FDAUs Antiviral Drugs Advisory Committee voted unanimouslyon Monday to recommend approval of Hoffmann-La RocheUsDDC (zalcitabine) as a monotherapy for treatment of HIV. Butthe committee also voted 6 to 2 to recommend that FDA rescindlast yearUs accelerated approval of DDC in combination withBurroughs Wellcome Co.Us AZT.
Roche presented two trials to the committee, ACTG 155, acombination trial with three arms comparing DDC, AZT andDDC/AZT, and Community Program for Clinical Research in AIDS(CPCRA) 002, comparing DDI vs. DDC.
Committee members concluded that there was no evidence thatDDC was either better or worse than AZT or DDI. RI amconvinced that (DDC) looked as good or as bad as (DDI),S saidcommittee member Fred Gordin, chief of the VA MedicalCenterUs Section of Infectious Diseases in Washington, D.C. RWedonUt have the ability to compare with a placebo, so the onlycomparison is with DDI.S The committee based the approvalrecommendation for DDC on the CPCRA trial and the twomonotherapy arms of the ACTG trial.
However, it felt that the ACTG 155 failed to show significantbenefits of adding DDI to AZT therapy. The FDA approved thedrug for combination therapy based on interim study results.The primary endpoint in ACTG 155 was an AIDS-defining eventor death and secondary endpoints were survival, changes inCD4 count and weight gain. Margaret Fischl of the Universityof Miami School of Medicine said that ROverall, no differencewas noted between the three treatment groups.SAIDS activists also spoke at the meeting against approval ofDDC. RIt feels very strange to come before you opposing anAIDS drug,S Lynda Dee, an attorney with AIDS Action Baltimoreand a member of the Johns Hopkins Community AdvisoryBoard, told the committee. RThe data are flimsy, at best.S
The committee approved monotherapy because members feltthat at the least, there was no evidence that DDC was inferior toAZT and DDI. Moreover, they said that since DDC has a differentside-effect profile than the other two drugs, it probably wouldwork in some cases where both AZT and DDI failed.
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.