disease, the side
effect profile of available medications, and the expectation of novel
treatment with higher efficacy and improved side effect profiles in the
next 3 to 5 years, patient selection for treatment is highly
individualized within treatment guidelines. Treatment recommendations
take into consideration a number of factors, including stage of disease
(as established by clinical factors such as blood tests and liver
biopsy) and co-existing chronic disease such as HIV, diabetes, heart
disease and psychiatric illness. Finally, treatment requires fully
informed consent of the patient regarding the risks and benefits of
treatment.

In the correctional setting, duration of incarceration is often used to
determine eligibility for anti-viral therapy (Proceedings of Management
of Hepatitis C in Prisons Conference, 2003). As interruption in therapy
can adversely affect effectiveness, treatment while incarcerated is
typically reserved for those patients who will remain institutionalized
for the complete period of anti-viral therapy (24 or 48 weeks depending
on genotype). Treatment for patients with shorter sentences is generally
safely deferred to the community.

Unfortunately for the large number of inmates being released from
correctional facilities with hepatitis C, resources for evaluation and
management of this disease are scarce in the community. Public health
agencies have generally not been funded to address the high burden of
disease in the largely uninsured, post-correctional population.

Response to Hepatitis C in Corrections

Despite the high prevalence of hepatitis C in corrections, response by
correctional institutions has been measured. Most facilities have great
difficulty in accessing sub-specialty evaluation for the large number of
patients who are infected. While some states have developed protocols
for evaluation and treatment by general internists (Allen et al., 2003),
others have to date failed to offer any treatment at all. States with
limited or no access to treatment have been subjected to class action
lawsuits seeking access to care for infected inmates. At this time, most
states and the Federal Bureau of Prisons are in the process of devising
guidelines and protocols for evaluation and management of hepatitis C in
the correctional setting (Proceedings of Management of Hepatitis C in
Prisons Conference, 2003). In January 2003, the Centers for Disease
Control and the National Commission of Correctional Healthcare sponsored
a meeting of state and federal correctional healthcare professionals to
encourage the sharing of data, treatment experience and strategy for
correctional settings (Allen, 2003).

In rare cases, clinically advanced disease can lead to major and
potentially fatal complications, with implications for sentencing,
classification, probation and parole. In the majority of cases, however,
chronic hepatitis C can be safely managed within the prison setting,
provided hepatitis C evaluation and treatment are accessible. For
inmates undergoing active treatment--typically for 24 or 48 weeks--the
significant side effects of therapy can impact on the patient's ability
to participate in work and recreational activities. Consequently, timing
of therapy and work assignment needs coordination.

 

  


 

Costs of Treatment

In addition to the human cost of treatment-related side effects, the
potential financial impact on stressed correctional budgets is a major
public policy concern. Funding for medical care of inmates is covered
almost entirely by public funds under a constitutional obligation to
provide care (Estelle v. Gamble, 1976). Cost for a course of treatment
ranges between a low estimate of $7,000 and a high estimate of $20,000
per patient.

Legitimate logistic constraints resulting from short periods of
incarceration result in deferral of treatment until after release for
the majority of individuals incarcerated with Hepatitis C Virus infection (J. Paris,
personal communication, 2003; Allen et al., 2003). Other clinical
criteria and informed consent resulting in patient decision to defer
therapy further reduce the pool of candidates for treatment during the
period of incarceration. While correctional facilities have been able to
take advantage of reduced cost drugs in some settings, the potential
cost impacts are considerable (Spaulding et al., 1999). For the
foreseeable future, correctional systems will struggle to provide
cost-effective care while not unreasonably limiting access to care.
Anticipation of newer therapies with greater effectiveness and improved
side-effect profiles can be expected to be more costly than currently
available therapies.

Associated issues: Substance Abuse and Mental Health

The strong association between remote and/or current injection drug use
(IDU) and hepatitis C infection has already been described. In prisons,
the vast majority of Hepatitis C Virus infected patients acquired their infection from
drug-related risk behaviors. In addition, alcoholism can have an
accelerating effect on the clinical course of the infection (Schiff,
1999) and may help explain some of the more advanced clinical stages of
fibrosis and cirrhosis found in some incarcerated patients.

A history of substance abuse had long been considered a relative
contraindication to treatment for Hepatitis C Virus infection. However, a careful
review of published experience has demonstrated little clinical
justification for withholding treatment to Hepatitis C Virus patients with a history
of substance abuse (Edlin, 2001). In 2002, the NIH Consensus Statement
on Hepatitis C removed substance abuse from the list of
contraindications for anti-viral therapy. The forced sobriety of prison
also provides for a window of opportunity for safe and successful
treatment (Allen et al., 2003) that, when coupled with substance abuse
treatment--including methadone (Tomasino et al.), education, risk
reduction counseling and intervention--has the potential to reduce the
risk of re-infection. Furthermore, fears about re-infection may be
largely theoretical; there are only two confirmed cases of patients
re-infecting themselves by drug injection after successful treatment
with interferon and ribavirin (Kao et al., 2001; Dalgard et al., 2002).

Still, efforts aimed at addressing Hepatitis C Virus in corrections need to be closely
coupled with treatment and referral for the health problem of drug
dependence. While no longer considered a prerequisite for access to
treatment, responsible treatment protocols include counseling, referral
and treatment for substance-abuse-related issues as part of their Hepatitis C Virus
program. Given the persistently high cost of medical anti-viral therapy
for Hepatitis C Virus for the minority of incarcerated infected patients who will be
eligible, broader efforts aimed at dealing with the activity most
closely associated with transmission of infection are critical.

Because the side effects of interferon-based anti-viral therapies
include significant psychiatric side effects including major depression
(Zdilar et al., 2000), caution must be exercised when considering using
interferon in patients with a history of psychiatric illness. Evaluation
for possible treatment should include screening for history of
depression, suicidality and other significant psychiatric illness.
Mental illness, including depression, anxiety, and post-traumatic stress
disorder, is encountered more commonly in correctional populations than
in the general public (Ditton, 1999; Beck and Maruschak, 2000). However,
interferon-related depression does respond to anti-depressant medication
(Hauser, 2002). Concerns about adverse psychiatric effects in
individuals with histories of psychiatric disorders are extrapolated
from studies reporting psychiatric side effects in patients without
psychiatric diagnoses who were treated for hepatitis C (Schaefer et al.,
2003). In fact, a growing body of literature supports the safety of
treating hepatitis C in individuals with a history of psychiatric
diagnoses (Relault et al., 1987). Hepatitis C treatment can be safely
initiated in patients with a history of mental illness provided the
illness is stable, a psychiatrist has evaluated and cleared the patient,
and the medical and psychiatric teams collaborate closely during the
treatment period. In correctional settings where there are comprehensive
mental health services, the controlled and monitored environment of a
correctional facility may provide one of the safest settings in which
interferon therapies can be undertaken in those with mental illness
(Allen et al., 2003).

Have We Been Here Before? The HIV Experience

Corrections has faced the challenge of an epidemic of a chronic
blood-borne infectious disease prior to the recognition of the hepatitis
C epidemic with HIV, the virus that causes AIDS. There are similarities
that may be useful to consider, and factors that make these epidemics
quite distinct. The risk factors for HIV and Hepatitis C Virus are similar, and in
corrections, injection drug use accounts for the majority of both
infections (Centers for Disease Control and Prevention, 2003). However,
Hepatitis C Virus is more effectively transmitted, and is consequently much more
common. HIV prevalence among releasees from correctional facilities is
estimated to be 2-3 percent, compared to 17-18.6 percent for Hepatitis C Virus
(National Commission on Correctional Health Care, 2002). While the
majority of individuals infected with Hepatitis C Virus will not progress to end-stage
complications of liver failure, cancer and death even if untreated, the
majority of HIV-infected individuals would face fatal outcome from
untreated infection.

Still, there is much to learn about the current Hepatitis C Virus epidemic from the
HIV experience in corrections. First, HIV treatment programs have shown
that inmates who are engaged in well-designed longitudinal treatment
programs have lower recidivism rates and are more likely to practice
health-conscious behaviors (Conklin et al., 1998). Second, in the early
days of antiretroviral therapy for HIV, providers were often reluctant
to prescribe these life-saving medications to drug users and persons
with mental illness because of fears of non-adherence and potential drug
interactions (Clarke and Mulcahy, 2000). However, in the context of
programs that specifically address the unique needs of these populations
(Mitty et al., 2002), including adherence programs for incarcerated
persons (Kirkland et al., 2002), drug users and persons with psychiatric
illness are consistently safely and successfully treated for HIV.

A Public Health Opportunity

Many observers understandably look at the large concentration of chronic
hepatitis C within prisons as a daunting medical and fiscal challenge to
state and federal correctional systems, which indeed it is. At the same
time, it is also a significant public health opportunity. One-third of
Americans with a clinically silent and often undiagnosed transmissible
infectious disease are congregating in jails and prisons. The majority
of these individuals will return to the community. The Centers for
Disease Control and Prevention estimate that 1.3 million individuals
with hepatitis C, or 39 percent of all Americans with this disease, are
released from correctional facilities each year. Once back in the
community, infected individuals may continue to transmit the infection,
particularly if they remain undiagnosed and untreated. This situation
presents a rare opportunity for targeted interventions aimed at reducing
spread of the virus. Including the incarcerated population in efforts to
impact the burden of infectious disease is a valid and effective
approach, and is now recognized as an important strategy by those in
corrections and public health agencies (Glaser and Greifinger, 1993;
Association of State and Territorial Health Officials, 2002).

While medical treatment of Hepatitis C Virus has the theoretical effect of reducing
the size of the infectious pool for those returning to the community,
other preventive interventions, such as diagnosis of the disease,
education and counseling about transmission, education about harm
reduction through clean needle access, and referral and treatment for
substance abuse make sense from a public health and safety perspective.
Related cost-effective interventions, such as vaccination of
Hepatitis C Virus-infected inmates against hepatitis B (whose co-infection could
accelerate liver failure) would also save money and lives for states and
localities (Rich et al., 2003).

Conclusions

Hepatitis C is a significant problem for individuals involved with the
correctional justice system nationally. This epidemic has significant
policy and fiscal implications, and correctional institutions are in the
early stages of developing systematic responses to the epidemic. A
significant minority (39 percent) of Americans infected with the virus
congregates in correctional institutions. This situation provides a
unique opportunity to diagnose, educate and treat appropriate
individuals, and to reduce transmission in the community upon the
inmate's release.

 

  


 

While diagnosis, evaluation and treatment has significant medical
implications for individual patients, access to proper medical care
after prison also has the potential to influence future criminal
behavior. Linkage of incarcerated HIV-seropositive patients to medical
care upon prison release has been associated with improved access to
health services and reduced recidivism (Flanigan et al., 1996; Kim et
al., 1997). Addressing the factors that influence the ability to
tolerate Hepatitis C Virus treatment (substance abuse, stable mental health, social
support) will likely also reduce recidivism. In substance abuse
treatment settings, linkage to medical care is associated with improved
addiction-related outcomes (Friedmann et al., 2003). The same positive
effect on recidivism and addiction outcomes will likely accrue to
drug-involved prison releasees who become motivated to address their Hepatitis C Virus
infection. Continuity of care will help the drug-involved offender
develop "trust in the system" work toward rehabilitative goals and
community readjustment (Mitty et al., 1998), and address mental health
and substance abuse issues as part of community management of Hepatitis C Virus.

Systematic approaches to the hepatitis C epidemic in corrections are
needed. Unlike the early days of the HW epidemic, which spawned a highly
organized, politically influential constituency, incarcerated
individuals with substance abuse histories have few advocates. As a
result, the public and legislative response to hepatitis C in
corrections has been muted. The public health and fiscal implication of
this epidemic, however, warrant a more proactive response.
Cost-effective interventions, such as targeted screening, health
education and individual counseling, clean needle access, immunization
against hepatitis B and substance abuse treatment, should form the
foundation of that response.

Acknowledgements

The work described was supported, in part, by grant number P30-AI-42853
from the National Institutes of Health, Center for AIDS Research (NIH
CFAR); and by grant number H79-TI-014562 from The Center for Substance
Abuse Treatment of the Substance Abuse and Mental Health Services
Administration (SAMHSA CSAT)and U01-DA016191-01 from the National
Institute on Drug Abuse. Its contents are solely the responsibility of
the authors and do not necessarily represent the official views of the
awarding Agencies.

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~~~~~~~~

By Scott A. Allen, M.D.; Josiah D. Rich, M.D., M.P.H.; Beth
Schwartzapfel and Peter D. Friedmann, M.D., M.P.H.

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Source: Federal Probation, Sep2003, Vol. 67 Issue 2, p22, 5p
Item: 11265884
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