Pegasys Study Authors Conclude that Patients Successfully Treated for Hepatitis C Can be Considered ''Cured''WASHINGTON--(BUSINESS WIRE)--May 21, 2007 - Results from a new study, presented at the 38th annual Digestive Disease Week (DDW) conference, showed that more than 99 percent of patients with chronic hepatitis C virus (HCV) infection who were treated successfully with PEGASYS(R) (peginterferon alfa-2a) had no detectable virus up to seven years later - validating the use of the word "cured" to describe these patients, according to study authors. Currently, the best indicator of treatment success is a sustained viral response (SVR), defined as undetectable hepatitis C virus in the blood six months after the end of treatment. The results announced today are from a long-term follow-up study to determine whether the virus re-emerges in patients who achieve an SVR. (Studies show that, overall, about half of patients with hepatitis C monoinfection can achieve an SVR with PEGASYS and ribavirin treatment, the current standard of care.)
"The results announced today are encouraging because it is rare in the treatment of life-threatening viral diseases that can we tell patients they have the chance for a cure," said Dr. Mitchell L. Shiffman, Professor of Medicine, Chief of Hepatology and Medical Director of the Liver Transplant Program, Virginia Commonwealth University Medical Center, and study author. "But in hepatitis C today, we are able to help some patients achieve an outcome that effectively enables them to put their disease behind them."
About the Study (Abstract ID #444)
This study monitored 997 patients (either mono-infected with chronic HCV or co-infected HCV and HIV) who achieved an SVR following treatment with PEGASYS monotherapy or combination therapy with PEGASYS and ribavirin. Serum levels of HCV were monitored on an annual basis for an average of 4.1 years (range 0.4 to 7 years) following successful treatment. Of the 997 patients, 989 (greater than 99 percent) maintained undetectable levels of HCV; the remaining eight patients tested positive for HCV, at an average of two years following the completion of treatment. The study found that these eight patients exhibited no consistency in age, gender or HCV genotype, and it has not been determined if these patients experienced a relapse or if they were re-infected with HCV.
"We at Roche are proud to be able to offer some hepatitis C patients the prospect of such a positive outcome with our currently-available therapies, but we also recognize the urgent need to further improve response rates," said Tom Klein, Vice President, Hepatology, Roche. "In addition to ongoing research with PEGASYS, Roche has the most comprehensive pipeline in the area, with four compounds currently in human development that target the virus in a number of different ways. The development of R1626 and partnerships with InterMune, Maxygen and Pharmasset, all underscore our long-term commitment to finding effective new therapies with the goal of successfully treating more patients with chronic hepatitis C."
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of cirrhosis, liver cancer and the need for liver transplants. According to the Centers for Disease Control and Prevention (CDC), an estimated 4.1 million Americans (1.6 percent) have been infected with hepatitis C; 3.2 million are chronically infected. The number of new infections per year has declined from an average of 240,000 in the 1980s to about 26,000 in 2004. CDC estimates the number of hepatitis C-related deaths could increase to 38,000 annually by the year 2010, surpassing annual HIV/AIDS deaths.
PEGASYS, in combination with COPEGUS, are indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Efficacy has been demonstrated in patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that are clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy). In addition, PEGASYS in combination with COPEGUS is the first and only FDA-approved regimen for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV. PEGASYS is the only pegylated interferon indicated for the treatment of adult patients with chronic hepatitis B (HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation).
PEGASYS is dosed at 180mcg as a subcutaneous injection taken once a week. COPEGUS is available as a 200mg tablet, and is administered orally two times a day as a split dose. Roche has backed PEGASYS 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 co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.
Important Safety Information about PEGASYS
What is PEGASYS?
PEGASYS is a medicine used to treat some adults who have hepatitis C or hepatitis B and signs of liver damage. PEGASYS works to reduce the amount of virus in your blood, helping your body fight the virus.
PEGASYS (Peginterferon alfa-2a), like other alpha interferons, can cause fatal or make life-threatening problems worse (like mental, immune system, heart, liver, lung, intestinal and infections). Your doctor should monitor you during regular visits. If you show signs or symptoms of these conditions, your doctor may stop your medication. In most patients, these conditions get better after you stop taking PEGASYS (see medication guide for more information and warnings).
What is COPEGUS?
COPEGUS is a medicine that works by slowing down the growth of the virus. COPEGUS should be taken with PEGASYS to fight the virus. Do not take COPEGUS by itself.
COPEGUS (Ribavirin, USP) can be extremely harmful and cause birth defects in an unborn baby. Female patients and the female partners of male patients should avoid getting pregnant. Ribavirin is known to cause anemia (low red blood cells), which can make heart disease worse. Also, ribavirin can harm your DNA and possibly cause cancer (see medication guide for more information and warnings).
Who should not take PEGASYS and COPEGUS?
Do not take PEGASYS alone or with COPEGUS if:
-- You are pregnant or your partner is pregnant
-- You or your partner plans to get pregnant during therapy or within 6 months after treatment ends
-- You are breastfeeding
-- You have hepatitis caused by your immune system (autoimmune hepatitis)
-- You have unstable or severe liver disease before or during treatment
-- You are allergic to alpha interferons or any of the ingredients in PEGASYS and COPEGUS
-- You have abnormal red blood cells (caused by conditions like sickle-cell anemia or thalassemia major)
What if I am pregnant or thinking about having a baby?
If you are a woman who could get pregnant, you must take pregnancy tests before, during and for 6 months after treatment ends to make sure you are not pregnant.
During treatment and for 6 months after treatment, female and male patients must:
-- Use two forms of birth control (one being a condom with spermicide)
-- Tell your doctor right away if you or your partner becomes pregnant. You or your doctor should also call the Ribavirin Pregnancy Registry at 1-800-593-2214
What medication should I avoid when I am taking PEGASYS and COPEGUS?
You should not take didanosine with COPEGUS. Talk to your doctor about all medications that you are taking.
What are the possible side effects?
The most common side effects of PEGASYS and COPEGUS are:
-- Flu-like symptoms (including fever, chills, muscle aches, joint pain, headaches)
-- Upset stomach (like nausea, taste changes, diarrhea)
-- Blood sugar problems (may lead to diabetes)
-- Skin problems (like rash, dry or itchy skin, redness and swelling at injection site)
-- Hair loss (temporary)
-- Trouble sleeping
The most serious side effects of PEGASYS and COPEGUS are:
-- Risks to pregnancies
-- Mental health problems (such as irritability, depression, anxiety, aggressiveness, trouble with drug addiction or overdose, thoughts about suicide, suicide attempts, suicide and thoughts about homicide)
-- Blood problems (like a drop in blood cells leading to increased risk for infections, bleeding and/or heart or circulatory problems)
-- Infections (which sometimes cause death)
-- Lung problems (like trouble breathing, pneumonia)
-- Eye problems (like blurred vision, loss of vision)
-- Autoimmune problems (such as psoriasis, thyroid problems)
-- Heart problems (including chest pain and, rarely, a heart attack)
-- Liver problems (rarely, liver function worsens). Patients with both the hepatitis C virus and HIV can have an increased chance of having liver failure during PEGASYS treatment. Change in a blood test that measures liver inflammation occurs more often in patients with hepatitis B. If you have a rise in this blood test you may need to be watched more closely with additional blood tests.
Tell your doctor immediately if you think you or your partner may be pregnant or if any of these symptoms occur.
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19-24, 2007, at the Washington Convention Center, Washington, DC. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.
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Posted: May 2007