Announcing: HCV Study to Examine Fixed Dose Induction of PEGASYS
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Roche Driving PROGRESS in Treatment of Hepatitis C Patients with New PEGASYS® Trial
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Large study examines fixed dose induction of PEGASYS in patients with difficult to treat characteristics
NUTLEY, N.J.–(BUSINESS WIRE)–Roche today announced the start of a large, multinational trial to examine a new treatment strategy in hepatitis C patients with difficult-to-treat characteristics. This study will evaluate the effect of PEGASYS® (peginterferon alfa-2a) and ribavirin in patients who have a high level of genotype 1 virus in their blood (high viral load) and who are heavier than average in weight. The trial, known as PROGRESS (PEGASYS and Ribavirin Optimized in Genotype 1 high virRal load patiEntS to improve SVR), will examine the potential benefits of using a fixed dose induction (360 mcg) of PEGASYS for the first 12 weeks of therapy.
“We have seen major advances in treatment success rates for hepatitis C in recent years,” said Dr. Rajender Reddy, University of Pennsylvania and one of the lead study investigators. “However, patients with high levels of genotype 1 virus in their blood and who also are overweight tend not to respond as well to current antiviral therapy regimens. PROGRESS will reveal whether induction dosing with PEGASYS in combination with either a higher dose or a standard dose of ribavirin offers these patients an improved chance of treatment success.”
About the PROGRESS Trial
More than 1,000 patients will be enrolled in PROGRESS and will be randomized to receive one of four dosing regimens of PEGASYS plus ribavirin for 48 weeks, followed by a 24-week treatment-free follow-up period. The four dosing regimens are:
- A fixed-dose induction (360 mcg) of PEGASYS given once every week for the first 12 weeks then the standard 180 mcg dose of PEGASYS for the following 36 weeks. Patients will also receive a 1,400-1,600 mg daily ribavirin dose for the full 48 week treatment period.
- A fixed-dose induction (360 mcg) of PEGASYS given once every week for the first 12 weeks then the standard 180 mcg dose of PEGASYS for the following 36 weeks. Patients will also receive the standard dose of ribavirin (1,000-1,200 mg daily) for the full 48 week treatment period.
- The standard 180 mcg dose of PEGASYS for 48 weeks plus a 1,400-1,600 mg daily ribavirin dose for the full 48 week treatment period.
- Control group who will receive the standard of care with weekly 180 mcg PEGASYS dose plus ribavirin (1,000-1,200 mg daily) for the full 48 week treatment period.
Large Multinational Clinical Trial
Fifteen countries will participate in the trial with a total of 150 trial sites. Enrollment is ongoing in the U.S., and well as Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Hungary, Norway, Poland, Romania, Russia, Sweden and the United Kingdom. The trial is expected to conclude in 2008.
“Roche recognizes that there is an urgent need to improve the chances of patients with difficult-to-treat characteristics to achieve treatment success, which is why we are launching PROGRESS,” said Tom Klein, Vice President, Hepatology, Roche. “This new, landmark trial with PEGASYS underscores our long-term commitment to finding treatment solutions for as many patients as possible.”
Previous studies have suggested that induction doses of PEGASYS, together with higher doses of ribavirin, may be of value in improving outcomes in patients with heavier than average bodyweight, genotype 1 hepatitis C and a high viral load. PROGRESS also will assess the critical and evolving role of ribavirin in optimizing treatment for patients with hepatitis C.
Those interested in the trial can find more information at www.roche-trials.com.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver, is transmitted through body fluids, primarily blood or blood products, and by sharing needles. Hepatitis C chronically infects an estimated 2.7 million Americans and 170 million people worldwide and is the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S.
About PEGASYS
PEGASYS, in combination with COPEGUS (ribavirin), is 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)
- Tiredness
- 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.
About Roche
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.
Contacts
Roche
Mike Nelson, 973-562-2409
mike.nelson@roche.com
or
MS&L
Joseph St. Martin, 212-468-3731
joe.stmartin@mslpr.com
