Basel, Switzerland (February 12, 2004) � The results of APRICOT (AIDS PEGASYS� Ribavirin International CO-infection Trial) � the largest and only multinational study evaluating the efficacy and safety of pegylated interferon combination therapy in people co-infected with HIV-HCV � were presented at a scientific meeting in San Francisco this week. APRICOT found that the combination of PEGASYS and COPEGUS achieved a 40% sustained virological response (SVR) � the highest ever reported in a trial of co-infected patients.
Importantly, for the 30% of people living with HIV who are co-infected with HCV, the study confirmed that HCV can be treated effectively and safely, without compromising a patient�s HIV therapy. Approximately 85% of patients in APRICOT were on Anti-Retroviral Therapy (referred to as ART).
The abstract submitted by lead study investigators, Dr. Francesca Torriani, Associate Professor of Medicine, Antiviral Research Center, University of California at San Diego, and, Dr. Douglas Dieterich, Vice Chair and Chief Medical Officer, Mount Sinai School of Medicine in New York City, concluded that �Based on an SVR of 40%, PEGASYS + COPEGUS is the preferred treatment for HCV in co-infected patients.�
�With APRICOT, PEGASYS continues to offer new landmark data that will benefit patients with a high medical need,� said William M. Burns, Head of the Pharmaceutical Division at Roche. �This pivotal and clinically relevant trial establishes PEGASYS/COPEGUS as the new standard of care in co-infected patients and offers physicians the confidence to successfully treat them.�
Mr Burns added that �These new results with the APRICOT study confirm what we have seen with PEGASYS and COPEGUS in other trials of patients with difficult-to-treat disease and we believe the efficacy that we are seeing is due to the drug�s unique ability to apply constant viral suppression over the full once weekly dosing schedule.�
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 three times a week in combination with ribavirin 800mg daily, all for 48 weeks.
The key APRICOT findings were:
- 40% of patients treated with PEGASYS/COPEGUS achieved a sustained virological response compared to 20% of patients treated with PEGASYS monotherapy and 12% of patients treated with conventional interferon/ribavirin.
- Genotype 1 patients treated with PEGASYS and COPEGUS achieved a four-fold increase in SVR compared to conventional interferon/ribavirin (29% vs 7%)
- 62% of genotype 2/3 patients treated with PEGASYS/COPEGUS combination therapy achieved a SVR compared to 20% with conventional interferon/ribavirin
�The results from APRICOT have been eagerly anticipated by the medical community and I am personally delighted to see a sustained virological response or �cure� in hepatitis C being achieved by a remarkable number of people,� said Dr. Dieterich, who presented the results this week. �Historically, response rates in co-infected patients have been about half of this.�
�APRICOT has the largest group of HIV-HCV co-infected patients ever studied from around the world and this will provide treating physicians with ample evidence of the excellent safety profile and high degree of efficacy that can now be achieved for the treatment of HCV using PEGASYS and COPEGUS combination therapy, said Dr. Torriani, one of the two lead investigators.
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 of 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 constant viral suppression 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, a leading protease inhibitor is widely used as a first line therapy for treatment of HIV. 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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