Spotlight: HCV -- To Treat or Not to Treat? That Is the Question ...
The 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.
Public Health Concerns
- 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.
- Some of those who are infected may continue to participate in activities that put them at high risk for reinfection.
- Most individuals (80%) do not develop complications from HCV infection.
- HCV mutates easily, making it unlikely that a vaccine will be developed in the near future.
Reflecting 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:
- Harm reduction programs directed at persons at increased risk for infection to reduce the incidence of new HCV infections;
- Counseling, testing, and medical evaluation and management of infected persons to control HCV-related chronic liver disease;
- Surveillance to evaluate the effectiveness of prevention activities;
- 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 jails -- one 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.
Although 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.
However, some 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 claim:
- 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;
- The morbidity of treatment for treatment is very high;
- Risk of re-infection is very high unless the patient modifies his/her behavior;
- The long-term effects of treatment and repeated treatment is unknown;
- Waiting until there are better drugs available is a better course for the protection of our patients;
- Of the patients who undergo therapy, it is not possible to predict those who will have a long-term benefit and those who will not;
- 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.
Systems with policies for treatment of HCV in place claim:
- Some people may be cured by treatment;
- 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);
- The morbidity of treatment is very low;
- Cost concerns should not play a role in our decision to advocate for our patients;
- 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.
Personal Physician/Patient Responsibility
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.
David Thomas, M.D., J.D., holds a Chair at the Department of Surgery, Division of Correctional Medicine, NovaSoutheastern University, College of Osteopathic Medicine. Disclosures: Nothing to disclose.
- 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, Texas.
- Personal communication. Mortality and Morbidity. FL DOC. 2002-2003.
- US DOJ National Institute of Corrections Bureau of Justice Statistics -- 2001; 2002.
- Personal communication. Diane Moratti, Deputy Attorney General.
- Management of Hepatitis C in Prisons 2003. January 25-26, 2003, San Antonio, Texas.