A medication approved as a therapy to stimulate the production of platelets (cells necessary for normal clotting) in the blood may also be useful in reducing the inflammation that often accompanies liver disease in people who have previously failed conventional interferon/ribavirin therapy for chronic hepatitis. That's the finding of a small pilot study involving 20 hepatitis C patients.1
It's believed that there are about 1 million newly diagnosed cases of hepatitis C each year around the world, according to estimates. Nearly 4 million people in the United States alone are thought to be infected with the disease caused by the hepatitis C virus. It's the leading reason for liver transplant procedures.2
Attacking Hepatitis-Caused Inflammation
The drug, known as oprelvekin and marketed by Wyeth Laboratories as Neumega, is a recombinant form of interleukin-11, an anti-inflammatory substance in the body that plays a role in antibody responses to infection. Neumega is currently prescribed for patients with a condition known as thrombocytopenia (thrawm-boh-sye-toe-PEEN-yuh), an abnormal decrease in blood platelets, potentially allowing people to bleed more easily. People who undergo chemotherapy for cancer face a higher risk of developing this condition.3 There is also a risk of anemia in people who take interferon and ribavirin.4 Thus, the investigators hypothesized that Neumega may be beneficial in this regard.
Previous animal studies had suggested that Neumega helps improve liver inflammation caused by T-cells, one of the immune system white blood cells.5 T-cells play a key role in inflammation produced at sites of injury in the body.
Neumega Scrutiny
In their open-label study, doctors led by Eric Lawitz, MD, medical director of the Viral Hepatitis Clinic at Brooke Army Medical Center in San Antonio, Texas tested the effects of Neumega on liver inflammation caused by hepatitis C in people who failed antiviral therapy previously. The patients received doses of the medication measured at 5 micrograms per kilogram of body weight. (For example, someone who weighed about 75 kilograms (165 pounds) received doses of 375 micrograms.) Patients received the drug as an injection once per day for a total of 12 weeks.
Liver biopsies were taken before the study began, and the results were then compared to liver biopsies taken when the trial was over. The researchers also measured changes in blood levels of alanine aminotransferase (ALT), a liver enzyme that, at higher levels in the blood, is an indicator of liver disease. Blood platelet tests were also taken.
At the end of treatment, Lawitz's team found that 40 percent of the patients had significant improvement in the health of their livers, according to their post-treatment biopsy results. ALT levels also dropped significantly in the study for all the patients who took part. Neumega also increased blood platelet levels in each of the patients by the 12th week of therapy, the investigators reported.
"Overall, rhIL-11 [recombinant human interleukin-11] was well tolerated and no serious adverse events were reported," Lawitz's group noted. "The most common adverse event was edema of the lower extremities, which occurred in all subjects."
Thus, the research team concluded that Neumega "may be beneficial for patients with hepatic inflammation and advanced liver disease" caused by chronic hepatitis C, but they stressed that larger clinical trials aimed at replicating these findings are necessary first.
1. Lawitz EJ, Hepburn MJ, Casey TJ. A pilot study of interleukin-11 in subjects with chronic hepatitis C and advanced liver disease nonresponsive to antiviral therapy. Am J Gastroenterol 2004 Dec;99(12):2359-64.
2. Zein NN. Clinical significance of hepatitis C virus genotypes. Clin Microbiol Rev 2000 Apr;13(2):223-35.
3. Wyeth Pharmaceuticals. Neumega. Prescribing Information. Available at: http://www.wyeth.com/content/ShowLabeling.asp?id=121. Accessed February 3, 2005.
4. Bacon BR. Managing hepatitis C. Am J Manag Care 2004 Mar;10(2 Suppl):S30-40.
5. Bozza M, Bliss JL, Maylor R et al. Interleukin-11 reduces T-cell-dependent experimental liver injury in mice. Hepatology 1999 Dec;30(6):1441-7.
Dr. Lawitz has been a host of Hepatitis Neighborhood chats.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
