Roche Announces First Major Study to Examine Efficacy of Hepatitis C Treatment in Latinos

[Guest guest]

Roche Announces First Major Study to Examine Efficacy of Hepatitis C

Treatment in Latinos

Information on Pegasys® study sites available through 1-800-526-6367

NUTLEY, N.J., Nov. 22 /PRNewswire/ -- Roche today announced that the

company will conduct the largest study to date comparing hepatitis C

treatment

response rates in Latinos and Non-Latino Caucasians with Pegasys®

(peginterferon alfa-2a) plus Copegus® (ribavirin, USP), the most

prescribed

hepatitis C combination treatment in the United States.

Hepatitis C, a blood-borne infectious disease of the liver, can lead to

cirrhosis, liver failure, and liver cancer. Latinos are disproportionately

affected by hepatitis C; 2.1 percent of all Latinos, compared to 1.5 percent

of all Non-Latino Caucasians have the disease. In addition, recent studies

have presented evidence that hepatitis C may progress faster to cirrhosis

and

liver failure in Latinos compared to Non-Latino Caucasians and African

Americans.

" According to the most recent U.S. census figures, more than 13 percent

of

the U.S. population is Latino. Yet, Latinos have been underrepresented in

clinical trials. Roche made a decision to conduct this study because we

believe that it will answer several important questions about hepatitis C in

Latinos, " said Salvatore Badalamenti, M.D., Medical Director, Roche.

The Latino study, which began enrolling in September 2004, will compare

response rates to Pegasys combination therapy in Latino patients and Non-

Latino Caucasian patients. Previous studies with pegylated interferon

combination therapy for chronic hepatitis C have shown that African

Americans

are less likely to respond to treatment than Caucasians. This study is

designed to determine if differences in response rates exist between Latinos

and Non-Latino Caucasians.

" This is a very exciting study for the Latino community and we commend

Roche for investing in this innovative study, " said Debbie Delgado Vega,

Founder/CEO of the Latino Organization for Liver Awareness. " We know

Latinos

are more likely to be impacted by hepatitis C and soon we will be able to

answer the question of whether or not Latinos can expect the same results

from

hepatitis C therapy as non-Latinos, "

The Latino study will enroll approximately 540 patients; 270 Latinos and

270 Non-Latino Caucasians. The study will include 45 trial sites throughout

the U.S. and Puerto Rico. Eligible patients for the Latino group will

include

those who are either from, or descendants of those from, Spanish-speaking

countries in North, South and Central America.

All patients must be interferon-naove and over 18 years of age. They

will

receive 180 mcg subcutaneously of Pegasys, once weekly, along with either

1000

or 1200 mg/day of Copegus, depending on their weight, for 48 weeks, with 24

weeks of treatment-free follow-up.

For more information about this trial and to locate a study site call

1-800-526-6367.

About Pegasys

Pegasys, a pegylated alpha interferon, and Copegus, an oral antiviral,

were approved by the FDA in December 2002 for use in combination for the

treatment of adults with chronic hepatitis C who have compensated liver

disease and have not previously been treated with interferon alpha.

Patients

in whom efficacy was demonstrated included patients with compensated liver

disease and histological evidence of cirrhosis.

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 web site at: http://www.rocheusa.com

Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus

Indication

* Pegasys®, a pegylated alpha interferon, alone or in combination

with

Copegus® (ribavirin, USP) is indicated for the treatment of adults

with chronic hepatitis C who have compensated liver disease and have

not previously been treated with alpha interferon. Patients in whom

efficacy was demonstrated included patients with compensated liver

disease and histological evidence of cirrhosis (Child-Pugh class A).

Dosing and Administration

* Pegasys, a premixed solution, is dosed at 180mcg as a subcutaneous

injection once a week. Copegus, available as a 200mg tablet, is

administered at 800 to 1200mg taken twice daily as a split dose. The

two products are sold separately.

Combination Therapy Clinical Studies

* The two combination therapy pivotal study findings:

* Study 5, including 1,284 patients receiving medication, showed that

patients with certain genotypes (strains) of the hepatitis C virus

should be treated with different dosing regimens of Pegasys and

Copegus. The treatment regimens and resulting sustained

virological

response rates for these groups treated with Pegasys and Copegus

therapy were:

-- Genotype 1: 48 week duration with 1000 - 1200mg Copegus:

51

percent

-- Genotype non-1: 24 week duration with 800mg Copegus: 82

percent

* Study 4, published in the September 26, 2002 New England Journal of

Medicine, including 1,121 patients receiving medication, showed that

Pegasys and Copegus combination therapy is a more effective treatment

for chronic hepatitis C than interferon alfa-2b and ribavirin. The

sustained virological response rate in the Pegasys and Copegus

treated

patients was 53 percent compared to 44 percent in the interferon

alfa-

2b and ribavirin group. Sustained virological response refers to a

patient's continued undetectable serum hepatitis C RNA levels 24

weeks

after finishing a course of treatment.

Adverse Events

* Alpha interferons, including Pegasys, may cause or aggravate fatal or

life-threatening neuropsychiatric, autoimmune, ischemic, and

infectious

disorders. Patients should be monitored closely with periodic

clinical

and laboratory evaluations. Therapy should be withdrawn in patients

with persistently severe or worsening signs or symptoms of these

conditions. In many, but not all cases, these disorders resolve

after

stopping Pegasys therapy (see CONTRAINDICATIONS, WARNINGS,

PRECAUTIONS

and ADVERSE EVENTS in complete product information).

* Use with Ribavirin. Ribavirin, including Copegus may cause birth

defects and/or death of the fetus. Extreme care must be taken to

avoid

pregnancy in female patients and in female partners of male patients.

Ribavirin causes hemolytic anemia. The anemia associated with

ribavirin therapy may result in worsening of cardiac disease.

Ribavirin is genotoxic, mutagenic, and should be considered a

potential

carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE

EVENTS in complete product information).

* Pegasys is contraindicated in patients with hypersensitivity to

Pegasys

or any of its components, autoimmune hepatitis, and decompensated

hepatic disease (Child-Pugh class B and C) before or during treatment

with Pegasys. Pegasys is also contraindicated in neonates and

infants

because it contains benzyl alcohol. Benzyl alcohol has been reported

to be associated with an increased incidence of neurological and

other

complications in neonates and infants, which are sometimes fatal.

Pegasys and Copegus therapy is additionally contraindicated in

patients

with a hypersensitivity to Copegus or any of its components, women

who

are pregnant, men whose female partners are pregnant, and patients

with

hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).

* COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE

PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF

THERAPY. Women of childbearing potential and men must use two forms

of

effective contraception during treatment and during the six months

after treatment has concluded. Routine monthly pregnancy test must

be

performed during this time. If pregnancy should occur during

treatment

or during six months post-therapy, the patient must be advised of the

significant teratogenic risk of Copegus therapy to the fetus.

Healthcare providers and patients are strongly encouraged to

immediately report any pregnancy in a patient or partner of a patient

during treatment or during 6 months after treatment cessation to the

Ribavirin Pregnancy Registry at 1-800-593-2214.

* The most common adverse events reported for Pegasys and Copegus

combination therapy, observed in clinical trials (n=451), were

fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%),

irritability/anxiety/nervousness (33%), insomnia (30%), alopecia

(28%),

neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia

(24%),

injection site reaction (23%), arthralgia (22%), depression (20%),

pruritus (19%) and dermatitis (16%).

* Serious adverse events include neuropsychiatric disorders (suicidal

ideation and suicide attempt), serious and severe bacterial

infections,

bone marrow toxicity (cytopenia and rarely, aplastic anemia),

cardiovascular disorders (hypertension, arrhythmias and myocardial

infarction), hypersensitivity (including anaphylaxis), endocrine

disorders (including thyroid disorders and diabetes mellitus),

autoimmune disorders (including psoriasis and lupus), pulmonary

disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial

pneumonitis and sarcoidosis), colitis (ulcerative and

hemorrhagic/ischemiccolitis), pancreatitis, and opthalmologic

disorders

(decrease or loss of vision, retinopathy including macular edema and

retinal thrombosis/hemorrhages, optic neuritis and papilledema).

* The complete package inserts for Pegasys and Copegus are available at

http://www.pegasys.com, or by calling 1-877-PEGASYS.

SOURCE Roche

Web Site: http://www.rocheusa.com http://www.pegasys.com

[Guest guest]

Roche Announces First Major Study to Examine Efficacy of Hepatitis C

Treatment in Latinos

Information on Pegasys® study sites available through 1-800-526-6367

NUTLEY, N.J., Nov. 22 /PRNewswire/ -- Roche today announced that the

company will conduct the largest study to date comparing hepatitis C

treatment

response rates in Latinos and Non-Latino Caucasians with Pegasys®

(peginterferon alfa-2a) plus Copegus® (ribavirin, USP), the most

prescribed

hepatitis C combination treatment in the United States.

Hepatitis C, a blood-borne infectious disease of the liver, can lead to

cirrhosis, liver failure, and liver cancer. Latinos are disproportionately

affected by hepatitis C; 2.1 percent of all Latinos, compared to 1.5 percent

of all Non-Latino Caucasians have the disease. In addition, recent studies

have presented evidence that hepatitis C may progress faster to cirrhosis

and

liver failure in Latinos compared to Non-Latino Caucasians and African

Americans.

" According to the most recent U.S. census figures, more than 13 percent

of

the U.S. population is Latino. Yet, Latinos have been underrepresented in

clinical trials. Roche made a decision to conduct this study because we

believe that it will answer several important questions about hepatitis C in

Latinos, " said Salvatore Badalamenti, M.D., Medical Director, Roche.

The Latino study, which began enrolling in September 2004, will compare

response rates to Pegasys combination therapy in Latino patients and Non-

Latino Caucasian patients. Previous studies with pegylated interferon

combination therapy for chronic hepatitis C have shown that African

Americans

are less likely to respond to treatment than Caucasians. This study is

designed to determine if differences in response rates exist between Latinos

and Non-Latino Caucasians.

" This is a very exciting study for the Latino community and we commend

Roche for investing in this innovative study, " said Debbie Delgado Vega,

Founder/CEO of the Latino Organization for Liver Awareness. " We know

Latinos

are more likely to be impacted by hepatitis C and soon we will be able to

answer the question of whether or not Latinos can expect the same results

from

hepatitis C therapy as non-Latinos, "

The Latino study will enroll approximately 540 patients; 270 Latinos and

270 Non-Latino Caucasians. The study will include 45 trial sites throughout

the U.S. and Puerto Rico. Eligible patients for the Latino group will

include

those who are either from, or descendants of those from, Spanish-speaking

countries in North, South and Central America.

All patients must be interferon-naove and over 18 years of age. They

will

receive 180 mcg subcutaneously of Pegasys, once weekly, along with either

1000

or 1200 mg/day of Copegus, depending on their weight, for 48 weeks, with 24

weeks of treatment-free follow-up.

For more information about this trial and to locate a study site call

1-800-526-6367.

About Pegasys

Pegasys, a pegylated alpha interferon, and Copegus, an oral antiviral,

were approved by the FDA in December 2002 for use in combination for the

treatment of adults with chronic hepatitis C who have compensated liver

disease and have not previously been treated with interferon alpha.

Patients

in whom efficacy was demonstrated included patients with compensated liver

disease and histological evidence of cirrhosis.

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 web site at: http://www.rocheusa.com

Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus

Indication

* Pegasys®, a pegylated alpha interferon, alone or in combination

with

Copegus® (ribavirin, USP) is indicated for the treatment of adults

with chronic hepatitis C who have compensated liver disease and have

not previously been treated with alpha interferon. Patients in whom

efficacy was demonstrated included patients with compensated liver

disease and histological evidence of cirrhosis (Child-Pugh class A).

Dosing and Administration

* Pegasys, a premixed solution, is dosed at 180mcg as a subcutaneous

injection once a week. Copegus, available as a 200mg tablet, is

administered at 800 to 1200mg taken twice daily as a split dose. The

two products are sold separately.

Combination Therapy Clinical Studies

* The two combination therapy pivotal study findings:

* Study 5, including 1,284 patients receiving medication, showed that

patients with certain genotypes (strains) of the hepatitis C virus

should be treated with different dosing regimens of Pegasys and

Copegus. The treatment regimens and resulting sustained

virological

response rates for these groups treated with Pegasys and Copegus

therapy were:

-- Genotype 1: 48 week duration with 1000 - 1200mg Copegus:

51

percent

-- Genotype non-1: 24 week duration with 800mg Copegus: 82

percent

* Study 4, published in the September 26, 2002 New England Journal of

Medicine, including 1,121 patients receiving medication, showed that

Pegasys and Copegus combination therapy is a more effective treatment

for chronic hepatitis C than interferon alfa-2b and ribavirin. The

sustained virological response rate in the Pegasys and Copegus

treated

patients was 53 percent compared to 44 percent in the interferon

alfa-

2b and ribavirin group. Sustained virological response refers to a

patient's continued undetectable serum hepatitis C RNA levels 24

weeks

after finishing a course of treatment.

Adverse Events

* Alpha interferons, including Pegasys, may cause or aggravate fatal or

life-threatening neuropsychiatric, autoimmune, ischemic, and

infectious

disorders. Patients should be monitored closely with periodic

clinical

and laboratory evaluations. Therapy should be withdrawn in patients

with persistently severe or worsening signs or symptoms of these

conditions. In many, but not all cases, these disorders resolve

after

stopping Pegasys therapy (see CONTRAINDICATIONS, WARNINGS,

PRECAUTIONS

and ADVERSE EVENTS in complete product information).

* Use with Ribavirin. Ribavirin, including Copegus may cause birth

defects and/or death of the fetus. Extreme care must be taken to

avoid

pregnancy in female patients and in female partners of male patients.

Ribavirin causes hemolytic anemia. The anemia associated with

ribavirin therapy may result in worsening of cardiac disease.

Ribavirin is genotoxic, mutagenic, and should be considered a

potential

carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE

EVENTS in complete product information).

* Pegasys is contraindicated in patients with hypersensitivity to

Pegasys

or any of its components, autoimmune hepatitis, and decompensated

hepatic disease (Child-Pugh class B and C) before or during treatment

with Pegasys. Pegasys is also contraindicated in neonates and

infants

because it contains benzyl alcohol. Benzyl alcohol has been reported

to be associated with an increased incidence of neurological and

other

complications in neonates and infants, which are sometimes fatal.

Pegasys and Copegus therapy is additionally contraindicated in

patients

with a hypersensitivity to Copegus or any of its components, women

who

are pregnant, men whose female partners are pregnant, and patients

with

hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).

* COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE

PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF

THERAPY. Women of childbearing potential and men must use two forms

of

effective contraception during treatment and during the six months

after treatment has concluded. Routine monthly pregnancy test must

be

performed during this time. If pregnancy should occur during

treatment

or during six months post-therapy, the patient must be advised of the

significant teratogenic risk of Copegus therapy to the fetus.

Healthcare providers and patients are strongly encouraged to

immediately report any pregnancy in a patient or partner of a patient

during treatment or during 6 months after treatment cessation to the

Ribavirin Pregnancy Registry at 1-800-593-2214.

* The most common adverse events reported for Pegasys and Copegus

combination therapy, observed in clinical trials (n=451), were

fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%),

irritability/anxiety/nervousness (33%), insomnia (30%), alopecia

(28%),

neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia

(24%),

injection site reaction (23%), arthralgia (22%), depression (20%),

pruritus (19%) and dermatitis (16%).

* Serious adverse events include neuropsychiatric disorders (suicidal

ideation and suicide attempt), serious and severe bacterial

infections,

bone marrow toxicity (cytopenia and rarely, aplastic anemia),

cardiovascular disorders (hypertension, arrhythmias and myocardial

infarction), hypersensitivity (including anaphylaxis), endocrine

disorders (including thyroid disorders and diabetes mellitus),

autoimmune disorders (including psoriasis and lupus), pulmonary

disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial

pneumonitis and sarcoidosis), colitis (ulcerative and

hemorrhagic/ischemiccolitis), pancreatitis, and opthalmologic

disorders

(decrease or loss of vision, retinopathy including macular edema and

retinal thrombosis/hemorrhages, optic neuritis and papilledema).

* The complete package inserts for Pegasys and Copegus are available at

http://www.pegasys.com, or by calling 1-877-PEGASYS.

SOURCE Roche

Web Site: http://www.rocheusa.com http://www.pegasys.com

[Guest guest]

Roche Announces First Major Study to Examine Efficacy of Hepatitis C

Treatment in Latinos

Information on Pegasys® study sites available through 1-800-526-6367

NUTLEY, N.J., Nov. 22 /PRNewswire/ -- Roche today announced that the

company will conduct the largest study to date comparing hepatitis C

treatment

response rates in Latinos and Non-Latino Caucasians with Pegasys®

(peginterferon alfa-2a) plus Copegus® (ribavirin, USP), the most

prescribed

hepatitis C combination treatment in the United States.

Hepatitis C, a blood-borne infectious disease of the liver, can lead to

cirrhosis, liver failure, and liver cancer. Latinos are disproportionately

affected by hepatitis C; 2.1 percent of all Latinos, compared to 1.5 percent

of all Non-Latino Caucasians have the disease. In addition, recent studies

have presented evidence that hepatitis C may progress faster to cirrhosis

and

liver failure in Latinos compared to Non-Latino Caucasians and African

Americans.

" According to the most recent U.S. census figures, more than 13 percent

of

the U.S. population is Latino. Yet, Latinos have been underrepresented in

clinical trials. Roche made a decision to conduct this study because we

believe that it will answer several important questions about hepatitis C in

Latinos, " said Salvatore Badalamenti, M.D., Medical Director, Roche.

The Latino study, which began enrolling in September 2004, will compare

response rates to Pegasys combination therapy in Latino patients and Non-

Latino Caucasian patients. Previous studies with pegylated interferon

combination therapy for chronic hepatitis C have shown that African

Americans

are less likely to respond to treatment than Caucasians. This study is

designed to determine if differences in response rates exist between Latinos

and Non-Latino Caucasians.

" This is a very exciting study for the Latino community and we commend

Roche for investing in this innovative study, " said Debbie Delgado Vega,

Founder/CEO of the Latino Organization for Liver Awareness. " We know

Latinos

are more likely to be impacted by hepatitis C and soon we will be able to

answer the question of whether or not Latinos can expect the same results

from

hepatitis C therapy as non-Latinos, "

The Latino study will enroll approximately 540 patients; 270 Latinos and

270 Non-Latino Caucasians. The study will include 45 trial sites throughout

the U.S. and Puerto Rico. Eligible patients for the Latino group will

include

those who are either from, or descendants of those from, Spanish-speaking

countries in North, South and Central America.

All patients must be interferon-naove and over 18 years of age. They

will

receive 180 mcg subcutaneously of Pegasys, once weekly, along with either

1000

or 1200 mg/day of Copegus, depending on their weight, for 48 weeks, with 24

weeks of treatment-free follow-up.

For more information about this trial and to locate a study site call

1-800-526-6367.

About Pegasys

Pegasys, a pegylated alpha interferon, and Copegus, an oral antiviral,

were approved by the FDA in December 2002 for use in combination for the

treatment of adults with chronic hepatitis C who have compensated liver

disease and have not previously been treated with interferon alpha.

Patients

in whom efficacy was demonstrated included patients with compensated liver

disease and histological evidence of cirrhosis.

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 web site at: http://www.rocheusa.com

Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus

Indication

* Pegasys®, a pegylated alpha interferon, alone or in combination

with

Copegus® (ribavirin, USP) is indicated for the treatment of adults

with chronic hepatitis C who have compensated liver disease and have

not previously been treated with alpha interferon. Patients in whom

efficacy was demonstrated included patients with compensated liver

disease and histological evidence of cirrhosis (Child-Pugh class A).

Dosing and Administration

* Pegasys, a premixed solution, is dosed at 180mcg as a subcutaneous

injection once a week. Copegus, available as a 200mg tablet, is

administered at 800 to 1200mg taken twice daily as a split dose. The

two products are sold separately.

Combination Therapy Clinical Studies

* The two combination therapy pivotal study findings:

* Study 5, including 1,284 patients receiving medication, showed that

patients with certain genotypes (strains) of the hepatitis C virus

should be treated with different dosing regimens of Pegasys and

Copegus. The treatment regimens and resulting sustained

virological

response rates for these groups treated with Pegasys and Copegus

therapy were:

-- Genotype 1: 48 week duration with 1000 - 1200mg Copegus:

51

percent

-- Genotype non-1: 24 week duration with 800mg Copegus: 82

percent

* Study 4, published in the September 26, 2002 New England Journal of

Medicine, including 1,121 patients receiving medication, showed that

Pegasys and Copegus combination therapy is a more effective treatment

for chronic hepatitis C than interferon alfa-2b and ribavirin. The

sustained virological response rate in the Pegasys and Copegus

treated

patients was 53 percent compared to 44 percent in the interferon

alfa-

2b and ribavirin group. Sustained virological response refers to a

patient's continued undetectable serum hepatitis C RNA levels 24

weeks

after finishing a course of treatment.

Adverse Events

* Alpha interferons, including Pegasys, may cause or aggravate fatal or

life-threatening neuropsychiatric, autoimmune, ischemic, and

infectious

disorders. Patients should be monitored closely with periodic

clinical

and laboratory evaluations. Therapy should be withdrawn in patients

with persistently severe or worsening signs or symptoms of these

conditions. In many, but not all cases, these disorders resolve

after

stopping Pegasys therapy (see CONTRAINDICATIONS, WARNINGS,

PRECAUTIONS

and ADVERSE EVENTS in complete product information).

* Use with Ribavirin. Ribavirin, including Copegus may cause birth

defects and/or death of the fetus. Extreme care must be taken to

avoid

pregnancy in female patients and in female partners of male patients.

Ribavirin causes hemolytic anemia. The anemia associated with

ribavirin therapy may result in worsening of cardiac disease.

Ribavirin is genotoxic, mutagenic, and should be considered a

potential

carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE

EVENTS in complete product information).

* Pegasys is contraindicated in patients with hypersensitivity to

Pegasys

or any of its components, autoimmune hepatitis, and decompensated

hepatic disease (Child-Pugh class B and C) before or during treatment

with Pegasys. Pegasys is also contraindicated in neonates and

infants

because it contains benzyl alcohol. Benzyl alcohol has been reported

to be associated with an increased incidence of neurological and

other

complications in neonates and infants, which are sometimes fatal.

Pegasys and Copegus therapy is additionally contraindicated in

patients

with a hypersensitivity to Copegus or any of its components, women

who

are pregnant, men whose female partners are pregnant, and patients

with

hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).

* COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE

PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF

THERAPY. Women of childbearing potential and men must use two forms

of

effective contraception during treatment and during the six months

after treatment has concluded. Routine monthly pregnancy test must

be

performed during this time. If pregnancy should occur during

treatment

or during six months post-therapy, the patient must be advised of the

significant teratogenic risk of Copegus therapy to the fetus.

Healthcare providers and patients are strongly encouraged to

immediately report any pregnancy in a patient or partner of a patient

during treatment or during 6 months after treatment cessation to the

Ribavirin Pregnancy Registry at 1-800-593-2214.

* The most common adverse events reported for Pegasys and Copegus

combination therapy, observed in clinical trials (n=451), were

fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%),

irritability/anxiety/nervousness (33%), insomnia (30%), alopecia

(28%),

neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia

(24%),

injection site reaction (23%), arthralgia (22%), depression (20%),

pruritus (19%) and dermatitis (16%).

* Serious adverse events include neuropsychiatric disorders (suicidal

ideation and suicide attempt), serious and severe bacterial

infections,

bone marrow toxicity (cytopenia and rarely, aplastic anemia),

cardiovascular disorders (hypertension, arrhythmias and myocardial

infarction), hypersensitivity (including anaphylaxis), endocrine

disorders (including thyroid disorders and diabetes mellitus),

autoimmune disorders (including psoriasis and lupus), pulmonary

disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial

pneumonitis and sarcoidosis), colitis (ulcerative and

hemorrhagic/ischemiccolitis), pancreatitis, and opthalmologic

disorders

(decrease or loss of vision, retinopathy including macular edema and

retinal thrombosis/hemorrhages, optic neuritis and papilledema).

* The complete package inserts for Pegasys and Copegus are available at

http://www.pegasys.com, or by calling 1-877-PEGASYS.

SOURCE Roche

Web Site: http://www.rocheusa.com http://www.pegasys.com

[Guest guest]

Roche Announces First Major Study to Examine Efficacy of Hepatitis C

Treatment in Latinos

Information on Pegasys® study sites available through 1-800-526-6367

NUTLEY, N.J., Nov. 22 /PRNewswire/ -- Roche today announced that the

company will conduct the largest study to date comparing hepatitis C

treatment

response rates in Latinos and Non-Latino Caucasians with Pegasys®

(peginterferon alfa-2a) plus Copegus® (ribavirin, USP), the most

prescribed

hepatitis C combination treatment in the United States.

Hepatitis C, a blood-borne infectious disease of the liver, can lead to

cirrhosis, liver failure, and liver cancer. Latinos are disproportionately

affected by hepatitis C; 2.1 percent of all Latinos, compared to 1.5 percent

of all Non-Latino Caucasians have the disease. In addition, recent studies

have presented evidence that hepatitis C may progress faster to cirrhosis

and

liver failure in Latinos compared to Non-Latino Caucasians and African

Americans.

" According to the most recent U.S. census figures, more than 13 percent

of

the U.S. population is Latino. Yet, Latinos have been underrepresented in

clinical trials. Roche made a decision to conduct this study because we

believe that it will answer several important questions about hepatitis C in

Latinos, " said Salvatore Badalamenti, M.D., Medical Director, Roche.

The Latino study, which began enrolling in September 2004, will compare

response rates to Pegasys combination therapy in Latino patients and Non-

Latino Caucasian patients. Previous studies with pegylated interferon

combination therapy for chronic hepatitis C have shown that African

Americans

are less likely to respond to treatment than Caucasians. This study is

designed to determine if differences in response rates exist between Latinos

and Non-Latino Caucasians.

" This is a very exciting study for the Latino community and we commend

Roche for investing in this innovative study, " said Debbie Delgado Vega,

Founder/CEO of the Latino Organization for Liver Awareness. " We know

Latinos

are more likely to be impacted by hepatitis C and soon we will be able to

answer the question of whether or not Latinos can expect the same results

from

hepatitis C therapy as non-Latinos, "

The Latino study will enroll approximately 540 patients; 270 Latinos and

270 Non-Latino Caucasians. The study will include 45 trial sites throughout

the U.S. and Puerto Rico. Eligible patients for the Latino group will

include

those who are either from, or descendants of those from, Spanish-speaking

countries in North, South and Central America.

All patients must be interferon-naove and over 18 years of age. They

will

receive 180 mcg subcutaneously of Pegasys, once weekly, along with either

1000

or 1200 mg/day of Copegus, depending on their weight, for 48 weeks, with 24

weeks of treatment-free follow-up.

For more information about this trial and to locate a study site call

1-800-526-6367.

About Pegasys

Pegasys, a pegylated alpha interferon, and Copegus, an oral antiviral,

were approved by the FDA in December 2002 for use in combination for the

treatment of adults with chronic hepatitis C who have compensated liver

disease and have not previously been treated with interferon alpha.

Patients

in whom efficacy was demonstrated included patients with compensated liver

disease and histological evidence of cirrhosis.

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 web site at: http://www.rocheusa.com

Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus

Indication

* Pegasys®, a pegylated alpha interferon, alone or in combination

with

Copegus® (ribavirin, USP) is indicated for the treatment of adults

with chronic hepatitis C who have compensated liver disease and have

not previously been treated with alpha interferon. Patients in whom

efficacy was demonstrated included patients with compensated liver

disease and histological evidence of cirrhosis (Child-Pugh class A).

Dosing and Administration

* Pegasys, a premixed solution, is dosed at 180mcg as a subcutaneous

injection once a week. Copegus, available as a 200mg tablet, is

administered at 800 to 1200mg taken twice daily as a split dose. The

two products are sold separately.

Combination Therapy Clinical Studies

* The two combination therapy pivotal study findings:

* Study 5, including 1,284 patients receiving medication, showed that

patients with certain genotypes (strains) of the hepatitis C virus

should be treated with different dosing regimens of Pegasys and

Copegus. The treatment regimens and resulting sustained

virological

response rates for these groups treated with Pegasys and Copegus

therapy were:

-- Genotype 1: 48 week duration with 1000 - 1200mg Copegus:

51

percent

-- Genotype non-1: 24 week duration with 800mg Copegus: 82

percent

* Study 4, published in the September 26, 2002 New England Journal of

Medicine, including 1,121 patients receiving medication, showed that

Pegasys and Copegus combination therapy is a more effective treatment

for chronic hepatitis C than interferon alfa-2b and ribavirin. The

sustained virological response rate in the Pegasys and Copegus

treated

patients was 53 percent compared to 44 percent in the interferon

alfa-

2b and ribavirin group. Sustained virological response refers to a

patient's continued undetectable serum hepatitis C RNA levels 24

weeks

after finishing a course of treatment.

Adverse Events

* Alpha interferons, including Pegasys, may cause or aggravate fatal or

life-threatening neuropsychiatric, autoimmune, ischemic, and

infectious

disorders. Patients should be monitored closely with periodic

clinical

and laboratory evaluations. Therapy should be withdrawn in patients

with persistently severe or worsening signs or symptoms of these

conditions. In many, but not all cases, these disorders resolve

after

stopping Pegasys therapy (see CONTRAINDICATIONS, WARNINGS,

PRECAUTIONS

and ADVERSE EVENTS in complete product information).

* Use with Ribavirin. Ribavirin, including Copegus may cause birth

defects and/or death of the fetus. Extreme care must be taken to

avoid

pregnancy in female patients and in female partners of male patients.

Ribavirin causes hemolytic anemia. The anemia associated with

ribavirin therapy may result in worsening of cardiac disease.

Ribavirin is genotoxic, mutagenic, and should be considered a

potential

carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE

EVENTS in complete product information).

* Pegasys is contraindicated in patients with hypersensitivity to

Pegasys

or any of its components, autoimmune hepatitis, and decompensated

hepatic disease (Child-Pugh class B and C) before or during treatment

with Pegasys. Pegasys is also contraindicated in neonates and

infants

because it contains benzyl alcohol. Benzyl alcohol has been reported

to be associated with an increased incidence of neurological and

other

complications in neonates and infants, which are sometimes fatal.

Pegasys and Copegus therapy is additionally contraindicated in

patients

with a hypersensitivity to Copegus or any of its components, women

who

are pregnant, men whose female partners are pregnant, and patients

with

hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).

* COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE

PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF

THERAPY. Women of childbearing potential and men must use two forms

of

effective contraception during treatment and during the six months

after treatment has concluded. Routine monthly pregnancy test must

be

performed during this time. If pregnancy should occur during

treatment

or during six months post-therapy, the patient must be advised of the

significant teratogenic risk of Copegus therapy to the fetus.

Healthcare providers and patients are strongly encouraged to

immediately report any pregnancy in a patient or partner of a patient

during treatment or during 6 months after treatment cessation to the

Ribavirin Pregnancy Registry at 1-800-593-2214.

* The most common adverse events reported for Pegasys and Copegus

combination therapy, observed in clinical trials (n=451), were

fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%),

irritability/anxiety/nervousness (33%), insomnia (30%), alopecia

(28%),

neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia

(24%),

injection site reaction (23%), arthralgia (22%), depression (20%),

pruritus (19%) and dermatitis (16%).

* Serious adverse events include neuropsychiatric disorders (suicidal

ideation and suicide attempt), serious and severe bacterial

infections,

bone marrow toxicity (cytopenia and rarely, aplastic anemia),

cardiovascular disorders (hypertension, arrhythmias and myocardial

infarction), hypersensitivity (including anaphylaxis), endocrine

disorders (including thyroid disorders and diabetes mellitus),

autoimmune disorders (including psoriasis and lupus), pulmonary

disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial

pneumonitis and sarcoidosis), colitis (ulcerative and

hemorrhagic/ischemiccolitis), pancreatitis, and opthalmologic

disorders

(decrease or loss of vision, retinopathy including macular edema and

retinal thrombosis/hemorrhages, optic neuritis and papilledema).

* The complete package inserts for Pegasys and Copegus are available at

http://www.pegasys.com, or by calling 1-877-PEGASYS.

SOURCE Roche

Web Site: http://www.rocheusa.com http://www.pegasys.com