UCSF researchers are recommending that illicit drug users should be eligible to receive treatment for the hepatitis C virus. The recommendation, published in the July 19 issue of The New England Journal of Medicine (NEJM), differs from the 1997 National Institutes of Health (NIH) Consensus Statement on the Management of Hepatitis C. This recommends that people using illicit drugs be denied treatment for hepatitis C until they have stopped drug use for at least six months.
The researchers noted that drug users are the source of most hepatitis C transmission in the United States. Hepatitis C is caused by a virus that is readily transmitted through contaminated needles and syringes.
"Controlling hepatitis C will require providing treatment to people who use illegal drugs. We believe that when treatment is guided by evidence, tolerance, and compassion, this can be done," said Brian R. Edlin, MD, director of Urban Health Study in the UCSF Department of Family and Community Medicine and the Institute for Health Policy Studies. Edlin is lead author of the article.
The article was authored by seven USCF scientists but reflects the consensus of a group of 38 national and international experts in AIDS, liver disease, substance abuse, and health policy. The members of this group, called the Hepatitis C
Illicit Drug User Treatment Policy Group, are listed at the end of this news release.
"Illicit drug users are a stigmatized group with many health problems. A recommendation to withhold medical treatment from them raises questions about fairness and discrimination," the authors said.
The researchers examined the rationale for excluding drug users from treatment for infection with HCV, the hepatitis C virus, in light of clinical data, ethical guidelines, and accepted medical and public health practices. Based on this examination, they propose a less restrictive policy.
Treatment decisions for illicit drug-using patients should be based on individualized risk-benefit assessment, according to UCSF researchers. They explained that the patient and
physician should make the decision together after a thorough discussion of the need for adherence to the treatment regimen and the risks of adverse effects and reinfection. The patient's willingness to stay on medication, mental health and risk of depression, access to safe injection equipment, and knowledge of safe injection practices should also be considered, they said.
Arguments against allowing drug users to be treated for hepatitis C include a concern that they will not finish the treatment, a preference that they receive substance abuse treatment first, and the fear that they will get infected with HCV again.
Regarding the first issue, "poor adherence to medication is common when we treat hypertension, asthma, and diabetes," said Edlin. "If poor adherence were a reason to withhold treatment, most medical conditions would go untreated. The fact is that when treatment strategies take into account patients' life circumstances, adherence by drug users to medical interventions is as good as in any group of patients-and often very good."
The desire that patients stop using drugs is commendable, said the UCSF researchers, but unfortunately many patients are not ready or able to stop using drugs, and for those who are, substance abuse treatment programs are often too expensive or just don't have room. Although all patients using drugs are now told they cannot be treated for HCV, delaying HCV treatment only makes sense when there is a plan for substance abuse treatment.
"For patients for whom there is no such plan, deferring therapy amounts to a tacit decision to withhold it indefinitely. A policy of deferring HCV treatment indefinitely in patients who do not have access to substance abuse treatment effectively abandons those most effected by the HCV epidemic," said the researchers.
Some experts argue that because injection drug users can be reinfected with the hepatitis C virus, there is no point in treating them for the virus until they stop using drugs. "But persons who inject drugs while receiving treatment for HCV can avoid reinfection by using a new sterile syringe for each injection and by not sharing their injection equipment with other users," said the researchers. Syringe-exchange programs exist in more than 120 cities in the U.S., and some states allow syringes to be bought in drug stores without a prescription. "Experience has shown that when they are given access to sterile syringes, injection drug users readily make use of them, reducing their risk behavior and disease transmission," Edlin said.
Nor are patients whose behaviors could cause recurrence of a condition generally denied treatment in other settings, the researchers noted. Smokers are not denied coronary artery bypass surgery or treatment for emphysema, chronic drinkers are not denied treatment for gastrointestinal problems, and commercial sex workers and others with high-risk sex practices are not denied treatment for sexually transmitted infections because of the risk of reinfection. In fact, they are specifically targeted for treatment to interrupt disease transmission, according to Edlin.
"The difficulties of caring for drug users should not be underestimated. Users engage in behaviors that society defines as illegal. They may fail to keep appointments or take medications as directed. Sensing the disapproval of their providers, they may resist ongoing health care relationships. They may be unwilling to plan ahead and make changes in their lives," said Edlin. "Withholding treatment, researchers have found, is a common response to the frustration doctors understandably feel. But drug users are human beings who need treatment."
"Physicians treating patients with hepatitis should take a page from AIDS doctors, who have learned many lessons from caring for disenfranchised groups for two decades. There's no need to reinvent the wheel. HCV infection is considerably easier to treat than HIV infection, yet AIDS doctors have found ways of providing HIV therapy to active drug users. Successful programs adopt a respectful approach to substance abusers, understand the medical and behavioral cycle of addition, and refrain from moralistic judgments."
A new study published in the June issue of the medical journal Hepatology provides evidence to support the UCSF researchers' view. The article reports on 50 patients in Germany who were drug users with HCV infection who were treated for both substance abuse and HCV at the same time. Although 80 percent of the patients relapsed and went back to using drugs during the study, the overall sustained response rate to the HCV treatment was 36%-which is similar to that seen in the best of clinical trials done with non-drug-using patients. This study shows that it is possible to treat drug users with HCV successfully even if they continue to use drugs, if the circumstances are right. The physicians treating the patients in the study were experts in both liver diseases and substance abuse medicine, and the patients were allowed to continue receiving their treatment for HCV regardless of whether they used drugs.
The editors of NEJM solicited a response to the article by UCSF researchers from Gary L. Davis, M.D., director of hepatobiliary diseases, University of Florida, Gainsville and one of the liver disease experts who participated in the consensus conference at which the NIH guidelines were written. In his reply, Davis, while defending the guidelines generally, discussed circumstances under which some drug users can be successfully treated for HCV infection. Davis recommended collaboration between physicians with expertise in treating hepatitis and substance abuse to maximize benefit to the patient.
NOTE: The Hepatitis C Illicit Drug User Treatment Policy Group is comprised of 38 national and international experts in AID, liver disease, substance abuse and health policy.
1. Frederick L. Altice, MD, Associate Professor of Medicine, Yale University School of Medicine.
2. Tom├ís Arag├│n, MD, MPH, Director, Community Health Epidemiology & Disease Control, San Francisco Department of Public Health.
3. Joshua D. Bamberger, MD, MPH, Medical Director, Housing and Urban Health, San Francisco Department of Public Health.
4. David R. Bangsberg, MD, MPH, Assistant Adjunct Professor of Medicine, University of California, San Francisco.
5. Robert E. Booth, PhD, Professor of Psychiatry, University of Colorado.
6. Scott Burris, JD, Professor of Law, Temple University School of Law.
7. Charles C. J. Carpenter, MD, Professor of Medicine, Brown University School of Medicine.
8. Margaret A. Chesney PhD, Professor of Medicine, University of California, San Francisco. 9. Daniel H. Ciccarone, MD, MPH, Assistant Adjunct Professor of Family and Community Medicine, University of California, San Francisco.
10. James W. Curran, MD, MPH, Dean, Rollins School of Public Health, Emory University. 11. Don C. Des Jarlais, PhD, Director of Research, Beth Israel Medical Center and National Development and Research Institutes.
12. Brian R. Edlin, MD, Associate Adjunct Professor and Director, Urban Health Study, University of California, San Francisco.
13. Neil Flynn, MD, Professor of Clinical Medicine, University of California, Davis.
14. Gerald H. Friedland, MD, Professor of Medicine, Epidemiology, Public Health, Yale University School of Medicine.
15. Samuel R. Friedman, PhD, Senior Research Fellow, National Development and Research Institutes.
16. Lawrence O. Gostin, JD, LLD (Hon.), Professor of Law and Public Health, Co-Director, Georgetown/Johns Hopkins Program on Law and Public Health, Georgetown University Law Center and Johns Hopkins University.
17. Marc N. Gourevitch, MD, MPH, Director, Addiction Medicine, Montefiore Medical Center, and Associate Professor of Psychiatry and Behavioral Sciences and Medicine, Albert Einstein College of Medicine.
18. Robert Heimer, PhD, Associate Professor of Epidemiology and Public Health, Yale University School of Medicine.
19. James G. Kahn MD, MPH, Associate Adjunct Professor of Epidemiology and Health Policy, Institute for Health Policy Studies, University of California, San Francisco.
20. Mitchell H. Katz, MD, Director, City and County of San Francisco Department of Public Health.
21. Robert S. Klein, MD, Professor of Medicine and Epidemiology and Social Medicine, Albert Einstein College of Medicine.
22. Alex H. Kral, PhD, Assistant Adjunct Professor of Family and Community Medicine, University of California, San Francisco.
23. Bernard Lo, MD, Professor of Medicine, University of California, San Francisco.
24. Jennifer Lorvick, Urban Health Study, University of California, San Francisco.
25. David S. Metzger, PhD, Associate Professor and Director, Opiate and AIDS Research Division, University of Pennsylvania.
26. Lisa D. Moore, DrPH, Assistant Professor of Health Education, San Francisco State University.
27. Stephen F. Morin, PhD, Associate Adjunct Professor of Medicine, University of California, San Francisco.
28. Allan Rosenfield, MD, Dean, Mailman School of Public Health, Columbia University, and Chairman, New York State AIDS Advisory Council.
29. Josiah D. Rich, MD, MPH, Associate Professor of Medicine and Community Health, Brown University School of Medicine.
30. Ellie E. Schoenbaum MD, Associate Professor of Epidemiology and Social Medicine and Medicine, Albert Einstein College of Medicine.
31. Karen H. Seal, MD, MPH, Assistant Adjunct Professor of Family and Community Medicine, University of California, San Francisco.
32. Peter A. Selwyn, MD, MPH, Professor of Family Medicine and Internal Medicine, Albert Einstein College of Medicine.
33. James L. Sorensen, PhD, Adjunct Professor of Psychiatry, University of California, San Francisco
34. Steffanie A. Strathdee, PhD, Associate Professor of Epidemiology, Johns Hopkins School of Hygiene and Public Health.
35. David L. Thomas, MD, Associate Professor of Medicine, Johns Hopkins University School of Medicine.
36. David Vlahov, PhD, Director, Center for Urban Epidemiologic Studies, New York Academy of Medicine.
37. Paul A. Volberding, MD, Professor of Medicine, University of California, San Francisco.
38. Teresa L. Wright, MD, Professor of Medicine, University of California, San Francisco.