RESEARCHERS IDENTIFY BETTER HEPATITIS C TREATMENT FOR PEOPLE WITH HIV

[Guest guest]

U.S. Department of Health and Human Services

NATIONAL INSTITUTES OF HEALTH

NIH News

National Institute of Allergy and Infectious Diseases

http://www.niaid.nih.gov/

EMBARGOED FOR RELEASE

Wednesday, July 28, 2004

5:00 p.m. ET

CONTACT:

Joy

301-402-1663

ljoy@...

RESEARCHERS IDENTIFY BETTER HEPATITIS C TREATMENT FOR

PEOPLE WITH HIV

The preferred treatment for hepatitis C, peg-interferon and

ribavirin, is safe for people who are also infected with

HIV, according to a new study in the July 29 issue of " The

New England Journal of Medicine " . Moreover, this treatment

proved superior for the treatment of hepatitis C virus

(HCV) in HIV-coinfected persons when compared with the

previously accepted treatment, standard interferon and

ribavirin.

The study compared the effectiveness of two forms of

interferon: a once-weekly dose of peg-interferon and

standard interferon taken three times weekly. Peg-

interferon with ribavirin is currently the approved

treatment for hepatitis C in persons without HIV. Prior to

this study, limited data were available on the benefit and

safety of peg-interferon and ribavirin in HIV-infected

people.

The study was funded by the National Institute of Allergy

and Infectious Diseases (NIAID) and the National Center for

Research Resources (NCRR), both parts of the National

Institutes of Health (NIH). NIAID's Adult AIDS Clinical

Trials Group conducted the study at 21 research centers in

the United States.

" We are pleased to see such a clear and definitive result

from this study, " says NIAID Director S. Fauci,

M.D. " Just a decade ago treatment of HCV in persons

infected with HIV was not a priority because they died from

AIDS before developing serious complications of hepatitis C

infection. As new anti-HIV drug treatments extend the lives

of HIV-positive individuals, studies like this one provide

essential guidance on treating other serious health

problems affecting people living with HIV. "

HCV is primarily spread through infected blood. Most people

with the virus have no signs of illness, but in some the

infection progresses to chronic liver disease, liver

failure or liver cancer. The disease progresses more

rapidly in people who have HIV.

The Centers for Disease Control and Prevention (CDC)

estimate that HCV infects about 25,000 Americans annually

and is responsible for about 8,000 to 10,000 deaths per

year. About 3.9 million Americans have been infected with

HCV, 2.7 million of whom are chronically infected,

according to the CDC. It is also estimated that of the 1

million HIV-infected Americans, about 300,000 are also

infected with HCV.

" We carefully monitored the study volunteers for side

effects. Most tolerated the treatments well, and relatively

few discontinued therapy prematurely. We were also

encouraged that HIV infection remained under control during

the study, " says T. Chung, M.D., lead investigator

and director of the Center for Liver Disorders in the

Gastrointestinal Unit at Massachusetts General Hospital.

The 133 HIV-positive study volunteers were randomly

assigned to take peg-interferon or interferon for 48 weeks.

All study volunteers also took ribavirin, an antiviral drug

that is also part of standard therapy for hepatitis C.

Study volunteers who completed the treatments - 16 withdrew

early for various reasons - were followed for 24 more weeks

to evaluate long term treatment success.

In the group that took peg-interferon, 27 percent of

patients had no detectable HCV in their blood 24 weeks

after completing treatment (sustained response). In

contrast, of those who took interferon, only 12 percent had

a sustained response. Importantly, more than one third of

those volunteers who failed to clear HCV appeared to

experience improvement in their liver biopsies, suggesting

the treatment was beneficial in this group as well.

Researchers also found that the volunteers whose HCV levels

failed to fall substantially within the first 12 weeks

never experienced a sustained response.

Roche Laboratories provided study medications and

participated in the protocol team.

NCRR supported this research through its General Clinical

Research Center Program with grants to University of

Rochester, NY; University of North Carolina, Chapel Hill;

and New York University. NCRR provides NIH-supported

investigators with access to specialized basic and clinical

research facilities, technologies, instrumentation,

biomaterials, animal models, genetic stocks and more.

NIAID is a component of the National Institutes of Health,

an agency of the U.S. Department of Health and Human

Services. NIAID supports basic and applied research to

prevent, diagnose and treat infectious diseases such as

HIV/AIDS and other sexually transmitted infections,

influenza, tuberculosis, malaria and illness from potential

agents of bioterrorism. NIAID also supports research on

transplantation and immune-related illnesses, including

autoimmune disorders, asthma and allergies. Press releases,

fact sheets and other NIAID-related materials are available

on the NIAID Web site at <http://www.niaid.nih.gov>.

--------------------------------------------------

REFERENCE: R.T. Chung et al. A randomized controlled trial

of PEG-interferon alfa-2a plus ribavirin vs. interferon

alfa-2a plus ribavirin for chronic hepatitis C virus

infection in HIV-co-infected persons: the U.S. AIDS

Clinical Trials Group A5071 study team. " The New England

Journal of Medicine " 351(5):451-459 (2004).

##

This NIH News Release is available online at:

http://www.nih.gov/news/pr/jul2004/niaid-28.htm

To subscribe (or unsubscribe) from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.

[Guest guest]

U.S. Department of Health and Human Services

NATIONAL INSTITUTES OF HEALTH

NIH News

National Institute of Allergy and Infectious Diseases

http://www.niaid.nih.gov/

EMBARGOED FOR RELEASE

Wednesday, July 28, 2004

5:00 p.m. ET

CONTACT:

Joy

301-402-1663

ljoy@...

RESEARCHERS IDENTIFY BETTER HEPATITIS C TREATMENT FOR

PEOPLE WITH HIV

The preferred treatment for hepatitis C, peg-interferon and

ribavirin, is safe for people who are also infected with

HIV, according to a new study in the July 29 issue of " The

New England Journal of Medicine " . Moreover, this treatment

proved superior for the treatment of hepatitis C virus

(HCV) in HIV-coinfected persons when compared with the

previously accepted treatment, standard interferon and

ribavirin.

The study compared the effectiveness of two forms of

interferon: a once-weekly dose of peg-interferon and

standard interferon taken three times weekly. Peg-

interferon with ribavirin is currently the approved

treatment for hepatitis C in persons without HIV. Prior to

this study, limited data were available on the benefit and

safety of peg-interferon and ribavirin in HIV-infected

people.

The study was funded by the National Institute of Allergy

and Infectious Diseases (NIAID) and the National Center for

Research Resources (NCRR), both parts of the National

Institutes of Health (NIH). NIAID's Adult AIDS Clinical

Trials Group conducted the study at 21 research centers in

the United States.

" We are pleased to see such a clear and definitive result

from this study, " says NIAID Director S. Fauci,

M.D. " Just a decade ago treatment of HCV in persons

infected with HIV was not a priority because they died from

AIDS before developing serious complications of hepatitis C

infection. As new anti-HIV drug treatments extend the lives

of HIV-positive individuals, studies like this one provide

essential guidance on treating other serious health

problems affecting people living with HIV. "

HCV is primarily spread through infected blood. Most people

with the virus have no signs of illness, but in some the

infection progresses to chronic liver disease, liver

failure or liver cancer. The disease progresses more

rapidly in people who have HIV.

The Centers for Disease Control and Prevention (CDC)

estimate that HCV infects about 25,000 Americans annually

and is responsible for about 8,000 to 10,000 deaths per

year. About 3.9 million Americans have been infected with

HCV, 2.7 million of whom are chronically infected,

according to the CDC. It is also estimated that of the 1

million HIV-infected Americans, about 300,000 are also

infected with HCV.

" We carefully monitored the study volunteers for side

effects. Most tolerated the treatments well, and relatively

few discontinued therapy prematurely. We were also

encouraged that HIV infection remained under control during

the study, " says T. Chung, M.D., lead investigator

and director of the Center for Liver Disorders in the

Gastrointestinal Unit at Massachusetts General Hospital.

The 133 HIV-positive study volunteers were randomly

assigned to take peg-interferon or interferon for 48 weeks.

All study volunteers also took ribavirin, an antiviral drug

that is also part of standard therapy for hepatitis C.

Study volunteers who completed the treatments - 16 withdrew

early for various reasons - were followed for 24 more weeks

to evaluate long term treatment success.

In the group that took peg-interferon, 27 percent of

patients had no detectable HCV in their blood 24 weeks

after completing treatment (sustained response). In

contrast, of those who took interferon, only 12 percent had

a sustained response. Importantly, more than one third of

those volunteers who failed to clear HCV appeared to

experience improvement in their liver biopsies, suggesting

the treatment was beneficial in this group as well.

Researchers also found that the volunteers whose HCV levels

failed to fall substantially within the first 12 weeks

never experienced a sustained response.

Roche Laboratories provided study medications and

participated in the protocol team.

NCRR supported this research through its General Clinical

Research Center Program with grants to University of

Rochester, NY; University of North Carolina, Chapel Hill;

and New York University. NCRR provides NIH-supported

investigators with access to specialized basic and clinical

research facilities, technologies, instrumentation,

biomaterials, animal models, genetic stocks and more.

NIAID is a component of the National Institutes of Health,

an agency of the U.S. Department of Health and Human

Services. NIAID supports basic and applied research to

prevent, diagnose and treat infectious diseases such as

HIV/AIDS and other sexually transmitted infections,

influenza, tuberculosis, malaria and illness from potential

agents of bioterrorism. NIAID also supports research on

transplantation and immune-related illnesses, including

autoimmune disorders, asthma and allergies. Press releases,

fact sheets and other NIAID-related materials are available

on the NIAID Web site at <http://www.niaid.nih.gov>.

--------------------------------------------------

REFERENCE: R.T. Chung et al. A randomized controlled trial

of PEG-interferon alfa-2a plus ribavirin vs. interferon

alfa-2a plus ribavirin for chronic hepatitis C virus

infection in HIV-co-infected persons: the U.S. AIDS

Clinical Trials Group A5071 study team. " The New England

Journal of Medicine " 351(5):451-459 (2004).

##

This NIH News Release is available online at:

http://www.nih.gov/news/pr/jul2004/niaid-28.htm

To subscribe (or unsubscribe) from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.

[Guest guest]

U.S. Department of Health and Human Services

NATIONAL INSTITUTES OF HEALTH

NIH News

National Institute of Allergy and Infectious Diseases

http://www.niaid.nih.gov/

EMBARGOED FOR RELEASE

Wednesday, July 28, 2004

5:00 p.m. ET

CONTACT:

Joy

301-402-1663

ljoy@...

RESEARCHERS IDENTIFY BETTER HEPATITIS C TREATMENT FOR

PEOPLE WITH HIV

The preferred treatment for hepatitis C, peg-interferon and

ribavirin, is safe for people who are also infected with

HIV, according to a new study in the July 29 issue of " The

New England Journal of Medicine " . Moreover, this treatment

proved superior for the treatment of hepatitis C virus

(HCV) in HIV-coinfected persons when compared with the

previously accepted treatment, standard interferon and

ribavirin.

The study compared the effectiveness of two forms of

interferon: a once-weekly dose of peg-interferon and

standard interferon taken three times weekly. Peg-

interferon with ribavirin is currently the approved

treatment for hepatitis C in persons without HIV. Prior to

this study, limited data were available on the benefit and

safety of peg-interferon and ribavirin in HIV-infected

people.

The study was funded by the National Institute of Allergy

and Infectious Diseases (NIAID) and the National Center for

Research Resources (NCRR), both parts of the National

Institutes of Health (NIH). NIAID's Adult AIDS Clinical

Trials Group conducted the study at 21 research centers in

the United States.

" We are pleased to see such a clear and definitive result

from this study, " says NIAID Director S. Fauci,

M.D. " Just a decade ago treatment of HCV in persons

infected with HIV was not a priority because they died from

AIDS before developing serious complications of hepatitis C

infection. As new anti-HIV drug treatments extend the lives

of HIV-positive individuals, studies like this one provide

essential guidance on treating other serious health

problems affecting people living with HIV. "

HCV is primarily spread through infected blood. Most people

with the virus have no signs of illness, but in some the

infection progresses to chronic liver disease, liver

failure or liver cancer. The disease progresses more

rapidly in people who have HIV.

The Centers for Disease Control and Prevention (CDC)

estimate that HCV infects about 25,000 Americans annually

and is responsible for about 8,000 to 10,000 deaths per

year. About 3.9 million Americans have been infected with

HCV, 2.7 million of whom are chronically infected,

according to the CDC. It is also estimated that of the 1

million HIV-infected Americans, about 300,000 are also

infected with HCV.

" We carefully monitored the study volunteers for side

effects. Most tolerated the treatments well, and relatively

few discontinued therapy prematurely. We were also

encouraged that HIV infection remained under control during

the study, " says T. Chung, M.D., lead investigator

and director of the Center for Liver Disorders in the

Gastrointestinal Unit at Massachusetts General Hospital.

The 133 HIV-positive study volunteers were randomly

assigned to take peg-interferon or interferon for 48 weeks.

All study volunteers also took ribavirin, an antiviral drug

that is also part of standard therapy for hepatitis C.

Study volunteers who completed the treatments - 16 withdrew

early for various reasons - were followed for 24 more weeks

to evaluate long term treatment success.

In the group that took peg-interferon, 27 percent of

patients had no detectable HCV in their blood 24 weeks

after completing treatment (sustained response). In

contrast, of those who took interferon, only 12 percent had

a sustained response. Importantly, more than one third of

those volunteers who failed to clear HCV appeared to

experience improvement in their liver biopsies, suggesting

the treatment was beneficial in this group as well.

Researchers also found that the volunteers whose HCV levels

failed to fall substantially within the first 12 weeks

never experienced a sustained response.

Roche Laboratories provided study medications and

participated in the protocol team.

NCRR supported this research through its General Clinical

Research Center Program with grants to University of

Rochester, NY; University of North Carolina, Chapel Hill;

and New York University. NCRR provides NIH-supported

investigators with access to specialized basic and clinical

research facilities, technologies, instrumentation,

biomaterials, animal models, genetic stocks and more.

NIAID is a component of the National Institutes of Health,

an agency of the U.S. Department of Health and Human

Services. NIAID supports basic and applied research to

prevent, diagnose and treat infectious diseases such as

HIV/AIDS and other sexually transmitted infections,

influenza, tuberculosis, malaria and illness from potential

agents of bioterrorism. NIAID also supports research on

transplantation and immune-related illnesses, including

autoimmune disorders, asthma and allergies. Press releases,

fact sheets and other NIAID-related materials are available

on the NIAID Web site at <http://www.niaid.nih.gov>.

--------------------------------------------------

REFERENCE: R.T. Chung et al. A randomized controlled trial

of PEG-interferon alfa-2a plus ribavirin vs. interferon

alfa-2a plus ribavirin for chronic hepatitis C virus

infection in HIV-co-infected persons: the U.S. AIDS

Clinical Trials Group A5071 study team. " The New England

Journal of Medicine " 351(5):451-459 (2004).

##

This NIH News Release is available online at:

http://www.nih.gov/news/pr/jul2004/niaid-28.htm

To subscribe (or unsubscribe) from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.

[Guest guest]

U.S. Department of Health and Human Services

NATIONAL INSTITUTES OF HEALTH

NIH News

National Institute of Allergy and Infectious Diseases

http://www.niaid.nih.gov/

EMBARGOED FOR RELEASE

Wednesday, July 28, 2004

5:00 p.m. ET

CONTACT:

Joy

301-402-1663

ljoy@...

RESEARCHERS IDENTIFY BETTER HEPATITIS C TREATMENT FOR

PEOPLE WITH HIV

The preferred treatment for hepatitis C, peg-interferon and

ribavirin, is safe for people who are also infected with

HIV, according to a new study in the July 29 issue of " The

New England Journal of Medicine " . Moreover, this treatment

proved superior for the treatment of hepatitis C virus

(HCV) in HIV-coinfected persons when compared with the

previously accepted treatment, standard interferon and

ribavirin.

The study compared the effectiveness of two forms of

interferon: a once-weekly dose of peg-interferon and

standard interferon taken three times weekly. Peg-

interferon with ribavirin is currently the approved

treatment for hepatitis C in persons without HIV. Prior to

this study, limited data were available on the benefit and

safety of peg-interferon and ribavirin in HIV-infected

people.

The study was funded by the National Institute of Allergy

and Infectious Diseases (NIAID) and the National Center for

Research Resources (NCRR), both parts of the National

Institutes of Health (NIH). NIAID's Adult AIDS Clinical

Trials Group conducted the study at 21 research centers in

the United States.

" We are pleased to see such a clear and definitive result

from this study, " says NIAID Director S. Fauci,

M.D. " Just a decade ago treatment of HCV in persons

infected with HIV was not a priority because they died from

AIDS before developing serious complications of hepatitis C

infection. As new anti-HIV drug treatments extend the lives

of HIV-positive individuals, studies like this one provide

essential guidance on treating other serious health

problems affecting people living with HIV. "

HCV is primarily spread through infected blood. Most people

with the virus have no signs of illness, but in some the

infection progresses to chronic liver disease, liver

failure or liver cancer. The disease progresses more

rapidly in people who have HIV.

The Centers for Disease Control and Prevention (CDC)

estimate that HCV infects about 25,000 Americans annually

and is responsible for about 8,000 to 10,000 deaths per

year. About 3.9 million Americans have been infected with

HCV, 2.7 million of whom are chronically infected,

according to the CDC. It is also estimated that of the 1

million HIV-infected Americans, about 300,000 are also

infected with HCV.

" We carefully monitored the study volunteers for side

effects. Most tolerated the treatments well, and relatively

few discontinued therapy prematurely. We were also

encouraged that HIV infection remained under control during

the study, " says T. Chung, M.D., lead investigator

and director of the Center for Liver Disorders in the

Gastrointestinal Unit at Massachusetts General Hospital.

The 133 HIV-positive study volunteers were randomly

assigned to take peg-interferon or interferon for 48 weeks.

All study volunteers also took ribavirin, an antiviral drug

that is also part of standard therapy for hepatitis C.

Study volunteers who completed the treatments - 16 withdrew

early for various reasons - were followed for 24 more weeks

to evaluate long term treatment success.

In the group that took peg-interferon, 27 percent of

patients had no detectable HCV in their blood 24 weeks

after completing treatment (sustained response). In

contrast, of those who took interferon, only 12 percent had

a sustained response. Importantly, more than one third of

those volunteers who failed to clear HCV appeared to

experience improvement in their liver biopsies, suggesting

the treatment was beneficial in this group as well.

Researchers also found that the volunteers whose HCV levels

failed to fall substantially within the first 12 weeks

never experienced a sustained response.

Roche Laboratories provided study medications and

participated in the protocol team.

NCRR supported this research through its General Clinical

Research Center Program with grants to University of

Rochester, NY; University of North Carolina, Chapel Hill;

and New York University. NCRR provides NIH-supported

investigators with access to specialized basic and clinical

research facilities, technologies, instrumentation,

biomaterials, animal models, genetic stocks and more.

NIAID is a component of the National Institutes of Health,

an agency of the U.S. Department of Health and Human

Services. NIAID supports basic and applied research to

prevent, diagnose and treat infectious diseases such as

HIV/AIDS and other sexually transmitted infections,

influenza, tuberculosis, malaria and illness from potential

agents of bioterrorism. NIAID also supports research on

transplantation and immune-related illnesses, including

autoimmune disorders, asthma and allergies. Press releases,

fact sheets and other NIAID-related materials are available

on the NIAID Web site at <http://www.niaid.nih.gov>.

--------------------------------------------------

REFERENCE: R.T. Chung et al. A randomized controlled trial

of PEG-interferon alfa-2a plus ribavirin vs. interferon

alfa-2a plus ribavirin for chronic hepatitis C virus

infection in HIV-co-infected persons: the U.S. AIDS

Clinical Trials Group A5071 study team. " The New England

Journal of Medicine " 351(5):451-459 (2004).

##

This NIH News Release is available online at:

http://www.nih.gov/news/pr/jul2004/niaid-28.htm

To subscribe (or unsubscribe) from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.