BioSpace has reported on data from an ongoing study comparing entecavir and adefovir in the treatment of patients with chronic hepatitis B and decompensated cirrhosis, presented at the 60th Annual Meeting of the American Association for the Study of Liver Diseases.

Study ETV-048 is a randomised, open-label, Phase III study in which 195 treatment-naïve and lamivudine-experienced patients with chronic hepatitis B infection and decompensated cirrhosis (Child-Pugh score ≥ 7) were randomised to entecavir 1mg or adefovir 10mg daily for a minimum of 96 weeks.  The primary endpoint was the mean change from baseline HBV DNA at Week 24, adjusted for baseline HBV DNA and lamivudine resistance status.

The main results presented include:

• At Week 24, entecavir achieved a greater reduction in viral load than adefovir: -4.48 (0.200) versus -3.40 (0.251) log copies/mL, respectively (p < 0.0001).

• At 24 weeks, 49% (49/100) of patients treated with entecavir compared with 16% (15/91) of patients who received adefovir achieved an undetectable viral load (HBV DNA <300 copies/mL as measured by polymerase chain reaction and ALT normalisation).  At 48 weeks, respective values were 57% and 20% (p< 0.0001).

• The results for Child-Pugh score were similar for the two treatments (secondary endpoint; see link below for further details)

• The change from baseline in Model for End-Stage Liver Disease (MELD) Score (assesses severity of hepatic decompensation) was a decrease of 2.6 points for patients treated with entecavir compared with 1.7 points for patients treated with adefovir at Week 48.

The overall incidence of adverse events was 89% (91/102) for the entecavir arm and 97% (86/89) for the adefovir arm; for serious events the rates were 69% and 66%, respectively.  Overall, 23% of entecavir-treated patients died compared with 33% of adefovir-treated patients. Hepatocellular carcinoma occurred in 12% and 20%, respectively.