Promising Results for Albuferon in Chronic Hepatitis C Treatment

Human Genome Sciences, Inc., (HGSI) has announced promising 12-week interim results from a phase IIb clinical trial evaluating the efficacy and safety of Albuferon (albumin-interferon alpha 2b) in combination with ribavirin in patients with genotype 1 chronic hepatitis C (HCV) who are naive to interferon alpha-based treatment regimens. The results demonstrate that Albuferon in combination with ribavirin was safe, well-tolerated, and showed robust antiviral activity. The trial was presented at the 41st annual meeting of the European Association for the Study of the Liver (EASL).

Key Takeaways:

  • Albuferon showed efficacy and safety comparable to pegylated interferon with an improved dosing schedule.
  • The treatment arm receiving 900-mcg Albuferon at 2-week intervals exhibited efficacy similar to pegylated interferon.
  • Albuferon 900-mcg and 1200-mcg doses administered every 2 weeks showed a trend for greater antiviral activity compared to Pegasys administered every 7 days.
  • Patient-reported quality-of-life scores based on the SF-36 assessment showed that Albuferon treatment groups consistently performed better than pegylated interferon, with significantly less impairment of psychological well-being in mental health.
  • Interim data from other phase II studies supported the exploration of an Albuferon treatment regimen with monthly administration at higher doses than those investigated in the current phase IIb trial.
  • Albuferon doses of 1500 mcg and 1800 mcg were well-tolerated and had greater antiviral activity than the 900-mcg and 1200-mcg doses.

Statistics:

  • The trial was presented at the 41st annual meeting of the EASL.
  • Albuferon was tested in combination with ribavirin in patients with genotype 1 chronic hepatitis C (HCV).
  • The trial had 12-week interim results.
  • Albuferon 900-mcg and 1200-mcg doses showed a trend for greater antiviral activity compared to Pegasys administered every 7 days.
  • Patient-reported quality-of-life scores showed that Albuferon treatment groups performed better than pegylated interferon in 8 individual domain scores.
  • Albuferon 1500 mcg and 1800 mcg doses had greater antiviral activity than the 900-mcg and 1200-mcg doses.

Sources:

  • "Interim (Week 12) phase IIb Virological Efficacy and Safety Results of Albumin Interferon Alfa-2b Combined with Ribavirin in Genotype 1 Chronic Hepatitis C Infection," presented at the 41st annual meeting of the European Association for the Study of the Liver (EASL).
  • World Disease Weekly editors from staff and other reports. Copyright 2006, World Disease Weekly via NewsRx.com.