The trial evaluated the efficacy and safety of Albuferon in combination with ribavirin in patients with chronic hepatitis C.
The data suggested that Albuferon may offer efficacy at least comparable to the standard therapy pegylated interferon for treatment-naive patients, with similar safety, fewer injections and the potential to improve health-related quality of life.
The phase II results also demonstrated that the lower doses of Albuferon, 900mcg and 1200mcg, sustained a virologic response of 21% in previous non-responders to hepatitis C therapy.
Furthermore, the 1800mcg Albuferon dose cohort showed the highest rate of hepatitis C RNA negativity in the difficult-to-treat subgroup of genotype 1 patients who previously failed to respond to treatment with pegylated interferon and ribavirin.
“We look forward to continuing the evaluation of Albuferon at these higher doses over the full term of the current study,” said Mani Subramanian, senior director of Clinical Research, Infectious Diseases at Human Genome Sciences.
Human Genome said it was intending to initiate phase III trials of Albuferon in treatment-naive patients before the end of 2006.