Pegasys in Post-Liver Transplant

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PEGASYS® (peginterferon Alfa-2a) Studied in

Post-Liver Transplant

Patients With Recurrent Hepatitis C Infection

Investigational Treatment Option for Most Difficult to

Treat Patients

CHICAGO, May 15 /PRNewswire/ -- Preliminary data

presented in a plenary

session at the American Society of Liver

Transplantation (AST) is the

first to study PEGASYS® (peginterferon Alfa-2a) in

patients with

recurrent hepatitis C infection after liver

transplantation.

Some 4,900 people undergo liver transplantation in the

US each year.

The

majority of these cases are caused by hepatitis C, a

blood-borne virus

that chronically infects an estimated 2.7 million

Americans. Although

many patients with HCV infection remain symptom-free

for up to 20

years,

others develop cirrhosis and advanced liver disease,

which in some

cases

will eventually require a liver transplant. Of all

patients who

undergo

liver transplants related to HCV infection, more than

95 percent are

re-infected as early as four weeks after transplant

surgery because

hepatitis C can remain in the bloodstream and

re-attack their new

liver.

" Although only a very small percentage of people with

hepatitis C will

ever need a liver transplant, because so many liver

transplantations

are

related to hepatitis C, it is a critical connection, "

said Chris

Pappas,

MD, Medical Director for Roche.

" This study is especially important because it

examines the effect of

PEGASYS on post-transplant HCV positive patients, who

present a

particularly difficult problem, " said Caroline Riely,

M.D., University

of

Tennessee, Memphis, who presented the study. " It is

important to study

the effects of PEGASYS in this population, where it is

often

challenging

to attain a response. "

The study investigates the efficacy and safety of

PEGASYS in patients

with

recurrent HCV infection 6-to-60 months after liver

transplantation. Of

the 56 treatment-naive patients in the study, 78

percent (44 of 56)

were

infected with genotype-1 and 88 percent (49 of 56) had

HCV viral loads

greater than 1 x 106 IU/ml. Half (28 of 56) were

given PEGASYS

once-weekly injections (180 mcg.) and the other half

did not receive

treatment. After 24 weeks on PEGASYS, 44 percent of

patients (7 of 16)

exhibited an HCV RNA 2log drop. Additionally, 25

percent of patients on

PEGASYS (4 of 16) had undetectable virus levels

(defined as <50 IU/ml

as

assessed by Amplicor Monitor v2.0) at 24 weeks. This

study will be

completed in January 2002 with comprehensive study

data available

shortly

thereafter.

The most common side effects associated with PEGASYS

in this study were

fatigue, nausea, diarrhea, fever, abdominal pain and

headache. Of the

subjects on PEGASYS, 95 percent experienced at least

one side effect,

while 81 percent of the subjects left untreated

displayed similar

reactions. None of the subjects discontinued

treatment due to side

effects.

More About Pegylation

Pegylation is the attachment of one or more chains of

polyethelene

glycol

(also known as PEG) to another molecule. In PEGASYS,

a 40 kilodalton

branched, mobile PEG is covalently bound to the

interferon alfa-2a

molecule and provides a selectively protective

barrier, without

significantly reducing binding site receptivity.

Pharmacokinetic

behavior

of a pegylated molecule depends on the size of the PEG

and the

structure

of the link between the PEG moiety and the protein.

Researchers believe the PEG creates a barrier that

shields the

interferon

alfa-2a molecule from being rapidly degraded by

proteases in the body

and

maintains its ability to consistently suppress the

hepatitis C virus

over

the one-week dosing period. Specifically, clinical

trials have

demonstrated that drug levels following a single dose

of PEGASYS last

more

than one full week (168 hours).

Preliminary pre-clinical and human volunteer data

suggest that the high

molecular weight (40 kilodalton) branched PEG in

PEGASYS helps provide

sustained pegylated interferon alfa-2a exposure at

clinically

significant

levels over the one-week dosing period. In contrast,

according to

earlier

Roche studies using smaller PEGs developed by the

company, interferons

with smaller PEGs are degraded quickly, requiring more

frequent dosing.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J.,

is the U.S.

prescription drug unit of the Roche Group, a leading

research-based

health

care enterprise that ranks among the world's leaders

in

pharmaceuticals,

diagnostics and vitamins. Roche discovers, develops,

manufactures and

markets numerous important prescription drugs that

enhance people's

health, well-being and quality of life. Among the

company's areas of

therapeutic interest are: dermatology; genitourinary

disease;

infectious

diseases, including influenza; inflammation, including

arthritis and

osteoporosis; metabolic diseases, including obesity

and diabetes;

neurology; oncology; transplantation; vascular

diseases; and virology,

including HIV/AIDS and hepatitis C.

For more information on the Roche pharmaceuticals

business in the

United

States, visit the company's website at:

http://www.rocheusa.com

SOURCE Hoffmann-La Roche Inc.

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