Valeant Pharmaceuticals Initiates Infergen Phase 4 Study

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Article Summary

Valeant Pharmaceuticals Initiates Infergen Phase 4 Study

PharmaLive News Archive - 11-Dec-2006

The study will evaluate the use of Infergen 15 ug/day plus ribavirin

(1.0-1.2 g/day) in patients who did not have an optimal response at week 12

of treatment with pegylated interferon and ribavirin. " Approximately 50

percent of patients do not respond to initial pegylated interferon and

ribavirin therapy.

Summary

• The study will evaluate the use of Infergen 15 ug/day plus ribavirin

(1.0-1.2 g/day) in patients who did not have an optimal response at week 12

of treatment with pegylated interferon and ribavirin.

• " Approximately 50 percent of patients do not respond to initial pegylated

interferon and ribavirin therapy.

• Week 12 has been shown to be a pivotal time point in determining the

likelihood of responding to therapy.

• Patients who still have detectable virus at week 12 have less chance of

sustaining an SVR than those who are undetectable at week 12.

• These patients are in need of a new treatment regimen to improve their

chance at achieving a sustained response, " commented L. Shiffman,

the study's principal investigator and Chief of Hepatology at Virginia

Commonwealth University Medical Center.

• The multi-center, randomized U.S. study will enroll patients who received

initial treatment with pegylated interferon and ribavirin and achieve a

greater than 2log10 decline in HCV RNA at week 12 but still have detectable

virus.

• The patients will be immediately randomized to receive Infergen 15 ug/day

plus ribavirin (1.0-1.2 g/day) for 36 or 48 weeks or continue on their

pegylated interferon and ribavirin regimen for an additional 36 weeks of

therapy.

• All treatment groups will have a 24 week follow up period to measure

sustained virologic response.

http://www.therapeuticsdaily.com/news/summary.cfm?id=399037 & channelID=31

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[Guest guest]

Article Summary

Valeant Pharmaceuticals Initiates Infergen Phase 4 Study

PharmaLive News Archive - 11-Dec-2006

The study will evaluate the use of Infergen 15 ug/day plus ribavirin

(1.0-1.2 g/day) in patients who did not have an optimal response at week 12

of treatment with pegylated interferon and ribavirin. " Approximately 50

percent of patients do not respond to initial pegylated interferon and

ribavirin therapy.

Summary

• The study will evaluate the use of Infergen 15 ug/day plus ribavirin

(1.0-1.2 g/day) in patients who did not have an optimal response at week 12

of treatment with pegylated interferon and ribavirin.

• " Approximately 50 percent of patients do not respond to initial pegylated

interferon and ribavirin therapy.

• Week 12 has been shown to be a pivotal time point in determining the

likelihood of responding to therapy.

• Patients who still have detectable virus at week 12 have less chance of

sustaining an SVR than those who are undetectable at week 12.

• These patients are in need of a new treatment regimen to improve their

chance at achieving a sustained response, " commented L. Shiffman,

the study's principal investigator and Chief of Hepatology at Virginia

Commonwealth University Medical Center.

• The multi-center, randomized U.S. study will enroll patients who received

initial treatment with pegylated interferon and ribavirin and achieve a

greater than 2log10 decline in HCV RNA at week 12 but still have detectable

virus.

• The patients will be immediately randomized to receive Infergen 15 ug/day

plus ribavirin (1.0-1.2 g/day) for 36 or 48 weeks or continue on their

pegylated interferon and ribavirin regimen for an additional 36 weeks of

therapy.

• All treatment groups will have a 24 week follow up period to measure

sustained virologic response.

http://www.therapeuticsdaily.com/news/summary.cfm?id=399037 & channelID=31

_________________________________________________________________

Stay up-to-date with your friends through the Windows Live Spaces friends

list.

http://clk.atdmt.com/MSN/go/msnnkwsp0070000001msn/direct/01/?href=http://spaces.\

live.com/spacesapi.aspx?wx_action=create & wx_url=/friends.aspx & mk