Drug cuts hepatitis C levels in blood

May 17, 2002

MADRID, Apr 18 (Reuters) - An interferon-based drug currently in

clinical trials cut levels of hepatitis C virus in patients' blood by a

record amount when used in combination with a second drug, ribavirin,

according to results presented at a meeting here on Thursday.

The drug is Roche Holding AG's Pegasys and it is a pegylated interferon.

In this type of drug, a synthetic polymer called polyethylene glycol

(PEG) is attached to the interferon molecule to keep the drug active in

the bloodstream longer.

A European Union advisory committee recommended last month that Pegasys

should be approved for use both on its own and in combination with

antiviral medication ribavirin.

The drug is still awaiting clearance in the US following a series of

delays.

Roche's pharmaceuticals chief Burns said earlier this week that

the group hoped to get a fast-track US regulatory review of Pegasys when

it submits data in June.

Another pegylated interferon is already approved for use in the US.

Schering-Plough Corp has already launched its rival PEG-Rebetron product

there.

The new products are more effective and can be given less frequently

than existing treatments for hepatitis C, a blood-borne disease that

infects an estimated 170 million people worldwide and can lead to

cirrhosis and liver cancer.

Dr. Jensen of the Rush-Presbyterian-St Luke's Medical Center in

Chicago said 61% of patients in a 1,284-strong Phase III study had

undetectable levels of the virus in their blood 6 months after ending

treatment.

" These results are unprecedented, " Jensen, a leading investigator on the

trial, told the European Association for the Study of Liver annual

meeting.

The study also found that best results could be achieved by adapting the

treatment regime according to the particular type of virus in the

patient's bloodstream. There are six different strains of hepatitis C,

some of which are easier to treat than others.

" These data are very important because we know that for certain

patients, we can use a lower dose of therapy and cut the treatment

duration by half without sacrificing efficacy. Potentially, this can

spare some patients nearly 6 months of unnecessary treatment, " said

Jensen.

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