Re: Peg

[Guest guest]

In a message dated 6/4/00 12:23:38 AM Eastern Daylight Time, LEST2001@...

writes:

<< During my treatment I was doing 5 million IU daily for the first 6

months, and the went to 3 million IU daily for the last 5 months >>

I stand corrected! I forgot that...and I know you wrote it, previously.

Well, I am on heavy medication - doncha know?! lol.

BTW - do you know the studys' results? Or is it too early? Just curious.

Peace,

Jane

[Guest guest]

Dear Les,

I've heard that the earlier you go undetectable the better chance you

have of sustaining that response. I'd say things are looking good for you!

Good luck!

Claudine

>From: LEST2001@...

> No, I don't know the results form my study yet. I do know that I went

>undetectable the first two weeks of treatment, and have stayed same ever

>sense.

>Take care,

>Les

________________________________________________________________________

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[Guest guest]

Dear Les,

I've heard that the earlier you go undetectable the better chance you

have of sustaining that response. I'd say things are looking good for you!

Good luck!

Claudine

>From: LEST2001@...

> No, I don't know the results form my study yet. I do know that I went

>undetectable the first two weeks of treatment, and have stayed same ever

>sense.

>Take care,

>Les

________________________________________________________________________

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[Guest guest]

No, I don't know the results form my study yet. I do know that I went

undetectable the first two weeks of treatment, and have stayed same ever

sense.

Take care,

Les

[Guest guest]

No, I don't know the results form my study yet. I do know that I went

undetectable the first two weeks of treatment, and have stayed same ever

sense.

Take care,

Les

[Guest guest]

Alley,

Probably wouldn't even run out because there is an extra dose in the pens to

compensate for air bubbles and the removal of them. so you could still go

the full treatment course. I have been using my extra and it really helped

because a pen fell out of refrigerator and so i lost it all as my company

set it on top of the frig!! I have wondered the same thing but mostly

because on the 3 day of the weeks i usually feel really bad maybe because

i've gone so long without an injection? dOESN'T ALWAYS WORK THAT WAY

SOMETIMES FEEL WORSE wED but heck its worth a shot and you already have the

med. somepeople are already doing it every other day or even every day for

those fortunate to have docs that will treat them aggressively.

Good Luck

Suzy

________________________________________________________________________

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[Guest guest]

Alley,

Probably wouldn't even run out because there is an extra dose in the pens to

compensate for air bubbles and the removal of them. so you could still go

the full treatment course. I have been using my extra and it really helped

because a pen fell out of refrigerator and so i lost it all as my company

set it on top of the frig!! I have wondered the same thing but mostly

because on the 3 day of the weeks i usually feel really bad maybe because

i've gone so long without an injection? dOESN'T ALWAYS WORK THAT WAY

SOMETIMES FEEL WORSE wED but heck its worth a shot and you already have the

med. somepeople are already doing it every other day or even every day for

those fortunate to have docs that will treat them aggressively.

Good Luck

Suzy

________________________________________________________________________

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[Guest guest]

The drug's name you refer to is Amantidine...mzgee

" We can do no great things; only small things with great Love. " Mother

[Guest guest]

----------

>From: " gorski " <gorski@...>

> There is a study in progress with the above three. The one study I know of

> has four arms as follows:

>

> Randomized PEG study (ROCHE) with four arms

> for relapsers:

>

> 1) PEG plus Ribavirin

> 2) PEG plus Amantidine

> 3) PEG plus Ribaviron & Amantidine

> 4) PEG plus Cellcept

>

>

>

>

What's cellcept?

Gail

[Guest guest]

Thanks for pointing that out Sharon. I know here in Dallas.. they are doing

3 yr long PEG maintenance studies for nonresponders. I've also read that the

time release only actually works for 4 - 5 days. Yeah... if more people can

tolerate the sides, then more will continue treatment and more will

hopefully go into remission

alley/

ICQ 12631861

alleypat@...

http://www.flash.net/~alleypat

http://community.dallasnews.com/dmn/dfwliver

[Guest guest]

Dear Sharon,

I went to your article regarding pegylated interferon. You state:

**At this time, the clinical trials for PEG-INTRON in the US and Canada

should begin this year. However, there are several differing opinions on

exactly which dates this product will be available for use on Hepatitis C

patients. There were reports released that Clinics around the North American

region could expect product availability by September 2000, however that

date has now been postponed, possibly to December 2000.

Please do not be confused regarding the upcoming clinical trials of PEG.

This is using the coated interferon product only. For the year 2000, the

clinical trials will not include the Ribavirin (PEG combo) therapy. This

singular product might decrease the overall effectiveness of treatment for

those who might respond to the current Combination Rebetron therapy.

After the US PEG clinical trials, Schering-Plough will apply to the FDA

again for the use of PEG in conjunction with the Ribavirin product. This is

the more promising combination, because it will allow the interferon more

effective and lasting capabilities in the body, and be easier for the

patient. Quoting a member of the Schering-Plough research team, " We hope to

have the PEG Combo therapy available for clinical trails by 2002, FDA

willing! " **

While I agree with you that Schering's pegylated monotherapy results

are not as good as current interferon combo therapy, I disagree with your

information about peg with ribavirin. The trials for Schering's Peg-Intron

WITH ribavirin are ALREADY into phase III. In fact, in the report

Schering-Plough presented on May 1, 2000 at the EASL meeting Schering

stated:

PEG-INTRON PLUS REBETOL COMBINATION THERAPY

Results of a Phase II dose-ranging study of PEG-INTRON in combination with

REBETOL (Ribavirin, USP) Capsules were presented by Esteban Mur,

M.D., professor of medicine, Servei de Medicina Interna-Hepatologia,

Hospital Vall d’Hebron, Barcelona, Spain, at a satellite symposium sponsored

by Schering-Plough. " The results of this study indicate that REBETOL

enhances the antiviral activity of PEG-INTRON and that sustained virologic

response with the combination therapy is dose dependent, " Esteban Mur said.

" While preliminary, these results are encouraging. " The combination of

PEG-INTRON and REBETOL is currently being studied in Phase III trials to

further define its clinical profile.

They then go on to report the results of the phase II study. Trials on

Roche's version of the pegylated interferon with ribavirin are also well

under way.

Since ribavirin is already approved for use with interferon in the

treatment of hepatitis C I don't think there will be much delay in an

approval of the pegylated-ribavirin combination. After all, it's still just

interferon. There are NO NEW medications involved here. (I think that

Schering's pegylated would already have been approved if it weren't for the

law suits between Schering and Roche.) However, ribavirin can be prescribed

NOW for use with other interferons, such as Roferon or Infergen, and can

also be prescribed with a pegylated interferon when available, if you have a

doctor that is willing to do so. It can be obtained through Fisher's

pharmacy (for now) and shipped to you. I have already discussed with my

doctor that I want to take ribavirin with the Roche brand of pegylated

interferon, and he didn't seem to think this would be a problem (and he is

NOT a doctor too willing to stick his neck out either.) He also thinks

Schering will be pressured into 'unlocking' their ribavirin from their

interferon so it will be more easily available for use with medications

other than those manufactured by Schering. I hope he is right, but I will

have to see it to believe it.

I really don't think you can trust the word of the Schering reps 100%.

I have heard of other things they have said which were not true. It is NOT

in their best interests to have anyone wait for a pegylated interferon to

become available. They want people on treatment NOW. Waiting costs them

money, and I don't believe they would mind at all if you relapse and need to

take treatment all over again (buying more of their products, of course).

Also, they have what just about amounts to a monopoly on treatments for

hepatitis C at this time, but that may change when Roche's version of the

pegylated interferon is out, since studies so far seem to show that the

Roche version of pegylated interferon is more effective than Schering's

version. So again, it's NOT in Schering's best interests to have anyone

postpone treatment now. For myself, I will look at the published studies,

news releases, etc., and NOT what the Schering reps have to say. Besides,

my fibrosis is only stage 1, and at the rate this disease progresses I could

wait several years if I needed to. Being a genotype 1b non-responder, even

if I was stage three, or already had cirrhosis, I still think (after all the

research I've been doing) that I would wait for something more better than

this combo treatment, even if it was only pegylated monotherapy, since the

latest news out is that pegylated monotherapy is more effective than

standard interferon for improving liver histology, and that would be a real

concern of mine. Depending on individual circumstances, I still think

waiting for the pegylated is the best option for many people.

Claudine

________________________________________________________________________

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[Guest guest]

Schering-Plough Announces European Union Approval Of PEGINTRON for

Treatment of Hepatitis C

>>> First Pegylated Interferon Approved in the World <<<

MADISON, N.J., May 30 /PRNewswire/ -- Schering-Plough Corporation

(NYSE: SGP) today announced that the European Union's (EU) Commission of the

European Communities has granted marketing authorization to PEGINTRON

(peginterferon alfa-2b) as once-weekly monotherapy for the treatment of adult

patients with chronic hepatitis C. PEGINTRON is the first pegylated

interferon approved for marketing in the world.

In clinical studies, once-weekly administration of PEGINTRON has been

shown to be twice as active and just as well tolerated as Schering-Plough's

INTRON® A (interferon alfa-2b, recombinant) Injection, the world's

largest-selling alpha interferon, administered three times weekly as

monotherapy for hepatitis C.

PEGINTRON is a longer-acting form of INTRON A that uses proprietary PEG

technology developed by Enzon, Inc. (Nasdaq: ENZN) of Piscataway, N.J.

Schering-Plough holds an exclusive worldwide license to PEGINTRON.

Commission approval of the centralized application for PEGINTRON results

in a single Marketing Authorization with unified labeling that is immediately

valid in all 15 EU-Member States. The Commission's decision follows the

product's unanimous recommendation for approval in February 2000 by the

EU's Committee for Proprietary Medicinal Products (CPMP) of the European

Agency for the Evaluation of Medicinal Products (EMEA).

PEGINTRON will be introduced upon receiving pricing approvals, where

necessary, from individual EU countries.

PEGINTRON is indicated as monotherapy in case of intolerance or

contraindication to ribavirin for the treatment of adult patients with

histologically proven chronic hepatitis C who have serum markers indicating

virus replication, e.g., those patients who have elevated transaminases(1)

without liver decompensation and who are positive for serum HCV-RNA(2) or

anti-HCV(3).

The approved labeling in the EU for PEGINTRON indicates that the optimal

treatment for chronic hepatitis C is considered to be the administration of a

combination of interferon alfa-2b with ribavirin. The safety and efficacy of

the combination of PEGINTRON and ribavirin has not yet been documented.

PEGINTRON monotherapy is administered subcutaneously at a dose of 0.5 or

1.0 mcg/kg once weekly for at least six months. In patients showing loss of

HCV-RNA at six months, treatment is continued for an additional six months,

i.e. for a total course of treatment of one year.

A worldwide, controlled clinical study designed to establish the activity

and tolerance of PEGINTRON versus INTRON A monotherapy was conducted in adult

patients with previously untreated chronic hepatitis C and compensated liver

disease. A total of 1,219 patients, who were positive for serum HCV-RNA and

who had elevated liver enzymes (serum alanine aminotransferase), were treated

with one of three doses of PEGINTRON (0.5, 1.0, 1.5 mcg/kg) administered once

weekly or INTRON A (3 MIU) administered three times weekly for 48 weeks. The

primary efficacy endpoint of the study was sustained loss of detectable

HCV-RNA at 24 weeks from the end of 48 weeks of treatment. PEGINTRON at all

three doses studied was shown to be superior to, and as safe as, INTRON A in

treating all HCV genotypes.

The study results showed that sustained virologic responses were achieved

in 25% of patients receiving PEGINTRON 1.0 mcg/kg and 18% of patients

receiving PEGINTRON 0.5 mcg/kg, compared to 12% of patients receiving INTRON

A. In patients having genotype 2 or 3 and low viral load (<2 million

copies/ml), sustained virologic responses were achieved in 62% of patients

treated with PEGINTRON 1.0 mcg/kg and 58% of patients treated with PEGINTRON

0.5 mcg/kg, compared to 36% of patients treated with INTRON A.

The demographic/disease characteristics of patients in this study were

similar to those in previous Schering-Plough hepatitis C registration studies,

with a majority of patients having genotype 1, the most difficult genotype to

treat (70% genotype 1), and high viral load (74% HCV-RNA>2 million copies/ml).

Adverse events (AEs) for all doses of PEGINTRON were similar to those for

INTRON A. Most AEs were mild to moderate and were manageable with dose

adjustment. Discontinuation of therapy due to AEs was similar for all

treatment groups (6-11%). Dose reductions were similar for INTRON A and

PEGINTRON 0.5 mcg/kg and higher for PEGINTRON 1.0 and 1.5 mcg/kg (6%, 9%,

14% and 19%, respectively). The most common side effects occurring with

PEGINTRON were " flu-like " symptoms, such as headache, fatigue, myalgia and

fever, which appeared to decrease in severity as treatment continued.

Chronic hepatitis C is estimated to affect some 10 million people in major

world markets. As many as 5 million Europeans (1 to 2 percent of the general

population) are chronically infected with the hepatitis C virus, according to

a study conducted by the World Health Organization (WHO). In Europe, chronic

hepatitis C is the leading cause of chronic liver disease and the most common

reason for liver transplant.

In the United States, Schering-Plough on Dec. 23, 1999, submitted a

Biologics License Application (BLA) to the U.S. Food and Drug Administration

(FDA) seeking marketing approval for PEG-INTRON (peginterferon alfa-2b)

Powder for Injection as once-weekly monotherapy for the treatment of chronic

hepatitis C. Some 4 million Americans are chronically infected with the

hepatitis C virus, according to the Centers for Disease Control and Prevention

(CDC).

INTRON A is a recombinant version of naturally occurring alpha interferon,

which has been shown to exert both antiviral and immunomodulatory effects.

Schering-Plough markets INTRON A worldwide for 16 major antiviral and

anticancer indications.

REBETOL® (Ribavirin, USP) Capsules is an oral formulation of ribavirin,

a synthetic nucleoside analog with broad-spectrum antiviral activity.

Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C

in all major world markets through a licensing agreement with ICN

Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif.

Schering-Plough is a research-based company engaged in the discovery,

development, manufacturing and marketing of pharmaceutical products worldwide.

(1) Elevated enzyme levels indicating ongoing liver inflammation.

(2) HCV-RNA: hepatitis C viral RNA (ribonucleic acid).

(3) Anti-HCV: antibodies to hepatitis C virus.

SOURCE Schering-Plough Corporation

Web Site: http://www.schering-plough.com

Sharon Nicholson

Hepatitis Education & Patient Coalition (H. E. P. C. in AZ)

Executive Director

<A HREF= " http://www.suite101.com/welcome.cfm/hepatitis_abc " >Hepatitis A, B,

C's - editor Suite101.com</A>

http://www.suite101.com/welcome.cfm/hepatitis_abc

Join our e-group mailing list online!

<A HREF= " ArizonaHepatitis C " >eGroups :

ArizonaHepatitis C</A>

ArizonaHepatitis C

[Guest guest]

Schering-Plough Announces European Union Approval Of PEGINTRON for

Treatment of Hepatitis C

>>> First Pegylated Interferon Approved in the World <<<

MADISON, N.J., May 30 /PRNewswire/ -- Schering-Plough Corporation

(NYSE: SGP) today announced that the European Union's (EU) Commission of the

European Communities has granted marketing authorization to PEGINTRON

(peginterferon alfa-2b) as once-weekly monotherapy for the treatment of adult

patients with chronic hepatitis C. PEGINTRON is the first pegylated

interferon approved for marketing in the world.

In clinical studies, once-weekly administration of PEGINTRON has been

shown to be twice as active and just as well tolerated as Schering-Plough's

INTRON® A (interferon alfa-2b, recombinant) Injection, the world's

largest-selling alpha interferon, administered three times weekly as

monotherapy for hepatitis C.

PEGINTRON is a longer-acting form of INTRON A that uses proprietary PEG

technology developed by Enzon, Inc. (Nasdaq: ENZN) of Piscataway, N.J.

Schering-Plough holds an exclusive worldwide license to PEGINTRON.

Commission approval of the centralized application for PEGINTRON results

in a single Marketing Authorization with unified labeling that is immediately

valid in all 15 EU-Member States. The Commission's decision follows the

product's unanimous recommendation for approval in February 2000 by the

EU's Committee for Proprietary Medicinal Products (CPMP) of the European

Agency for the Evaluation of Medicinal Products (EMEA).

PEGINTRON will be introduced upon receiving pricing approvals, where

necessary, from individual EU countries.

PEGINTRON is indicated as monotherapy in case of intolerance or

contraindication to ribavirin for the treatment of adult patients with

histologically proven chronic hepatitis C who have serum markers indicating

virus replication, e.g., those patients who have elevated transaminases(1)

without liver decompensation and who are positive for serum HCV-RNA(2) or

anti-HCV(3).

The approved labeling in the EU for PEGINTRON indicates that the optimal

treatment for chronic hepatitis C is considered to be the administration of a

combination of interferon alfa-2b with ribavirin. The safety and efficacy of

the combination of PEGINTRON and ribavirin has not yet been documented.

PEGINTRON monotherapy is administered subcutaneously at a dose of 0.5 or

1.0 mcg/kg once weekly for at least six months. In patients showing loss of

HCV-RNA at six months, treatment is continued for an additional six months,

i.e. for a total course of treatment of one year.

A worldwide, controlled clinical study designed to establish the activity

and tolerance of PEGINTRON versus INTRON A monotherapy was conducted in adult

patients with previously untreated chronic hepatitis C and compensated liver

disease. A total of 1,219 patients, who were positive for serum HCV-RNA and

who had elevated liver enzymes (serum alanine aminotransferase), were treated

with one of three doses of PEGINTRON (0.5, 1.0, 1.5 mcg/kg) administered once

weekly or INTRON A (3 MIU) administered three times weekly for 48 weeks. The

primary efficacy endpoint of the study was sustained loss of detectable

HCV-RNA at 24 weeks from the end of 48 weeks of treatment. PEGINTRON at all

three doses studied was shown to be superior to, and as safe as, INTRON A in

treating all HCV genotypes.

The study results showed that sustained virologic responses were achieved

in 25% of patients receiving PEGINTRON 1.0 mcg/kg and 18% of patients

receiving PEGINTRON 0.5 mcg/kg, compared to 12% of patients receiving INTRON

A. In patients having genotype 2 or 3 and low viral load (<2 million

copies/ml), sustained virologic responses were achieved in 62% of patients

treated with PEGINTRON 1.0 mcg/kg and 58% of patients treated with PEGINTRON

0.5 mcg/kg, compared to 36% of patients treated with INTRON A.

The demographic/disease characteristics of patients in this study were

similar to those in previous Schering-Plough hepatitis C registration studies,

with a majority of patients having genotype 1, the most difficult genotype to

treat (70% genotype 1), and high viral load (74% HCV-RNA>2 million copies/ml).

Adverse events (AEs) for all doses of PEGINTRON were similar to those for

INTRON A. Most AEs were mild to moderate and were manageable with dose

adjustment. Discontinuation of therapy due to AEs was similar for all

treatment groups (6-11%). Dose reductions were similar for INTRON A and

PEGINTRON 0.5 mcg/kg and higher for PEGINTRON 1.0 and 1.5 mcg/kg (6%, 9%,

14% and 19%, respectively). The most common side effects occurring with

PEGINTRON were " flu-like " symptoms, such as headache, fatigue, myalgia and

fever, which appeared to decrease in severity as treatment continued.

Chronic hepatitis C is estimated to affect some 10 million people in major

world markets. As many as 5 million Europeans (1 to 2 percent of the general

population) are chronically infected with the hepatitis C virus, according to

a study conducted by the World Health Organization (WHO). In Europe, chronic

hepatitis C is the leading cause of chronic liver disease and the most common

reason for liver transplant.

In the United States, Schering-Plough on Dec. 23, 1999, submitted a

Biologics License Application (BLA) to the U.S. Food and Drug Administration

(FDA) seeking marketing approval for PEG-INTRON (peginterferon alfa-2b)

Powder for Injection as once-weekly monotherapy for the treatment of chronic

hepatitis C. Some 4 million Americans are chronically infected with the

hepatitis C virus, according to the Centers for Disease Control and Prevention

(CDC).

INTRON A is a recombinant version of naturally occurring alpha interferon,

which has been shown to exert both antiviral and immunomodulatory effects.

Schering-Plough markets INTRON A worldwide for 16 major antiviral and

anticancer indications.

REBETOL® (Ribavirin, USP) Capsules is an oral formulation of ribavirin,

a synthetic nucleoside analog with broad-spectrum antiviral activity.

Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C

in all major world markets through a licensing agreement with ICN

Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif.

Schering-Plough is a research-based company engaged in the discovery,

development, manufacturing and marketing of pharmaceutical products worldwide.

(1) Elevated enzyme levels indicating ongoing liver inflammation.

(2) HCV-RNA: hepatitis C viral RNA (ribonucleic acid).

(3) Anti-HCV: antibodies to hepatitis C virus.

SOURCE Schering-Plough Corporation

Web Site: http://www.schering-plough.com

Sharon Nicholson

Hepatitis Education & Patient Coalition (H. E. P. C. in AZ)

Executive Director

<A HREF= " http://www.suite101.com/welcome.cfm/hepatitis_abc " >Hepatitis A, B,

C's - editor Suite101.com</A>

http://www.suite101.com/welcome.cfm/hepatitis_abc

Join our e-group mailing list online!

<A HREF= " ArizonaHepatitis C " >eGroups :

ArizonaHepatitis C</A>

ArizonaHepatitis C

[Guest guest]

Schering-Plough Announces European Union Approval Of PEGINTRON for

Treatment of Hepatitis C

>>> First Pegylated Interferon Approved in the World <<<

MADISON, N.J., May 30 /PRNewswire/ -- Schering-Plough Corporation

(NYSE: SGP) today announced that the European Union's (EU) Commission of the

European Communities has granted marketing authorization to PEGINTRON

(peginterferon alfa-2b) as once-weekly monotherapy for the treatment of adult

patients with chronic hepatitis C. PEGINTRON is the first pegylated

interferon approved for marketing in the world.

In clinical studies, once-weekly administration of PEGINTRON has been

shown to be twice as active and just as well tolerated as Schering-Plough's

INTRON® A (interferon alfa-2b, recombinant) Injection, the world's

largest-selling alpha interferon, administered three times weekly as

monotherapy for hepatitis C.

PEGINTRON is a longer-acting form of INTRON A that uses proprietary PEG

technology developed by Enzon, Inc. (Nasdaq: ENZN) of Piscataway, N.J.

Schering-Plough holds an exclusive worldwide license to PEGINTRON.

Commission approval of the centralized application for PEGINTRON results

in a single Marketing Authorization with unified labeling that is immediately

valid in all 15 EU-Member States. The Commission's decision follows the

product's unanimous recommendation for approval in February 2000 by the

EU's Committee for Proprietary Medicinal Products (CPMP) of the European

Agency for the Evaluation of Medicinal Products (EMEA).

PEGINTRON will be introduced upon receiving pricing approvals, where

necessary, from individual EU countries.

PEGINTRON is indicated as monotherapy in case of intolerance or

contraindication to ribavirin for the treatment of adult patients with

histologically proven chronic hepatitis C who have serum markers indicating

virus replication, e.g., those patients who have elevated transaminases(1)

without liver decompensation and who are positive for serum HCV-RNA(2) or

anti-HCV(3).

The approved labeling in the EU for PEGINTRON indicates that the optimal

treatment for chronic hepatitis C is considered to be the administration of a

combination of interferon alfa-2b with ribavirin. The safety and efficacy of

the combination of PEGINTRON and ribavirin has not yet been documented.

PEGINTRON monotherapy is administered subcutaneously at a dose of 0.5 or

1.0 mcg/kg once weekly for at least six months. In patients showing loss of

HCV-RNA at six months, treatment is continued for an additional six months,

i.e. for a total course of treatment of one year.

A worldwide, controlled clinical study designed to establish the activity

and tolerance of PEGINTRON versus INTRON A monotherapy was conducted in adult

patients with previously untreated chronic hepatitis C and compensated liver

disease. A total of 1,219 patients, who were positive for serum HCV-RNA and

who had elevated liver enzymes (serum alanine aminotransferase), were treated

with one of three doses of PEGINTRON (0.5, 1.0, 1.5 mcg/kg) administered once

weekly or INTRON A (3 MIU) administered three times weekly for 48 weeks. The

primary efficacy endpoint of the study was sustained loss of detectable

HCV-RNA at 24 weeks from the end of 48 weeks of treatment. PEGINTRON at all

three doses studied was shown to be superior to, and as safe as, INTRON A in

treating all HCV genotypes.

The study results showed that sustained virologic responses were achieved

in 25% of patients receiving PEGINTRON 1.0 mcg/kg and 18% of patients

receiving PEGINTRON 0.5 mcg/kg, compared to 12% of patients receiving INTRON

A. In patients having genotype 2 or 3 and low viral load (<2 million

copies/ml), sustained virologic responses were achieved in 62% of patients

treated with PEGINTRON 1.0 mcg/kg and 58% of patients treated with PEGINTRON

0.5 mcg/kg, compared to 36% of patients treated with INTRON A.

The demographic/disease characteristics of patients in this study were

similar to those in previous Schering-Plough hepatitis C registration studies,

with a majority of patients having genotype 1, the most difficult genotype to

treat (70% genotype 1), and high viral load (74% HCV-RNA>2 million copies/ml).

Adverse events (AEs) for all doses of PEGINTRON were similar to those for

INTRON A. Most AEs were mild to moderate and were manageable with dose

adjustment. Discontinuation of therapy due to AEs was similar for all

treatment groups (6-11%). Dose reductions were similar for INTRON A and

PEGINTRON 0.5 mcg/kg and higher for PEGINTRON 1.0 and 1.5 mcg/kg (6%, 9%,

14% and 19%, respectively). The most common side effects occurring with

PEGINTRON were " flu-like " symptoms, such as headache, fatigue, myalgia and

fever, which appeared to decrease in severity as treatment continued.

Chronic hepatitis C is estimated to affect some 10 million people in major

world markets. As many as 5 million Europeans (1 to 2 percent of the general

population) are chronically infected with the hepatitis C virus, according to

a study conducted by the World Health Organization (WHO). In Europe, chronic

hepatitis C is the leading cause of chronic liver disease and the most common

reason for liver transplant.

In the United States, Schering-Plough on Dec. 23, 1999, submitted a

Biologics License Application (BLA) to the U.S. Food and Drug Administration

(FDA) seeking marketing approval for PEG-INTRON (peginterferon alfa-2b)

Powder for Injection as once-weekly monotherapy for the treatment of chronic

hepatitis C. Some 4 million Americans are chronically infected with the

hepatitis C virus, according to the Centers for Disease Control and Prevention

(CDC).

INTRON A is a recombinant version of naturally occurring alpha interferon,

which has been shown to exert both antiviral and immunomodulatory effects.

Schering-Plough markets INTRON A worldwide for 16 major antiviral and

anticancer indications.

REBETOL® (Ribavirin, USP) Capsules is an oral formulation of ribavirin,

a synthetic nucleoside analog with broad-spectrum antiviral activity.

Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C

in all major world markets through a licensing agreement with ICN

Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif.

Schering-Plough is a research-based company engaged in the discovery,

development, manufacturing and marketing of pharmaceutical products worldwide.

(1) Elevated enzyme levels indicating ongoing liver inflammation.

(2) HCV-RNA: hepatitis C viral RNA (ribonucleic acid).

(3) Anti-HCV: antibodies to hepatitis C virus.

SOURCE Schering-Plough Corporation

Web Site: http://www.schering-plough.com

Sharon Nicholson

Hepatitis Education & Patient Coalition (H. E. P. C. in AZ)

Executive Director

<A HREF= " http://www.suite101.com/welcome.cfm/hepatitis_abc " >Hepatitis A, B,

C's - editor Suite101.com</A>

http://www.suite101.com/welcome.cfm/hepatitis_abc

Join our e-group mailing list online!

<A HREF= " ArizonaHepatitis C " >eGroups :

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ArizonaHepatitis C

[Guest guest]

Schering-Plough Announces European Union Approval Of PEGINTRON for

Treatment of Hepatitis C

>>> First Pegylated Interferon Approved in the World <<<

MADISON, N.J., May 30 /PRNewswire/ -- Schering-Plough Corporation

(NYSE: SGP) today announced that the European Union's (EU) Commission of the

European Communities has granted marketing authorization to PEGINTRON

(peginterferon alfa-2b) as once-weekly monotherapy for the treatment of adult

patients with chronic hepatitis C. PEGINTRON is the first pegylated

interferon approved for marketing in the world.

In clinical studies, once-weekly administration of PEGINTRON has been

shown to be twice as active and just as well tolerated as Schering-Plough's

INTRON® A (interferon alfa-2b, recombinant) Injection, the world's

largest-selling alpha interferon, administered three times weekly as

monotherapy for hepatitis C.

PEGINTRON is a longer-acting form of INTRON A that uses proprietary PEG

technology developed by Enzon, Inc. (Nasdaq: ENZN) of Piscataway, N.J.

Schering-Plough holds an exclusive worldwide license to PEGINTRON.

Commission approval of the centralized application for PEGINTRON results

in a single Marketing Authorization with unified labeling that is immediately

valid in all 15 EU-Member States. The Commission's decision follows the

product's unanimous recommendation for approval in February 2000 by the

EU's Committee for Proprietary Medicinal Products (CPMP) of the European

Agency for the Evaluation of Medicinal Products (EMEA).

PEGINTRON will be introduced upon receiving pricing approvals, where

necessary, from individual EU countries.

PEGINTRON is indicated as monotherapy in case of intolerance or

contraindication to ribavirin for the treatment of adult patients with

histologically proven chronic hepatitis C who have serum markers indicating

virus replication, e.g., those patients who have elevated transaminases(1)

without liver decompensation and who are positive for serum HCV-RNA(2) or

anti-HCV(3).

The approved labeling in the EU for PEGINTRON indicates that the optimal

treatment for chronic hepatitis C is considered to be the administration of a

combination of interferon alfa-2b with ribavirin. The safety and efficacy of

the combination of PEGINTRON and ribavirin has not yet been documented.

PEGINTRON monotherapy is administered subcutaneously at a dose of 0.5 or

1.0 mcg/kg once weekly for at least six months. In patients showing loss of

HCV-RNA at six months, treatment is continued for an additional six months,

i.e. for a total course of treatment of one year.

A worldwide, controlled clinical study designed to establish the activity

and tolerance of PEGINTRON versus INTRON A monotherapy was conducted in adult

patients with previously untreated chronic hepatitis C and compensated liver

disease. A total of 1,219 patients, who were positive for serum HCV-RNA and

who had elevated liver enzymes (serum alanine aminotransferase), were treated

with one of three doses of PEGINTRON (0.5, 1.0, 1.5 mcg/kg) administered once

weekly or INTRON A (3 MIU) administered three times weekly for 48 weeks. The

primary efficacy endpoint of the study was sustained loss of detectable

HCV-RNA at 24 weeks from the end of 48 weeks of treatment. PEGINTRON at all

three doses studied was shown to be superior to, and as safe as, INTRON A in

treating all HCV genotypes.

The study results showed that sustained virologic responses were achieved

in 25% of patients receiving PEGINTRON 1.0 mcg/kg and 18% of patients

receiving PEGINTRON 0.5 mcg/kg, compared to 12% of patients receiving INTRON

A. In patients having genotype 2 or 3 and low viral load (<2 million

copies/ml), sustained virologic responses were achieved in 62% of patients

treated with PEGINTRON 1.0 mcg/kg and 58% of patients treated with PEGINTRON

0.5 mcg/kg, compared to 36% of patients treated with INTRON A.

The demographic/disease characteristics of patients in this study were

similar to those in previous Schering-Plough hepatitis C registration studies,

with a majority of patients having genotype 1, the most difficult genotype to

treat (70% genotype 1), and high viral load (74% HCV-RNA>2 million copies/ml).

Adverse events (AEs) for all doses of PEGINTRON were similar to those for

INTRON A. Most AEs were mild to moderate and were manageable with dose

adjustment. Discontinuation of therapy due to AEs was similar for all

treatment groups (6-11%). Dose reductions were similar for INTRON A and

PEGINTRON 0.5 mcg/kg and higher for PEGINTRON 1.0 and 1.5 mcg/kg (6%, 9%,

14% and 19%, respectively). The most common side effects occurring with

PEGINTRON were " flu-like " symptoms, such as headache, fatigue, myalgia and

fever, which appeared to decrease in severity as treatment continued.

Chronic hepatitis C is estimated to affect some 10 million people in major

world markets. As many as 5 million Europeans (1 to 2 percent of the general

population) are chronically infected with the hepatitis C virus, according to

a study conducted by the World Health Organization (WHO). In Europe, chronic

hepatitis C is the leading cause of chronic liver disease and the most common

reason for liver transplant.

In the United States, Schering-Plough on Dec. 23, 1999, submitted a

Biologics License Application (BLA) to the U.S. Food and Drug Administration

(FDA) seeking marketing approval for PEG-INTRON (peginterferon alfa-2b)

Powder for Injection as once-weekly monotherapy for the treatment of chronic

hepatitis C. Some 4 million Americans are chronically infected with the

hepatitis C virus, according to the Centers for Disease Control and Prevention

(CDC).

INTRON A is a recombinant version of naturally occurring alpha interferon,

which has been shown to exert both antiviral and immunomodulatory effects.

Schering-Plough markets INTRON A worldwide for 16 major antiviral and

anticancer indications.

REBETOL® (Ribavirin, USP) Capsules is an oral formulation of ribavirin,

a synthetic nucleoside analog with broad-spectrum antiviral activity.

Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C

in all major world markets through a licensing agreement with ICN

Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif.

Schering-Plough is a research-based company engaged in the discovery,

development, manufacturing and marketing of pharmaceutical products worldwide.

(1) Elevated enzyme levels indicating ongoing liver inflammation.

(2) HCV-RNA: hepatitis C viral RNA (ribonucleic acid).

(3) Anti-HCV: antibodies to hepatitis C virus.

SOURCE Schering-Plough Corporation

Web Site: http://www.schering-plough.com

Sharon Nicholson

Hepatitis Education & Patient Coalition (H. E. P. C. in AZ)

Executive Director

<A HREF= " http://www.suite101.com/welcome.cfm/hepatitis_abc " >Hepatitis A, B,

C's - editor Suite101.com</A>

http://www.suite101.com/welcome.cfm/hepatitis_abc

Join our e-group mailing list online!

<A HREF= " ArizonaHepatitis C " >eGroups :

ArizonaHepatitis C</A>

ArizonaHepatitis C

[Guest guest]

Ruth, As far as I know here in the USA, it has not been released for us. I

talked to my Dr. today and asked him the same ? If anyone knows, please let

us know. Also I heard a weird thing, actually read it. That Ribivirin is

RADIOACTIVE! Wouldn't that be like radiation? Can someone help me on this

please. Janet xoxoxo Ps. Best to you Ruth!

[Guest guest]

Ruth, I also have more problems now than before combo... it was good just to

get a confirmation that that can happen though I am sorry for you and your

husband. What problems does he have as a result of treatment? I have

extremely sensitive skin and emotional agitation...

Always, Mesa

>From: " Ruth White " <rwhite@...>

>Reply-Hepatitis Cegroups

><Hepatitis Cegroups>

>Subject: Re: PEG

>Date: Tue, 10 Oct 2000 09:50:15 -0500

>

>Thanks for your reply Janet. As far as the Ribavirin being radioactive, I

>wouldn't be a bit surprised. I don't have much faith in doctors lately. My

>husband did the combo and has more problems now that he had before.

>Anxiously await the outcome of the PEG trials. Take care. Ruth

>

> >>> jlyjan@... 10/09/00 03:32PM >>>

>Ruth, As far as I know here in the USA, it has not been released for us. I

>talked to my Dr. today and asked him the same ? If anyone knows, please let

>us know. Also I heard a weird thing, actually read it. That Ribivirin is

>RADIOACTIVE! Wouldn't that be like radiation? Can someone help me on this

>please. Janet xoxoxo Ps. Best to you Ruth!

>

>

>

>

>

>

_________________________________________________________________________

Get Your Private, Free E-mail from MSN Hotmail at http://www.hotmail.com.

Share information about yourself, create your own public profile at

http://profiles.msn.com.

[Guest guest]

Thanks for your reply Janet. As far as the Ribavirin being radioactive, I

wouldn't be a bit surprised. I don't have much faith in doctors lately. My

husband did the combo and has more problems now that he had before. Anxiously

await the outcome of the PEG trials. Take care. Ruth

>>> jlyjan@... 10/09/00 03:32PM >>>

Ruth, As far as I know here in the USA, it has not been released for us. I

talked to my Dr. today and asked him the same ? If anyone knows, please let

us know. Also I heard a weird thing, actually read it. That Ribivirin is

RADIOACTIVE! Wouldn't that be like radiation? Can someone help me on this

please. Janet xoxoxo Ps. Best to you Ruth!

[Guest guest]

He had extremely sensitive skin before doing the combo because he also has a

medical condition called PCT (Porphyria Cutanea Tarda) which in short means

sensitive to the sun, it's also a liver/blood disorder. The combo aggravated

this previous condition making his skin blister and sensitive, it's getting a

little better now as long as he gets phlebotomized every 4 months, keeping his

iron levels down. He also developed a rash that won't go away as a result of

the combo and has a hard time remembering things. He also has a short fuse,

very little patience. Such fun.

>>> wintermesa@... 10/10/00 02:38PM >>>

Ruth, I also have more problems now than before combo... it was good just to

get a confirmation that that can happen though I am sorry for you and your

husband. What problems does he have as a result of treatment? I have

extremely sensitive skin and emotional agitation...

Always, Mesa

>From: " Ruth White " <rwhite@...>

>Reply-Hepatitis Cegroups

><Hepatitis Cegroups>

>Subject: Re: PEG

>Date: Tue, 10 Oct 2000 09:50:15 -0500

>

>Thanks for your reply Janet. As far as the Ribavirin being radioactive, I

>wouldn't be a bit surprised. I don't have much faith in doctors lately. My

>husband did the combo and has more problems now that he had before.

>Anxiously await the outcome of the PEG trials. Take care. Ruth

>

> >>> jlyjan@... 10/09/00 03:32PM >>>

>Ruth, As far as I know here in the USA, it has not been released for us. I

>talked to my Dr. today and asked him the same ? If anyone knows, please let

>us know. Also I heard a weird thing, actually read it. That Ribivirin is

>RADIOACTIVE! Wouldn't that be like radiation? Can someone help me on this

>please. Janet xoxoxo Ps. Best to you Ruth!

>

>

>

>

>

>

_________________________________________________________________________

Get Your Private, Free E-mail from MSN Hotmail at http://www.hotmail.com.

Share information about yourself, create your own public profile at

http://profiles.msn.com.

[Guest guest]

HI.....

When you all talk about the " combo " treatment, what exactly is that? I have

just now gone to a GI Dr. that is talking about some kind of new treatment he

wants me to try. I think he mentioned the word 'combo' but I can't remember

exactly what he called it. It was where I would go to his office once a week

to get an injection, for 3-6 months. Can anyone offer any info on this? He

was shocked that my Drs. have known of my HepC for over 4 yrs, and had not

referred me to a specialist.

Thanks for any help.....

Sherry from NC

[Guest guest]

At 03:19 PM 10/10/2000 -0500, you wrote:

> He also developed a rash that won't go away as a

>result of the combo and has a hard time remembering things. He also has a

>short fuse, very little patience. Such fun.

>

Right there with you, Ruth and Mesa. My husband's always had extremely dry

skin in winter, and this year it's cracking open and bleeding if I don't

slather his back with lotion at least 2-3 times a day. He had some success

with Zoloft for his depression and irritability, but combined with the

taste changes from the combo it completely eliminated his ability to taste

anything. Since he's already lost 30 pounds, this was a problem so he quit

taking the zoloft and is back to snapping my head off if I hesitate when

speaking or answer yes/no questions with too much explanation. It's like he

can't stand the sound of my voice. (He'd become very affectionate again on

the zoloft.) He's been given another prescription to try, but keeps saying

he's not depressed, he can manage it himself. At least his blood work says

his viral load is undetectable -- now if we can just get through 6 more

months without our relationship becoming undetectable . . .

Hepatitis Neighborhood just had a chat on anxiety and mood disorders - they

had some technical problems, so there's not as much info as usual but you

can see the transcript in the Town Hall archive. According to the physician

who hosted, the depression is caused by the combo's effect on seratonin in

the brain. I hadn't read that before. That's why it's usually treated with

zoloft, paxil or another seratonin uptake inhibitor.

Last night was a chat on side effects, the transcript should be up by

Friday. (I never go to the chats, but I like to read the transcripts.)

Belinda

[Guest guest]

At 09:17 PM 10/10/2000 -0400, you wrote:

>HI.....

>When you all talk about the " combo " treatment, what exactly is that? I have

>just now gone to a GI Dr. that is talking about some kind of new treatment he

>wants me to try. I think he mentioned the word 'combo' but I can't remember

>exactly what he called it. It was where I would go to his office once a week

>to get an injection, for 3-6 months. Can anyone offer any info on this?

Hi Sherry -

Sounds like he might be putting you in a trial for pegalated Interferon and

Ribivirin, although that's usually a 36 or 48 week program.

Right now people taking the Combo (interferon & ribivirin) usually take 3

interferon shots a week, plus ribivirin pills every day. (There are some

studies doing daily shots.) " Pegalated " (and I'm probably misspelling it)

is a time-release process that only requires one shot a week. Peg

interferon is supposed to have FDA approval early next year, but peg plus

ribivirin as a combo is still in clinical trials.

I really, really recommend you go to www.hepatitis-central.com for info on

combo therapy, and talk, talk, talk to your doctor until you're comfortable

with what he's planning. It's a hard course of treatment, you need to know

what to expect (both in terms of how you're going to feel while on it and

what you may or may not gain from it) and YOU need to make an active

decision about whether to do it or not. www.hepatitisneighborhood.com is

another useful site (you have to register). And of course, ask lots of

questions here - there are wonderful, compassionate people on this list and

between us we've accumulated lots of resources.

Wishing you the best, Sherry -

Belinda

[Guest guest]

Thanks Belinda! I know that the Dr. said this treatment was new. He also

mentioned a study he is still conducting in Columbia, SC. Apparently, I was

one of his first " official " patients....the day he saw me was his first day

practicing as a Dr. He told me that he had studied in Columbia, SC and all of

his clinical work has been on the liver. He says he specializes in liver

disorders. I asked a lot about the side effects. He said that in the 70

patients he has been following, one has suffered severe depression (to the

point of being suicidal; but this patient was already on anti-depressants

before starting the treatment), and one lady lost all her hair. He also

mentioned the possibility of flu like symptoms, bone marrow problems, and a

few other things. He told me he was trying to be as up-front about the side

effects as possible. He says that in 65-70 percent of the cases reported,

the virus is undetectable after treatment. Like I said, I am still in the

learning process. It is scary to think of all these possible side effects,

when I am having no problems at the moment. I have never been on any meds,

and have had no ill effects from the HepC as far as I can tell so far.

I will check out those places you mentioned, and I appreciate your help!!

Thanks again......

Sherry from NC

[Guest guest]

Something you all might like to consider participating in. I did.

http://www.hepcchallenge.org/HTML/SURVEY.htm

Re: PEG

> At 09:17 PM 10/10/2000 -0400, you wrote:

> >HI.....

> >When you all talk about the " combo " treatment, what exactly is that? I

have

> >just now gone to a GI Dr. that is talking about some kind of new

treatment he

> >wants me to try. I think he mentioned the word 'combo' but I can't

remember

> >exactly what he called it. It was where I would go to his office once a

week

> >to get an injection, for 3-6 months. Can anyone offer any info on this?

>

> Hi Sherry -

>

> Sounds like he might be putting you in a trial for pegalated Interferon

and

> Ribivirin, although that's usually a 36 or 48 week program.

>

> Right now people taking the Combo (interferon & ribivirin) usually take 3

> interferon shots a week, plus ribivirin pills every day. (There are some

> studies doing daily shots.) " Pegalated " (and I'm probably misspelling it)

> is a time-release process that only requires one shot a week. Peg

> interferon is supposed to have FDA approval early next year, but peg plus

> ribivirin as a combo is still in clinical trials.

>

> I really, really recommend you go to www.hepatitis-central.com for info on

> combo therapy, and talk, talk, talk to your doctor until you're

comfortable

> with what he's planning. It's a hard course of treatment, you need to know

> what to expect (both in terms of how you're going to feel while on it and

> what you may or may not gain from it) and YOU need to make an active

> decision about whether to do it or not. www.hepatitisneighborhood.com is

> another useful site (you have to register). And of course, ask lots of

> questions here - there are wonderful, compassionate people on this list

and

> between us we've accumulated lots of resources.

>

> Wishing you the best, Sherry -

>

> Belinda

>

>

>

>

[Guest guest]

<<<<<I'm thinking about, first seeing if I can find other AS families in the

area that are interested, and then purchasing a set of social skills

curriculum to use at our meetings. I also need to check around and see if I

can find a place where we can hold our meetings (our place is pretty small

and cramped). >>>

Nothing like a Borg Mom in action!

Good luck ,Peg!!

F