Promise With Agouron's Viracept & Roche's Invirase

3 February 1997

Agouron Pharmaceuticals' Viracept (nelfinavir mesylate) and Roche'sInvirase (saquinavir) have demonstrated efficacy in combination with each other and with other HIV therapies, according to data presented at the 4th Conference on Retroviruses and Opportunistic Infections, held in Washington, USA.

In December last year, Agouron submitted a New Drug Application to the US Food and Drug Administration for the protease inhibitor Viracept. The Phase II/III trial data, which formed the basis of the NDA, investigated two doses of Viracept, 500mg and 750mg, administered three times a day.

The first trial with 91 HIV-positive patients looked at Viracept as a stand-alone therapy, a second evaluated 297 patients receiving Viracept plus Bristol-Myers Squibb's Zerit (stavudine), or Zerit alone, and a third trial in 308 patients investigated the effects of Viracept plus Glaxo Wellcome's Retrovir (zidovudine) and GW's Epivir (lamivudine), or the latter two alone. Both viral load and the CD4 cell levels were measured as the primary clinical endpoints.

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