Bristol-Myers Squibb has reported 48-week data from an ongoing study (ETV-048) of chronic hepatitis B patients with decompensated cirrhosis. According to the data Baraclude demonstrated greater viral suppression compared to adefovir. The new Baraclude data were presented at the 60th annual meeting of the American Association for the Study of Liver Diseases.
Study ETV-048 is a randomised, open-label, comparative phase IIIb study of Baraclude compared to adefovir in treatment-naive and lamivudine-experienced patients with chronic hepatitis B infection and decompensated cirrhosis.
In the study, the patients were randomised to receive Baraclude 1mg or adefovir 10mg daily and were treated for a minimum of 96 weeks. Baseline patient populations were comparable in the two treatment arms. Patients had a mean MELD score of 17 and 15, respectively, in the Baraclude and adefovir treatment groups. Approximately one third of patients were previously exposed and resistant to lamivudine.
The primary study endpoint was the mean change from baseline HBV DNA at Week 24, analysed by linear regression and adjusted for baseline HBV DNA and lamivudine resistance status.
Secondary study endpoints specific to measuring improvement in cirrhosis included the MELD Score, an exam which scores patients on the severity of chronic liver disease, and the Child-Pugh Score (greater than or equal to a two-point decrease), which were evaluated at baseline, Week 24 and Week 48.
In the study a significant difference was observed in the proportion of patients achieving undetectable viral load and ALT normalisation. At 24 weeks, 49% of patients treated with Baraclude (entecavir) achieved an undetectable viral load, compared with 16% of patients who received adefovir; at 48 weeks, 57% of patients on Baraclude achieved an undetectable viral load, compared with 20% of patients on adefovir.
Moreover, among patients with baseline abnormal ALT, a higher proportion of Baraclude-treated patients achieved ALT normalisation at Weeks 24 and 48, 59% and 63% respectively, compared with 39% and 46% of adefovir-treated patients.
Hugo Cheinquer, investigator of ETV-048 study, said: “This study represents an important first step in addressing an unmet medical need, as this is one of the first comparative studies to evaluate the safety and efficacy of antiviral therapy in this difficult-to-treat patient population. Chronic hepatitis B is a lifelong disease and these data suggest that treatment with Baraclude may offer chronic hepatitis B patients with decompensated cirrhosis a treatment option.”