Elinore F. McCance-Katz, MD, PhD; Ronald O. Valdiserri, MD, MPH
This article was published online first at www.annals.org on 30 June 2015.
Disclosures: Authors disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0007.
Requests for Single Reprints: Elinore F. McCance-Katz, MD, PhD, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 8-1057, Rockville, MD 20857; e-mail, email@example.com.
Current Author Addresses: Dr. McCance-Katz: Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 8-1057, Rockville, MD 20857.
Dr. Valdiserri: Office of HIV/AIDS and Infectious Disease Policy, U.S. Department of Health and Human Services, 200 Independence Avenue Southwest, Hubert H. Humphrey Building, Room 443-H, Washington, DC 20201.
Author Contributions: Conception and design: R.O. Valdiserri.
Analysis and interpretation of the data: R.O. Valdiserri.
Drafting of the article: E.F. McCance-Katz.
Critical revision of the article for important intellectual content: E.F. McCance-Katz, R.O. Valdiserri.
Final approval of the article: E.F. McCance-Katz, R.O. Valdiserri.
Administrative, technical, or logistic support: E.F. McCance-Katz, R.O. Valdiserri.
Collection and assembly of data: R.O. Valdiserri.
McCance-Katz E., Valdiserri R.; Hepatitis C Virus Treatment and Injection Drug Users: It Is Time to Separate Fact From Fiction. Ann Intern Med. 2015;163:224-225. doi: 10.7326/M15-0007
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Published: Ann Intern Med. 2015;163(3):224-225.
We are witnessing revolutionary advances in the treatment of hepatitis C virus (HCV) infection. The development of medications that can be taken orally for shorter periods and with fewer adverse effects than the older regimens of injected pegylated interferon and ribavirin (1) has initiated a profound change in our approach to treating this disease. It is now possible to cure many more infections and thus reduce life-threatening occurrences of cirrhosis and hepatocellular carcinoma, which can lead to the need for liver transplantation or take the lives of those waiting for a donor liver. However, as widely reported in the press, these impressive new pharmacotherapies are associated with stunning costs that threaten their widespread use (2).
Jason Grebely (Ph.D.)1, Gregory J. Dore (M.B.B.S. Ph.D)1, Robert Greenwald (J.D.)2, Tracy Swan3, Soumitri Barua4 and Lynn E. Taylor (M.D.)4,5
1) The Kirby Institute, UNSW Australia, Sydney, Australia, 2) Center for Health Law and Policy Innovation, Harvard Law School, Cambridge, Massachusetts, United States, 3) Treatment Action Group, New Y
July 7, 2015
Conflict of Interest:
Financial Support: The Kirby Institute is funded by the Australian Government Department of Health and Ageing. Dr. Grebely is supported by a National Health and Medical Research Council Career Development Fellowship. Dr. Dore is supported by a National Health and Medical Research Council Practitioner Fellowship. Mr. Greenwald is supported by Harvard Law School. Dr. Taylor is supported by a Rhode Island Innovation Fellowship from the Rhode Island Foundation for her “Rhode Island Defeats Hep C” project and the Lifespan/Tufts/Brown Center for AIDS Research (grant P30AI042853 from the National Institute of Allergy and Infectious Diseases). Ms. Barua was supported by the Lifespan/Tufts/Brown Center for AIDS Research Summer Student Internship program (grant P30AI042853).<br/><br/>Disclosures: Dr. Grebely is a consultant/advisor and has received research grants from Abbvie, Bristol Myers Squibb, Gilead Sciences and Merck. Mr. Greenwald is a consultant/advisor and has received research grants from Bristol Myers Squibb, Gilead Sciences and Janssen. Dr. Dore is a consultant/advisor and has received research grants from Abbvie, Bristol Myers Squibb, Gilead, Merck, Janssen and Roche. Dr. Taylor has received research grant support from Gilead Sciences.<br/>
Time to really separate fact from fiction: Hepatitis C treatment and people who use drugs
We are alarmed by statements made by McCance-Katz and Valdiserri that: “the best outcomes occur in persons who have ceased injection and other drug use”; Medicaid restrictions based on drug/alcohol criteria are “necessary due to the high cost of treatment”; and that people with a history of injecting should be advised to continue opioid substitution therapy (OST) “indefinitely” (1). There is no rationale for establishing a salient difference between people with HCV who do and do not use alcohol and/or drugs (2). As highlighted by international recommendations (3), HCV treatment is effective for people with a history of injecting, those receiving OST and recent injectors, with responses similar to non-drug using populations (3, 4). Recent injecting drug use at treatment initiation and occasional drug use during treatment has limited impact on adherence, treatment completion, and response (3, 4). Exclusion criteria for drug and/or alcohol use/abuse cannot be justified by drug pricing, yet 88% of State Medicaid programs have imposed restrictions (2, 5). Decisions to provide HCV treatment to people with drug/alcohol use must be based on clinical/public health benefits, not drug prices. Even if treatment was less effective for people who use drugs/alcohol, it is not equitable or just to exclude them (2, 5). There is no evidence to support indefinite OST for people with a history of injecting. OST has benefits for many people, but there are no data demonstrating that it should be life-long, or that it can prevent reinfection. Furthermore, OST is not always necessary or available¬. People do not always need OST, nor do they have access to it, since many OST programs in the United States do not accept Medicaid. Many OST programs do not dispense HCV treatment and are not appropriate medical settings for everyone.The authors should be cautioned against making judgments, such as “drug users can be successfully treated for substance disorders, enter recovery, and lead productive lives”. Many people who use drugs lead productive lives without drug treatment. People who use drugs are a highly marginalized population and such statements perpetuate stigmatization. Systematically denying HCV treatment to a population and allowing incorrect assumptions and biased attitudes about people who use drugs to inform Medicaid programs exacerbates health care disparities and discrimination faced by people with HCV. If we are to successfully implement a response to the HCV epidemic, it must be based on human rights, clinical evidence, and public health benefits. REFERENCES1. McCance-Katz EF, Valdiserri RO. Hepatitis C Virus Treatment and Injection Drug Users: It Is Time to Separate Fact From Fiction. Ann Intern Med. 2015.2. Grebely J, Haire B, Taylor LE, Macneill P, Litwin AH, Swan T, et al. Excluding people who use drugs or alcohol from access to hepatitis C treatments – Is this fair, given the available data? J Hepatol. 2015;In Press.3. Robaeys G, Grebely J, Mauss S, Bruggmann P, Moussalli J, De Gottardi A, et al. Recommendations for the management of hepatitis C virus infection among people who inject drugs. Clin Infect Dis. 2013;57 Suppl 2:S129-37.4. Aspinall EJ, Corson S, Doyle JS, Grebely J, Hutchinson SJ, Dore GJ, et al. Treatment of hepatitis C virus infection among people who are actively injecting drugs: a systematic review and meta-analysis. Clin Infect Dis. 2013;57 Suppl 2:S80-9.5. Barua S, Greenwald R, Grebely J, Dore GJ, Swan T, Taylor LE. Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States. Ann Intern Med. 2015.
Elinore F. McCance-Katz, MD, PhD, Ronald O. Valdiserri, MD
September 16, 2015
We appreciate the comments from Grebely and colleagues (1) as it provides the opportunity for several clarifications related to our opinion advocating for HCV treatment for drug users. Our editorial was written to underscore the point that those with a history of injection and other drug use can be successfully treated for HCV. While active injection drug use may not pose an absolute contraindication to HCV therapy we do believe that successful treatment of a substance use disorder helps to ensure optimal outcomes for the treatment of other relevant comorbidities, including hepatitis C infection. We also maintain that engagement of people who inject drugs (PWID) into the treatment system can be useful in the development of a trusting relationship with a health care provider thereby increasing positive health outcomes (2). We also did not mean to imply that opioid therapy for the treatment of opioid use disorder must be indefinite. Our statement was aimed at underscoring the need to allow people access to treatment for as long as they need it rather than to be subject to arbitrary limitations. Unfortunately, this remains an issue in some jurisdictions. Finally, our statement that current Medicaid restrictions have developed in response to high HCV treatment costs is not an endorsement of rationing HCV treatment, but instead, an expression of current reality. The authors take exception to our statement that “drug users can be successfully treated for substance disorders, enter recovery, and lead productive lives” asserting such statements perpetuate stigmatization. They maintain that many drug users lead productive lives without treatment. Again, we will not argue the point that not everyone needs or obtains substance use disorder treatment. However, statements such as this inadvertently trivialize drug and alcohol addiction—conditions which for many are life threatening illnesses. We strongly believe that these those suffering with severe addiction must have access to evidence-based treatment and we contend that such individuals can and do recover. Elinore F. McCance-Katz, MD, PhDRonald O. Valdiserri, MD1. Grebely J, Dore GJ, Greenwald R, et al.: Response to “Time to really separate fact from fiction: hepatitis C treatment and people who use drugs”. Ann Int Med 2015. 2. Treloar C, Rance J Backmund M. Understanding barriers to hepatitis C virus care and stigmatization from a social perspective. Clin Infect Dis. 2013:57 (Suppl 2) S51-S55.
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Gastroenterology/Hepatology, Infectious Disease, Tobacco, Alcohol, and Other Substance Abuse, Viral Hepatitis.
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