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Hepatitis C Virus (HCV) is among the more common serious
infections in the U.S. today. No especially good
data exist on the numbers of people infected, but estimates range somewhere
between two and four million.
Even that lower estimate is about twice the number estimated to be infected
with HIV.
In correctional systems the rates of HCV are thought to be
much greater than in the population at large since
one of the most common means of transmission is via shared injection drug
paraphernalia. Behaviors that can
spread HCV are also behaviors that can lead to incarceration, so there is
little surprise in finding high rates of
the infection within correctional systems.
Lanette Linthicum, M.D., medical director of the Texas
Department of Criminal Justice and co-authors looked
at the rate of HCV among newly incarcerated persons and found rates of about
27% for males and 45% for
females. (“Hepatitis C Seroprevalence
Among Newly Incarcerated Inmates in the Texas Correctional System,”
Public Health, 2003 Jan). In another study of inmates in the Puerto
Rican correctional system, more than 49%
were found to be HCV positive. Other systems have found infection rates to
be in the 20% to 28% range among
inmates.
Just as important, as many
as one-third of all persons infected with HCV in the US have been
incarcerated at
some point. And therein lays the rub. In mates newly entering the
system with HCV present both medical and
policy problems for correctional healthcare. HCV infection is relatively
easy to diagnose. Deciding who will develop
serious illness is less easy and more costly. Add in the fact that
infections occur in the community and deciding
who should pay for care presents difficult policy conflicts for corrections
administrators.
According to David Thomas, MD, JD, there was little interest
initially in diagnosing HCV among inmates for several
reasons. First the prognoses in HCV in the early days of treatment were not
very good and there was concern that
inmates being treated for the infection may revert to the behaviors that
caused infection. In addition, Dr. Thomas
noted that at that time (in the late 1990’s) treatment outcomes were not
very good. For genotype 1 (the type most
common in the US) only 20% or so of those treated were able to reduce
viral load below levels that were detectable,
a sustained viral suppression. Dr. Thomas was quick to point out that with
pegylated Interferons the response rate
for genotype 1 is much closer to 50% now. Still other reasons cited by
Thomas were side effects such as, “blood
dyscrasias (abnormal condition of blood cells) and psychiatric” concerns
coupled with the “nuisance of three
injections a week” for the initially available Interferons. Currently with
the newer versions injections are once a week.
s the infection became better known among the general public as well as
inmates came lawsuits from inmates
wanting treatment. Additionally there were pressures from outside advocacy
groups. But, says Dr. Thomas,
“These groups did not have the high-profile celebrities that other illnesses
such as HIV were able to mobilize.
They did not have the impact of AIDS activists.” One reason for the slow
start to advocacy is that many persons
with HCV used injection drugs, hardly a group likely to elicit much
sympathy. About the only case requiring some
action by a correctional department was in an on-going case from California
which only applied to one institution a
nd only necessitated offering antibody testing if an inmate requested it.
Then beginning in about 1999 some states
began to reconsider their approach to HCV treatment. Partially, according
to Dr. Thomas, this may have been
motivated by a desire to avoid legal repercussions from lawsuits.
Pennsylvania initiated a program offering HCV
testing on inmate requests and for those interested in pursuing treatment
they would be entered into a protocol for
evaluation and possible treatment.
(That program was profi led in
Positive Populations
Vol. 5 Num. 1
available at
www.positivepopulations.org).
About one
year later, New Jersey won a decision on
its stance in not offering treatment for HCV. In about 2002
Pennsylvania began to reassess its nearly universal HCV testing and
treatment protocol, partly due to costs of
providing medications to large numbers of inmates. Pennsylvania then adopted
a protocol very similar to that of
the United States Bureau of Prisons currently in place. Up to this point the
legal challenges for inmates wanting
interferon combination or monotherapy had all failed, mainly due to
differing medical opinions as to the efficacy of
treatment which made courts hesitant to require treatment. (Dr. Thomas
served several of the states in these
challenges.)
In his opinion the major obstacles to overcome in these
court cases were that no clear clinical predictors existed
to determine who would develop severe liver disease from the infection and
that the true natural history of the
illness was unknown. One complication is that HCV may not cause significant
liver illness for between 10-30
years and by 2000, the virus had been identified for only 12 years. Among
the more common tests to determine
disease impacts on the liver are liver function tests (LFTs). In the case of
HCV infection these tests do not provide
a reliable prediction as to who will develop serious illness.
As Dr. Thomas notes, test results can be high, low or in
between. In fact HCV can exact severe liver damage with
normal to only slightly elevated LFTs. On the other hand, patients with very
high LFTs can have no damage at all.
Another evaluation often used in HCV infection is a viral load, an
assessment of how much virus is circulating in
the bloodstream. Again, these tests are not predictive of who will develop
illness; some with high viral loads will
suffer little or no liver damage while some with lower values may face
significant illness.
Even today, Dr. Thomas notes there is no other surrogate
marker for determining if a patient will eventually
become seriously ill. The best analysis of liver damage is by conducting a
liver biopsy, an often painful procedure
that can entail some risks for a patient.
The National Institute of Health notes, “Liver biopsy is an
invasive procedure that is expensive and not without
complications. At least 20 percent of patients have pain requiring
medications after liver biopsy. More uncommon
complications include puncture of another organ, infection, and bleeding.
Significant bleeding after liver biopsy
occurs in 1/100 to 1/1,000 cases, and deaths are reported in 1/5,000 to
1/10,000 cases.” Dr. Thomas noted that
many patients do not want even the first biopsy, let alone follow-up
tests. Thomas described liver biopsies this
way, “Traditionally liver biopsies are done with the patient awake and
either sitting up or lying with the head
elevated and right arm over the head for safety reasons. In a percutaneous
liver biopsy, there is no good way to
anesthetize the peritoneum or liver capsule and I have found that most
patients have more discomfort than they
would like. Bad outcomes (other than pain) are uncommon.”
The diversity of opinion regarding the efficacy of treating
persons with HCV extends beyond the correctional
health care system. With as many as 4 million persons infected with HCV and
perhaps 20,000 or so currently ill,
public health systems have to some degree placed HCV on the back burner
since there are plenty of other issues
acing public providers of care.
Another contributing factor to the diversity of medical
opinion in the late 1990s and the first years of the new
century is the lack of any immunity to the virus once someone has been
infected and clears the virus. This means
both those who clear the virus naturally and those who are treated can
be re-infected if exposed to the virus again.
That is particularly an issue in a population with high risk for continued
injection substance HCV being a single-
stranded RNA virus, mutates quickly, thus making vaccine development
difficult .Even among specialists dealing
with liver or infectious diseases, there existed substantial
difference of opinion. Some hepatologists and
gastroenterologists point out that HCV is the leading reason for
offering liver transplants, numbering some 10,000
or so each year. Some of these specialists point out that with limited
organs available for transplantation and the
costs and risks of this surgery, treatment that could delay or prevent liver
failure is imperative. Infectious disease
specialists on the other hand may be less concerned with HCV as the illness
is long-term and better treatments
may become available in the future.
Dr. Thomas notes that, “Several years ago I specifically asked three ID
specialists, well known and respected in
their field, that if they had Hep C would they treat it—all three said no.”
He went on, “I do believe now—with
pegylated interferon. that most would consider treatment for at least the fi
rst twelve weeks to see if they are
responders or not.”
More recently, the divergent medical opinion seems to be
converging. With pegylated interferons and
combination treatment with ribavirin, sustained viral response (SVR) among
those infected with genotypes 2 and
3 (viruses with specific genetic composition) approaches 80%. Genotype 1,
the form most common in the U.S.
and especially among the incarcerated, results are less successful, but
still in the 45% to 50% SVR.
Even with these developments the National Institutes of
Health notes on its webpage, “Chronic hepatitis C
varies greatly in its course and outcome. At one end of the spectrum are
patients who have no signs or
symptoms of liver disease and completely normal levels of serum liver
enzymes. Liver biopsy usually shows
some degree of chronic hepatitis, but the degree of injury is usually mild,
and the overall prognosis may be good.
At the other end of the spectrum are patients with severe hepatitis C who
have symptom s, HCV RNA in serum,
and elevated serum liver enzymes, and who ultimately develop cirrhosis and
end-stage liver disease. In the
middle of the spectrum are many patients who have few or no symptoms, mild
to moderate elevations in liver
enzymes, and an uncertain prognosis. ”(http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc
accessed
2-11-06)
Despite some uncertainty it appears even those who do not
reduce viral levels below the limit of tests’ ability to
detect, do get some benefit. In some of these patients the visible damage to
the liver is lowered when follow-up
biopsies are performed. Another factor is the number of persons with HCV
who are co-infected with HIV. Those
who have both infections are more likely to experience liver damage. HIV
seems to make HCV worse, although
HCV does not appear to hasten the onset of complications from HIV. The
initial approach to those dually diagnosed
with HIV and HCV was to treat and control the HIV infection fi rst and then
consider treatment for the liver infection.
More recently medical opinion has converged on treating HCV first if liver
damage is imminent and, if necessary
hold off on HIV until the liver is better stabilized. As Dr. Thomas said,
“you must treat the disease that is most
destroying the liver at that particular moment and if you do not ‘stabilize’
it—then it may be too late to do anything.
Traditionally we got the HIV under control and then treated other
conditions. Now we treat to preserve the liver in
the best condition we can, whether we treat the HIV first or HCV.”
There seems to be an emerging consensus that if it is
medically necessary, both illnesses can and should be
treated concurrently. In Dr. Thomas’ view the facts that in at least some
cases treatment is warranted and there
is Food and Drug Administration approved treatment available, the courts are
likely to see continued on page 6
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Editor’s Note: Thirty years ago the United States Supreme
Court issued the Estelle v. Gamble decision.
While for many Americans that decision meant little, for those
incarcerated it began a continuing process of i
mproving health care in jails and prisons. For those working to provide that
care, Estelle v. Gamble has meant
vast changes in the way they work and the services they can offer. To those
responsible for managing
correctional systems it has meant, among other things, continued growth in
the health care portion of their
budgets. From time to time in the coming year Positive Populations
will contain articles related to
implications
of that decision that reverberate within and beyond correctional systems.
This issue carries an article on
Hepatitis C Virus, evolving standards of care and potential legal
requirements.
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