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Tipranavir to be Considered for Use in Multi-drug Resistant HIV Infection
Apr 5, 2005, 09:00, Reviewed by: Dr.
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Aptivus is a non-peptidic protease inhibitor. The drug is used in combination with other antiretroviral agents in patients previously treated with protease inhibitors.
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By FDA advisory committe ,
The Antiviral Drugs Advisory Committee will meet May 19 to discuss Boehringer Ingelheim�s NDA for Aptivus (tipranavir).
The committee will consider the HIV therapy for use in patients with multi-drug resistant disease.
Aptivus is a non-peptidic protease inhibitor. The drug is used in combination with other antiretroviral agents in patients previously treated with protease inhibitors.
In clinical trials, use of Aptivus was associated with both gastro-intestinal adverse events and elevated triglycerides.
If approved, Aptivus would be the second marketed non-peptidic PI; Pfizer�s Viracept (nelfinavir) was approved in 1997.
- The Antiviral Drugs Advisory Committee
FDA advisory committe
This meeting will be held May 19, 2005 at the Hilton in Gaithersburg, Md. beginning at 8 a.m.
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