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EMBARGOED FOR RELEASE: Monday, November 9, 12:00 p.m. EST

NEW DRUGS, DRUG "COCKTAILS" PROVE EFFECTIVE AGAINST HEPATITIS

Research Also Links New Virus and Unexplained Liver Disease

CHICAGO, November 9 -- At The American Association for the Study of Liver Diseases 1998 Annual Meeting in Chicago, November 6 - 10, some of the world's top biomedical researchers unveiled studies of drug therapies that are offering new hope in the fight against Hepatitis B and C. Another study examined the role of a newly discovered virus in liver disease.

HIV Drug Lamivudine Helps Hepatitis B Patients When Interferon Can't At the AASLD Annual Meeting, Eugene Schiff, MD, University of Miami, discussed a study of the effects of a new drug, Lamivudine, that was given to chronic Hepatitis B patients who had previously failed Interferon therapy. There are many such patients, because Interferon is effective only 30%-40% of the time. Lamivudine, a drug that has been used to treat HIV patients, can be taken orally unlike Interferon, which must be injected every day. The study found that patients who took Lamivudine did much better than those who took a placebo, or who took Lamivudine in combination with Interferon. All those who took the new drug alone depressed the level of Hepatitis B virus in their bodies. Almost three quarters cleared the virus, either permanently or as long as they kept taking the drug "All in all, Lamivudine appears safe and effective," said Schiff. "In the future, I expect it will be used in combination with other drugs as part of an overall treatment of chronic Hepatitis B pat! ients."

Interferon alfa-2b + ribavirin vs. Hepatitis C -- Three Studies Three studies on treatment of chronic Hepatitis C, reported at the AASLD Annual Meeting, found that a combination of Interferon alfa-2b and ribavirin (Rebetol) was dramatically effective.

John McHutchison, MD, of Scripps Clinic and Research Foundation, reported on one study of more than 900 chronic Hepatitis C patients who had not had antiviral therapy before. Half the patients were given a daily dose of the Interferon alfa-2b and ribavirin (Rebetol) combination for 24 or 48 weeks, while the other half were given interferon alone. Those patients who received the combination did much better than those who did not. According to the abstract of the research, the drug combination was "significantly more effective than Interferon alone." In addition, "This combination therapy has an acceptable safety profile."

Another study, presented at the AASLD Annual Meeting by Thierry Poynard, MD, of the Hepato Gastro Groupe Hospitale Pitie Salpetriere in Paris, examined the results of an International European trial of the Interferon alfa-2b and ribavirin combination as a treatment for chronic Hepatitis C. This study, too, found the combination to be effective. "Intron A[interferon]/Rebetol combination therapy was significantly more effective than Introl A monotherapy," according to the study abstract. "This is a huge breakthrough," says Poynard.

A third study, also presented by Poynard, unveiled the results of using the Interferon alfa-2b/ribavirin to treat liver fibrosis in Hepatitis C patients. The last stage of liver fibrosis in such patients is cirrhosis, which can be fatal. The huge study of almost 2,000 patients found that the combination of drugs reduces dramatically the rate of liver fibrosis progression. "This is now the most promising form of therapy," says Poynard. "It appears to be both effective and probably cost effective because of the reduction of cirrhosis incidence."

Possible Role of New TT-Virus in Liver Disease Some 5% of liver disease is of unknown origin. A paper presented at the AASLD Annual meeting by Philip Adjei, Mayo Clinic, examined the possible role in liver disease played by a newly discovered single-strand DNA virus, TT-virus (TTV). Researchers studied patients who had received liver transplants and who showed no evidence of any of the known causes of liver disease. The patients were monitored both for the presence of TTV and evidence of liver disease over time. After 12 months, the presence of liver disease was significantly greater among those patients who were TTV infected than among those who were not. "This study does not by itself indicate that TTV causes liver disease," says Adjei. "But TTV is certainly worthy of further study."

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AASLD is the leading medical organization for liver researchers and physicians. Founded by physicians in 1950, AASLD's mission is to advance the science and practice of hepatology. Today, AASLD provides representation and education for more than 2,200 hepatologists worldwide.

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