Response-guided treatment of cirrhotic chronic hepatitis B patients: multicenter prospective study.

Aim: To observe the effect of response-guided add-on therapy with adefovir (ADV) and lamivudine (LAM) in cirrhotic hepatitis B (CHB) patients.

Methods: A total of 100 patients with CHB and cirrhosis were divided into three arms according to hepatitis B virus (HBV) DNA level after 24 wk LAM monotherapy: Arm A (complete response, HBV DNA ≤ 60 IU/mL, n = 49), Arm B (partial response, HBV DNA: 60-2000 IU/mL, n = 31) and Arm C (inadequate response, HBV DNA > 2000 IU/mL, n = 20). ADV was added to LAM at week 48 in Arms A and B, but at week 24 in Arm C.

[Results of 3 years of continuous entecavir treatment in nucleos(t)ide-naive chronic hepatitis B patients].

Objective: To evaluate the virological, serological and biochemical outcomes of 3 years of entecavir (ETV) treatment in nucleoside-naive chronic hepatitis B patients.

Methods: This study was divided into two stages: Patients receiving either ETV 0.5 mg/d (n = 258) or lamivudine (LAM) 100 mg/d (n = 261) entered the initial 96-week randomized, double blind, controlled efficacy study.

[The clinical characteristics of primary biliary cirrhosis in China: a systematic review].

Objective: To summarize the clinical features, diagnosis and treatment of patients with primary biliary cirrhosis (PBC) in China.

Methods: Systematic analysis of clinical characteristics by searching the Chinese literatures.

Results: From 1955 to 2007, 2740 PBC patients were reported in 103 papers (duplicated reports were deleted).

A 7-year study of lamivudine therapy for hepatitis B virus e antigen-positive chronic hepatitis B patients in China.

Objective: To evaluate the long-term efficacy and safety of lamivudine treatment for chronic hepatitis B and the impact of emergence of YMDD mutation of hepatitis B virus (HBV).

Methods: A total of 429 patients with serum HBsAg, HBeAg and HBV DNA positive were randomized to receive either lamivudine 100 mg daily or a placebo in a 3:1 ratio for the first 12 weeks. Thereafter, all patients were administered with lamivudine 100 mg/d for 5 years and followed up for 2 years.

[A double-blind, double-dummy, randomized, controlled study of entecavir versus lamivudine for treatment of chronic hepatitis B].

Objective: This study was to evaluate the antiviral efficacy and safety in nucleoside naive Chinese patients with chronic hepatitis B (CHB) treated with entecavir (ETV) or lamivadine (LVD).

Methods: The trial was a randomized, double-blind, double-dummy and control design. 519 nucleoside naive CHB patients were treated with daily dose of ETV 0.

A double-blind randomized trial of adefovir dipivoxil in Chinese subjects with HBeAg-positive chronic hepatitis B.

Four hundred and eighty Chinese subjects with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) were enrolled in a multicenter, double-blind, randomized, placebo-controlled study of adefovir dipivoxil (ADV) 10 mg once daily. There was a significant difference in reduction of serum hepatitis B virus (HBV) DNA after 12 weeks between subjects who received ADV and those who received the placebo (3.4 and 0.

[Durability of HBeAg seroconversion in lamivudine treatment of chronic hepatitis B patients].

Objective: To investigate the factors which may affect the rate of HBeAg seroconversion and its durability after long-term lamivudine therapy in chronic hepatitis B patients.

Methods: 81 patients were treated in a phase III clinical trial with lamivudine 100 mg daily for up to 5 years. The mean period of treatment was (48.

[Efficacy and safety in chronic hepatitis B adolescent patients with lamivudine therapy].

Objective: To analysis the efficacy and safety of lamivudine (made in China) therapy for 52 weeks in adolescent patients with chronic hepatitis B (CHB).

Methods: One hundred and five teenage CHB patients were treated with lamivudine 100 mg once daily for 52 weeks. Patients with elevated ALT at baseline were in group 1 and those with normal ALT were in group 2.

A 3-year clinical trial of lamivudine in treatment of patients with chronic hepatitis B.

Background: Lamivudine was approved for the treatment of chronic hepatitis B in China in 1999; however the long-term result has not yet been reported in detail. This clinical trial was to evaluate the long-term efficacy and safety of 3-year lamivudine treatment for chronic hepatitis B and the impact of emergence of YMDD mutation of hepatitis B virus (HBV).

Methods: This multi-center, randomized, double-blind, placebo controlled trial began from 1996 to 1999.

Long-term safety of lamivudine treatment in patients with chronic hepatitis B.

Background & Aims: Data on the long-term safety of lamivudine are limited. The aim of this analysis was to determine the incidence of hepatitis flares, hepatic decompensation, and liver-disease-related (LDR) serious adverse events (SAE) during long-term lamivudine treatment.

Methods: We reviewed data on 998 patients with HBeAg-positive compensated chronic hepatitis B who received lamivudine for up to 6 years (median, 4 years) and 200 patients who received placebo for 1 year.

[Liver histological changes after lamivudine treating in chronic hepatitis B patients with HBeAg positive].

Objectives: To investigate the histological changes in liver biopsy tissues taken from chronic hepatitis B patients with HBsAg and HBeAg positive and ALT abnormal after lamivudine therapy for one year.

Methods: Lamivudine was given orally at the dose of 100 mg once a day for one year. 101 patients were enrolled into this open-label study.

[The long-term efficacy of lamivudine in chronic hepatitis B: interim analysis of 3-year's clinical course].

Objective: To evaluate the long-term efficacy and safety of 3-year lamivudine treatment for chronic hepatitis B and the impact of emergence of YMDD mutation of hepatitis B virus (HBV).

Methods: This multi-center, randomized, double-blind, placebo-controlled trial began in 1996. A total of 429 patients with serum HBsAg, HBeAg and HBV DNA positive were randomized to receive either lamivudine 100 mg daily (n = 322) or placebo (n = 107) in a 3:1 ratio for the first 12 weeks.

[Chronic hepatitis B treated with domestic manufactured lamivudine in 2200 patients: a phase IV study].

Objective: To further verify the efficacy and safety of locally manufactured lamivudine on patients with chronic hepatitis B (CHB).

Methods: 2200 patients with CHB were recruited and received lamivudine orally 100 mg once daily for 12 months. The efficacy assessments included virologic response rate (defined by the absence of serum HBV DNA, HBeAg loss and HBeAg/HBeAb seroconversion), percentage of patients with normalization of alanine aminotransferase (ALT).