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Biotech / Medical : Agouron Pharmaceuticals (AGPH)
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To: Oliver & Co who wrote (5347)9/19/1998 11:11:00 AM
From: Zirdu  Read Replies (2) of 6136
 
Here's a recent post from LMoss on the AOL board:

Subject: Sustiva package insert to report combinations with Viracept are superior
Date: 9/18/98 5:24 PM Mountain Daylight Time
From: LMoss
Message-id:

The package insert for Sustiva (efavirenz) will report that Viracept + Sustiva combinations are superior for treatment-experienced patients.

This result comes from the ACTG 364 study, after DuPont Pharmaceuticals performed an unplanned week 24 analysis of the data as part of the application procedure for FDA approval of Sustiva. The original plan was to perform a week 16 analysis (presented at the Geneva HIV/AIDS Conference) and a week 48 analysis (now underway).

The ACTG 364 study is double-blinded, placebo-controlled. Patients were randomly assigned to receive one of three possible treatment arms at entry:

Arm I: Viracept + Sustiva placebo (inactive drug) + 2 NRTIs
Arm II: Viracept placebo + Sustiva + 2 NRTIs
Arm III: Viracept + Sustiva + 2 NRTIs

All patients were treatment-experienced and had experienced prior treatment failure (viral load > 500 copies/ml). One or two new RTIs were assigned to each patient based on RTI therapies previously received.

By week 24, there was a statistically significant difference between the 4-drug combination (Arm III) and the other arms. The percentage of patients experiencing treatment failure (viral load > 500 copies/ml) in Arm III was about half that in the other arms. The difference between Arms I and II was not statistically significant.

Of the Arm III patients, 78% had viral loads less than 500 copies/ml at week 24, which is a good result in such a treatment-experience population.

These results were stated in a memorandum from the ACTG Study Team to ACTG Study Volunteers dated Sept. 9, 1998.

In short, the primary marketing document for Sustiva (the package insert) will note these results in order to give appropriate information to HIV practitioners in prescribing the best drugs to use in combination therapy. The use of Viracept with Sustiva is likely to become an important component of such therapy.

LMoss
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