Common Type Of Hepatitis C Suppressed By Combination Of Oral Drugs

[Guest guest]

Common Type Of Hepatitis C Suppressed By Combination Of Oral

Drugs

20 Jan 2012

A new combination of investigational drugs successfully suppressed

hepatitis C genotype 1 infection in a high percent of patients who

had not responded to previous treatment in a study led by a

University of Michigan hepatologist.

The study, which was published Jan. 19 in the New England

Journal of Medicine, focused on hepatitis C genotype 1, which

is predominant in the United States and the most difficult to treat.

Hepatitis C is a virus that infects the liver and can cause liver

cancer and liver cirrhosis. It is transmitted through direct contact

with infected blood and blood products.

In this pilot study, patients with hepatitis C genotype 1 infection,

who had not responded to previous treatment with PEG-interferon alfa

and ribavirin, were given a combination of two investigational

direct-acting antiviral agents (daclatasvir and asunaprevir) alone,

or were given these two antiviral agents along with PEG-interferon

alfa-2a and ribavirin. All the patients saw their hepatitis C viral

load drop rapidly, says S. Lok, M.D., professor of Internal

Medicine, Division of Gastroenterology at the University of Michigan

Medical School and lead author of the study.

All 10 patients given the four drug treatment -- two direct-acting

antiviral agents (daclastasvir and asunaprevir) that block the NS3

and NS5A regions of the hepatitis C virus plus PEG-interferon alfa

and ribavirin -- had sustained virologic response with undetectable

virus at the end of treatment and at 12 weeks after stopping

treatment. Four of the 11 patients given the two direct-acting

antiviral agents only also achieved sustained virologic response.

A sustained virologic response or SVR means there is no detectable

Hepatitis C virus in a patient's blood after treatment is stopped.

Achieving sustained virologic response is important, because

research has shown that late relapse is rare.

"The two recently approved hepatitis C drugs - telaprevir or

boceprevir - combined with PEG-interferon alfa and ribavirin have

limited success in patients who have not responded to previous

treatment with PEG-interferon alfa and ribavirin. Because of this

high unmet medical need, there is a necessity for new combination

regimens that can increase response rates in that population," says

Lok, who also is Director of Clinical Hepatology at U-M. "The high

rate of sustained virologic response in patients who received the

four drug regimen is very exciting. Although only four of 11

patients given the two direct-acting antiviral agents only achieved

sustained virologic response, this is the first study to show that

sustained virologic response can be achieved without the use of

interferon or ribavirin. These data are very encouraging because

PEG-interferon alfaand ribavirin are associated with many side

effects and many patients with hepatitis C choose not to receive

treatment for fear that they cannot tolerate those drugs."

An estimated 170 million people worldwide are infected with

hepatitis C, with genotype 1 being the most prevalent genotype. Up

to 80 percent of those infected with hepatitis C will become

chronically infected. Twenty percent of people with chronic

hepatitis C will develop cirrhosis and, of those, up to 25 percent

may progress to liver cancer. Although there is no vaccine to

prevent hepatitis C, it is a potentially curable disease.

In the Phase II clinical trial, Lok, along with a team of

researchers including scientists from Bristol-Myers Squibb, studied

patients with Hepatitis C genotype 1, who had not responded to prior

therapy with PEG-interferon alfa and ribavirin. The study was funded

by Bristol-Myers Squibb.

"Overall, these results suggest that further research into

combinations of direct-acting antiviral agents, with or without

PEG-interferon and ribavirin, should be encouraged," Lok says.

"Caution must be exercised in selecting the right combination of

direct-acting antiviral agents in studies of interferon-free

regimens because in this study, all 7 patients who received only two

direct-acting antiviral agents that did not achieve sustained

virologic response had emergence of drug resistance variants to both

drugs."

In this study there were no serious adverse events on treatment or

discontinuations due to adverse events. Diarrhea was the most common

adverse event in both groups, but it was mild or moderate in all

cases.

References:

Journal citation: N Engl J Med 2012;366:216-24

Funding: Bristol Myers Squibb.

Additional authors: F. Gardiner, M.D., Kurt Zhu, Ph.D.,

Dessislava I. Dimitrova, M.D., Eley, Ph.D., Dennis M.

Grasela, Pharm.D., Ph.D., Claudio Pasquinelli, M.D., Ph.D., Fiona

McPhee, Ph.D., Tong Guo, Ph.D., Wind-Rotolo, Ph.D.,

Persson, Ph.D., all of Bristol Myers Squibb; Lawitz, M.D., of

Alamo Medical Research, San , Texas; Martorell,

M.D., of The Research Institute, Springfield, Mass.; T.

Everson, M.D., of the University of Colorado-Denver; Reem Ghalib,

M.D., of the Texas Clinical Research Institute; Reindollar,

M.D., of the Carolinas Center for Liver Disease; and Vinod Rustgi,

M.D., of Metropolitan Research, Fairfax, Va.

University of

Michigan Health System

Citations:

Please use one of the following formats to cite this article in your

essay, paper or report:

MLA

University of Michigan Health System.

"Common Type Of Hepatitis C Suppressed By Combination Of Oral

Drugs." Medical News Today. MediLexicon, Intl.,

20 Jan. 2012. Web.

29 Jan. 2012.

<http://www.medicalnewstoday.com/releases/240528.php>

APA

University of Michigan Health System.

(2012, January 20). "Common Type Of Hepatitis C Suppressed By

Combination Of Oral Drugs." Medical News Today.

Retrieved from

http://www.medicalnewstoday.com/releases/240528.php.

Please note: If no author information is provided, the source is

cited instead.

--

Bill Eastman

www.ke5asu.com/links.html

[Guest guest]

Thank you Bill for researching this for us.

Love

Janet

"There are souls in this world that have the gift of finding joy everywhere and of leaving it behind them when they go"

Frederick Faber

To: Hepatitis_C_Central Sent: Monday, January 30, 2012 12:37 AMSubject: Common Type Of Hepatitis C Suppressed By Combination Of Oral Drugs

Common Type Of Hepatitis C Suppressed By Combination Of Oral Drugs20 Jan 2012 A new combination of investigational drugs successfully suppressed hepatitis C genotype 1 infection in a high percent of patients who had not responded to previous treatment in a study led by a University of Michigan hepatologist. The study, which was published Jan. 19 in the New England Journal of Medicine, focused on hepatitis C genotype 1, which is predominant in the United States and the most difficult to treat. Hepatitis C is a virus that infects the liver and can cause liver cancer and liver cirrhosis. It is transmitted through direct contact with infected blood and blood products. In this pilot study, patients with hepatitis C genotype 1 infection, who had not responded to previous treatment with PEG-interferon alfa and ribavirin, were given a combination of two investigational direct-acting antiviral agents

(daclatasvir and asunaprevir) alone, or were given these two antiviral agents along with PEG-interferon alfa-2a and ribavirin. All the patients saw their hepatitis C viral load drop rapidly, says S. Lok, M.D., professor of Internal Medicine, Division of Gastroenterology at the University of Michigan Medical School and lead author of the study. All 10 patients given the four drug treatment -- two direct-acting antiviral agents (daclastasvir and asunaprevir) that block the NS3 and NS5A regions of the hepatitis C virus plus PEG-interferon alfa and ribavirin -- had sustained virologic response with undetectable virus at the end of treatment and at 12 weeks after stopping treatment. Four of the 11 patients given the two direct-acting antiviral agents only also achieved sustained virologic response. A sustained virologic response or SVR means there is no detectable Hepatitis C virus in a patient's blood after treatment is stopped.

Achieving sustained virologic response is important, because research has shown that late relapse is rare. "The two recently approved hepatitis C drugs - telaprevir or boceprevir - combined with PEG-interferon alfa and ribavirin have limited success in patients who have not responded to previous treatment with PEG-interferon alfa and ribavirin. Because of this high unmet medical need, there is a necessity for new combination regimens that can increase response rates in that population," says Lok, who also is Director of Clinical Hepatology at U-M. "The high rate of sustained virologic response in patients who received the four drug regimen is very exciting. Although only four of 11 patients given the two direct-acting antiviral agents only achieved sustained virologic response, this is the first study to show that sustained virologic response can be achieved without the use of interferon or ribavirin. These data are very encouraging because

PEG-interferon alfaand ribavirin are associated with many side effects and many patients with hepatitis C choose not to receive treatment for fear that they cannot tolerate those drugs." An estimated 170 million people worldwide are infected with hepatitis C, with genotype 1 being the most prevalent genotype. Up to 80 percent of those infected with hepatitis C will become chronically infected. Twenty percent of people with chronic hepatitis C will develop cirrhosis and, of those, up to 25 percent may progress to liver cancer. Although there is no vaccine to prevent hepatitis C, it is a potentially curable disease. In the Phase II clinical trial, Lok, along with a team of researchers including scientists from Bristol-Myers Squibb, studied patients with Hepatitis C genotype 1, who had not responded to prior therapy with PEG-interferon alfa and ribavirin. The study was funded by Bristol-Myers Squibb. "Overall, these results suggest

that further research into combinations of direct-acting antiviral agents, with or without PEG-interferon and ribavirin, should be encouraged," Lok says. "Caution must be exercised in selecting the right combination of direct-acting antiviral agents in studies of interferon-free regimens because in this study, all 7 patients who received only two direct-acting antiviral agents that did not achieve sustained virologic response had emergence of drug resistance variants to both drugs." In this study there were no serious adverse events on treatment or discontinuations due to adverse events. Diarrhea was the most common adverse event in both groups, but it was mild or moderate in all cases.

References:Journal citation: N Engl J Med 2012;366:216-24 Funding: Bristol Myers Squibb. Additional authors: F. Gardiner, M.D., Kurt Zhu, Ph.D., Dessislava I. Dimitrova, M.D., Eley, Ph.D., Dennis M. Grasela, Pharm.D., Ph.D., Claudio Pasquinelli, M.D., Ph.D., Fiona McPhee, Ph.D., Tong Guo, Ph.D., Wind-Rotolo, Ph.D., Persson, Ph.D., all of Bristol Myers Squibb; Lawitz, M.D., of Alamo Medical Research, San , Texas; Martorell, M.D., of The Research Institute, Springfield, Mass.; T. Everson, M.D., of the University of Colorado-Denver; Reem Ghalib, M.D., of the Texas Clinical Research Institute; Reindollar, M.D., of the Carolinas Center for Liver Disease; and Vinod Rustgi, M.D., of Metropolitan Research, Fairfax, Va. University of Michigan Health System

Citations:Please use one of the following formats to cite this article in your essay, paper or report:MLA

University of Michigan Health System. "Common Type Of Hepatitis C Suppressed By Combination Of Oral Drugs." Medical News Today. MediLexicon, Intl., 20 Jan. 2012. Web.29 Jan. 2012. <http://www.medicalnewstoday.com/releases/240528.php> APA

University of Michigan Health System. (2012, January 20). "Common Type Of Hepatitis C Suppressed By Combination Of Oral Drugs." Medical News Today. Retrieved fromhttp://www.medicalnewstoday.com/releases/240528.php.

Please note: If no author information is provided, the source is cited instead.

-- Bill Eastmanwww.ke5asu.com/links.html

[Guest guest]

You're welcome Janet.  This is just one of the things that was

posted on my website.  I don't check it daily.  When I do check it,

if I see something I think the group should know, I forward it.  You

would need to follow the link for the whole story though.  It only

post a summary.

It includes information about liver cancer too, but I don't forward

that.

Thank you

Bill for researching this for us.

Love

Janet

 

"There are souls in this world that have the gift of

finding joy everywhere and of leaving it behind them when they

go"

Frederick Faber

 

 

From: Bill

Eastman

To:

Hepatitis_C_Central

Sent:

Monday, January 30, 2012 12:37 AM

Subject:

Common Type Of Hepatitis C

Suppressed By Combination Of Oral Drugs

 

Common Type Of Hepatitis C Suppressed By

Combination Of Oral Drugs

20 Jan 2012   

A new combination of investigational drugs

successfully suppressed hepatitis C genotype 1

infection in a high percent of patients who had not

responded to previous treatment in a study led by a

University of Michigan hepatologist.

The study, which was published Jan. 19 in the New

England Journal of Medicine, focused on

hepatitis C genotype 1, which is predominant in the

United States and the most difficult to treat.

Hepatitis C is a virus that infects the liver and can

cause liver cancer and liver cirrhosis. It is

transmitted through direct contact with infected blood

and blood products.

In this pilot study, patients with hepatitis C

genotype 1 infection, who had not responded to

previous treatment with PEG-interferon alfa and

ribavirin, were given a combination of two

investigational direct-acting antiviral agents

(daclatasvir and asunaprevir) alone, or were given

these two antiviral agents along with PEG-interferon

alfa-2a and ribavirin. All the patients saw their

hepatitis C viral load drop rapidly, says S. Lok,

M.D., professor of Internal Medicine, Division of

Gastroenterology at the University of Michigan Medical

School and lead author of the study.

All 10 patients given the four drug treatment -- two

direct-acting antiviral agents (daclastasvir and

asunaprevir) that block the NS3 and NS5A regions of

the hepatitis C virus plus PEG-interferon alfa and

ribavirin -- had sustained virologic response with

undetectable virus at the end of treatment and at 12

weeks after stopping treatment. Four of the 11

patients given the two direct-acting antiviral agents

only also achieved sustained virologic response.

A sustained virologic response or SVR means there is

no detectable Hepatitis C virus in a patient's blood

after treatment is stopped. Achieving sustained

virologic response is important, because research has

shown that late relapse is rare.

"The two recently approved hepatitis C drugs -

telaprevir or boceprevir - combined with

PEG-interferon alfa and ribavirin have limited success

in patients who have not responded to previous

treatment with PEG-interferon alfa and ribavirin.

Because of this high unmet medical need, there is a

necessity for new combination regimens that can

increase response rates in that population," says Lok,

who also is Director of Clinical Hepatology at U-M.

"The high rate of sustained virologic response in

patients who received the four drug regimen is very

exciting. Although only four of 11 patients given the

two direct-acting antiviral agents only achieved

sustained virologic response, this is the first study

to show that sustained virologic response can be

achieved without the use of interferon or ribavirin.

These data are very encouraging because PEG-interferon

alfaand ribavirin are associated with many side

effects and many patients with hepatitis C choose not

to receive treatment for fear that they cannot

tolerate those drugs."

An estimated 170 million people worldwide are infected

with hepatitis C, with genotype 1 being the most

prevalent genotype. Up to 80 percent of those infected

with hepatitis C will become chronically infected.

Twenty percent of people with chronic hepatitis C will

develop cirrhosis and, of those, up to 25 percent may

progress to liver cancer. Although there is no vaccine

to prevent hepatitis C, it is a potentially curable

disease.

In the Phase II clinical trial, Lok, along with a team

of researchers including scientists from Bristol-Myers

Squibb, studied patients with Hepatitis C genotype 1,

who had not responded to prior therapy with

PEG-interferon alfa and ribavirin. The study was

funded by Bristol-Myers Squibb.

"Overall, these results suggest that further research

into combinations of direct-acting antiviral agents,

with or without PEG-interferon and ribavirin, should

be encouraged," Lok says. "Caution must be exercised

in selecting the right combination of direct-acting

antiviral agents in studies of interferon-free

regimens because in this study, all 7 patients who

received only two direct-acting antiviral agents that

did not achieve sustained virologic response had

emergence of drug resistance variants to both drugs."

In this study there were no serious adverse events on

treatment or discontinuations due to adverse events.

Diarrhea was the most common adverse event in both

groups, but it was mild or moderate in all cases.

References:

Journal citation: N Engl J Med 2012;366:216-24

Funding: Bristol Myers Squibb.

Additional authors: F. Gardiner, M.D., Kurt

Zhu, Ph.D., Dessislava I. Dimitrova, M.D.,

Eley, Ph.D., Dennis M. Grasela, Pharm.D., Ph.D.,

Claudio Pasquinelli, M.D., Ph.D., Fiona McPhee,

Ph.D., Tong Guo, Ph.D., Wind-Rotolo, Ph.D.,

Persson, Ph.D., all of Bristol Myers Squibb;

Lawitz, M.D., of Alamo Medical Research, San

, Texas; Martorell, M.D., of The

Research Institute, Springfield, Mass.; T.

Everson, M.D., of the University of Colorado-Denver;

Reem Ghalib, M.D., of the Texas Clinical Research

Institute; Reindollar, M.D., of the Carolinas

Center for Liver Disease; and Vinod Rustgi, M.D., of

Metropolitan Research, Fairfax, Va.

University of Michigan Health

System

Citations:

Please use one of the following formats to cite this

article in your essay, paper or report:

MLA

University of Michigan Health System.

"Common Type Of Hepatitis C Suppressed By

Combination Of Oral Drugs." Medical

News Today. MediLexicon, Intl., 20 Jan. 2012.

Web.

29 Jan. 2012. <http://www.medicalnewstoday.com/releases/240528.php>

APA

University of Michigan Health System.

(2012, January 20). "Common Type Of Hepatitis C

Suppressed By Combination Of Oral Drugs." Medical

News Today. Retrieved from

http://www.medicalnewstoday.com/releases/240528.php.

Please note: If no author information is

provided, the source is cited instead.

--

Bill Eastman

www.ke5asu.com/links.html

No virus

found in this message.

Checked by AVG - www.avg.com

Version: 2012.0.1901 / Virus Database: 2109/4777 - Release Date:

01/30/12

--

Bill Eastman

www.ke5asu.com/links.html