Albuferon Plus Ribavirin in Nonresponders to Interferon Therapy

D. Nelson and others presented results of a Phase II study of Albuferon in combination with ribavirin (RBV) in nonresponders to prior interferon therapy.

71 study participants enrolled in parallel into 3 Albuferon treatment cohorts (900 mg Q2 wks, 1200 mg Q2wk or 1200 mg Q4wk) in combination with ribavirin (RBV) 1000-1200 mg/day.

The treatment duration is 48 wk with 24 wk follow-up. The primary end-point is SVR. Following evaluation of 8wk of safety data, 22 subjects were enrolled in a 4th treatment cohort of Albuferon 1500 mg Q2 wk with RBV.

The most common adverse events were fatigue (86%), headache (70%), myalgia (59%) and nausea (58%). The adverse events were similar across all treatment arms.  No subject required discontinuation of Albuferon or ribavirin for hematologic abnormalities.

Conclusions

Albuferon in combination with ribavirin is safe, well tolerated and shows antiviral activity in IFNa nonresponders;

No significant drug accumulation between week 12 and 24;

No significant increase severity of adverse events between week 12 and week 24;

Hemotologic reductions were maximal by week 8 and are well managed with dose reductions;

Evaluation is ongoing.

                                                Table 1

11/18/05

Reference
D Nelson and others. A PHASE 2 STUDY OF ALBUFERON IN COMBINATION WITH RIBAVIRIN IN NON-RESPONDERS TO PRIOR INTERFERON THERAPY FOR CHRONIC HEPATITIS C. Abstract 204. Abstracts of the annual meeting of the American Association for the Study of Liver Diseases (56^th AASLD). November 11-15, 2005. San Francisco, CA.