Human Genome Sciences Hepatitis C Drug Passes Test

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.Swiss drugmaker Roche sells the most popular interferon, called Pegasys, which is taken with a pill called ribavirin to treat the often-deadly virus. Schering-Plough Corp.’s interferon, called Peg-Intron, is also taken alongside ribavirin.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.Based on the promising results of its Phase II trial, Human Genome Sciences said it plans to conduct a larger 48-week mid-stage trial pairing Albuferon with ribavirin. The trial will pit the combo treatment against either the Roche or Schering-Plough combination therapy in patients with genotype 1.David Stump, head of drug development for Human Genome Sciences, told Reuters he hopes Albuferon, when paired with ribavirin, will supercede the Roche or Schering-Plough combo in effectiveness as well as tolerability.”If we show superiority in the head-to-head trial, we would become the new gold standard of treatment,” he said.(Source: Reuters Health, April 2005)