Expanded Access Urged For Protease Inhibitors

After the disappointing results seen with the currently-available therapies for HIV infection, the US National Task Force on AIDS Drug Development has heard from three companies developing protease inhibitors, the most promising therapeutic class for treating the disease, regarding current status of the drugs and their plans for expanded access programs.

Presenting at the meeting, Hoffmann-La Roche said that it has finalized plans to make its protease inhibitor Invirase (saquinavir) available on an expanded access basis during the third quarter of 1995, pending the outcome of final bioequivalence studies with the drug.

The last set of clinical results reported by the company was a combination of saquinavir, Wellcome's Retrovir (zidovudine) and Hoffmann-La Roche's Hivid (zalcitabine). The trial demonstrated more effectiveness with respect to parameters such as CD4 counts than a combination of saquinavir and Retrovir or Retrovir and Hivid. The randomized, double-blind trial involved 302 HIV-positive subjects with CD4 cell counts between 50/mm3 and 300/mm3. The period of administration for the drug was 24 weeks. According to the researchers, the three-drug combination was the most effective therapy in the maintenance of CD4 levels.