Moves In HIV Therapy As FDA Panel Delivers Verdicts

The future of drug therapy for HIV infection could undergo a fundamental change following the deliberations of the US Food and Drug Administration's Antiviral Drugs Advisory Committee meeting at the end of last week.

Several issues were discussed at the meeting. Marketing applications for two new protease inhibitors were scheduled for review on February 29 and March 1, too late for reporting in this issue of the Marketletter. Earlier on, the discussion centered on three studies which suggested that Bristol-Myers Squibb's Videx (didanosine) delays progression to AIDS and may be more effective in this regard than the current gold-standard antiviral, Glaxo Wellcome's Retrovir (zidovudine). The panel agreed with B-MS on this issue, and voted to recommend the drug for approval as a first-line monotherapy.

ACTG 152 Shows Videx Benefit New data, from the AIDS Clinical Trial Group (ACTG) 152 pediatric study, was presented to the advisory panel as one of three large-scale trials which, says B-MS, establish Videx as the basic platform for antiretroviral therapy, either alone or in combination. The ACTH 152 trial compared three treatment regimens for children with symptomatic HIV infection or AIDS; Videx alone, Videx plus Retrovir and Retrovir alone.