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

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

Key to Optimal Treatment

12/27/2007

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

more than 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.

" 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 percent vs. 10

percent); a lower rate was shown in the general study population with genotype 1

HCV, 34 percent vs. 28.9 percent. (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 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 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 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.

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.

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

Medical College

http://www.infectioncontroltoday.com/hotnews/weight-based-dosing.html

_________________________________________________________________

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[Guest guest]

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

Key to Optimal Treatment

12/27/2007

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

more than 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.

" 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 percent vs. 10

percent); a lower rate was shown in the general study population with genotype 1

HCV, 34 percent vs. 28.9 percent. (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 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 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 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.

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.

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

Medical College

http://www.infectioncontroltoday.com/hotnews/weight-based-dosing.html

_________________________________________________________________

Get the power of Windows + Web with the new Windows Live.

http://www.windowslive.com?ocid=TXT_TAGHM_Wave2_powerofwindows_122007