APPROXIMATELY 3 million Americans are thought to be infected with hepatitis C virus (HCV).1 HCV causes chronic infection in about 85 percent of infected persons, and cirrhosis may develop in as many as 20 percent of those with chronic infection.2 HCV infection results in 8000 to 10,000 deaths annually and is the most common reason for liver transplantation in the United States. The rates of morbidity and mortality from HCV infection are increasing, and this trend is expected to continue in the coming decades.1 Treatment with interferon, with or without ribavirin, for 6 to 12 months results in viral clearance in up to 40 percent of patients and histologic improvement, possibly, in more.3 Side effects of this regimen, however, include depression, emotional lability, and hemolytic anemia.
Injection-drug users constitute the largest group of persons in the United States who are infected with HCV and account for the majority of new infections.1Of the 15 million Americans who currently use illicit drugs, an estimated 1.0 to 1.5 million inject them,4 and some 80 to 95 percent of injection-drug users have been infected with HCV.5,6 In a consensus statement on the management of hepatitis C, however, the National Institutes of Health recommended in 1997 that persons who use illicit drugs not be offered treatment for HCV infection until they had stopped all such use for at least six months.7 Other national and international guidelines have reiterated this policy.8,9
Illicit-drug users are a stigmatized group with disproportionately high rates of many medical conditions.10 A recommendation to withhold medical treatment from a stigmatized class of persons raises questions about fairness and discrimination.11 Groups issuing guidelines that include such a recommendation can provide reassurance that the policy is warranted by clearly articulating the rationale for it, making sure that it is based on evidence and is consistent with policies for other, similar conditions, and ensuring that less restrictive alternative policies have been explored. In this article, we argue that guidelines for the treatment of HCV infection have, unfortunately, met none of these criteria. Published guidelines provide little explanation for the current policy.7-9 We are unaware of studies that have reported results of attempts to treat HCV infection in active drug users. After examining the rationale for excluding drug users from treatment of HCV infection in the light of available clinical data, ethical guidelines, and accepted medical and public health practices, we propose a less restrictive alternative policy.