In Largest U.S. Hepatitis C Trial, Researchers Determine Weight-Based Dosing Is Key to Optimal Treat

[Guest guest]

Source: NewYork-Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell

Medical College Released: Thu 27-Dec-2007, 11:35 ET

In Largest U.S. Hepatitis C Trial, Researchers Determine Weight-Based Dosing Is

Key to Optimal Treatment

DR. IRA JACOBSON, HEPATITIS C VIRUS, CLINICAL MEDICINE, GASTROENTEROLOGY,

HEPATOLOGY, LIVER DISEASE

As reported recently in the journal Hepatology, WIN-R, a multicenter study of

over 5,000 patients with hepatitis C virus (HCV) showed treatment with

weight-based REBETOL® (ribavirin, USP) (RBV) in combination with pegylated

interferon (PEG-IFN) alfa-2b achieved significantly higher rates of sustained

virologic response (SVR) and lower relapse rates compared to combination therapy

using a flat dose of RBV 800 mg/day. Superior response was found particularly in

patients with the most difficult-to-treat form of the disease, genotype 1 HCV.

Efficacy was consistent across all weight groups.

Newswise — As reported recently in the journal Hepatology, WIN-R, a multicenter

study of over 5,000 patients with hepatitis C virus (HCV) showed treatment with

weight-based REBETOL® (ribavirin, USP) (RBV) in combination with pegylated

interferon (PEG-IFN) alfa-2b achieved significantly higher rates of sustained

virologic response (SVR) and lower relapse rates compared to combination therapy

using a flat dose of RBV 800 mg/day. Superior response was found particularly in

patients with the most difficult-to-treat form of the disease, genotype 1 HCV.

Efficacy was consistent across all weight groups.

For patients infected with genotype 2 or 3, a 24 week course of treatment with

flat dose RBV + PEG-IFN was as effective as the standard 48-week course, with

better tolerability, and in the overall study population flat dosing of

ribavirin was as effective as weight-based ribavirin. However, within the

flat-dose cohort of patients with genotypes 2 and 3, sustained response rates

showed a slight decline in the higher weight patients given flat-dosed

ribavirin.

http://www.newswise.com/articles/view/536529/

" These findings help define optimal therapy for U.S. hepatitis C patients, " says

the study's principal investigator, Dr. Ira M. son, the Astor

Professor of Clinical Medicine at Weill Cornell Medical College and chief of the

Division of Gastroenterology and Hepatology at NewYork-Presbyterian

Hospital/Weill Cornell Medical Center. " Our findings underscore that

weight-based-dosed combination therapy is significantly more effective than the

flat-dosed RBV regimen, especially in more difficult-to-treat patient groups,

such as patients with genotype 1 and African-American patients. Patients being

treated for hepatitis C should talk to their doctors to be sure they are

receiving the most effective therapy. "

Reported in the same journal is a subanalysis of the WIN-R data that evaluates

the efficacy of weight-based dosing among African-American participants with

genotype 1 infection. Twice as many of these patients cleared the virus when

treated with the weight-based RBV regimen vs. the flat dose (21% vs. 10%); a

lower rate was shown in the general study population with genotype 1 HCV, 34%

vs. 28.9%. (However, the fact that over 300 patients with an end of treatment

response missed their 24-week, post-treatment follow-up appointment accounts for

some treatment failures under a strict intent-to-treat analysis.)

" These results are particularly significant for African-Americans, a group with

known lower rates of response to HCV therapy than reported in other ethnic

groups. Weight-based dosing vs. flat dosing clearly showed the greatest

therapeutic impact in this group, " says Dr. son.

" The study data strongly suggest adopting a 1400 mg/dose for patients who weigh

more than 105 kg. In my opinion, the larger dose provides an opportunity for

very heavy patients to have the same chance of cure as lighter patients without

compromising safety, " says Dr. son.

Overall safety with weight-based dosing was similar to that of the flat 800 mg

dose. There was no difference in the occurrence of serious adverse events in the

entire group, as well as in the African-American group.

Researchers at NewYork-Presbyterian/Weill Cornell are at the forefront of

developing more effective prescription therapy for patients with HCV genotype 1

and are testing many drugs in various stages of development.

Collaborating with the study's principal investigator Dr. son was Dr.

S. Brown Jr., co-principal investigator of the study and associate

professor of clinical medicine at Columbia University College of Physicians and

Surgeons; and chief of clinical hepatology and medical director of the Center of

Liver Disease and Transplantation at NewYork-Presbyterian Hospital/Columbia

University Medical Center.

Dr. son is also medical director of the Center for the Study of Hepatitis C

in New York City, a unique interdisciplinary Center established jointly by The

Rockefeller University, New York-Presbyterian Hospital, and Weill Cornell

Medical College. He serves as a consultant, investigator and speaker for

Schering-Plough.

WIN-R Study

WIN-R (Weight-Based Dosing of PEG-INTRON and REBETOL) is a community-based

access trial involving more than 5,000 patients at 225 centers across the U.S.

The uniquely large database of the WIN-R study allowed investigators to address

other questions of interest, which have been presented at international

meetings, including analyses of the response to HCV therapy based on age,

baseline viral load, degree of liver fibrosis (scarring), and the study site at

which the medication was delivered.

WIN-R is an investigator-initiated clinical study supported by Schering-Plough

Corporation and monitored by Schering-Plough Research Institute as part of a

post-marketing commitment to the U.S. Food and Drug Administration (FDA).

PEG-INTRON and REBETOL are registered trademarks of Schering-Plough.

Hepatitis C

Hepatitis C is the most common blood-borne infection in America. It affects

approximately 4 million people, or about one in every 50 adults, including a

disproportionately high percentage of African-Americans. Chronic hepatitis C can

cause cirrhosis, liver failure and liver cancer. It has been estimated that at

least 20 percent of patients with chronic hepatitis C develop cirrhosis, and a

smaller percentage of patients with chronic disease develop liver cancer.

Patients with chronic hepatitis C and related cirrhosis are 100 times more

likely to develop liver cancer than uninfected persons. About half of all cases

of primary liver cancer in the developed world are caused by hepatitis C, and

hepatitis C–related liver disease is now the leading cause for liver

transplants.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York

City, is one of the leading academic medical centers in the world, comprising

the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College,

the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell

provides state-of-the-art inpatient, ambulatory and preventive care in all areas

of medicine, and is committed to excellence in patient care, education, research

and community service. Weill Cornell physician-scientists have been responsible

for many medical advances -- from the development of the Pap test for cervical

cancer to the synthesis of penicillin, the first successful embryo-biopsy

pregnancy and birth in the U.S., the first clinical trial for gene therapy for

Parkinson's disease, the first indication of bone marrow's critical role in

tumor growth, and, most recently, the world's first successful use of deep brain

stimulation to treat a minimally-conscious brain-injured patient.

NewYork-Presbyterian, which is ranked sixth on the U.S.News & World Report's

list of top hospitals, also comprises NewYork-Presbyterian Hospital/Columbia

University Medical Center, Stanley Children's Hospital of

NewYork-Presbyterian, NewYork-Presbyterian Hospital/Westchester Division and

NewYork-Presbyterian Hospital/The Pavilion. Weill Cornell Medical College

is the first U.S. medical college to offer a medical degree overseas and

maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey

and Qatar. For more information, visit http://www.nyp.org and

http://www.med.cornell.edu.

_________________________________________________________________

The best games are on Xbox 360. Click here for a special offer on an Xbox 360

Console.

http://www.xbox.com/en-US/hardware/wheretobuy/

[Guest guest]

Source: NewYork-Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell

Medical College Released: Thu 27-Dec-2007, 11:35 ET

In Largest U.S. Hepatitis C Trial, Researchers Determine Weight-Based Dosing Is

Key to Optimal Treatment

DR. IRA JACOBSON, HEPATITIS C VIRUS, CLINICAL MEDICINE, GASTROENTEROLOGY,

HEPATOLOGY, LIVER DISEASE

As reported recently in the journal Hepatology, WIN-R, a multicenter study of

over 5,000 patients with hepatitis C virus (HCV) showed treatment with

weight-based REBETOL® (ribavirin, USP) (RBV) in combination with pegylated

interferon (PEG-IFN) alfa-2b achieved significantly higher rates of sustained

virologic response (SVR) and lower relapse rates compared to combination therapy

using a flat dose of RBV 800 mg/day. Superior response was found particularly in

patients with the most difficult-to-treat form of the disease, genotype 1 HCV.

Efficacy was consistent across all weight groups.

Newswise — As reported recently in the journal Hepatology, WIN-R, a multicenter

study of over 5,000 patients with hepatitis C virus (HCV) showed treatment with

weight-based REBETOL® (ribavirin, USP) (RBV) in combination with pegylated

interferon (PEG-IFN) alfa-2b achieved significantly higher rates of sustained

virologic response (SVR) and lower relapse rates compared to combination therapy

using a flat dose of RBV 800 mg/day. Superior response was found particularly in

patients with the most difficult-to-treat form of the disease, genotype 1 HCV.

Efficacy was consistent across all weight groups.

For patients infected with genotype 2 or 3, a 24 week course of treatment with

flat dose RBV + PEG-IFN was as effective as the standard 48-week course, with

better tolerability, and in the overall study population flat dosing of

ribavirin was as effective as weight-based ribavirin. However, within the

flat-dose cohort of patients with genotypes 2 and 3, sustained response rates

showed a slight decline in the higher weight patients given flat-dosed

ribavirin.

http://www.newswise.com/articles/view/536529/

" These findings help define optimal therapy for U.S. hepatitis C patients, " says

the study's principal investigator, Dr. Ira M. son, the Astor

Professor of Clinical Medicine at Weill Cornell Medical College and chief of the

Division of Gastroenterology and Hepatology at NewYork-Presbyterian

Hospital/Weill Cornell Medical Center. " Our findings underscore that

weight-based-dosed combination therapy is significantly more effective than the

flat-dosed RBV regimen, especially in more difficult-to-treat patient groups,

such as patients with genotype 1 and African-American patients. Patients being

treated for hepatitis C should talk to their doctors to be sure they are

receiving the most effective therapy. "

Reported in the same journal is a subanalysis of the WIN-R data that evaluates

the efficacy of weight-based dosing among African-American participants with

genotype 1 infection. Twice as many of these patients cleared the virus when

treated with the weight-based RBV regimen vs. the flat dose (21% vs. 10%); a

lower rate was shown in the general study population with genotype 1 HCV, 34%

vs. 28.9%. (However, the fact that over 300 patients with an end of treatment

response missed their 24-week, post-treatment follow-up appointment accounts for

some treatment failures under a strict intent-to-treat analysis.)

" These results are particularly significant for African-Americans, a group with

known lower rates of response to HCV therapy than reported in other ethnic

groups. Weight-based dosing vs. flat dosing clearly showed the greatest

therapeutic impact in this group, " says Dr. son.

" The study data strongly suggest adopting a 1400 mg/dose for patients who weigh

more than 105 kg. In my opinion, the larger dose provides an opportunity for

very heavy patients to have the same chance of cure as lighter patients without

compromising safety, " says Dr. son.

Overall safety with weight-based dosing was similar to that of the flat 800 mg

dose. There was no difference in the occurrence of serious adverse events in the

entire group, as well as in the African-American group.

Researchers at NewYork-Presbyterian/Weill Cornell are at the forefront of

developing more effective prescription therapy for patients with HCV genotype 1

and are testing many drugs in various stages of development.

Collaborating with the study's principal investigator Dr. son was Dr.

S. Brown Jr., co-principal investigator of the study and associate

professor of clinical medicine at Columbia University College of Physicians and

Surgeons; and chief of clinical hepatology and medical director of the Center of

Liver Disease and Transplantation at NewYork-Presbyterian Hospital/Columbia

University Medical Center.

Dr. son is also medical director of the Center for the Study of Hepatitis C

in New York City, a unique interdisciplinary Center established jointly by The

Rockefeller University, New York-Presbyterian Hospital, and Weill Cornell

Medical College. He serves as a consultant, investigator and speaker for

Schering-Plough.

WIN-R Study

WIN-R (Weight-Based Dosing of PEG-INTRON and REBETOL) is a community-based

access trial involving more than 5,000 patients at 225 centers across the U.S.

The uniquely large database of the WIN-R study allowed investigators to address

other questions of interest, which have been presented at international

meetings, including analyses of the response to HCV therapy based on age,

baseline viral load, degree of liver fibrosis (scarring), and the study site at

which the medication was delivered.

WIN-R is an investigator-initiated clinical study supported by Schering-Plough

Corporation and monitored by Schering-Plough Research Institute as part of a

post-marketing commitment to the U.S. Food and Drug Administration (FDA).

PEG-INTRON and REBETOL are registered trademarks of Schering-Plough.

Hepatitis C

Hepatitis C is the most common blood-borne infection in America. It affects

approximately 4 million people, or about one in every 50 adults, including a

disproportionately high percentage of African-Americans. Chronic hepatitis C can

cause cirrhosis, liver failure and liver cancer. It has been estimated that at

least 20 percent of patients with chronic hepatitis C develop cirrhosis, and a

smaller percentage of patients with chronic disease develop liver cancer.

Patients with chronic hepatitis C and related cirrhosis are 100 times more

likely to develop liver cancer than uninfected persons. About half of all cases

of primary liver cancer in the developed world are caused by hepatitis C, and

hepatitis C–related liver disease is now the leading cause for liver

transplants.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York

City, is one of the leading academic medical centers in the world, comprising

the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College,

the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell

provides state-of-the-art inpatient, ambulatory and preventive care in all areas

of medicine, and is committed to excellence in patient care, education, research

and community service. Weill Cornell physician-scientists have been responsible

for many medical advances -- from the development of the Pap test for cervical

cancer to the synthesis of penicillin, the first successful embryo-biopsy

pregnancy and birth in the U.S., the first clinical trial for gene therapy for

Parkinson's disease, the first indication of bone marrow's critical role in

tumor growth, and, most recently, the world's first successful use of deep brain

stimulation to treat a minimally-conscious brain-injured patient.

NewYork-Presbyterian, which is ranked sixth on the U.S.News & World Report's

list of top hospitals, also comprises NewYork-Presbyterian Hospital/Columbia

University Medical Center, Stanley Children's Hospital of

NewYork-Presbyterian, NewYork-Presbyterian Hospital/Westchester Division and

NewYork-Presbyterian Hospital/The Pavilion. Weill Cornell Medical College

is the first U.S. medical college to offer a medical degree overseas and

maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey

and Qatar. For more information, visit http://www.nyp.org and

http://www.med.cornell.edu.

_________________________________________________________________

The best games are on Xbox 360. Click here for a special offer on an Xbox 360

Console.

http://www.xbox.com/en-US/hardware/wheretobuy/