Gilead Sciences Announces Promising Interim Data from VISTIDE Study for CMV Retinitis in AIDS Patients

Strategic Insights -

Foster City, Calif.--(HealthWire)--Sept. 18, 1995--Gilead Sciences, Inc. (Nasdaq: GILD) announced today the presentation of interim data from a randomized, controlled pivotal study indicating that VISTIDE(TM) (cidofovir intravenous) delayed the time to progression of retinitis in patients with relapsing CMV retinitis, when compared to historical controls. Prior to receiving VISTIDE, these patients had experienced disease progressions despite extensive treatment with approved CMV therapies. Untreated, CMV retinitis progresses rapidly, impairs a patient's vision over time and ultimately may lead to blindness. This interim analysis included data from the first 60 of the 126 patients enrolled to date in the multicenter, dose-comparison study.

Key Takeaways:

  • The study found that VISTIDE treatment resulted in median time to progression of 115 days in the higher dose group (5 mg/kg) and median time to progression of 49 days in the lower dose group (3 mg/kg), compared to historical controls.
  • The study included data from 60 of the 126 patients enrolled to date in the multicenter, dose-comparison study, all of whom had previously progressed despite a median of four courses of other CMV systemic treatments.
  • The patients' baseline characteristics were comparable between both treatment groups, with a median CD4 count of 5 cells/mm(3).
  • VISTIDE is associated with a manageable side effect profile, including asymptomatic proteinuria (18%), creatinine increases to greater than or equal to 2 mg/dL (7%), and reversible probenecid reactions (5%).
  • The survival rates in the two groups were similar and consistent with historical controls.

Statistical Data:

  • Median time to progression was 115 days for the higher dose group (5 mg/kg) and 49 days for the lower dose group (3 mg/kg).
  • 18% of patients experienced asymptomatic proteinuria, 7% had creatinine increases to greater than or equal to 2 mg/dL, and 5% had reversible probenecid reactions.
  • Survival rates in the two groups were similar and consistent with historical controls.

Sources:

  • Gilead Sciences, Inc. (Nasdaq: GILD)
  • HealthWire, "Gilead Sciences Announces Presentation of Interim Data from VISTIDE Study for CMV Retinitis in AIDS Patients", September 18, 1995
  • 35th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), San Francisco, September 18, 1995
  • Jacob Lalezari, M.D., co-director of HIV Clinical Research at the Mt. Zion Medical Center, University of California -- San Francisco