HIVID TRIAL SETBACK NOT SERIOUS, SAYS ROCHE

As mentioned in the Marketletter last week, Hoffmann-La Roche has called to a halt a trial comparing its nucleoside analog compound Hivid (zalcitabine) with Wellcome's Retrovir (zidovudine) as a first-line treatment in AIDS or AIDS-related complex (ARC) patients. The study population included patients with either no prior Retrovir use or less than three months' use at entry.

Last April, the company discovered that six-month interim analyses of the study, called N3300, showed a consistent trend in survival which was more favorable to patients receiving Retrovir, but as this was not statistically significant the study was continued for a further six-month period.

The one-year interim analysis of N3300 has recently been completed and reviewed by Roche investigators, US Food and Drug Administration medical reviewers the National Institute of Allergy and Infectious Diseases' AIDS division and the AIDS Clinical Trials Group executive committee. The trend which was observed at six months has been maintained and has now become statistically significant, with 59 deaths out of 320 patients receiving Hivid and 33 out of 315 patients receiving Retrovir. This trend is relevant for all patient subgroups, including those with AIDS and ARC, and is irrespective of the baseline CD4+ T helper cell levels.