Hepatitis C virus (HCV) infects and inflames the liver. In some people, the immune system can bring HCV under control. In other people, the virus cannot be controlled, and over a period of many years, it slowly scars and destroys the liver. Currently available treatments for HCV include interferon-alpha and ribavirin. Even when these two medications are used together, about 50% of treated people fail to recover. These drugs also have unpleasant side effects. Researchers are testing several therapies for use by people with HCV infection, including IL-12 (interleukin-12). They hope that repeated use of this immune booster will be able to strengthen the immune system's ability to fight the virus.
Researchers enrolled 24 adults (7 females, 17 males) who were positive for HCV, but not HIV, into their study. All subjects had previously received treatment with interferon-alpha, but this failed to help them recover from HCV. The basic profile of subjects was as follows:
Subjects were randomly assigned to receive one of the three following doses of IL-12 injected under the skin twice weekly for three months:
Although three different doses of IL-12 were used in this study, beneficial effects occurred only in three of six subjects receiving the highest dose (300 nanograms). At that dose, levels of HCV in the blood of subjects fell to undetectable levels. In two of these three subjects, levels of ALT fell within the normal range during the study. Unfortunately, once subjects stopped taking IL-12, HCV and ALT levels rose.
Common side effects experienced by the following proportion of IL-12 users included:
Two subjects became depressed and two experienced temporary mild loss of hair.
The results seen in the three responding subjects at the highest dose suggest that IL-12 may be beneficial for some people with HCV infection. But there are at least two hurdles to be faced by people who may, in the future, participate in clinical trials of this drug. First, IL-12 will probably need to be taken for far longer than three months. Second, given the side effects from IL-12, it is not certain that users will be able to tolerate this drug over the long-term. The IL-12 used in this study was made by the Genetics Institute in Cambridge, Massachusetts.
REFERENCE
1. O'Brien CB, Moonka DK, Henzel BS, et al. A pilot trial of recombinant interleukin-12 in patients with chronic hepatitis C who previously failed treatment with itnerferon-alpha. American Journal of Gastroenterology 2001;96(8):2473.
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Copyright © 2001 - TreatmentUpdate. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Editor, The Canadian AIDS Treatment Information Exchange, 555 Richmond St. West, Suite 505, Box 1104, Toronto, ON, M5V 3B1 • Phone: 416-203-7122 • Toll Free: 1-800-263-1638 • Fax: 416-203-8284 http://www.catie.ca.
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