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Safety and Activity of Once-Monthly Albinterferon Alfa-2b (Albuferon) in Genotype 2/3 Chronic Hepatitis C Patients

By Ronald Baker, PhD

Albinterferon alfa-2b (albumin interferon; brand name Albuferon) is a novel longer-acting form of interferon alfa-2b created using albumin-fusion technology developed by Human Genome Sciences, Inc (HGS). The company is developing Albuferon in collaboration with Novartis, Inc.

Researchers at the University of Alberta in Edmonton, Canada, conducted a randomized, multicenter, open-label Phase 2 study to evaluate the safety and efficacy of albinterferon in previously untreated chronic hepatitis C patients with HCV genotypes 2 or 3.

In this study, 43 participants were randomly assigned in a 1:1 ratio to receive subcutaneous 1500 mcg albinterferon alfa-2b every 4 weeks (q4wk) or every 2 weeks (q2wk) with 800 mg/day oral ribavirin for 24 weeks. (For comparison, conventional interferon alfa is given 3 times weekly and pegylated interferon alfa is administered once per week).

The primary efficacy endpoint was sustained virological response (SVR; undetectable HCV RNA 24 weeks after completion of treatment). Insulin resistance was also assessed.

Results of the study, published in the online edition of Clinical Gastroenterology and Hepatology, are summarized below:

Results

• Rapid virological response (RVR) rates at week 4 were 68.2% and 76.2% for the q4wk and q2wk arms, respectively.

• The corresponding SVR rates were 77.3% and 61.9%.

• Insulin resistance at baseline was significantly associated with lower SVR rates independent of body mass index.

• The safety of albinterferon alfa-2b was acceptable, with similar adverse event profiles in both treatment arms.

• Discontinuation as a result of adverse events occurred in 4.5% and 14.3% of patients in the q4wk and q2wk arms, respectively.

• No albinterferon dose reductions due to adverse events were reported in the q4wk arm versus 9.5% in the q2wk arm.


Based on these findings, the study authors concluded that albinterferon administered at 4-week intervals was safe and well-tolerated, and that "the drug demonstrated significant antiviral activity in patients with genotype 2/3 chronic hepatitis C virus." They also noted that, "Insulin resistance appeared to have an independent effect on treatment response."

Discussion

Two studies presented at the recent Digestive Disease Week (DDW) 2008 conference looked at viral kinetics, pharmacodynamics, and quality of life in genotype 1 chronic hepatitis C patients.

Human Genome Sciences is currently conducting two Phase 3 clinical trials of Albuferon in combination with ribavirin: ACHIEVE 1 in treatment-naive patients with HCV genotype 1, and ACHIEVE 2/3 in treatment-naive patients with genotypes 2 or 3.

Assuming that ACHIEVE 1 and ACHIEVE 2/3 are successful, these studies could provide the pivotal data to support global marketing authorization applications for Albuferon, which HGS and Novartis expect to file in Fall 2009, according to HGS.

In a statement on its website, HGS states that, "Albuferon requires half as many injections as Pegasys (peginterferon alfa-2a), the leading available long-acting interferon, and Phase 2 clinical results suggest that Albuferon could offer efficacy and safety comparable to Pegasys, with the potential for improved quality of life and fewer lost days of work during therapy."

"Assuming that Phase 2 results are confirmed in Phase 3, HGS believes that Albuferon could become the market-leading interferon in treatment regimens for chronic hepatitis C," the company added.

5/23/08

 


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