Posted: 15-Apr-2005 << BACK
Human Genome Sciences Inc. on Thursday said its experimental drug for hepatitis C met its primary goal in a mid-stage trial of patients who had not previously been treated for the liver-damaging virus.
The Rockville, Maryland-based company said the favorable results were seen in a trial of 56 patients with the genotype 1 strain of hepatitis C, the hardest to treat of three main strains, who were given varying doses of its Albuferon injectable drug. The patients had never previously been treated for their condition.
Albuferon is a laboratory-altered form of interferon-alpha, a standard treatment for hepatitis C. But unlike standard interferon treatments that must be injected once weekly, researchers said the Phase II trial indicated Albuferon is highly effective with injections only every two to four weeks.
Patients taking the two highest doses of the drug saw their levels of virus decline by over 99.9 percent 28 days after treatment began. That satisfied the trial's primary goal of showing at least a 99 percent reduction in virus, meaning a reduction to undetectable levels, after four weeks.
The company said 69 percent of patients in those two high-dose groups achieved the 99 percent reduction of virus after four weeks. Undetectable virus levels after 42 days were seen in 23 percent of the same patients.
Those standard combo treatments are considered the best available therapies for the virus, but use of them for up to 48 weeks only knocks down the virus to undetectable levels in about 42 percent of patients with genotype 1, Human Genome Sciences said.
Reuters 2005. All Rights Reserved.
Phase II Study Evaluates Albuferon, a Promising New Form of Interferon, for Treatment of Hepatitis C
By Marina Nunez, MD, PhD
Albuferon is a novel recombinant protein obtained from the fusion of interferon (IFN)-alfa with human serum albumin. The resulting polypeptide combines in one molecule the antiviral properties of IFN-alfa with the long serum half-life of albumin.
A randomized, dose-ranging phase II study was performed in IFN-alfa nave patients infected with HCV-1. Ten subjects in each group were enrolled to receive two subcutaneous injections with 200 mcg, 450 mcg, 670 mcg, 900 mcg, or 1,200 mcg of Albuferon (given 14 days apart).
The mean baseline HCV RNA levels were 6.63 log10 IU/ml. The most common side effects were headache (52%), arthralgia (48%) and myalgia (45%), but the treatment was well tolerated for the most part.
Better responses were achieved with the highest doses (900 mcg and 1,200 mcg). Thus, at week 4, the median decrease in HCV RNA levels was of 3.2 log10 among subjects receiving the two highest doses. A decrease of at least 2 log10 at week 4 was achieved in 69% of patients who received 900 or 1,200 mcg of Albuferon. Responses were not related to the body mass index, suggesting that there is no place for weight-based dosage.
The authors concluded that Albuferon was safe and showed robust antiviral activity after two doses in IFN-alfa nave, genotype 1 HCV subjects. The results are encouraging and further studies are needed to explore the efficacy of this new compound.
04/18/05
Reference: V Bain and others. A phase 2 study to assess antiviral response, safety, and pharmacokinetics of albuferon in IFN-a nave subjects with genotype 1 chronic hepatitis C. Abstract 18. 40th EASL. April 13-17, 2005. Paris, France.
