(BETA) News Briefs: Abbott Agrees to Expanded Access for Ritonavir

(BETA) News Briefs: Abbott Agrees to Expanded Access for Ritonavir

Bulletin of Experimental Treatments for AIDS, No. 26 September 1995
Ronald Baker, PhD

In a meeting with community treatment advocates on August 28 in Chicago, Abbott Laboratories announced plans for an expanded access program for ritonavir (formerly called ABT-538), a promising protease inhibitor drug now in Phase III studies. The company said at least 1,500 people with AIDS who have failed or are intolerant to standard therapies would receive ritonavir. Abbott has not yet formulated a complete patient eligibility profile for enrollment in the "open label" protocol for the drug. They hope to avoid using a lottery for selecting participants. Abbott expects to release more details on the expanded access program for ritonavir by October 1995.

John Leonard, MD, and Andre Pernet, MD, told community representatives at the Chicago meeting that their earlier concerns about elevated triglyceride and liver enzyme levels among individuals on ritonavir had proven unfounded. They also revealed that the current liquid (syrup) formulation of the drug will be abandoned in favor of a solid (capsule) formulation in the coming months. The ritonavir syrup is notorious for its bad taste, a problem that may be resolved by the conversion to a capsule.

Leonard and Pernet also briefly discussed encouraging results of laboratory tests of the simultaneous combination of ritonavir with Roche's saquinavir (Invirase). It appears that, in vitro, ritonavir increases the concentration of saquinavir by 100-fold. In addition, the resistance mutations are different for each drug. This new information suggests that a combination of these 2 protease drugs may produce a powerful anti-HIV effect for a sustained period of time. Discussions between Roche and Abbott are underway for a clinical study of the double combination of ritonavir and saquinavir. Roche and Merck are also planning a double combination clinical study of Invirase plus Crixivan.

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