PEGASYS(R) COMBINATION THERAPY APPROVED FOR THE TREATMENT OF HEPATITIS C AND HIV CO-INFECTION IN EUROPE

PEGASYS Becomes the First and Only Hepatitis C Treatment Indicated for Patients Suffering From Both HIV and HCV.

The European Commission has approved PEGASYS(R) (peginterferon alfa-2a (40KD)) in combination with ribavirin for the treatment of chronic hepatitis C (HCV) in clinically stable patients co-infected with HIV. This Commission decision comes only one month after the positive opinion was granted by the European Medicines Agency (EMEA), and it is now the first hepatitis C treatment to be indicated in HIV-HCV co-infected patients in the European Union. Co-infection has emerged as a major public health concern with data suggesting that globally 30% of patients with HIV infection are also infected with HCV [i],[ii],[iii].”This new indication represents a major breakthrough in the treatment of patients infected with both HIV and HCV in Europe,” said William M. Burns, CEO of Roche’s Pharmaceutical Division. “Roche has a strong heritage of developing anti-viral medications for hepatitis, and this new indication further reinforces our commitment to finding innovative solutions for patients with unmet medical needs.”The approval of PEGASYS combination therapy for the treatment of HIV-HCV co-infected patients follows the recent European Commission approval of PEGASYS for the treatment of hepatitis C patients with persistently ‘normal’ liver enzymes, as well as several approvals worldwide for PEGASYS in the treatment of chronic hepatitis B with additional milestones expected for this leading hepatitis treatment throughout 2005.The study on which the approval has been granted.The extension of the current label is based on the results of APRICOT (AIDS PEGASYS Ribavirin International CO-infection Trial). APRICOT is the first and only international multi-centre prospective study evaluating the efficacy and safety of pegylated interferon combination therapy in HIV-HCV co-infected patients. Results from the trial were recently published in the peer-reviewed New England Journal of Medicine[iv].According to Dr. Francesca Torriani, Associate Professor of Medicine, Antiviral Research Centre, University of California and the lead author of the APRICOT study, “It is clearly important that we treat these patients as we now know that the leading cause of death in HIV-HCV co-infected patients is liver disease as a result of hepatitis C. With great strides being made in potent antiretroviral therapy, allowing HIV-infected patients to live longer, we don’t want to see those benefits disappear by the emergence of fatal liver disease.”APRICOT ResultsInvestigators randomised 868 patients from 19 countries into APRICOT. Patients co-infected with HIV-HCV were randomised to receive either PEGASYS 180 micrograms once weekly plus ribavirin 800 mg daily; PEGASYS 180 micrograms monotherapy once weekly (plus placebo), or conventional interferon alfa-2a (Roferon A(R)) 3MIU three times a week in combination with ribavirin 800 mg daily, all for 48 weeks.The key results of APRICOT were:- 40% of patients treated with PEGASYS plus ribavirin achieved a sustained virological response (SVR, which is indicative of a cure) compared with 20% of patients treated with PEGASYS monotherapy and 12% of patients treated with conventional interferon/ribavirin.- Genotype 1 patients, those with the most difficult to treat type of the virus, treated with PEGASYS plus ribavirin achieved a four-fold increase in SVR compared with conventional interferon/ribavirin (29% vs 7%).- 62% of genotype 2/3 patients treated with PEGASYS plus ribavirin combination therapy achieved an SVR compared to 20% with conventional interferon/ribavirin.- PEGASYS plus ribavirin therapy effectively treated hepatitis C in patients with HIV-HCV co-infection being compatible with antiviral treatment and had a positive effect on the virological control of HIV infection.- In APRICOT, treatment with PEGASYS plus ribavirin was associated with the greatest overall histological improvement, even in patients who do not achieve an SVR.About PEGASYSPEGASYS, the market leader worldwide in hepatitis C therapy, provides significant benefit over conventional combination interferon therapy in HCV patients of all genotypes. The benefits of PEGASYS are derived from its large 40 kilodalton (KD) branched-chain polyethylene glycol (PEG) construction, which allows for sustained drug levels over the course of a full week. PEGASYS also distributes more readily to the liver (the primary site of infection) than conventional interferon. PEGASYS is the only pegylated interferon available as a ready-to-administer solution. Each weekly subcutaneous injection contains 180 micrograms of pegylated interferon alfa-2a (40KD), which is the approved dose for all patients, regardless of body weight.Roche in VirologyRoche is committed to the field of virology, having introduced effective treatments for hepatitis C as well as having a range of medications for HIV. Roche introduced Roferon-A, followed by PEGASYS in hepatitis C and now PEGASYS is demonstrating similar superior efficacy over conventional interferon in hepatitis B. Roche also has its own brand of ribavirin, COPEGUS(R), to be used in conjunction with Roferon- A or PEGASYS for HCV. Since 1986, Roche has been at the forefront of groundbreaking research and development of new drugs and technologies for care of patients with HIV. Medications developed by Roche for HIV include Fortovase(R) and Invirase(R) (two formulations of saquinavir), administered in combination with ritonavir, and Viracept(R) (nelfinavir). Viracept, introduced in 1997, has proven efficacy and safety in the treatment of HIV infection, is widely used in early treatment and has a unique cross-resistance profile. Most recently, Roche introduced Fuzeon(R) (enfuvirtide), the world’s first HIV fusion inhibitor and the first innovation in HIV treatment since 1996. Roche manufactures HIV, HBV and HCV diagnostic systems under the tradename AMPLICOR(TM) to detect the presence of, and quantity of HIV RNA, HCV RNA, or HBV DNA in a person’s blood.RocheHeadquartered 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 2004, the Pharmaceuticals Division generated 21.7 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.8 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.(Source: ITNewswire, Roche, February 2005)