Efficacy and safety of entecavir in lamivudine‐refractory patients with chronic hepatitis B: Randomized controlled trial in Japanese patients

Background and Aim:  Entecavir is a potent inhibitor of both wild‐type and lamivudine‐resistant hepatitis B virus (HBV) with proven clinical efficacy. We conducted a randomized, double‐blind, multicenter study in Japan (ETV‐052) evaluating the efficacy and safety of two doses of entecavir in adult patients with lamivudine‐refractory chronic hepatitis B infection.

[1]  A. Cross,et al.  [781] FOUR YEAR ASSESSMENT OF ETV RESISTANCE IN NUCLEOSIDE-NAIVE AND LAMIVUDINE REFRACTORY PATIENTS , 2007 .

[2]  C. Mazzucco,et al.  Two-Year Assessment of Entecavir Resistance in Lamivudine-Refractory Hepatitis B Virus Patients Reveals Different Clinical Outcomes Depending on the Resistance Substitutions Present , 2006, Antimicrobial Agents and Chemotherapy.

[3]  C. Mazzucco,et al.  Entecavir resistance is rare in nucleoside naïve patients with hepatitis B , 2006, Hepatology.

[4]  A. Cross,et al.  Entecavir for treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B. , 2006, Gastroenterology.

[5]  Ching-Lung Lai,et al.  Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. , 2006, The New England journal of medicine.

[6]  Chien-Jen Chen,et al.  Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. , 2006, Gastroenterology.

[7]  J. Marrero,et al.  Virologic response and resistance to adefovir in patients with chronic hepatitis B. , 2006, Journal of hepatology.

[8]  Guan-Tarn Huang,et al.  Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. , 2006, JAMA.

[9]  E. Schiff,et al.  A dose-ranging study of the efficacy and tolerability of entecavir in Lamivudine-refractory chronic hepatitis B patients. , 2005, Gastroenterology.

[10]  Oliver N Keene,et al.  Lamivudine for patients with chronic hepatitis B and advanced liver disease. , 2004, The New England journal of medicine.

[11]  Pietro Andreone,et al.  Clinical outcome of HBeAg‐negative chronic hepatitis B in relation to virological response to lamivudine , 2004, Hepatology.

[12]  M. Bernardi,et al.  High risk of hepatocellular carcinoma in anti‐HBe positive liver cirrhosis patients developing lamivudine resistance , 2004, Journal of viral hepatitis.

[13]  Y. Liaw,et al.  No Benefit to Continue Lamivudine Therapy after Emergence of Ymdd Mutations , 2004, Antiviral therapy.

[14]  Ching-Lung Lai,et al.  Prevalence and clinical correlates of YMDD variants during lamivudine therapy for patients with chronic hepatitis B. , 2003, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[15]  R. Schinazi,et al.  The polymerase L528M mutation cooperates with nucleotide binding-site mutations, increasing hepatitis B virus replication and drug resistance. , 2001, The Journal of clinical investigation.

[16]  N. Leung,et al.  Chronic hepatitis B virus infection in Asian countries , 2000, Journal of gastroenterology and hepatology.

[17]  E. Schiff,et al.  Lamivudine as initial treatment for chronic hepatitis B in the United States. , 1999, The New England journal of medicine.

[18]  G. Yao,et al.  A randomized double-blind placebo-controlled study of lamivudine in the treatment of patients with chronic hepatitis B virus infection. , 1999, Chinese medical journal.

[19]  Takao Tsuji,et al.  New Inuyama classification; new criteria for histological assessment of chronic hepatitis , 1996 .

[20]  Neil Kaplowitz,et al.  Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis , 1981, Hepatology.

[21]  J. Stockman,et al.  A Comparison of Entecavir and Lamivudine for HBeAg-Positive Chronic Hepatitis B , 2007 .

[22]  P. Loehrer,et al.  Risk of Hepatocellular Carcinoma Across a Biological Gradient of Serum Hepatitis B Virus DNA Level , 2007 .

[23]  D. Snydman.  Entecavir versus Lamivudine for Patients with HBeAg-Negative Chronic Hepatitis BLai C-L, for the BEHoLD AI463027 Study Group (Queen Mary Hosp, Hong Kong; et al) N Engl J Med 354:1011–1020, 2006§ , 2007 .

[24]  N. Leung.  Clinical Experience With Lamivudine , 2002, Seminars in liver disease.

[25]  A. Eddleston.  The natural history of hepatitis B virus infection. , 1988, Chemioterapia : international journal of the Mediterranean Society of Chemotherapy.