New Hepatitis C Drug Enters Phase III Trial
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Human Genome Sciences tests Hep C drug
United Press International
ROCKVILLE, Md., Oct. 4 (UPI) — U.S. firm Human Genome Sciences said Wednesday it has begun a phase 3 trial of Albuferon in patients with chronic hepatitis C.
The company said it would test its albumin-interferon alpha 2b in more than 2,000 treatment-naive patients with the disease.
“We believe that Albuferon could become the best-in-class immunomodulator in treatment regimens for chronic hepatitis C, and we are pleased to move this important program forward,” said H. Thomas Watkins, HGS’s president and chief executive officer. “Advancing Albuferon to Phase 3 development is a major step toward the transformation of HGS into a development and commercialization company.”
The phase 3 development program will compare therapy with Albuferon in combination with ribavirin, versus PEGASYS, or PEG-IFN alpha 2a, in combination with ribavirin.
The testing will consist of two separate clinical trials — ACHIEVE 1, which will enroll at least 1,278 patients with chronic hepatitis C genotype 1 — and ACHIEVE 2/3, which will involve a minimum of 918 subjects with chronic hepatitis C genotype 2 or 3.
The studies will assess the drug’s efficacy, safety and impact on health-related quality of life.
