- 现金
- 62111 元
- 精华
- 26
- 帖子
- 30437
- 注册时间
- 2009-10-5
- 最后登录
- 2022-12-28
|
Antimicrob Agents Chemother. 2012 Mar 19. [Epub ahead of print]
Entecavir plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients with suboptimal Response to Lamivudine plus Adefovir : A Randomized Trial.Lim YS, Lee JY, Lee D, Shim JH, Lee HC, Lee YS, Suh DJ.
SourceDepartment of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
AbstractA substantial proportion of patients with lamivudine-resistant hepatitis B virus (HBV) show suboptimal virologic response during rescue combination treatment with lamivudine plus adefovir. In this randomized active-control trial, 90 patients with serum HBV DNA >2000 IU/mL after at least 24 weeks of treatment with lamivudine plus adefovir therapy for lamivudine-resistant HBV were randomized to combination treatment with entecavir plus adefovir (ETV+ADV, n=45) or continuation of lamivudine plus adefovir (LAM+ADV, n=45) for 52 weeks. At baseline, patients' mean serum HBV DNA was 4.60 log(10) IU/mL (SD 1.03). All 90 patients completed 52 weeks of treatment. At week 52, the proportion of patients with serum HBV DNA <60 IU/mL, the primary endpoint, was significantly higher in the ETV+ADV group than in the LAM+ADV group (n=13, 29% vs. n=2, 4%; P=0.004). The mean reduction in serum HBV DNA levels from baseline was significantly greater in the ETV+ADV group than in the LAM+ADV group (-2.2 log(10) IU/mL vs. -0.6 log(10) IU/mL; P<0.001). At week 52, additional resistance mutations to adefovir or entecavir were analyzed in all patients with detectable HBV DNA by restriction fragment mass polymorphism assays, and detected in none in the ETV+ADV group, but in 15% of patients in the LAM+ADV group (P=0.018). Safety and adverse event profiles were similar in the two groups. In conclusion, entecavir plus adefovir combination therapy provides superior virologic response and favorable resistance profiles, compared with continuing lamivudine plus adefovir combination, in patients with lamivudine-resistant HBV who fail to response to lamivudine plus adefovir combination therapy.
|
|