NATAP: Treating IVDUs for HCV, Ethics Commentary

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Ethics in Gastroenterology: Treatment of Hepatitis C in Injection Drug Users

The American Journal of Gastroenterology (OnlineEarly Articles).

March 2007

Larry D. , M.D., M.A.11University of Texas Health Science Center at Houston, Texas

1University of Texas Health Science Center at Houston, Texas

Abstract

CASE REPORT

The patient is a 43-yr-old male referred for further evaluation and management of hepatitis C. Considering his health to be good, he recently donated blood but was later notified that his blood could not be used because he had tested positive for hepatitis C. Laboratory studies performed at his primary care physician's office showed that the complete blood count (CBC) was normal. His chemistry profile was also normal, including liver tests, with the exception of the ALT and AST, which were 135 and 75, respectively. Thyroid function was normal. Hepatitis C antibody was confirmed to be positive; he was serologically negative for hepatitis B, but hepatitis A antibody was positive, IgM negative. On further questioning he admitted to using intravenous drugs when he was in the military 25 yr previously; he had continued this habit for a short time after discharge but apart from occasional cocaine use, said that he had not used or shared needles for the past 20 yr. He had never had a blood transfusion or tattoos. There was no history of psychiatric disorder or depression. The reminder of his medical history was without remarkable findings. After leaving the military he had gone to school in computer science and is working as a graphic designer; he is single and denies regular use of alcohol.

Physical exam was normal. He was 6-feet tall and weighed 180 lbs. He had no stigmata of chronic liver disease. Liver and spleen were not enlarged.

After discussing hepatitis C and its implications, along with management options, he agreed to further evaluation. Additional blood was drawn for quantitative hepatitis C virus (HCV) and HCV genotype. Liver biopsy was scheduled.

At a follow-up visit, his quantitative HCV was 2.5 × 106 copies per ml; the virus genotype 1. Liver biopsy showed Grade 3 necroinflammatory activity (moderate piecemeal necrosis with focal cell damage in the lobules) and Grade 1 fibrosis (increased portal fibrosis). There was no stainable iron.

In discussing treatment with pegylated interferon and ribavirin, his occasional use of cocaine came up. Further questioning about illicit drug use revealed that contrary to what he had initially reported, he had, in fact, not been "clean" with regard to intravenous (IV) drug use, and continued to use opiates. He had been enrolled in a methadone treatment program for a few months 3 yr previously but had subsequently dropped out and was not currently seeing a drug counselor.

COMMENT

Is this patient a candidate for treatment? From a strict medical perspective, he is. The most recent NIH consensus conference concluded that all patients with chronic hepatitis C are at least potential candidates and singled out in particular those at risk for ultimate development of cirrhosis (1). This patient's biopsy was active, already with some fibrosis, and would certainly raise concern. Moreover, there are no comorbid conditions such as major depression, anemia, autoimmune disease, or chronic renal insufficiency that are considered potential contraindications (2). Were it not for his use of illicit drugs, there likely would be no hesitation in recommending therapy. Yet, most physicians would hesitate. But why should it be withheld if by all other parameters, treatment is a logical next step?

Injection drug users (IDUs) are noncompliant and exhibit poor adherence to rigorous treatment regimens; at least this is a prevalent concept and offered as a reason to withhold treatment. However, published studies do not consistently report this, according to a review contained in a commentary by Edlin et al. (3). For example, there are reports that show no differences in adherence to therapy between users and nonusers in other diseases, such as tuberculosis that require demanding treatment regimens. This does not mean that IDUs are uniformly compliant; rather, it means that drug use per se may not be the sole reason for noncompliance when variables such as psychological duress, poor socioeconomic status, unstable housing, ineffective provider-patient relationship, and others are likely more important. There have also been concerns about the frequency of major depression in illicit drug users, but again, as summarized in that same review, depression is no more common in IDUs than it is in nonusers; regardless of the circumstances, however, depression can be a problem in hepatitis C treatment and would require attention. Clearly, generalizations are impossible, and simply being a member of a specific group may not justify, by itself, withholding treatment. Thus, while the first NIH consensus conference recommended withholding treatment in this population as long as they were actively using drugs (4), the 2002 conference concluded otherwise, as noted earlier. In addition, the conference pointed out that successful treatment could have the added benefit of reducing transmission. The one caveat, however, was the encouragement to pursue substance abuse treatment.

Thus, if the experience with treatment of hepatitis C in IDUs shows that success, as measured by sustained virological response, can be achieved in this setting, why is there still hesitation? The issues are complicated and in many cases morally based.

A common concern that is debated in cases like this is the responsibility of the individual in his or her own health. If one engages in high-risk behaviors, and is aware of the associated risk for disease, does this in any way alter the response of the provider? Does a patient or individual have a responsibility to promote their own health, and if he or she fails to do so, are they any less entitled to health care? Draper and Sorell have argued that patients have a moral obligation to follow a physician's advice, and that if we as physicians honor individual autonomy, they, as patients, in turn assume responsibility for their action (5). However, they also note that doctors are to some extent, "captive." While patients should honor a physician's decision to opt out of a relationship, a patient's best interests dominate and someone in need cannot be abandoned even if viewed as undeserving. Denying care under these circumstances is, in effect, judgmental and thus discriminatory. And if one starts judging one group, where do we stop? What about the patient with hypercholesterolemia who continues to consume a high-fat diet and develops coronary artery disease? Or the patient with chronic obstructive pulmonary disease (COPD) who continues to smoke? Or, more in line with the case at hand, the patient with alcoholic hepatitis, who continues to drink alcohol. We do not refuse to treat endocarditis in the IDU patient; similarly, we cannot logically refuse to treat the IDU with hepatitis C solely because he or she chose to use drugs and increased the risk of acquiring the infection. Moreover, the element of addiction, a significant medical problem in its own right, actually could be viewed as amplifying the need for care. There may be other reasons why treatment might be withheld, but high-risk behavior per se would not be one of them.

Another ethical issue is justice and the allocation of the health-care dollar. A classic situation is the alcoholic with end-stage liver disease who needs a liver transplant. In this case, there is, in addition to costly technology, the added issue of a scarce resource. Alcoholic patients are typically restricted from being listed for transplant, unless they have demonstrated commitment to abstinence for at least 6 months. The reasons offered are familiar ones: alcohol-dependent patients are less likely to adhere to the rigorous posttransplant care that is required and often will resume drinking, thereby placing the graft in jeopardy. Interestingly, when looked at critically, the outcome in these patients does not seem to be materially different from those with other causes of end-stage liver disease (6). In hepatitis C, the treatment resource is not scarce, but it is extremely costly, and with money available for health care somewhat fixed, restrictions in allocation are going to be necessary at some point. Are IDUs a group in which treatment should be restricted solely on a cost basis? The 1997 NIH consensus conference said this group in fact should be restricted until they had demonstrated abstinence for 6 months (4). Citing data referred to earlier, however, this restriction was lifted at the most recent consensus conference, in favor of individualizing decisions. A similar restrictive policy was enacted in Australia in the 1990s because of concern that the health-care dollar could be wasted in these patients; it was argued that IDUs already use more of their share, they do not adhere to demanding treatment regimens, and once treated, they would resume their high-risk behavior and again be at risk for reinfection, if not other parenterally transmitted diseases (7). This argument could not be sustained, however. Examples of discrimination were publicized and ultimately, these restrictions were lifted. Interestingly, at least one forecast of health care costs in New Zealand concluded that not treating IDUs with hepatitis C could be more costly in the long run because of the higher costs of treating end-stage liver disease that could result if treatment was withheld when the disease was less advanced (8).

There are clearly ethical problems with identifying groups who should not be eligible for care, especially when the groups are heterogeneous, and include among their numbers, individuals who, as in the case presented here, are very appropriate candidates for treatment. The decision to offer treatment should, then, be a medical and not a social one. This lesson was learned over 40 yr ago when the Scribner shunt was introduced thereby making hemodialysis a feasible option for managing end-stage renal disease. Because hemodialysis was in limited supply, candidates were selected on the basis of their assessed social value, as determined by what ultimately became known as "The God Committee" (9). This method of resource allocation was soon abandoned. Similarly, the assumption that IDUs are, as a group, unsuitable for interferon and ribavirin because of behavioral and social characteristics, is simply no longer valid. If there are social issues, they are likely more common to socioeconomic variables that create barriers such as homelessness, than they are to drug use, per se. These may or may not be manageable. The ethical and sensible approach is to consider all the variables that affect the likelihood of success, and prescribe or proscribe treatment accordingly. Treatment of hepatitis C remains imperfect; while responses to currently recommended regimens are improved by an order of magnitude over those of a decade ago, cure as measured by sustained virological response, is far from assured particularly in those infected with genotype 1. In this disease as much as any, individual evaluation is crucial, and shared decision making the key to a mutually acceptable outcome. Many IDUs may not meet the criteria, but many will.

OUTCOME

In this case presented here, treatment with pegylated interferon and ribavirin was recommended, and the patient agreed. An extensive patient education intervention was also undertaken. He joined a patient support group. Drug addiction was also identified as a problem. Needle exchange programs were discussed but such programs were not available in the city in which he resided and state law made it difficult for pharmacists to dispense syringes and needles for the purpose of preventing transmission of blood-borne infections. Ultimately, he agreed to resume counseling, which in turn led to enrollment in a methadone treatment program.

References

1. National Institutes of Health Consensus Development Conference Statement: Management of Hepatitis C: 2002-June 10-12, 2002. Hepatology 2002; 36( Suppl 1): S3- S20.

CrossRef, Medline, ISI

2. Russo MW, Zacks SL, Fried MW . Management of newly diagnosed hepatitis C infection. Cleve Clin J Med 2003; 70( Suppl 4): S14- S20.

Medline

3. Edlin BR, Seal KH, Lorvick J, et al . Is it justifiable to withhold treatment for hepatitis C from illicit-drug users? N Engl J Med 2001; 345: 211- 4.

CrossRef, Medline, ISI, CSA

4. National Institutes of Health Consensus Development Conference. Management of hepatitis C. Hepatology 1997; 26( Suppl 1): 2S- 10S.

CrossRef, Medline, ISI

5. Draper H, Sorell T . Patients' responsibilities in medical ethics. Bioethics 2002; 16: 335- 52.

Synergy, Medline, ISI, CSA

6. Tome S, Lucey MR . Review article: Current management of alcoholic liver disease. Aliment Pharmacol Ther 2004; 19: 707- 14.

Synergy, Medline, ISI

7. Batey RG . Denying treatment to drug and alcohol-dependent patients. Addiction 1997; 92: 1189- 93.

Synergy, Medline, ISI, CSA

8. Sheerin IG, Green FT, Sellman JD . The costs of not treating hepatitis C virus infection in injecting drug users in New Zealand. Drug Alcohol Rev 2003; 22: 159- 67.

CrossRef, Medline, ISI, CSA

9. Jonsen AR . A short history of medical ethics. : Oxford University Press, 2000: 104- 6.

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