Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

[Guest guest]

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

Three Rivers Pharmaceuticals, LLC, today received expanded labeling from the U.S. Food and Drug Administration (FDA) to include daily use of INFERGEN (Consensus Interferon) in combination with ribavirin (RBV) for retreatment of chronic hepatitis C patients. The expanded labeling targets hepatitis C patients who need retreatment. In the clinical trial leading to the expanded labeling, the primary endpoint of increased sustained virological response (SVR) was achieved demonstrating that INFERGEN provides a second chance for patients to clear their hepatitis C virus.“Our hope is that INFERGEN will become the standard of care for the retreatment of chronic hepatitis C patients.â€"Approximately 50 percent of patients with chronic hepatitis C do not respond to their initial course of therapy," stated Dr. Bruce Bacon, the lead investigator for the registration trial. "The FDA's

recognition of this expanded label allows patients failing therapy a safe and efficacious retreatment strategy. The results from this study legitimize how we properly treat these patients helping them to achieve SVR."The data reported and published in Hepatology (2009) from the U.S.-based, randomized, DIRECT clinical trial (Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy) led to the approval of the expanded label. Results from the DIRECT trial had shown that the use of INFERGEN and RBV is a safe and effective retreatment strategy for patients failing initial therapy with PEG-IFN/RBV. This was especially apparent with interferon-sensitive patients with lower baseline fibrosis scores. In fact, up to 38 percent of non-cirrhotic patients (in the 15mcg arm) who were sensitive to Peg-IFN/RBV and who did not modify their INFERGEN and RBV dosages achieved an SVR. Additionally, patients with cirrhosis were less likely to

benefit from retreatment with INFERGEN and RBV unless they displayed previous interferon sensitivity or at least 1-log10 drop in viral levels on prior therapy."The expanded labeling for INFERGEN is a significant step forward for retreatment of hepatitis C patients who deserve a second chance to overcome their HCV," stated Kerrish, R.Ph, M.B.A., President of Three Rivers Pharmaceuticals, LLC. "Our hope is that INFERGEN will become the standard of care for the retreatment of chronic hepatitis C patients."Three Rivers Pharmaceuticals, LLC is expanding its INFERGEN and hepatitis C education efforts via physician outreach and online patient support programs. An instructional video and guide about proper at-home injections of INFERGEN, tips for patient compliance, access to reimbursement specialists and a hotline staffed by nurse counselors are available at www.infergen.com.SOURCE Three Rivers Pharmaceuticals

http://Hepatitis Cnewdrugs.blogspot.com/2010/07/three-rivers-pharmaceuticals-receives.html

[Guest guest]

hi there

if infergen is the hope you are all hoping for, then i am in trouble, i tried it

and i am going to tell you that the side effects were way worse then peg and

riba, my doctor discontinued me off of it after two weeks, i had a horrible

experience on it. i tried two treatments and neither worked peg and riba and

then infergen, i am hoping for something else to be invented to really work for

us without all the crazt and dangerous side effects

sincerely suesha

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> Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

>  

> Three Rivers Pharmaceuticals, LLC, today received expanded labeling from the

U.S. Food and Drug Administration (FDA) to include daily use of INFERGEN

(Consensus Interferon) in combination with ribavirin (RBV) for retreatment of

chronic hepatitis C patients. The expanded labeling targets hepatitis C patients

who need retreatment. In the clinical trial leading to the expanded labeling,

the primary endpoint of increased sustained virological response (SVR) was

achieved demonstrating that INFERGEN provides a second chance for patients to

clear their hepatitis C virus.

>

> “Our hope is that INFERGEN will become the standard of care for the

retreatment of chronic hepatitis C patients.â€

>

> " Approximately 50 percent of patients with chronic hepatitis C do not respond

to their initial course of therapy, " stated Dr. Bruce Bacon, the lead

investigator for the registration trial. " The FDA's recognition of this expanded

label allows patients failing therapy a safe and efficacious retreatment

strategy. The results from this study legitimize how we properly treat these

patients helping them to achieve SVR. "

>

> The data reported and published in Hepatology (2009) from the U.S.-based,

randomized, DIRECT clinical trial (Daily-Dose Consensus Interferon and

Ribavirin: Efficacy of Combined Therapy) led to the approval of the expanded

label. Results from the DIRECT trial had shown that the use of INFERGEN and RBV

is a safe and effective retreatment strategy for patients failing initial

therapy with PEG-IFN/RBV. This was especially apparent with interferon-sensitive

patients with lower baseline fibrosis scores. In fact, up to 38 percent of

non-cirrhotic patients (in the 15mcg arm) who were sensitive to Peg-IFN/RBV and

who did not modify their INFERGEN and RBV dosages achieved an SVR. Additionally,

patients with cirrhosis were less likely to benefit from retreatment with

INFERGEN and RBV unless they displayed previous interferon sensitivity or at

least 1-log10 drop in viral levels on prior therapy.

>

> " The expanded labeling for INFERGEN is a significant step forward for

retreatment of hepatitis C patients who deserve a second chance to overcome

their HCV, " stated Kerrish, R.Ph, M.B.A., President of Three Rivers

Pharmaceuticals, LLC. " Our hope is that INFERGEN will become the standard of

care for the retreatment of chronic hepatitis C patients. "

>

> Three Rivers Pharmaceuticals, LLC is expanding its INFERGEN and hepatitis C

education efforts via physician outreach and online patient support programs. An

instructional video and guide about proper at-home injections of INFERGEN, tips

for patient compliance, access to reimbursement specialists and a hotline

staffed by nurse counselors are available at www.infergen.com.

>

> SOURCE Three Rivers Pharmaceuticals

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>

http://Hepatitis Cnewdrugs.blogspot.com/2010/07/three-rivers-pharmaceuticals-rece\

ives.html

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