FDA Approves Peginterferon alfa-2a/ Ribavirin Combination Therapy for Treatment of Chronic Hepatitis C in HIV Infected Patients
Feb 27, 2005 - 2:09:00 PM
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"For the first time, the 300,000 Americans who are coinfected with hepatitis C and HIV have an FDA-approved hepatitis C treatment option. This is a very important advance for the HIV community,"said Jeffery Smith,Director, Clinical Research, American Foundation for AIDS Research (amfAR).
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By Akanksha, Pharmacology Correspondent,
[RxPG] Roche announced today that the U.S.Food and Drug Administration(FDA)has approved Pegasys(peginterferon alfa-2a) and Copegus(ribavirin, USP) for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV. Peginterferon alfa-2a combination therapy is the first and only regimen FDA-approved for hepatitis C treatment in patients with HIV.
Peginterferon alfa-2a, the most prescribed hepatitis C medication in the U.S., was approved in 2002 by the FDA for use alone and in combination with ribavirin for the treatment of adults with chronic hepatitis C.
"For the first time, the 300,000 Americans who are coinfected with hepatitis C and HIV have an FDA-approved hepatitis C treatment option. This is a very important advance for the HIV community,"said Jeffery Smith,Director, Clinical Research, American Foundation for AIDS Research (amfAR)."Hepatitis C has become one of the leading killers of people with HIV because advances in HIV treatment are helping patients live longer and because hepatitis C progresses much more quickly to liver failure in people with
HIV."
Hepatitis C and HIV are the two most prevalent blood-borne infections in the United States. It is estimated that approximately 30 percent of Americans with HIV are also coinfected with the hepatitis C virus. Research has shown
that hepatitis C is more resistant to treatment in people with HIV. Recent guidelines by the National Institutes of Health and Centers for Disease Control and Prevention recommend that people with HIV be screened for hepatitis C and that all patients with chronic hepatitis C, including those with HIV, be considered for treatment.
"The risks and benefits of medications can be very different for people with HIV, and research has suggested that this is true for hepatitis C therapies as well," said Douglas Dieterich, MD, Professor of Medicine,Mount Sinai School of Medicine, New York City. "Studies have shown that hepatitis C and HIV coinfected patients treated with Peginterferon alfa-2a combination therapy had response rates that were three times higher than those treated with conventional interferon combination therapy."
"Making decisions based on evidence is particularly important for HIV patients given the unique and complex medical challenges that they face," said Salvatore Badalamenti, MD, Medical Director, Roche. "The safety and efficacy results from the APRICOT study and in our label can only be applied to Peginterferon alfa-2a combination therapy."
Peginterferon alfa-2a is the only pegylated interferon supported by published studies including U.S. patients for the treatment of hepatitis C in hepatitis C and HIV coinfected patients.
Peginterferon alfa-2a, a pegylated alpha interferon, and ribavirin were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of
cirrhosis.
The FDA is currently reviewing an indication for Peginterferon alfa-2a for the treatment of chronic hepatitis B.
Peginterferon alfa-2a is dosed at 180 mcg as a subcutaneous injection taken once a week.Ribavirin is available as a 200 mg tablet, and is administered orally two times a day as a split dose.
Roche has backed Peginterferon alfa-2a with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients coinfected with hepatitis C and HIV, African Americans, patients with cirrhosis, patients with normal ALT levels, and patients who have failed to respond to previous therapy.
Data from six Peginterferon alfa-2a studies have been published in The New England Journal of Medicine.
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More Than a Century in the U.S. and the World Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer,as well as a leader in virology and transplantation.As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.Roche's U.S. operations celebrate their American Centennial in 2005.
In another milestone this year, Roche was named in January to Fortune magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado,Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners,including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer,HIV/AIDS,hepatitis C, transplantation, dermatology and influenza.Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers,physicians,
patients,hospitals and laboratories world-wide.For further information,please visit the company's websites.
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