Adefovir Dipivoxil Produces Sustained Improvement in HBV over Long Term

[Guest guest]

DGDispatch

Adefovir Dipivoxil Produces Sustained Improvement in HBV over Long Term:

Presented at HEP DART

By Bonnie Darves

KOHALA COAST, HI -- December 29, 2005 -- Patients with chronic hepatitis B

(HBV) who continue taking adefovir dipivoxil (ADV) for up to 5 years

continue to see improvements in hepatic fibrosis, HBV DNA suppression and

alanine aminotransferase (ALT) levels, with few adverse effects.

The new data on ADV were presented here at the Frontiers in Drug Development

for Viral Hepatitis HEP DART 2005 meeting.

" At 5 years the durability of this [therapy] is still greater than 91%, and

efficacy increased over time in all patient populations and disease stages, "

said presenter Carol Brosgart, MD, Vice President of Public Health and

Policy for the drug's maker, Gilead Sciences, City, California,

United States.

In his presentation, Dr. Brosgart discussed long-term data on ADV, the first

of a new class of nucleotide analogues of adenosine monophosphate.

The study evaluated the drug in two primary groups of patients. The first

group included 123 treatment-naïve chronic HBV patients with compensated

liver function, and the second comprised three cohorts of nearly 500

lamivudine-resistant HBV patients -- those who were wait-listed for liver

transplantation, post-transplant patients, and those with HIV co-infection.

Efficacy at 5 years was similar across all groups, Dr. Brosgart noted, with

approximately 70% achieving increasingly improved fibrosis as measured by a

reduction of 1 point or greater on the Ishak Fibrosis scale. ALT

normalization occurred in 69% of the treatment-naïve patients at 5 years and

67%.

In HBV/HIV coinfected patients, ALT normalization occurred in 84% at 5

years, and the median log-10 reduction in serum HBV DNA was 6.4, Dr.

Brosgart noted. " The magnitude of those reductions continued to increase

with treatment duration, " she said.

The drug was well tolerated in all patient groups. Less than 3% of patients

developed confirmed serum creatinine increases of 0.5 mg/dL over baseline.

No ADV mutations were seen and virologic breakthrough occurred in one

patient.

" We now have nearly 400,000 patient years of [ADV] treatment data to date,

and it is clear that it is well tolerated, with no [tolerability] change

with extended dosing, " she said, adding that ADV's activity can be enhanced

over time.

She cited convenient dosing schedules, a single daily 10 mg dose that does

not require timing with food intake, as an additional advantage of the drug

over earlier HBV therapies.

[Presentation title: Significant and Sustained Clinical Improvement

following Long Term Treatment with Adefovir Dipivoxil: Results after 5 Years

of Therapy. Abstract 94]

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[Guest guest]

DGDispatch

Adefovir Dipivoxil Produces Sustained Improvement in HBV over Long Term:

Presented at HEP DART

By Bonnie Darves

KOHALA COAST, HI -- December 29, 2005 -- Patients with chronic hepatitis B

(HBV) who continue taking adefovir dipivoxil (ADV) for up to 5 years

continue to see improvements in hepatic fibrosis, HBV DNA suppression and

alanine aminotransferase (ALT) levels, with few adverse effects.

The new data on ADV were presented here at the Frontiers in Drug Development

for Viral Hepatitis HEP DART 2005 meeting.

" At 5 years the durability of this [therapy] is still greater than 91%, and

efficacy increased over time in all patient populations and disease stages, "

said presenter Carol Brosgart, MD, Vice President of Public Health and

Policy for the drug's maker, Gilead Sciences, City, California,

United States.

In his presentation, Dr. Brosgart discussed long-term data on ADV, the first

of a new class of nucleotide analogues of adenosine monophosphate.

The study evaluated the drug in two primary groups of patients. The first

group included 123 treatment-naïve chronic HBV patients with compensated

liver function, and the second comprised three cohorts of nearly 500

lamivudine-resistant HBV patients -- those who were wait-listed for liver

transplantation, post-transplant patients, and those with HIV co-infection.

Efficacy at 5 years was similar across all groups, Dr. Brosgart noted, with

approximately 70% achieving increasingly improved fibrosis as measured by a

reduction of 1 point or greater on the Ishak Fibrosis scale. ALT

normalization occurred in 69% of the treatment-naïve patients at 5 years and

67%.

In HBV/HIV coinfected patients, ALT normalization occurred in 84% at 5

years, and the median log-10 reduction in serum HBV DNA was 6.4, Dr.

Brosgart noted. " The magnitude of those reductions continued to increase

with treatment duration, " she said.

The drug was well tolerated in all patient groups. Less than 3% of patients

developed confirmed serum creatinine increases of 0.5 mg/dL over baseline.

No ADV mutations were seen and virologic breakthrough occurred in one

patient.

" We now have nearly 400,000 patient years of [ADV] treatment data to date,

and it is clear that it is well tolerated, with no [tolerability] change

with extended dosing, " she said, adding that ADV's activity can be enhanced

over time.

She cited convenient dosing schedules, a single daily 10 mg dose that does

not require timing with food intake, as an additional advantage of the drug

over earlier HBV therapies.

[Presentation title: Significant and Sustained Clinical Improvement

following Long Term Treatment with Adefovir Dipivoxil: Results after 5 Years

of Therapy. Abstract 94]

http://www.docguide.com/news/content.nsf/news/8525697700573E18852570E6005990B6?O\

penDocument & id=061C33FC2A7F39888525689900589BFE & c= & count=10

_________________________________________________________________

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[Guest guest]

DGDispatch

Adefovir Dipivoxil Produces Sustained Improvement in HBV over Long Term:

Presented at HEP DART

By Bonnie Darves

KOHALA COAST, HI -- December 29, 2005 -- Patients with chronic hepatitis B

(HBV) who continue taking adefovir dipivoxil (ADV) for up to 5 years

continue to see improvements in hepatic fibrosis, HBV DNA suppression and

alanine aminotransferase (ALT) levels, with few adverse effects.

The new data on ADV were presented here at the Frontiers in Drug Development

for Viral Hepatitis HEP DART 2005 meeting.

" At 5 years the durability of this [therapy] is still greater than 91%, and

efficacy increased over time in all patient populations and disease stages, "

said presenter Carol Brosgart, MD, Vice President of Public Health and

Policy for the drug's maker, Gilead Sciences, City, California,

United States.

In his presentation, Dr. Brosgart discussed long-term data on ADV, the first

of a new class of nucleotide analogues of adenosine monophosphate.

The study evaluated the drug in two primary groups of patients. The first

group included 123 treatment-naïve chronic HBV patients with compensated

liver function, and the second comprised three cohorts of nearly 500

lamivudine-resistant HBV patients -- those who were wait-listed for liver

transplantation, post-transplant patients, and those with HIV co-infection.

Efficacy at 5 years was similar across all groups, Dr. Brosgart noted, with

approximately 70% achieving increasingly improved fibrosis as measured by a

reduction of 1 point or greater on the Ishak Fibrosis scale. ALT

normalization occurred in 69% of the treatment-naïve patients at 5 years and

67%.

In HBV/HIV coinfected patients, ALT normalization occurred in 84% at 5

years, and the median log-10 reduction in serum HBV DNA was 6.4, Dr.

Brosgart noted. " The magnitude of those reductions continued to increase

with treatment duration, " she said.

The drug was well tolerated in all patient groups. Less than 3% of patients

developed confirmed serum creatinine increases of 0.5 mg/dL over baseline.

No ADV mutations were seen and virologic breakthrough occurred in one

patient.

" We now have nearly 400,000 patient years of [ADV] treatment data to date,

and it is clear that it is well tolerated, with no [tolerability] change

with extended dosing, " she said, adding that ADV's activity can be enhanced

over time.

She cited convenient dosing schedules, a single daily 10 mg dose that does

not require timing with food intake, as an additional advantage of the drug

over earlier HBV therapies.

[Presentation title: Significant and Sustained Clinical Improvement

following Long Term Treatment with Adefovir Dipivoxil: Results after 5 Years

of Therapy. Abstract 94]

http://www.docguide.com/news/content.nsf/news/8525697700573E18852570E6005990B6?O\

penDocument & id=061C33FC2A7F39888525689900589BFE & c= & count=10

_________________________________________________________________

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[Guest guest]

DGDispatch

Adefovir Dipivoxil Produces Sustained Improvement in HBV over Long Term:

Presented at HEP DART

By Bonnie Darves

KOHALA COAST, HI -- December 29, 2005 -- Patients with chronic hepatitis B

(HBV) who continue taking adefovir dipivoxil (ADV) for up to 5 years

continue to see improvements in hepatic fibrosis, HBV DNA suppression and

alanine aminotransferase (ALT) levels, with few adverse effects.

The new data on ADV were presented here at the Frontiers in Drug Development

for Viral Hepatitis HEP DART 2005 meeting.

" At 5 years the durability of this [therapy] is still greater than 91%, and

efficacy increased over time in all patient populations and disease stages, "

said presenter Carol Brosgart, MD, Vice President of Public Health and

Policy for the drug's maker, Gilead Sciences, City, California,

United States.

In his presentation, Dr. Brosgart discussed long-term data on ADV, the first

of a new class of nucleotide analogues of adenosine monophosphate.

The study evaluated the drug in two primary groups of patients. The first

group included 123 treatment-naïve chronic HBV patients with compensated

liver function, and the second comprised three cohorts of nearly 500

lamivudine-resistant HBV patients -- those who were wait-listed for liver

transplantation, post-transplant patients, and those with HIV co-infection.

Efficacy at 5 years was similar across all groups, Dr. Brosgart noted, with

approximately 70% achieving increasingly improved fibrosis as measured by a

reduction of 1 point or greater on the Ishak Fibrosis scale. ALT

normalization occurred in 69% of the treatment-naïve patients at 5 years and

67%.

In HBV/HIV coinfected patients, ALT normalization occurred in 84% at 5

years, and the median log-10 reduction in serum HBV DNA was 6.4, Dr.

Brosgart noted. " The magnitude of those reductions continued to increase

with treatment duration, " she said.

The drug was well tolerated in all patient groups. Less than 3% of patients

developed confirmed serum creatinine increases of 0.5 mg/dL over baseline.

No ADV mutations were seen and virologic breakthrough occurred in one

patient.

" We now have nearly 400,000 patient years of [ADV] treatment data to date,

and it is clear that it is well tolerated, with no [tolerability] change

with extended dosing, " she said, adding that ADV's activity can be enhanced

over time.

She cited convenient dosing schedules, a single daily 10 mg dose that does

not require timing with food intake, as an additional advantage of the drug

over earlier HBV therapies.

[Presentation title: Significant and Sustained Clinical Improvement

following Long Term Treatment with Adefovir Dipivoxil: Results after 5 Years

of Therapy. Abstract 94]

http://www.docguide.com/news/content.nsf/news/8525697700573E18852570E6005990B6?O\

penDocument & id=061C33FC2A7F39888525689900589BFE & c= & count=10

_________________________________________________________________

Don’t just search. Find. Check out the new MSN Search!

http://search.msn.click-url.com/go/onm00200636ave/direct/01/