Replicor HBV combo leads to functional control

Replicor Inc. (Montreal, Quebec) reported interim data from the Moldovan Phase II REP 401 trial to treat non-cirrhotic, hepatitis B e antigen (HBeAg)-negative, 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 8 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 <1 IU/mL and HBV DNA levels of <10 IU/mL. All 8 patients who responded to REP 2139-Mg maintained functional control after ending treatment, with follow-up data available at 24 weeks for 4 patients, 12 weeks for 3 patients and 4 weeks for 1 patient. Replicor said functional control was accompanied by asymptomatic "therapeutic liver flares" and anti-HBsAg antibodies in patient's blood of up to 223,055 mIU/mL. Additionally, 4 patients met the criteria for functional cure of HBV infection, defined as HBsAg loss and HBV DNA levels of <1,000 copies/mL for 6 months after the end of treatment...