Efficacy and Safety of Entecavir Versus Adefovir in Chronic Hepatitis B Patients with Evidence of Hepatic Decompensatio

Efficacy and Safety of Entecavir Versus Adefovir in Chronic Hepatitis B Patients with Evidence of Hepatic Decompensation - see attached full poster report



Reported by Jules Levin

Y.-F. Liaw1, M. Raptopoulou-Gigi2, H. Cheinquer3, S.K. Sarin4, T. Tanwandee5, N. Leung6, R.P. Myers7, R.S. Brown Jr8, M. Shiffman9, J. Bialkowska10, S. Tang11, E. Cooney11


Summary of Results

ETV 1.0 mg was superior to ADV 10 mg for the primary efficacy endpoint of HBV DNA change from baseline at Week 24

A greater proportion of ETV- versus ADV-treated patients achieved HBV DNA <300 copies/mL at Weeks 24 and 48

ETV provided clinical benefit in this setting, as shown by change in CTP and MELD scores, and normalization of measures of hepatic

function through Week 48

Short-term death rates observed in both groups are consistent with on-treatment results previously reported for this population (16%)2,3

Cumulative death and HCC event rates were 23% and 12% in ETV group and 33% and 20% in the ADV group, respectively. Clinical

outcome events, such as death and HCC, may require more patients followed for a longer period of time to demonstrate any potential

differences between the two treatment groups

Conclusions

Both therapies were well tolerated, and the safety experience in each group was comparable and consistent with what would be expected

in a CHB population with decompensated liver disease

Entecavir demonstrated superior antiviral activity to adefovir in this patient population

Entecavir provided clinical benefit in patients with CHB infection and decompensated cirrhosis