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FDA Approves New Formulation Of First Protease Inhibitor Saquinavir

November 7, 1997

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

FDA is receiving inquiries about Fortovase (saquinavir), a new formulation of a protease inhibitor for HIV infection. The following can be used to answer questions about this product, which was approved on Nov. 7:

Fortovase, a new formulation of Invirase, the first FDA-approved protease inhibitor, comes in a soft gelatin capsule that delivers more drug through the body than its predecessor. Fortovase also stays in the body at increased levels, thus improving treatment.

A controlled clinical study showed that at 16 weeks of treatment, twice as many patients who took Fortovase had undetectable virus levels in the blood compared to those who took Invirase.

Additionally, this is the first HIV drug to be approved since an FDA advisory committee recommended to the agency a more stringent reporting of clinical study results. This approach factors in all patients who start a clinical trial, even those who discontinue using the drug and drop out of the study for any reason. The FDA advisory committee had recommended this type of analysis to give health care providers and people with HIV a more realistic expectation of the efficacy of a given therapy in the clinical setting.

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Fortovase is generally well tolerated. The most common adverse effects are gastrointestinal, including diarrhea, nausea and abdominal discomfort. Side effects, for the most part, were similar to Invirase.

Fortovase is taken in 1,200 mg doses, three times a day. Hoffmann-La Roche of Nutley, N.J., manufactures both Invirase and Fortovase.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
 
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More on HIV Medications
More News on Saquinavir (Fortovase, Invirase)

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