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PEGASYS Approved for Chronic Hepatitis B in Switzerland
  Wednesday, December 22, 2004
BASEL, Switzerland, December 22 /PRNewswire/ -- Roche today announced that PEGASYS(R) (peginterferon alfa-2a (40KD)) has been granted marketing authorisation by the Swiss regulatory authorities, Swissmedic, for the treatment of chronic hepatitis B. The approval has been granted for both the HBe antigen-positive and HBe antigen-negative forms of the disease and was based on one of the largest clinical development programmes in hepatitis B ever, which included three global studies in more than 1,500 patients.
The studies showed that PEGASYS was superior to two therapies currently recommended first-line; interferon alfa and lamivudine. In contrast to lamivudine, the most commonly prescribed medication today, PEGASYS works by a two-pronged approach. It stimulates the immune system as well as inhibits virus replication. This offers physicians a new option with the advantages of a finite treatment duration and lasting remission from the disease.
"This is a major milestone, not only for Switzerland, but for the more than 90 other countries worldwide that rely on Swiss regulatory review for their own approval process," said William M. Burns, Head of Roche's Pharmaceutical Division. "Based on the results of our clinical programme, we would anticipate that PEGASYS will become a first-line treatment for chronic hepatitis B," he said, adding that PEGASYS is the worldwide market leader for the treatment of hepatitis C.
About Chronic Hepatitis B
Chronic hepatitis B is a major global healthcare problem affecting more than 350 million people and it is one of the principal causes of liver failure, cirrhosis, and liver cancer. Between one-quarter and one-third of people with chronic hepatitis B will go on to develop progressive liver disease; and approximately one million die annually, making it the 10th leading cause of death worldwide.
PEGASYS Superior to Standard Therapies
PEGASYS has been proven twice as effective as conventional interferon for the treatment of the most common form of chronic hepatitis B, hepatitis B e antigen (HBeAg)-positive chronic hepatitis B, in a multinational phase II trial. These findings were published in the July 2003 Journal of Viral Hepatitis.(i)
Two large-scale multinational phase III trials, in patients with both the HBeAg-positive and HBeAg-negative forms of chronic hepatitis B, demonstrated that after 48 weeks of therapy, more patients achieved a sustained response with PEGASYS than with lamivudine. Furthermore, these studies demonstrated that the addition of lamivudine to PEGASYS did not improve response rates over PEGASYS alone.
The phase III study results in HBeAg-negative chronic hepatitis B, the most difficult-to-treat form of the disease, were published in September in the New England Journal of Medicine,(ii)and the results of the phase III study in patients with HBeAg-positive chronic hepatitis B were presented at the 2004 Annual Meeting of the American Association for the Study of Liver Diseases in November.(iii) Both lead investigators have stated that the results of these trials warrant PEGASYS becoming the first-line treatment for HBeAg-positive or HBeAg-negative chronic hepatitis B.
"Until now, conventional interferon or lamivudine have been the first-line treatments for patients with chronic hepatitis B, but these clinical trials have proven that PEGASYS outperforms both," said Dr George Lau, gastroenterologist at the Queen Mary Hospital, Hong Kong; and Assistant Dean in the Department of Medicine at the University of Hong Kong. "This approval means that we have a significant new option whereby patients can achieve a lasting remission and we only need to provide treatment for a limited 48-week period."
PEGASYS was filed for the treatment of chronic hepatitis B simultaneously in Switzerland, the United States and the European Union in the summer of 2004, and approvals in the US and the EU are anticipated early in 2005. It is the first pegylated interferon indicated for the treatment of chronic hepatitis B anywhere in the world and has already been approved for this indication in Thailand and Taiwan.
PEGASYS, a new generation hepatitis therapy that is different by design, has already become the worldwide market leader in hepatitis C. PEGASYS has a dual immunomodulatory and antiviral mode of action. The improved pharmacokinetic profile ensures drug plasma concentrations are maintained at constant levels throughout the one week dosing interval. PEGASYS therapy in chronic hepatitis B is given once weekly as a 180 microgram subcutaneous injection for a 48-week period.
Roche in Hepatitis
Roche is committed to the viral hepatitis disease area, having introduced Roferon-A(R) for hepatitis B and C, followed by PEGASYS in hepatitis C and a full development program in hepatitis B. Roche has its own brand of ribavirin, COPEGUS(R), which is used in conjunction with Roferon A or PEGASYS for HCV. In addition, Roche manufactures HBV and HCV diagnostic and monitoring systems: The COBAS AMPLICOR(TM) Test, and the AMPLICOR(TM) MONITOR Test, two testing systems used to detect the presence of, and quantity of, HBV DNA or HCV RNA in a person's blood. Roche has just received a positive opinion from the EMEA in the European Union for a new indication for PEGASYS and COPEGUS as a treatment for patients co-infected with HIV and HCV. More than 40,000 patients worldwide continue to participate in trials with PEGASYS and COPEGUS as Roche examines the unmet medical needs of hepatitis C patients. Roche's commitment to viral hepatitis also extends to its pursuit of strategic alliances and partnerships to develop new compounds for the future.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
WHO Hepatitis B fact sheet: www.who.int/mediacentre/factsheets/fs204/en
(English) see below
(i) Cooksley WG, Piratvisuth T, Lee SD, et al. Peginterferon alpha-2a 40kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat 2003; 10:298-305. (ii) Marcellin P, Lau GK, Bonino F, et al. Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2004; 351:1206-17. (iii) Lau GK, et al. Peginterferon alfa-2a (40KD) (PEGASYS®) monotherapy and in combination with lamivudine is more effective than lamivudine monotherapy in HBeAg-positive chronic hepatitis B: results from a large, multinational study. Hepatology, 2004; Vol. 40 (4); Suppl. 1:171A
Roche Pharmaceuticals
Contact: Sheila Gies, Roche, +1-973-687-0188; Joanne Galea, Axon Communications, +44-(0)20-8822-6779
Hepatitis B
Hepatitis B is one of the major diseases of mankind and is a serious global public health problem. It is preventable with safe and effective vaccines that have been available since 1982. Of the 2 billion people who have been infected with the hepatitis B virus (HBV), more than 350 million have chronic (lifelong) infections. These chronically infected persons are at high risk of death from cirrhosis of the liver and liver cancer, diseases that kill about one million persons each year. Although the vaccine will not cure chronic hepatitis, it is 95% effective in preventing chronic infections from developing, and is the first vaccine against a major human cancer. In 1991, the World Health Organization (WHO) called for all children to receive the hepatitis B vaccine, and 116 countries have added this vaccine to their routine immunization programmes. However, the children in the poorest countries, who need the vaccine the most, have not been receiving it because their governments cannot afford it. Fortunately, hepatitis B vaccine will soon be available in these countries with the assistance of the Global Alliance for Vaccines and Immunization (GAVI) and the Global Fund for Children's Vaccines.
What is hepatitis?
Hepatitis means inflammation of the liver, and the most common cause is infection with one of 5 viruses, called hepatitis A,B,C,D, and E. All of these viruses can cause an acute disease with symptoms lasting several weeks including yellowing of the skin and eyes (jaundice); dark urine; extreme fatigue; nausea; vomiting and abdominal pain. It can take several months to a year to feel fit again. Hepatitis B virus can cause chronic infection in which the patient never gets rid of the virus and many years later develops cirrhosis of the liver or liver cancer. HBV is the most serious type of viral hepatitis and the only type causing chronic hepatitis for which a vaccine is available.
Who gets hepatitis B?
In much of the developing world, (sub-Saharan Africa, most of Asia, and the Pacific), most people become infected with HBV during childhood, and 8% to 10% of people in the general population become chronically infected. In these regions liver cancer caused by HBV figures among the first three causes death by cancer in men.
High rates of chronic HBV infection are also found in the Amazon and the southern parts of Eastern and Central Europe. In the Middle East and Indian sub-continent, about 5% are chronically infected. Infection is less common in Western Europe and North America, where less than 1% are chronically infected.
Young children who become infected with HBV are the most likely to develop chronic infection. About 90% of infants infected during the first year of life and 30% to 50% of children infected between 1 to 4 years of age develop chronic infection. The risk of death from HBV-related liver cancer or cirrhosis is approximately 25% for persons who become chronically infected during childhood.
How do people get infected ?
Hepatitis B virus is transmitted by contact with blood or body fluids of an infected person in the same way as human immunodeficiency virus (HIV), the virus that causes AIDS. However, HBV is 50 to 100 times more infectious than HIV.
The main ways of getting infected with HBV are:
• Perinatal (from mother to baby at the birth)
• Child-to-child transmission
• Unsafe injections and transfusions
• Sexual contact
Worldwide, most infections occur from infected mother to child, from child to child contact in household settings, and from reuse of unsterilized needles and syringes. In many developing countries, almost all children become infected with the virus.
In many industrialized countries (e.g. Western Europe and North America), the pattern of transmission is different. In these countries, mother-to-infant and child-to-child transmission accounted for up to one third of chronic infections before childhood hepatitis B vaccination programmes were implemented. However, the majority of infections in these countries are acquired during young adulthood by sexual activity, and injecting drug use. In addition, hepatitis B virus is the major infectious occupational hazard of health workers, and most health care workers have received hepatitis B vaccine.
Hepatitis B virus is not spread by contaminated food or water, and cannot be spread casually in the workplace.
Can chronic hepatitis B and liver cancer be treated?
Liver cancer is almost always fatal, and usually develops between 35 and 65 years of age, when people are maximally productive and with family responsibilities. The loss of a mother or a father in a developing country can devastate the entire family. In developing countries, most people with liver cancer die within months of diagnosis. In industrialized countries, surgery and chemotherapy can prolong life up to a few years. Chronic hepatitis B in some patients is treated with drugs called interferon or lamivudine, which can help some patients (note from Jules Levin: Pegasys and adefovir also can treat HBV; new drug in phase III trial, entecavir; tenofovir appro9ved for HIV but has HBV activity). However, interferon or lamivudine therapy costs thousands of dollars and will never be available to most patients in developing countries. Patients with cirrhosis are sometimes given liver transplants, with varying success. It is preferable to prevent this disease with vaccine than to try and cure it.
How safe and effective is the vaccine?
Hepatitis B vaccine has an outstanding record of safety and effectiveness. Since 1982, over one billion doses of hepatitis B vaccine have been used worldwide. The vaccine is given as a series of three intramuscular doses. Studies have shown that the vaccine is 95% effective in preventing children and adults from developing chronic infection if they have not yet been infected. In many countries where 8% to 15% of children used to become chronically infected with HBV, the rate of chronic infection has been reduced to less than 1% in immunized groups of children.
How is WHO trying to control hepatitis B?
Since 1991, WHO has called for all countries to add hepatitis B vaccine into their national immunization programmes. As of March 2000, 116 countries had included hepatitis B vaccine in their national programmes including most countries in Eastern and South- East Asia, the Pacific Islands, Australia, North and South America, Western Europe and the Middle East. However, many low income countries in sub-Saharan Africa, the Indian subcontinent and in the Newly Independent States do not use the vaccine. The price of the hepatitis B vaccine has been one of the main obstacles to its introduction in many of these countries.
The Global Alliance for Vaccines and Immunization (GAVI) was created in 1999. It is a unique coalition of public and private institutions where WHO has taken a leading role. The main mission of GAVI is to vaccinate as many children as possible against vaccine-preventable diseases. GAVI has introduced a new approach to international health funding: the Global Fund for Children's vaccines (GFCV). This fund will help 74 low-income countries to reinforce their national vaccine programmes and introduce hepatitis B, yellow fever and haemophilus influenzae type b(Hib) vaccines into their national immunization programmes.
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