Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - 26 March 1997.
"The benefits of extended therapy with interferon alfa-2b are seen in the significantly greater proportion of patients who achieved a sustained response," said Douglas T. Dieterich, M.D., Associate Professor of Medicine, New York University School of Medicine. "Early detection and immediate institution of aggressive therapy are proving to be the most effective in the treatment of hepatitis C."
Richard W. Zahn, president, Schering Laboratories, stated, "The FDA's prompt action on this extended-dosing submission now provides physicians with the opportunity to develop optimal therapy for their hepatitis C patients. Patients who are diagnosed early and treated for a duration of 18-to-24 months have a better chance of maintaining a long-term response."
Some 4 million to 4.5 million Americans are chronically infected with the hepatitis C virus, according to the Centers for Disease Control and Prevention (CDCP). Because the disease is often asymptomatic in its early stages, the vast majority of infected individuals are unaware of their disease until they develop serious liver complications. The CDCP has estimated that 20-50 percent of chronically infected hepatitis C patients will develop liver cirrhosis, and 20-30 percent of those will go on to develop liver cancer or liver failure requiring liver transplant. Hepatitis C infection contributes to the death of more than 12,000 Americans each year, and this toll is expected to triple by the year 2010, according to the CDCP. American Liver Foundation researchers state that liver failure due to hepatitis C infection is the leading cause of liver transplants in the United States.
STUDIES SUPPORT EXTENDED THERAPY OF 18-24 MONTHS
Two independent clinical studies were used to support the submission for 18-24 months therapy duration: In study No. 1, patients received 3 million international units (MIU), three times a week (TIW) of INTRON A for a period of 18 months. In study No. 2, patients received 3 MIU, TIW for a period of 24 months. In both studies, the extended duration arms were compared to the previously indicated six month course of therapy.
The combined results from the multicenter trials demonstrated that 24 percent of all patients treated for 18-24 months achieved a durable sustained response (6 months post-therapy) compared with 12.5 percent for those treated for six months.
Similarly, improvement in liver cell inflammation and death (necroinflammatory activity) -- another measure of response to treatment -- was seen in significantly more patients who received INTRON A for 18-24 months compared to those who received six months of therapy (58 percent versus 38 percent respectively).
INTRON A has been marketed for treatment of chronic viral hepatitis since 1991. INTRON A is the only interferon cleared for use in both chronic hepatitis C and chronic hepatitis B, which together afflict more than 5 million Americans.
Schering-Plough is a leader in hepatitis research and is currently evaluating new approaches to hepatitis treatment, including combination therapy with INTRON A and other antivirals as well as long-acting forms.
INTRON A is a recombinant version of a naturally occurring alpha interferon, with both antiviral and immunomodulatory effects. In the United States it has been cleared for use by the FDA for chronic viral hepatitis B, chronic viral hepatitis C, malignant melanoma, hairy cell leukemia, AIDS- related Kaposi's sarcoma and condylomata acuminata (venereal warts). INTRON A is marketed in 68 countries worldwide for 16 major indications.
Schering Laboratories is the U.S. prescription pharmaceutical marketing arm of Schering-Plough Corporation, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.
CONTACT: Media, William O'Donnell, 201-822-7476; or investors, Geraldine U. Foster, 201-822-7410, or Lisa W. DeBerardine, 201-822-7437, all of Schering-Plough/ 14:49 EST
Copyright (c) 1997/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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