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(BETA) News Briefs: Roche and Merck Begin Expanded Access Programs for Protease Inhibitor Drugs


By the end of September 1995, over 3,000 people with AIDS in the U.S. will be taking either the Hoffman-La Roche (Roche) or the Merck protease inhibitor drug as part of the 2 companies' limited expanded access ("compassionate use") programs. Expanded access is a program sponsored by a drug manufacturer that provides experimental drugs free of charge to people with life-threatening illnesses who have failed or are intolerant to standard therapies.

Safety data on the drug are collected by patients' physicians and reported to the drug manufacturer. Both Roche and Merck recently held "lotteries" (computerized random selection) to choose participants for the expanded access programs for the protease inhibitor drugs Invirase ( saquinavir) and Crixivan ( indinavir sulfate).

Over 10,000 people asked to receive Roche's Invirase between June 21 and July 21, 1995. Citing limited drug supply, Roche will initially provide the drug free to 2,280 people in the U.S. Also citing limited drug supply, Merck on August 15 randomly selected 1,100 people from a pool of 11,000 applicants who registered between July 17 and August 11, 1995 to receive free Crixivan through an expanded access program. The Roche program offered Inivirase to HIV positive individuals with fewer than 300 CD4 cells/mm^3. The Merck program provides Crixivan to people with AIDS and 50 or fewer CD4 cells/mm^3. Both programs were open only to individuals who are intolerant to or have failed standard treatments for HIV infection.

Both Roche and Merck have agreed to expand enrollment in the Invirase and Crixivan programs, if more drug supply becomes available. To register patients for a possible second lottery for Roche's Invirase, physicians may call toll-free 1-800-332-2144, Monday through Friday, 9:00 am to 5:00 pm Eastern Time. Patients may also call this same number for information, but only physicians can register patients for the Invirase program.

To register for Merck's Crixivan, patients or their physicians or friends may call toll-free 1-800-497-8383, seven days a week, 8:00 am to 11:00 pm Eastern Time. The names of individuals who register for Crixivan after August 11, 1995 will be put at the end of the 10,000-person waiting list, after the names of those who registered before that date.


Copyright © 1995 -BETA, Publisher. All rights reserved to the San Francisco AIDS Foundation. Reproduced by permission. Reproduction of this article (other than one copy for personal reference) must be cleared through BETA: PO Box 426182, San Francisco, CA 94142-6182. Tel: 415 487 8060 Fax: 415 487 8069 San Francisco AIDS Foundation, Mail SFAF..

Information in this article was accurate in September 9, 1995. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.