New Bioengineered Interferon Therapy Triples Success Rate For Relapsed Hepatitis C Patients


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MIAMI--(BUSINESS WIRE)--April 6, 1998--Hepatitis C patients, who previously relapsed following conventional interferon therapy, are now experiencing a three-times better chance of achieving remission, thanks to a recently approved bioengineered interferon studied at the University of Miami's Center for Liver Diseases and 40 other centers across the nation.

Treatment results are published in the April issue of Hepatology.

To date, interferons are the only FDA-approved treatment for hepatitis C, but only about half of the patients initially respond to therapy. Of those, only 20 percent ultimately achieve remission.

Yet, results from the multi-center study demonstrated that after 48 weeks of treatment with a high dose (15 mcg) of Infergen (Interferon-alfacon-1) nearly 60 percent of patients who initially responded to interferon treatment but eventually relapsed, successfully achieved a sustained response.

The Hepatitis C Virus: -- Is estimated to have infected 3.9 million Americans.
-- Is three to four times more common than the AIDS virus in the United States.
-- Is the leading cause of liver cirrhosis.
-- Is the leading cause of liver transplantation in adults because of the damage it causes.

The new treatment, Infergen, manufactured by Amgen, is a non-naturally occurring recombinant type-1 interferon. Interferon is a natural substance located in the body for the purpose of traveling from cell to cell to attack viruses, in this case, the hepatitis C virus.

Amgen's goal was to create the most successful interferon from taking the most commonly occurring amino acid sequences from each of the naturally occurring alpha interferons, thereby creating a "consensus interferon."

Also benefiting from Infergen are some hepatitis C patients who previously have had no response to therapy. The study showed that even these patients experienced a 13 to 17 percent success rate after 48 weeks of subsequent treatment with Infergen.

"Our data demonstrate that a higher dose of Infergen is safe and effective and can achieve a meaningful sustained response in hepatitis C patients who have failed or relapsed following previous interferon treatment," said K. Rajender Reddy, M.D., a University of Miami professor and a co-author of the Hepatology article.

"It is our hope that with each new advance in the fight against hepatitis C, we are able to offer newer and better treatment options for the millions of Americans who suffer from this chronic and serious health condition," Reddy added.

Benefits Shown for Relapsers

In this study, 337 patients with hepatitis C virus who had either not responded or relapsed after previous interferon therapy were treated with a higher dose of Infergen for 24 or 48 weeks, followed by a 24-week observation period.

Of the relapsed patients treated with Infergen for 48 weeks, the sustained virological response rate, which was measured by serum HCV RNA using a highly sensitive polymerase chain reaction (PCR) technique, was 58 percent. The sustained alanine aminotransferase (ALT) response rate was 52 percent at the end of the post-treatment observation period.

The principal biochemical marker of the disease is a persistent elevation in blood levels of the liver enzyme ALT. Another important blood measurement is the presence of HCV RNA, the genetic material of the hepatitis C virus. Normalization of ALT and reduction in viral HCV RNA concentration are the most common measures of response to therapy.

Data Demonstrates Success in Nonresponders

According to study investigators, a notable finding in this study was the achievement of significant responses among prior nonresponders. Of the patients treated with Infergen for 48 weeks, the sustained HCV RNA response rate among prior nonresponders was 13 percent and the sustained ALT response rate was 17 percent at the end of the post-treatment observation period.

The administration of Infergen was well tolerated and not associated with increased side effects. The most frequently reported adverse events were flu- like symptoms such as headache, unusual tiredness, fever, muscle aches and stiffness, joint pain and increased sweating.

One of the nation's youngest medical schools, founded in 1952, the University of Miami School of Medicine has already established a research enterprise which routinely ranks in the top 25 percent of the country's 125 medical schools in terms of research grants and other sponsored programs.

With a $109 million research budget and 1.5 million square feet of research space, the medical school's 1,000-plus full-time faculty members and an additional 400 research personnel, conduct clinical and basic science research crossing all disciplines, from epidemiology and pediatrics to AIDS, psychiatry and the neurosciences.

CONTACT: University of Miami School of Medicine, Miami Rebecca Riordan, 305/243-5671

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