Back to Hepatitis C
By Alan Franciscus
Executive Director, Hepatitis C Support Project
Editor-in-Chief, HCV Advocate
Back : Freedom to Be Cured
Back to Hepatitis C
Discovered by a German pharmacologist prior to World War II, methadone (brand name Dolophine, after the Latin for "dolor," or pain) is a synthetic narcotic with actions similar to heroin. Methadone works by blocking the euphoric effect of opiates and relieving the craving associated with opiate withdrawal. It is used for the treatment of addiction for a short-term period or over many years. Methadone can be dispensed only by hospital pharmacies and federally regulated drug treatment programs.
The perception that methadone is a substitute for heroin-rather than a treatment for addiction-accounts for the widespread discrimination against those on methadone maintenance therapy. However, scientific evidence has shown that methadone maintenance is an effective treatment for heroin addiction, and its use is best described as "dependence" on methadone maintenance therapy rather than "addiction" to methadone. Addiction implies compulsive drug use or loss of control over one's drug use. Methadone maintenance therapy stabilizes heroin addicts so that they can lead relatively normal and productive lives. Even former "Drug Czar" General Barry McCaffrey compares methadone maintenance therapy to the use of insulin to treat diabetes.
The 1997 hepatitis C treatment guidelines state, "Treatment for addiction should be provided prior to treatment for hepatitis C." However, patients on methadone maintenance therapy have for the most part been excluded from HCV treatment and lumped together with active drug users. In some studies the prevalence of HCV among those on methadone maintenance therapy approaches 90%, but there have been very few clinical trials to address the benefits and costs of treating this population with current HCV medications. However, some small trials have been conducted that can shed light on some basic questions.
Dr. Diana Sylvestre of the Organization to Achieve Solutions in Substance Abuse (OASIS) is a pioneer in the field of treating HCV positive patients on methadone maintenance therapy. In an ongoing clinical trial Dr. Sylvestre has treated 59 patients on methadone with interferon plus ribavirin combination therapy. An important aspect of this trial is the scope of services offered by OASIS, which combines medical and psychological services based on a peer-support model. Compared to average participants in HCV clinical trials, the patients on methadone maintenance in this trial were older, were infected for a longer period of time, had more advanced disease progression, reported higher rates of psychiatric illness, and were more racially and sexually balanced than in most studies. In other words, this group was more representative of the population with hepatitis C. In spite of these negative predictors of successful treatment outcomes, a carefully selected group of patients on methadone maintenance achieved an average SVR rate of 28%, compared with an average SVR rate of 41% in large trials of people with HCV that excluded patients on methadone maintenance therapy and active drug users.
Injection Drug Users
I think most prejudice-free people who closely examine the scientific data to date would agree that methadone maintenance patients should and can be successfully treated for hepatitis C. However, treating active drug users poses a more difficult problem due to a lack of scientific data, compounded by even greater prejudice than that experienced by people on methadone maintenance therapy. Critics argue that active drug users are a difficult group to treat, and that treatment would not be effective in this population.
However, some small clinical trials with limited data refute these claims. Markus Backmund and colleagues from Munich, Germany, studied 50 hepatitis C patients enrolled in a trial while undergoing drug detoxification. Participants were treated with interferon or with interferon plus ribavirin by liver specialists and physicians who specialize in addiction medicine. The average SVR in this group was 36% at 24 weeks after the end of treatment. The authors concluded that the sustained response rate was not significantly different than that of non-drug-using patients.
Another compelling argument against treating active drug users concerns the potential for HCV reinfection. In other words, why spend money, time, and effort treating patients if they are likely to reinfect themselves with HCV? In the study described above, Backmund's team instructed participants about prevention measures to avoid HCV reinfection if they resumed injecting drugs. The ten patients that continued to inject heroin during the 24-week post-treatment period did not become reinfected. In another study, Olav Dalgard and colleagues from Oslo, Norway, reported that of the 27 IDUs they treated, only one reinfection was observed during a follow-up period of 13-82 weeks. The researchers concluded that the long-term outcome of HCV treatment in IDUs was excellent, despite reinitiation of drug injection.
Cost is another argument critics use to discourage treatment of active injection drug users. The cost of HCV medications range from $20,000 to more than $30,000 annually, which does not include the costs associated with office visits, lab tests, and adjunct therapies. It has been proven that HCV treatment is cost-effective in comparison with the burden of long-term medical care and loss of work productivity. But is the same true for active drug users? The answer is yes, since the majority of new HCV infections occur in injection drug users, and successful treatment of this population would prevent new infections and would lower future medical costs associated with disease progression.
Clearly, more studies are needed to address these complex issues, but the limited evidence available to date indicates that people on methadone maintenance therapy and former and active injection drug users can be effectively treated, and that the majority will not become reinfected. It is also evident that treating these populations is a complicated process that is best carried out using an interdisciplinary approach that combines the expertise of addiction medicine and liver disease specialists. But isn't this what medicine is about-an integrative approach to the prevention and treatment of disease?
Hopefully, the 2002 NIH consensus guidelines for Management of Hepatitis C will open the door and researchers and doctors will step in to answer these complicated questions, rather than outright denying treatment to any segment of the population out of prejudice. The ultimate goal should be to put medical care into the hands of patients in collaboration with their healthcare providers.
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