or Not to Treat? That is the Question...
MD, J.D., Chair, Department of Surgery, Division of Correctional
University, College of Osteopathic Medicine
difficult question of if and when to treat those infected with
Hepatitis C Virus (HCV) can be evaluated from a myriad of
perspectives, including public health concerns, risk/benefit in
corrections, legal issues, ethical issues, and personal
physician-patient responsibility. The discussion that follows
reflects the opinions of the author.
1. There is no clinical test for HCV disease risk to determine which
of the 2.5 to 4 million HCV-infected people in the U.S. will develop
liver failure or hepatocellular carcinoma, and therefore, are most
in need of treatment.
2. Some of those who are infected may continue to participate in
activities that put them at high risk for reinfection.
3. Most individuals (80%) do not develop complications from HCV
4. HCV mutates easily, making it unlikely that a vaccine will be
developed in the near future.
these concerns, public health resources have been directed to the
prevention of infection and disease. The goals of the National
Hepatitis C Prevention Strategy are "to lower the incidence of acute
hepatitis C in the United States and reduce the disease burden from
chronic HCV infection," through:
1) Harm reduction programs directed at persons at increased risk for
infection to reduce the incidence of new HCV infections;
2) Counseling, testing, and medical evaluation and management of
infected persons to control HCV-related chronic liver disease;
3) Surveillance to evaluate the effectiveness of prevention
4) Research aimed at prevention and control of HCV.1
Risk/Benefit to Correctional Healthcare systems
Up to one third of those with HCV in this country have been
incarcerated. Correctional health care workers see two discrete HCV
epidemics in prisons and jailsone that is decades old and the other
that is comprised of "rapid progressors, i.e. patients who have not
been infected for the traditional two to three decades that are
required to show problems with this disease." 2 HIV has a clear
role in the more rapid progression of HCV disease in co-infected
patients. In some prison systems, HCV has become the single largest
cause of death,3 reminiscent of the situation of HIV a decade ago.
prisoners have a constitutional right to healthcare, correctional
healthcare standards vary significantly from state to state. Some
argue that to treat HCV aggressively would draw scarce resources
away from other essential correctional healthcare programs. Prison
budgets are at the whim of the respective state legislatures (and
the U.S. Congress in the federal system), and must compete with all
other healthcare initiatives. Few states have appropriated recurring
funding for HCV care as they have for the treatment of HIV. Some
prison systems have chosen to ignore the issue because with an
average length of stay of less than three years,4 it is unlikely
that while incarcerated, a patient with HCV will develop sequelae
that will lead to an economic burden for the penal system.
large systems, particularly in the South, have average lengths of
stays that approach a decade.5 These systems are more likely to face
the economic consequences of therapeutic nihilism. Paradoxically,
most of these systems have been among the least aggressive when it
comes to HCV treatment.
There are currently pending lawsuits involving correctional
facilities concerning failure to treat HCV;6 most of these cases are
progressing at a very slow pace. It is still unclear whether or not
the plaintiffs will prevail in these cases. Last year at the
"Management of Hepatitis C in Prisons 2003" meeting (San Antonio,
TX), healthcare providers discussed various approaches to developing
effective guidelines for HCV treatment in corrections but failed to
achieve a definitive consensus on management of this infection.7 It
is therefore unlikely that the courts will intervene and require a
particular approach to treatment.
One area in
which correctional systems may be vulnerable is by requiring an
inmate to have a specific amount of time left on their sentence to
be considered for treatment. The justification for this requirement
has been that it is necessary to allow the patient to be able to
complete a full course of therapy prior to release. In the same way
that one cannot withhold cancer treatment because the regimen may
not be completed prior to discharge, there is a requirement to
initiate treatment for eligible patients and then refer the patient
to non-correctional resources once the inmate has reached the
end-of-sentence. In this sense, requiring a specific period of time
left to serve may be more legally risky than having a policy of not
treating HCV at all.
Systems that have policies that do not offer treatment for HCV
1. The natural history of the disease is not well-studied because we
have interfered in a disease process before we have truly worked out
the natural history;
2. The morbidity of treatment for treatment is very high;
3. Risk of re-infection is very high unless the patient modifies
4. The long-term effects of treatment and repeated treatment is
5. Waiting until there are better drugs available is a better course
for the protection of our patients;
6. Of the patients who undergo therapy, it is not possible to
predict those who will have a long-term benefit and those who will
7. Using scarce resources on patients for whom treatment benefits
are uncertain leaves fewer resources for other patients who may be
in greater need or have better documented response to therapy.
policies for treatment of HCV in place claim:
1. Some people may be cured by treatment;
2. It is unethical to withhold treatment simply because the patient
will not comply with the physician's directive (e.g. diabetics who
do not remain on a diet);
3. The morbidity of treatment is very low;
4. Cost concerns should not play a role in our decision to advocate
for our patients;
5. The correctional setting is the ideal setting in which to reduce
the impact of this disease because illicit drug use is probably less
than outside the correctional setting and patients generally will
complete a regimen.
As with most
ethical dilemmas, all sides have compelling arguments. In addition,
most issues fall into grey areas.
Irrespective of our practice setting, each of us has a
responsibility to our individual patients. This responsibility
exceeds that of "what is good for most of the population." This
unique relationship is one reason why physicians understand the
global problem of antibiotic overuse, but continue to excessively
prescribe in their own practices. The legal issues notwithstanding,
(which in the correctional setting include malpractice and licensure
actions, as well as allegations of deliberate indifference and Civil
Rights infraction) there is the matter of patient trust. Your
patient expects you to do what is best for him or her. Your final
decision is based on your background of knowledge, your ethical
framework and the interaction between you and your patient at that
particular moment in time.
This kind of
subjectivity is the nemesis of managed care companies. As
physicians, we claim it is part of the art of medicine. It is one of
the major reasons there is not uniformity of decision-making among
physicians or, more importantly, even for a single physician seeing
patients with similar problems. Most of us would comfortably say
medicine is an art as well as a science and explain it that way.
Should it not be our unique physician/patient relationship that
determines whether to treat or not to treat? After all, it is our
name on the prescription and our irrevocable, non-delegable
responsibility for the patient.
National Hepatitis C Prevention Strategy-A Comprehensive Strategy
for the Prevention and Control of Hepatitis C Virus Infection and
its Consequences. CDC. Summer 2001.
Cassidy, WM. Treating Hepatitis C in Prison. Proceedings of the
Management of Hepatitis C in Prisons; 2003. Jan 25-26; San Antonio,
3.Personal communication. Mortality and Morbidity. FL DOC.
DOJ National Institute of Corrections Bureau of Justice
Personal communication. Diane Moratti, Deputy Attorney General.
Management of Hepatitis C in Prisons 2003. January 25-26, 2003, San