Replicor HBV combo leads to functional control

Replicor Inc. (Montreal, Quebec) reported interim data from the Moldovan Phase II REP 401 trial to treat chronic HBV infection showing that REP 2139-Mg in combination with Viread tenofovir disoproxil fumarate and Pegasys peginterferon alfa-2a led to functional disease control in eight of 10 patients. Replicor CSO Andrew Vaillant told BioCentury the company plans to start a U.S. Phase II trial of the combination next year.

The open-label trial defined functional control as hepatitis B surface antigen (HBsAg) levels of less than one IU/mL and HBV DNA levels of less than 10 IU/mL. Because nucleoside analogs already reduce HBV DNA, Replicor believes the key to a functional cure is adding HBsAg blockade and using interferon to provide an immune boost (see BioCentury, Aug. 11)...