Basel, Switzerland - July 29, 2004� The New England Journal of Medicine today published the keenly awaited results of APRICOT (AIDS PEGASYS� Ribavirin International CO-infection Trial). APRICOT is the largest and only multinational prospective study evaluating the efficacy and safety of pegylated interferon combination therapy in almost 900 people co-infected with HIV and HCV. APRICOT found that the combination of PEGASYS (peginterferon alfa 2a [40 KD] and COPEGUS (ribavirin) achieved a 40% sustained virological response (SVR) � the highest ever reported in a trial of co-infected patients.
�This has been a ground-breaking trial and shows that the combination of PEGASYS and COPEGUS is superior to anything we are currently using to treat co-infection,� said Dr. Francesca Torriani, Associate Professor of Medicine, Antiviral Research Centre, University of California at San Diego and the lead author of the study. �I think the impact of APRICOT will be tremendous and it will cause a paradigm shift in HIV-HCV treatment. In the past, many physicians have not treated hepatitis C and HIV because of a perceived lack of response along with unacceptable toxicities. APRICOT should lay those fears to rest.�
The key results of APRICOT are:
- 40% of patients treated with PEGASYS plus COPEGUS achieved an SVR compared to 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 COPEGUS achieved a four-fold increase in SVR compared to conventional interferon/ribavirin (29% vs 7%). The authors noted that this is the highest SVR that has been achieved in this group of patients.
- 62% of genotype 2/3 patients treated with PEGASYS plus COPEGUS combination therapy achieved an SVR compared to 20% with conventional interferon/ribavirin.
- PEGASYS/COPEGUS therapy effectively treats hepatitis C in patients with HIV-HCV co-infection �being compatible with antiviral treatment without compromising the virological control of HIV infection.
About the study
In this study, 868 patients from 19 countries who were co-infected with HIV-HCV were randomized to receive either PEGASYS 180mg once weekly in combination with COPEGUS (800 mg daily); PEGASYS 180mg monotherapy once weekly (plus placebo COPEGUS tablets), or conventional interferon alfa 2a 3MIU (Roferon�-A) three times a week in combination with COPEGUS 800mg daily, all for 48 weeks.
Real world patient population
The patients in this landmark study were predominantly male, middle-aged with stable HIV disease. However, patients had a wide range of HIV status; the majority (85%) were on anti-retroviral therapy and they had very high HCV viral loads (10-15 million copies/ml). The very low (12%) response achieved by patients randomized to the arm receiving conventional interferon combination therapy is illustrative of the challenging nature of the co-infection present in these patients.
�This is the fourth study with PEGASYS that has been published in the New England Journal of Medicine and it highlights Roche�s leadership role in conducting global clinical trials that have far-reaching implications for the management of hepatitis C patients,� commented Ciro Caravaggio Global Head of the Hepatitis Franchise at Roche. �The wealth of data we have published in hepatitis C has provided physicians with assurance of the benefits of PEGASYS and COPEGUS, which today is the market leader.�
About HIV-HCV Co-infection
HIV co-infection aggravates and accelerates the progression of liver disease in patients with HCV, resulting in a more rapid progression to cirrhosis and end stage liver disease. As improvements in antiretroviral therapy have prolonged life expectancy of patients with HIV, liver disease has emerged as the leading cause of morbidity and mortality for HIV patients.
In general, due to the concern over safety and low efficacy, people with HIV-HCV co-infection have largely been excluded from large clinical trials for the treatment for HCV, limiting the knowledge about how best to provide therapy for this significant and needy patient population.
About PEGASYS
PEGASYS, a new generation hepatitis C therapy that is different by design, provides significant benefit over conventional interferon therapy in patients infected with HBV and HCV. The benefits of PEGASYS are derived from its new generation 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. In HCV, PEGASYS provides superior efficacy compared to conventional interferon combination therapy in HCV patients of all genotypes. PEGASYS is the only pegylated interferon available as a ready-to-administer solution. Each weekly subcutaneous injection contains 180mcg of pegylated interferon alfa-2a (40KD), which is the approved dose for all patients, regardless of body weight.
Roche in Virology
Roche 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, 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 and Invirase (two formulations of saquinavir), administered in combination with ritonavir, and Viracept (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 (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 to detect the presence of, and quantity of HIV RNA, HCV RNA, or HBV DNA in a person�s blood.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world�s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of 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 employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
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