'IDEAL' Study Affirms Roche's Pegasys As Effective Treatment For Hepatitis C
In the trial Pegasys and Copegus treatment delivered an SVR of 41%, compared to peginterferon alfa 2b and ribavirin which showed 38-40% SVR in the two peginterferon alfa 2b and ribavirin arms of the study.[i] The Pegasys treatment arm of the study confirms the consistent, proven efficacy seen in earlier trials in genotype 1 patients (the most difficult to cure strain of the disease).
Dr Richard Marley, Consultant Hepatologist from the Royal London Hospital, commented "The outcomes of the IDEAL study continues to give me confidence in offering Pegasys and Copegus as a treatment of choice in the management of hepatitis C."
The principle purpose of the trial was not to provide a head-to-head comparison of Pegasys and peginterferon alfa 2b. In 2001, the U.S. Food and Drug Administration (FDA) required Schering-Plough to conduct a post-approval commitment trial to determine if a lower dose of peginterferon alfa 2b (1.0 mcg/kg) was as effective as the approved dose of 1.5 mcg/kg, in combination with identical ribavirin regimens. A third arm was added to the study in which patients received Pegasys 180 mcg with a different ribavirin dosing schedule. This mismatch of ribavirin dosing introduces several potential confounding factors into the study because experts agree that an optimised dose of ribavirin, with either pegylated interferon, is critical to achieving success in hepatitis C treatment. In particular, maintaining a full dose of ribavirin has shown an important ability to reduce relapse following the end of treatment.[ii]
Roche is committed to helping healthcare professionals support hepatitis C patients through their treatment with Pegasys to encourage the optimal outcome of a cure from a virus that can cause liver cirrhosis, liver cancer, and death. Research shows that a significant number of patients struggle through treatment and fail to show up for appointments, resulting in a waste of NHS resources. To enhance the expert care and support for hepatitis C patients undergoing therapy, Roche launched 'twentyfour7' - an innovative programme to support and encourage patients to stay on treatment.
Roche continues to advance the treatment of hepatitis C by optimising doses and duration of Pegasys and Copegus in patients with unmet medical need, whist developing new compounds that have the potential to offer a successful outcome to even more patients.
IDEAL Trial Design Issues
- Starting doses of ribavirin were different in the peginterferon alfa 2b and peginterferon alfa 2a arms of the study
- The design calls for a greater ribavirin dose reduction for side effect management in most patients in the peginterferon alfa 2a arm compared to patients in the peginterferon alfa 2b arms; in some cases, ribavirin dose reductions for patients in the peginterferon alfa 2a arm were three times greater than for patients in the peginterferon alfa 2b arms. This is important because a substantial number of patients being treated for hepatitis C require their ribavirin dose to be reduced to manage side effects, and this could have an impact on the efficacy of the regimen
- The peginterferon alfa 2a arm was not blinded, meaning that patients and physicians knew which treatment was being administered. Many comparative studies are blinded to ensure that bias does not compromise the results
- Erythropoetin (EPO) is a medication that is often given to treat ribavirin-related anemia and help patients maintain a higher ribavirin dose (although unlicensed for this use). However, physicians could only prescribe EPO after the first dose ribavirin reduction in the "IDEAL" trial. Since patients in the peginterferon alfa 2b arms generally had smaller ribavirin dose reductions, this introduces another potential bias and means those peginterferon alfa 2b patients were potentially able to maintain a higher dose of ribavirin compared to peginterferon alfa 2a patients
About Hepatitis C in the UK
Hepatitis C, one of the most common chronic blood-borne infections, is transmitted primarily through blood or blood products. Estimates of prevalence for hepatitis C in England and Wales vary considerably from 200,000 to 500,000. It is a leading cause of cirrhosis, liver cancer and liver failure. The future of hepatitis C therapy is likely to involve combinations of new small-molecule antiviral drugs and pegylated interferon-based treatment, like Pegasys.
About peginterferon alfa-2a (Pegasys)
Pegasys was launched by Roche in 2002 and quickly became the leading treatment for patients with hepatitis C. Pegasys plus Copegus is the only pegylated interferon combination regimen to have demonstrated superior benefits over conventional combination interferon therapy in HCV patients of all genotypes, irrespective of viral load. The benefits 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. The treatment also distributes more readily to the liver (the primary site of infection) than conventional interferon. It 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. As published in the New England Journal of Medicine, the unique ability of Pegasys to maintain a constant presence in a patient's body reduces side effects, compared with older interferon treatments. This includes fewer flu-like symptoms, less depression and fatigue. Fewer side effects helps patients stay on therapy, increasing the chance of a cure.
About Roche in the UK
Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia.
http://www.rocheuk.com
View drug information on Pegasys.
"IDEAL" Studiul afirmã Roche a Pegasys la fel de eficace de tratament pentru Hepatita C - 'IDEAL' Study Affirms Roche's Pegasys As Effective Treatment For Hepatitis C - articole medicale engleza - startsanatate