The Early study is an open-label, randomized, viral kinetics study of 69 antiviral-naive chronic hepatitis B e-antigen (HBeAg) positive patients, comparing the antiviral activity of Baraclude and adefovir. All patients in this study had a high viral load at study entry.
Of the 49 patients who remained in the study at 96 weeks, 79% (n=23/29) of Baraclude-treated patients and 50% (n=10/20) of adefovir-treated patients achieved undetectable viral load. The mean reduction in viral load from baseline in patients treated with Baraclude was -7.82 log(10) copies/mL and was -5.96 log(10) copies/mL in patients treated with adefovir at week 96.
The safety profile was comparable between the treatment groups through 96 weeks. Three percent of patients receiving Baraclude (entecavir) (n=1) and 12% of patients receiving adefovir (n=5) experienced a serious adverse event. By week 96, 22 of the 69 enrolled patients had discontinued the study. Of these, two patients receiving adefovir discontinued due to investigator-determined lack of treatment efficacy between the beginning of year two dosing and the 96-week analysis.