INFO: 'IDEAL' Study Affirms Roche's Pegasys As Effective Treatment For Hepatitis C

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'IDEAL' Study

Affirms Roche's Pegasys As Effective Treatment For Hepatitis C

Main Category: Liver Disease /

Hepatitis

Article Date: 17 Jan 2008 - 1:00 PST

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The announcement made by Schering-Plough on the early results of the IDEAL

study affirms the importance of Pegasys (peginterferon alfa 2a) and Copegus

(ribavirin) for the successful treatment of hepatitis C. The study demonstrates

that Pegasys and Copegus treatment delivered a similar sustained virological

response (SVR) - the key measure of treatment success in hepatitis C - to

Schering's peginterferon alfa 2b. This is in spite of projected inequalities of

ribavirin exposure, which may have potentially biased the results in favour of

the Schering Plough regimens. The study provides further support for the

position of Pegasys as the leading treatment for hepatitis C patients.

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. 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 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