Valeant Pharmaceuticals' oral antiviral compound pradefovir, for the treatment of compensated chronic hepatitis B, has posted positive 48-week results in a Phase II study. Pradefovir is a prodrug of adefovir. Pradefovir uses Metabasis Therapeutics' HepDirect technology which enables higher concentrations of the drug in the liver, the primary site of hepatitis B viral (HBV) replication.
The Phase II study is an open-label, randomized, multiple-dose study with 242 patients enrolled at 21 sites in the U.S., Taiwan, Singapore and Korea. Results show that 10, 20 and 30 mg of pradefovir had a statistically superior viral load reduction compared to 10 mg dosages of Gilead Sciences' Hepsera.
In the pradefovir treatment groups HBV DNA of less than 400c/mL was achieved in 45 percent of patients given a 5mg dose, 63 percent in the 10mg group, 56 percent in those given 20mg, and 71 percent of patients in the 30 mg group. This compares with 36 percent of patients given 10 mg of Hespera.