Facing Off: PEG-Intron by Schering, Pegasys by Hoffmann LaRoche

[Guest guest]

For the first time ever, the two most sought-after therapies for hepatitis

will square off in a large clinical study, pharmaceutical manufacturer

Schering-Plough announced in September.

Facing Off

PEG-Intron (peginterferon alfa-2b), made by Schering, will be directly

compared with the newest therapy to hit the market, Pegasys (peginterferon

alfa-2a), which was granted FDA approval just last year. Pegasys is

manufactured by Hoffmann LaRoche pharmaceuticals of Nutley, New Jersey.

" The study is just being started, and we would anticipate that it would take

2 to 3 years for the study to be completed, " Schering spokesman

Consalvo told Priority Healthcare.

Roche had little comment about the planned trial. " It's difficult for us to

comment on the study itself because we don't, at this point, know very much

about the protocol design, " said spokeswoman Pamela Van Houten.

" But, obviously, it will take several years before data will be available on

a head-to-head trial. Until then, physicians and patients need to make

decisions based on the information that they have now, " Van Houten told

Priority Healthcare.

Both therapies are pegylated, meaning they have been chemically altered to

last longer in the body than previous hepatitis therapies.

Schering-Plough Research Institute, the Kenilworth, New Jersey

pharmaceutical's research arm, will conduct the comparative study in

response to requests from both hepatitis specialists and patients around the

country.

" This is a very important study because these two treatment regimens have

never before been directly compared, " said McHutchinson, M.D., medical

director of the liver research division at Duke University Medical Center,

and the study's co-principal investigator. " Findings from previous studies

of PEG-Intron and Pegasys cannot be compared because of differences in study

design, patient populations and other variables. "

The study is being launched not only in response to requests for more direct

comparative data of the two hepatitis medications, but also as part of

Schering's commitment to the FDA to initiate post-marketing research of

PEG-Intron and Rebetol (ribavirin) therapy.

Further, Schering wants to study the effectiveness of Rebetol using

weight-based dosages, which it believes will optimize treatment outcomes

over flat dosing. In the U.S., Rebetol is currently given in flat doses of

800 milligrams (mg) per day, unlike in Europe.

" I think there's been some perception in the marketplace-and we think it's a

misperception-that all things are basically equivalent, whether it's

PEG-Intron or Pegasys, " said Consalvo. " We don't really agree with that. "

" While physicians can't compare the two drugs head-to-head, they can

certainly evaluate them each on their own merits, and we feel that Pegasys

is very strong, " said Roche's Van Houten. " Pegasys is backed by the most

extensive development program ever undertaken in hepatitis C. "

Other PEG-Intron Research

While both medications have been studied exhaustively, this will be the

first time that both will directly face off in a large, multi-center trial.

In a trial comparing the safety and efficacy of PEG-Intron with Intron-A

(interferon alfa-2b), a therapy that has a shorter half-life, doctors in

Germany found that of 1530 patients receiving higher or lower weekly doses

of PEG-Intron versus those given doses each week of Intron-A, those given

the higher doses of PEG-Intron had the highest sustained virologic response

(SVR).1

An SVR is defined as undetectable HCV levels at six months after the end of

48 weeks of treatment. That will be the main measure in the PEG-Intron vs.

Pegasys study, as well.

More specifically, 42 percent of genotype 1 patients in the earlier study

who received the higher dose of PEG-Intron achieved an SVR compared to only

about a third of the patients in the group taking lower doses of PEG-Intron

or Intron-A.

Pegasys Studied Elsewhere

Likewise, doctors at the University of North Carolina launched one of the

key studies testing the effectiveness and safety of Pegasys late last year,

just prior to its approval.2

The researchers recruited 1121 patients to receive either Pegasys and

ribavirin, Pegasys and placebo, or Intron-A over a 48-week treatment

regimen. They found that more than half of the patients in the first group

achieved an SVR at the 6-month follow-up point, compared to those taking

Pegasys alone or Intron-A.

Even more of those with higher viral loads at the start of the study

achieved an SVR after taking the Pegasys/ribavirin combination therapy, the

researchers reported.

Unprecedented 'Statistical Power'

In the planned IDEAL trial, doctors will compare the efficacy and safety of

PEG-Intron and Rebetol (Schering's form of ribavirin), and Pegasys and two

dosages of Copegus (Roche's form of ribavirin) in a group of 2,880 patients

with the genotype 1 strain of the virus.

Genotype 1 is the most common HCV strain, and the most difficult to treat

successfully. Combination therapy can get rid of the virus in about half of

those with this strain, compared to about 80 percent of those with genotypes

2 and 3.3

" The IDEAL trial will include a large number of patients, providing a high

degree of 'statistical power' to determine for the first time differences in

the efficacy and safety of these two therapies, " said Mark Sulkowski, M.D.,

medical director of the Viral Hepatitis Center at s Hopkins University,

and the study's co-principal investigator.

" Patients infected with the hepatitis C virus and their health care

providers want answers to these important questions as they seek the best

available treatment options for the patient's individual circumstances, "

said Sulkowski.

About 100 medical centers around the U.S. will be taking part in the trial,

and will eventually sign up interested patients. Schering said more

information about the study details, as well as information for patients

interested in taking part, will be available in early to mid-November.

Consalvo explained that patients will be able to sign up on the web, in

addition to other ways to enroll.

1. Manns MP et al. Peginterferon alfa-2b plus ribavirin compared with

interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis

C: a randomized trial. Lancet 2001 Sep 22;358(9286):958-65.

2. Fried MW et al. Peginterferon alfa-2a plus ribavirin for chronic

hepatitis C virus infection. N Engl J Med 2002 Sep 26;347(13):975-82.

3. Centers for Disease Control and Prevention. Viral Hepatitis C.

is a long-time health journalist and an editor for Priority

Healthcare. His credits include coverage of health news for the website of

Fox Television's The Health Network, and articles for the New York Post and

other consumer and trade publications.

[Guest guest]

For the first time ever, the two most sought-after therapies for hepatitis

will square off in a large clinical study, pharmaceutical manufacturer

Schering-Plough announced in September.

Facing Off

PEG-Intron (peginterferon alfa-2b), made by Schering, will be directly

compared with the newest therapy to hit the market, Pegasys (peginterferon

alfa-2a), which was granted FDA approval just last year. Pegasys is

manufactured by Hoffmann LaRoche pharmaceuticals of Nutley, New Jersey.

" The study is just being started, and we would anticipate that it would take

2 to 3 years for the study to be completed, " Schering spokesman

Consalvo told Priority Healthcare.

Roche had little comment about the planned trial. " It's difficult for us to

comment on the study itself because we don't, at this point, know very much

about the protocol design, " said spokeswoman Pamela Van Houten.

" But, obviously, it will take several years before data will be available on

a head-to-head trial. Until then, physicians and patients need to make

decisions based on the information that they have now, " Van Houten told

Priority Healthcare.

Both therapies are pegylated, meaning they have been chemically altered to

last longer in the body than previous hepatitis therapies.

Schering-Plough Research Institute, the Kenilworth, New Jersey

pharmaceutical's research arm, will conduct the comparative study in

response to requests from both hepatitis specialists and patients around the

country.

" This is a very important study because these two treatment regimens have

never before been directly compared, " said McHutchinson, M.D., medical

director of the liver research division at Duke University Medical Center,

and the study's co-principal investigator. " Findings from previous studies

of PEG-Intron and Pegasys cannot be compared because of differences in study

design, patient populations and other variables. "

The study is being launched not only in response to requests for more direct

comparative data of the two hepatitis medications, but also as part of

Schering's commitment to the FDA to initiate post-marketing research of

PEG-Intron and Rebetol (ribavirin) therapy.

Further, Schering wants to study the effectiveness of Rebetol using

weight-based dosages, which it believes will optimize treatment outcomes

over flat dosing. In the U.S., Rebetol is currently given in flat doses of

800 milligrams (mg) per day, unlike in Europe.

" I think there's been some perception in the marketplace-and we think it's a

misperception-that all things are basically equivalent, whether it's

PEG-Intron or Pegasys, " said Consalvo. " We don't really agree with that. "

" While physicians can't compare the two drugs head-to-head, they can

certainly evaluate them each on their own merits, and we feel that Pegasys

is very strong, " said Roche's Van Houten. " Pegasys is backed by the most

extensive development program ever undertaken in hepatitis C. "

Other PEG-Intron Research

While both medications have been studied exhaustively, this will be the

first time that both will directly face off in a large, multi-center trial.

In a trial comparing the safety and efficacy of PEG-Intron with Intron-A

(interferon alfa-2b), a therapy that has a shorter half-life, doctors in

Germany found that of 1530 patients receiving higher or lower weekly doses

of PEG-Intron versus those given doses each week of Intron-A, those given

the higher doses of PEG-Intron had the highest sustained virologic response

(SVR).1

An SVR is defined as undetectable HCV levels at six months after the end of

48 weeks of treatment. That will be the main measure in the PEG-Intron vs.

Pegasys study, as well.

More specifically, 42 percent of genotype 1 patients in the earlier study

who received the higher dose of PEG-Intron achieved an SVR compared to only

about a third of the patients in the group taking lower doses of PEG-Intron

or Intron-A.

Pegasys Studied Elsewhere

Likewise, doctors at the University of North Carolina launched one of the

key studies testing the effectiveness and safety of Pegasys late last year,

just prior to its approval.2

The researchers recruited 1121 patients to receive either Pegasys and

ribavirin, Pegasys and placebo, or Intron-A over a 48-week treatment

regimen. They found that more than half of the patients in the first group

achieved an SVR at the 6-month follow-up point, compared to those taking

Pegasys alone or Intron-A.

Even more of those with higher viral loads at the start of the study

achieved an SVR after taking the Pegasys/ribavirin combination therapy, the

researchers reported.

Unprecedented 'Statistical Power'

In the planned IDEAL trial, doctors will compare the efficacy and safety of

PEG-Intron and Rebetol (Schering's form of ribavirin), and Pegasys and two

dosages of Copegus (Roche's form of ribavirin) in a group of 2,880 patients

with the genotype 1 strain of the virus.

Genotype 1 is the most common HCV strain, and the most difficult to treat

successfully. Combination therapy can get rid of the virus in about half of

those with this strain, compared to about 80 percent of those with genotypes

2 and 3.3

" The IDEAL trial will include a large number of patients, providing a high

degree of 'statistical power' to determine for the first time differences in

the efficacy and safety of these two therapies, " said Mark Sulkowski, M.D.,

medical director of the Viral Hepatitis Center at s Hopkins University,

and the study's co-principal investigator.

" Patients infected with the hepatitis C virus and their health care

providers want answers to these important questions as they seek the best

available treatment options for the patient's individual circumstances, "

said Sulkowski.

About 100 medical centers around the U.S. will be taking part in the trial,

and will eventually sign up interested patients. Schering said more

information about the study details, as well as information for patients

interested in taking part, will be available in early to mid-November.

Consalvo explained that patients will be able to sign up on the web, in

addition to other ways to enroll.

1. Manns MP et al. Peginterferon alfa-2b plus ribavirin compared with

interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis

C: a randomized trial. Lancet 2001 Sep 22;358(9286):958-65.

2. Fried MW et al. Peginterferon alfa-2a plus ribavirin for chronic

hepatitis C virus infection. N Engl J Med 2002 Sep 26;347(13):975-82.

3. Centers for Disease Control and Prevention. Viral Hepatitis C.

is a long-time health journalist and an editor for Priority

Healthcare. His credits include coverage of health news for the website of

Fox Television's The Health Network, and articles for the New York Post and

other consumer and trade publications.

[Guest guest]

For the first time ever, the two most sought-after therapies for hepatitis

will square off in a large clinical study, pharmaceutical manufacturer

Schering-Plough announced in September.

Facing Off

PEG-Intron (peginterferon alfa-2b), made by Schering, will be directly

compared with the newest therapy to hit the market, Pegasys (peginterferon

alfa-2a), which was granted FDA approval just last year. Pegasys is

manufactured by Hoffmann LaRoche pharmaceuticals of Nutley, New Jersey.

" The study is just being started, and we would anticipate that it would take

2 to 3 years for the study to be completed, " Schering spokesman

Consalvo told Priority Healthcare.

Roche had little comment about the planned trial. " It's difficult for us to

comment on the study itself because we don't, at this point, know very much

about the protocol design, " said spokeswoman Pamela Van Houten.

" But, obviously, it will take several years before data will be available on

a head-to-head trial. Until then, physicians and patients need to make

decisions based on the information that they have now, " Van Houten told

Priority Healthcare.

Both therapies are pegylated, meaning they have been chemically altered to

last longer in the body than previous hepatitis therapies.

Schering-Plough Research Institute, the Kenilworth, New Jersey

pharmaceutical's research arm, will conduct the comparative study in

response to requests from both hepatitis specialists and patients around the

country.

" This is a very important study because these two treatment regimens have

never before been directly compared, " said McHutchinson, M.D., medical

director of the liver research division at Duke University Medical Center,

and the study's co-principal investigator. " Findings from previous studies

of PEG-Intron and Pegasys cannot be compared because of differences in study

design, patient populations and other variables. "

The study is being launched not only in response to requests for more direct

comparative data of the two hepatitis medications, but also as part of

Schering's commitment to the FDA to initiate post-marketing research of

PEG-Intron and Rebetol (ribavirin) therapy.

Further, Schering wants to study the effectiveness of Rebetol using

weight-based dosages, which it believes will optimize treatment outcomes

over flat dosing. In the U.S., Rebetol is currently given in flat doses of

800 milligrams (mg) per day, unlike in Europe.

" I think there's been some perception in the marketplace-and we think it's a

misperception-that all things are basically equivalent, whether it's

PEG-Intron or Pegasys, " said Consalvo. " We don't really agree with that. "

" While physicians can't compare the two drugs head-to-head, they can

certainly evaluate them each on their own merits, and we feel that Pegasys

is very strong, " said Roche's Van Houten. " Pegasys is backed by the most

extensive development program ever undertaken in hepatitis C. "

Other PEG-Intron Research

While both medications have been studied exhaustively, this will be the

first time that both will directly face off in a large, multi-center trial.

In a trial comparing the safety and efficacy of PEG-Intron with Intron-A

(interferon alfa-2b), a therapy that has a shorter half-life, doctors in

Germany found that of 1530 patients receiving higher or lower weekly doses

of PEG-Intron versus those given doses each week of Intron-A, those given

the higher doses of PEG-Intron had the highest sustained virologic response

(SVR).1

An SVR is defined as undetectable HCV levels at six months after the end of

48 weeks of treatment. That will be the main measure in the PEG-Intron vs.

Pegasys study, as well.

More specifically, 42 percent of genotype 1 patients in the earlier study

who received the higher dose of PEG-Intron achieved an SVR compared to only

about a third of the patients in the group taking lower doses of PEG-Intron

or Intron-A.

Pegasys Studied Elsewhere

Likewise, doctors at the University of North Carolina launched one of the

key studies testing the effectiveness and safety of Pegasys late last year,

just prior to its approval.2

The researchers recruited 1121 patients to receive either Pegasys and

ribavirin, Pegasys and placebo, or Intron-A over a 48-week treatment

regimen. They found that more than half of the patients in the first group

achieved an SVR at the 6-month follow-up point, compared to those taking

Pegasys alone or Intron-A.

Even more of those with higher viral loads at the start of the study

achieved an SVR after taking the Pegasys/ribavirin combination therapy, the

researchers reported.

Unprecedented 'Statistical Power'

In the planned IDEAL trial, doctors will compare the efficacy and safety of

PEG-Intron and Rebetol (Schering's form of ribavirin), and Pegasys and two

dosages of Copegus (Roche's form of ribavirin) in a group of 2,880 patients

with the genotype 1 strain of the virus.

Genotype 1 is the most common HCV strain, and the most difficult to treat

successfully. Combination therapy can get rid of the virus in about half of

those with this strain, compared to about 80 percent of those with genotypes

2 and 3.3

" The IDEAL trial will include a large number of patients, providing a high

degree of 'statistical power' to determine for the first time differences in

the efficacy and safety of these two therapies, " said Mark Sulkowski, M.D.,

medical director of the Viral Hepatitis Center at s Hopkins University,

and the study's co-principal investigator.

" Patients infected with the hepatitis C virus and their health care

providers want answers to these important questions as they seek the best

available treatment options for the patient's individual circumstances, "

said Sulkowski.

About 100 medical centers around the U.S. will be taking part in the trial,

and will eventually sign up interested patients. Schering said more

information about the study details, as well as information for patients

interested in taking part, will be available in early to mid-November.

Consalvo explained that patients will be able to sign up on the web, in

addition to other ways to enroll.

1. Manns MP et al. Peginterferon alfa-2b plus ribavirin compared with

interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis

C: a randomized trial. Lancet 2001 Sep 22;358(9286):958-65.

2. Fried MW et al. Peginterferon alfa-2a plus ribavirin for chronic

hepatitis C virus infection. N Engl J Med 2002 Sep 26;347(13):975-82.

3. Centers for Disease Control and Prevention. Viral Hepatitis C.

is a long-time health journalist and an editor for Priority

Healthcare. His credits include coverage of health news for the website of

Fox Television's The Health Network, and articles for the New York Post and

other consumer and trade publications.

[Guest guest]

For the first time ever, the two most sought-after therapies for hepatitis

will square off in a large clinical study, pharmaceutical manufacturer

Schering-Plough announced in September.

Facing Off

PEG-Intron (peginterferon alfa-2b), made by Schering, will be directly

compared with the newest therapy to hit the market, Pegasys (peginterferon

alfa-2a), which was granted FDA approval just last year. Pegasys is

manufactured by Hoffmann LaRoche pharmaceuticals of Nutley, New Jersey.

" The study is just being started, and we would anticipate that it would take

2 to 3 years for the study to be completed, " Schering spokesman

Consalvo told Priority Healthcare.

Roche had little comment about the planned trial. " It's difficult for us to

comment on the study itself because we don't, at this point, know very much

about the protocol design, " said spokeswoman Pamela Van Houten.

" But, obviously, it will take several years before data will be available on

a head-to-head trial. Until then, physicians and patients need to make

decisions based on the information that they have now, " Van Houten told

Priority Healthcare.

Both therapies are pegylated, meaning they have been chemically altered to

last longer in the body than previous hepatitis therapies.

Schering-Plough Research Institute, the Kenilworth, New Jersey

pharmaceutical's research arm, will conduct the comparative study in

response to requests from both hepatitis specialists and patients around the

country.

" This is a very important study because these two treatment regimens have

never before been directly compared, " said McHutchinson, M.D., medical

director of the liver research division at Duke University Medical Center,

and the study's co-principal investigator. " Findings from previous studies

of PEG-Intron and Pegasys cannot be compared because of differences in study

design, patient populations and other variables. "

The study is being launched not only in response to requests for more direct

comparative data of the two hepatitis medications, but also as part of

Schering's commitment to the FDA to initiate post-marketing research of

PEG-Intron and Rebetol (ribavirin) therapy.

Further, Schering wants to study the effectiveness of Rebetol using

weight-based dosages, which it believes will optimize treatment outcomes

over flat dosing. In the U.S., Rebetol is currently given in flat doses of

800 milligrams (mg) per day, unlike in Europe.

" I think there's been some perception in the marketplace-and we think it's a

misperception-that all things are basically equivalent, whether it's

PEG-Intron or Pegasys, " said Consalvo. " We don't really agree with that. "

" While physicians can't compare the two drugs head-to-head, they can

certainly evaluate them each on their own merits, and we feel that Pegasys

is very strong, " said Roche's Van Houten. " Pegasys is backed by the most

extensive development program ever undertaken in hepatitis C. "

Other PEG-Intron Research

While both medications have been studied exhaustively, this will be the

first time that both will directly face off in a large, multi-center trial.

In a trial comparing the safety and efficacy of PEG-Intron with Intron-A

(interferon alfa-2b), a therapy that has a shorter half-life, doctors in

Germany found that of 1530 patients receiving higher or lower weekly doses

of PEG-Intron versus those given doses each week of Intron-A, those given

the higher doses of PEG-Intron had the highest sustained virologic response

(SVR).1

An SVR is defined as undetectable HCV levels at six months after the end of

48 weeks of treatment. That will be the main measure in the PEG-Intron vs.

Pegasys study, as well.

More specifically, 42 percent of genotype 1 patients in the earlier study

who received the higher dose of PEG-Intron achieved an SVR compared to only

about a third of the patients in the group taking lower doses of PEG-Intron

or Intron-A.

Pegasys Studied Elsewhere

Likewise, doctors at the University of North Carolina launched one of the

key studies testing the effectiveness and safety of Pegasys late last year,

just prior to its approval.2

The researchers recruited 1121 patients to receive either Pegasys and

ribavirin, Pegasys and placebo, or Intron-A over a 48-week treatment

regimen. They found that more than half of the patients in the first group

achieved an SVR at the 6-month follow-up point, compared to those taking

Pegasys alone or Intron-A.

Even more of those with higher viral loads at the start of the study

achieved an SVR after taking the Pegasys/ribavirin combination therapy, the

researchers reported.

Unprecedented 'Statistical Power'

In the planned IDEAL trial, doctors will compare the efficacy and safety of

PEG-Intron and Rebetol (Schering's form of ribavirin), and Pegasys and two

dosages of Copegus (Roche's form of ribavirin) in a group of 2,880 patients

with the genotype 1 strain of the virus.

Genotype 1 is the most common HCV strain, and the most difficult to treat

successfully. Combination therapy can get rid of the virus in about half of

those with this strain, compared to about 80 percent of those with genotypes

2 and 3.3

" The IDEAL trial will include a large number of patients, providing a high

degree of 'statistical power' to determine for the first time differences in

the efficacy and safety of these two therapies, " said Mark Sulkowski, M.D.,

medical director of the Viral Hepatitis Center at s Hopkins University,

and the study's co-principal investigator.

" Patients infected with the hepatitis C virus and their health care

providers want answers to these important questions as they seek the best

available treatment options for the patient's individual circumstances, "

said Sulkowski.

About 100 medical centers around the U.S. will be taking part in the trial,

and will eventually sign up interested patients. Schering said more

information about the study details, as well as information for patients

interested in taking part, will be available in early to mid-November.

Consalvo explained that patients will be able to sign up on the web, in

addition to other ways to enroll.

1. Manns MP et al. Peginterferon alfa-2b plus ribavirin compared with

interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis

C: a randomized trial. Lancet 2001 Sep 22;358(9286):958-65.

2. Fried MW et al. Peginterferon alfa-2a plus ribavirin for chronic

hepatitis C virus infection. N Engl J Med 2002 Sep 26;347(13):975-82.

3. Centers for Disease Control and Prevention. Viral Hepatitis C.

is a long-time health journalist and an editor for Priority

Healthcare. His credits include coverage of health news for the website of

Fox Television's The Health Network, and articles for the New York Post and

other consumer and trade publications.