11th International AIDS Conference Vancouver, British Columbia — July 7-12, 1996

Int Conf AIDS 1996 Jul 7-12; 11:28 (abstract no. LB.B.6032)
Conant M, Self P, Liao E, Cocchetto D, Rubin M; Conant Medical Group, San Francisco, CA. Fax: (415) 661-6275.

OBJECTIVES: To establish an Expanded Access Program to provide access to and obtain safety data on Epivir therapy.

METHODS: Adult and pediatric patients in the U.S. and Canada with progressive, symptomatic HIV disease who had a baseline CD4 cell count less than or equal to 300 cells/mm³ and were refractory or intolerant to all approved antiretrovirals were enrolled in the program. Initially, patients were randomized to one of two monotherapy Epivir doses (150 mg or 300 mg BID). The combination therapy option of Epivir 150 mg BID plus Retrovir was added based on initial results from a European study of combination therapy. Patients were seen monthly for clinical assessments and collection of laboratory safety data.

RESULTS: From Oct. 1993 to Dec. 1995, 27,557 patients enrolled and initiated Epivir or Epivir plus Retrovir therapy. Investigators completed and submitted case report forms on 24,229 patients [93% M, 7% F, mean age = 40 yrs, mean baseline CD4 count = 96 cells/mm³]. Withdrawals due to an adverse event and deaths were 10% and 4%, respectively. (Table: see text)

CONCLUSION: In the largest Expanded Access Program ever undertaken in North America, the safety profile reported in the 24,229 patients receiving Epivir as monotherapy or in combination with Retrovir was similar with that reported from the controlled clinical trials.

960707
LBB6032

Copyright © 1996 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.