Healthcare Industry News:  antiviral 

Biopharmaceuticals

 News Release - October 27, 2006

Roche Oral Polymerase Inhibitor R1626 Shows Strong Antiviral Activity in Chronic Hepatitis C Patients in Early Trial

BOSTON--(HSMN NewsFeed)--New clinical data on the hepatitis C polymerase inhibitor R1626 - currently in development by Roche - show viral reductions greater than those described for other polymerase inhibitors, according to data presented at the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). These results were achieved in chronic hepatitis C patients infected with the difficult-to-treat genotype 1 virus.

"These Phase I study results suggest that R1626 holds significant promise for the treatment of hepatitis C," said Dr. Stuart Roberts, Director of Gastroenterology at Alfred Hospital in Melbourne, Australia and lead investigator of the study. "Adding R1626 to the current therapies could potentially improve treatment success rates in hepatitis C."

About the Study

In this Phase I study, 47 patients with genotype 1 hepatitis C were randomized to receive either oral treatment with R1626 twice daily or placebo for 14 days. The final results presented at AASLD included patients who received the higher doses of R1626 at 3,000 mg or 4,500 mg twice a day. The study found:
  • Clinically significant mean reductions in serum HCV RNA (a measure of how much virus is in the blood) of 2.6 and 3.7 log(10) were seen with R1626 at the doses of 3,000 mg and 4,500 mg, respectively;

  • R1626 showed good tolerability following dosing for 14 days up to 3,000 mg twice daily. No patient was prematurely withdrawn from the study. Increasing numbers of adverse events were noted at higher dose levels. Reversible mild to moderate hematological changes were observed with increasing doses.
As a result of these promising results, Roche has already commenced a Phase II trial to evaluate how well R1626 works in combination with PEGASYSŪ (peginterferon alfa-2a) and COPEGUSŪ (ribavirin USP).

"Roche is fully committed to developing better treatment options for hepatitis C so that as many patients as possible can have the best chance for successful treatment," said Nick Cammack, Head of Viral Diseases Research, Roche. "The development of R1626, ongoing research with PEGASYS and partnerships with Intermune, Pharmasset, and Maxygen underscore Roche's long-term commitment to finding effective therapies to benefit patients with chronic hepatitis C."

About the Phase II Study -- PV18369

PV18369 is an on-going multicenter Phase II trial that is enrolling patients with genotype 1 chronic hepatitis C who have not previously received treatment. Patients are randomized into four treatment groups assessing R1626 with PEGASYS or PEGASYS plus COPEGUS, versus the standard of care. Following the first four weeks of treatment, all patients will receive PEGASYS 180mcg subcutaneously every week plus COPEGUS 1,000-1,200mg daily for another 44 weeks, making the total treatment duration of 48 weeks.

The objectives of the study are to evaluate the four week safety and antiviral effect of combining R1626 with PEGASYS with or without COPEGUS. The study is currently enrolling patients in the US. Patients and healthcare providers interested in the trial can find more information at www.roche-trials.com.

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.

About PEGASYS

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)
  • 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 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.


Source: Roche

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