By Liz Highleyman

Albumin interferon (Albuferon) is a recombinant formulation of interferon alfa-2b genetically fused to the human blood protein albumin, which enables it to last longer in the body. Researchers have studied albumin interferon for the treatment of chronic hepatitis C in an effort to develop a therapy that can be administered less often -- and hopefully cause fewer side effects -- than conventional or pegylated interferon.

As reported in the August 2008 issue of Hepatology, Stephen Zeuzem and an international team of colleagues conducted an open-label Phase 2 study in which 458 treatment-naive patients with genotype 1 chronic hepatitis C were randomly assigned to receive either standard therapy with 180 mcg once-weekly pegylated interferon alfa-2a (Pegasys) or else albumin interferon alfa-2b at doses of 900 or 1200 mcg once every 2 weeks or 1200 mcg once every 4 weeks for 48 weeks. All participants also received 1000-1200 mg/day weight-based ribavirin.

Results

• In an intent-to-treat analysis, sustained virological response (SVR) rates were as follows:

• o 58.5% with albumin interferon 900 mcg once every 2 weeks;

• 55.5% with albumin interferon 1200 mcg once every 2 weeks;

• 50.9% with albumin interferon 1200 mcg once every 4 weeks;

• 57.9% with pegylated interferon (P = 0.64 for overall test).

• Rates of discontinuation due to adverse events were 9.3%, 18.2%, and 12.1%, respectively, in the albumin interferon arms, compared with 6.1% in the pegylated interferon group (P = 0.04).

• Dose reductions due to hematological toxicity were lowest in the albumin interferon once every 4 week arm, and comparable across the other groups.

• At week 12, participants receiving 900 mcg albumin interferon once every 2 weeks missed significantly fewer days of work due to treatment-associated adverse events compared with those taking pegylated interferon (1.1 vs 4.3 days; P = 0.006).

Based on these findings, the study authors concluded, "Albumin interferon administered [once every 2 weeks or once every 4 four weeks] may offer comparable efficacy, with an improved dosing schedule, compared with [pegylated interferon alfa-2a]."

J.W. Goethe-University Hospital, Frankfurt, Germany; University of British Columbia, Vancouver, Canada; Hôpital Pitié-Salpêtrière, Paris, France; Monash University Medical School, Victoria, Australia; University of Alberta, Edmonton, Canada; Hadassah University, Jerusalem, Israel; Medical University of Bialystok, Poland; Spitalul Clinic de Adulti Cluj-Napoca, Romania; Nuselská Poliklinika-Remedis, Prague, Czech Republic; University of Manitoba, Winnipeg, Canada; Human Genome Sciences Inc., Rockville, MD; Division of Gastroenterology, Duke Clinical Research Institute, Durham, NC.

9/23/08

Reference
S Zeuzem, EM Yoshida, Y Benhamou, and others. Albinterferon alfa-2b dosed every two or four weeks in interferon-naive patients with genotype 1 chronic hepatitis C. Hepatology 48(2): 407-417. August 2008. (Abstract).