Albuferon Demonstrates Robust Antiviral Activity in Phase II Clinical Trial

Strategic Insights -

Patients with chronic hepatitis C who are naive to interferon-alpha treatments showed significant antiviral activity and were well-tolerated to Albuferon, a new treatment option in development by Human Genome Sciences, Inc. (HGSI). The phase II clinical trial, presented at the 40th Annual Meeting of the European Association for the Study of the Liver (EASL), evaluated the safety, tolerability, pharmacology, and optimal dosing of Albuferon in 56 patients. The results demonstrate that Albuferon has a prolonged half-life, is well-tolerated, and exhibits robust antiviral activity, with durable dose-dependent reductions in hepatitis C viral load.

Key Takeaways:

  • Albuferon exhibited robust antiviral activity in genotype 1 HCV, with a mean reduction in HCV viral load of 3.2 log at Day 28.
  • A dose-dependent reduction in viral load was observed, with the majority of patients in the 900 mcg and 1200 mcg cohorts exhibiting a second-phase decline in viral load of 0.3 log per week.
  • Albuferon was detectable for up to 4 weeks following the second subcutaneous injection, and exhibited a median half-life of 148 hours.
  • The treatment was well-tolerated, with adverse events that were transient and mostly mild to moderate in severity.
  • One serious adverse event was reported (acute colitis) and has subsequently resolved.
  • Vincent Bain, MD, said, "A significant need exists for more convenient treatment options with fewer side effects."
  • David C. Stump, MD, Executive VP, Drug Development, said, "The results of the current phase II trial will inform our identification of an optimal range of doses to evaluate in a larger 48-week combination study of Albuferon with ribavirin."
  • Albuferon's pharmacokinetic profile supports dosing at intervals of 2 to 4 weeks.

Statistics:

  • 56 patients were enrolled in the phase II clinical trial.
  • 200, 450, 670, 900, and 1200 mcg doses of Albuferon were evaluated.
  • A mean reduction in HCV viral load of 3.2 log was observed at Day 28.
  • 18/26 patients (69%) in the 900 mcg and 1200 mcg dose cohorts showed a 2-log reduction in HCV viral load at Day 28.
  • Undetectable viral load was observed at Day 42 (28 days after the second injection) in 6/26 patients (23%) in the combined 900 mcg and 1200 mcg dose cohorts.
  • Albuferon's half-life was 148 hours, compared to 80 hours (50-140 hours) for Pegasys and 40 hours (22-60 hours) for PEG-Intron.
  • One serious adverse event was reported (acute colitis).

Sources:

  • "A phase II Study to Assess Antiviral Response, Safety, and Pharmacokinetics of Albuferon in IFNalpha-Naive Subjects with Genotype 1 Chronic Hepatitis C", presented at the 40th Annual Meeting of the European Association for the Study of the Liver (EASL)
  • Health & Medicine Week editors from staff and other reports, "Albuferon Demonstrates Robust Antiviral Activity in Phase II Clinical Trial", (Copyright 2005, Health & Medicine Week via NewsRx.com)