Healthcare Industry News:  liver failure 

Biopharmaceuticals

 News Release - October 27, 2006

Customizing Treatment with PEGASYS(R) May Improve Chances for Success in Hepatitis C

Results From Two Clinical Trials Point to Innovative Treatment Strategies

BOSTON--(HSMN NewsFeed)--Patients with chronic hepatitis C who respond quickly to PEGASYSŪ (peginterferon alfa-2a) and COPEGUSŪ (ribavirin, USP) may have an excellent chance of achieving treatment success with a shortened course of therapy, according to interim results presented at the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Three-quarters of patients with the difficult-to-treat viral genotypes 1 and 4 who had a rapid viral response (RVR) - defined as undetectable levels of the virus after four weeks of therapy - achieved treatment success after 24 weeks of therapy. (Patients with these genotypes are typically treated for 48 weeks.)

"These results show that within a month of starting therapy with peginterferon alfa-2a and ribavirin, we can give excellent news to some patients with difficult-to-treat genotypes - that they are likely to achieve treatment success with six months of therapy rather than 11 months," said Donald Jensen, M.D., Professor of Medicine and Director of the Center for Liver Diseases at the University of Chicago Hospital in Chicago. "If confirmed in further study, these data are encouraging because they could help motivate more patients to seek treatment and to stay on treatment."

Currently, the best indicator of treatment success is a sustained viral response (SVR), defined by undetectable hepatitis C virus RNA in the blood six months after the end of treatment. Long-term studies show that the virus returns to detectable levels in very few patients who achieve an SVR.

In this study, patients received PEGASYS 180mcg/week once weekly plus a 1000-1200mg daily dose of COPEGUS. After four weeks of treatment, virus levels in the blood were measured to identify patients who achieved an RVR. This group of patients was treated for another 20 weeks, receiving a total of 24 weeks of therapy (n=104). All other patients continued on treatment and were reassessed at week 12. Those who had an early virological response (EVR, defined as undetectable viral load or a drop in viral load to less than one percent of pre-treatment viral load) were randomized to receive either 48 weeks (n=105) or 72 weeks (n=108) of therapy. Those who did not have an EVR continued treatment up to 72 weeks (n=56). The study was designed to allow a comparison of 48 vs. 72 weeks of therapy in patients who achieved an EVR. Results of the study showed:
  • 78 percent of patients who achieved an RVR in the study achieved an SVR with 24 total weeks of therapy;

  • among those who did not achieve an RVR but had an EVR, SVR rates were similar for 48 or 72 weeks of treatment (57 percent and 59 percent of patients, respectively);

  • patients who did not have an EVR were highly unlikely to achieve an SVR (four percent) even after 72 weeks of treatment.
Higher Fixed Dosing with PEGASYS in Difficult-to-Treat Patients

The results of another study presented at AASLD show that intensifying treatment with a higher fixed dose of PEGASYS along with a higher dose of COPEGUS may yield higher response rates in patients with several characteristics that make hepatitis C more difficult-to-treat. It is well recognized that response rates to treatment can be significantly lower in patients who have these specific characteristics together, such as infection with genotype 1, high levels of virus in the blood and heavy bodyweight.

"We have known for some time that certain patients have characteristics that make their disease more difficult to treat, and improving their treatment success rates with currently available medications is an urgent need," said Michael W. Fried, M.D., Professor of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill. "If strategies using intensified treatment with peginterferon alfa-2a and ribavirin are validated in larger studies, these findings suggest that even more patients living with chronic hepatitis C can have treatment success."

This randomized, double-blind study enrolled 188 adults with previously untreated genotype 1 chronic hepatitis C infection, a bodyweight of more than 85 kg and high blood levels of hepatitis C (HCV RNA level greater than 800,000 IU/mL). Patients received 48 weeks of treatment with PEGASYS at either the standard fixed dose of 180mcg/week or a higher fixed dose of 270mcg/week, plus COPEGUS (ribavirin) at the standard dose of 1200mg/day or a higher dose of 1600mg/day, as follows:
  • peginterferon alfa-2a (40KD) 180mcg/week plus ribavirin 1200mg/day (Group A)
  • peginterferon alfa-2a (40KD) 180mcg/week plus ribavirin 1600mg/day (Group B)
  • peginterferon alfa-2a (40KD) 270mcg/week plus ribavirin 1200mg/day (Group C)
  • peginterferon alfa-2a (40KD) 270mcg/week plus ribavirin 1600mg/day (Group D)
It was the group receiving a combination of a higher dose of PEGASYS and a higher dose of COPEGUS (group D) which achieved the highest rate of SVR versus the current standard regimen (47 percent vs. 28 percent). This result also highlights the important role that COPEGUS plays in achieving an SVR.

The use of higher doses of PEGASYS and COPEGUS together was associated with an increase in the rate of serious adverse events compared with standard doses (up to 13 percent vs. 9 percent), an increase in the incidence of hematological abnormalities, including anemia, and an increase in premature withdrawals due to safety reasons.

"These two clinical trials underscore the commitment of Roche to finding better treatment solutions for patients living with chronic hepatitis C," said Thomas Klein, Vice President, Hepatology, Roche. "It is this commitment that has led to the status of PEGASYS as the most broadly-studied pegylated interferon, and which drives our extensive research efforts to develop new compounds and treatment strategies for 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.

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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