HGS’s partner Novartis initiates Phase IIb hepatitis trial

This Phase IIb trial is a randomized, open-label, multi-center, active-controlled, adaptive-design dose-ranging study to evaluate the safety and efficacy of albinterferon alfa-2b administered every four weeks plus daily ribavirin in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C.

Approximately 375 patients will be randomized in a 4:4:4:3 ratio into four treatment groups, including three that will receive albinterferon alfa-2b administered once every four weeks (900mcg, 1200mcg or 1500mcg), in addition to the active-control group, which will receive peginterferon alfa-2a at the standard 180mcg dose once every week.

All patients in the study will receive 800mg daily oral ribavirin. The total duration of treatment will be 24 weeks. The primary efficacy endpoint is sustained virologic response at week 48 (24 weeks following the end of treatment).

Albuferon is being developed by Human Genome Sciences (HGS) and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.

Mani Subramanian, executive director of clinical research – infectious diseases at HGS, said: Only an estimated 40% of US patients diagnosed with chronic hepatitis C have undertaken treatment to date – in part due to the side effects associated with interferon injections, which are currently required on a weekly basis. A monthly dosing schedule with Albuferon may well result in more patients choosing to be treated.