Quantitative hepatitis B core antibody level is a new predictor for treatment response in HBeAg-positive chronic hepatitis B patients receiving peginterferon.

A recent study revealed that quantitative hepatitis B core antibody (qAnti-HBc) level could serve as a novel marker for predicting treatment response. In the present study, we further investigated the predictive value of qAnti-HBc level in HBeAg-positive patients undergoing PEG-IFN therapy. A total of 140 HBeAg-positive patients who underwent PEG-IFN therapy for 48 weeks and follow-up for 24 weeks were enrolled in this study.

Two-year results of a randomized, phase III comparative trial of telbivudine versus lamivudine in Chinese patients.

Purpose: The burden of chronic hepatitis B infection is high in China, where prevalence exceeds 7 %. This was a randomized, double-blinded, phase III study of the efficacy and safety of telbivudine and lamivudine treatment at 104 weeks in Chinese patients with chronic hepatitis B.

Methods: Hepatitis B e antigen-positive (n = 290) and -negative (n = 42) adults with nucleoside analog-naïve compensated chronic hepatitis B were randomized to receive telbivudine 600 mg/day or lamivudine 100 mg/day for 104 weeks.

Expert recommendations on the application of interferon for chronic hepatitis B.

To help the clinicians correctly and scientifically apply interferon for the treatment of chronic hepatitis B, more than 40 experts majored in infectious and liver diseases updated the 'Expert recommendations on the treatment of chronic hepatitis B with interferon (2007)' following a systematic literature review, summary of clinical experiences and thorough consultation and discussion. The updated expert recommendations primarily included fundamental new knowledge of the use of interferon and individualized interferon therapy. Specifically, we provided recommendations for implementing optimized therapeutic regimens based on quantitative changes in hepatitis B surface antigen and hepatitis B virus DNA levels 24 weeks after interferon therapy.

Efficacy and safety of prolonged 3-year telbivudine treatment in patients with chronic hepatitis B.

Background: In the GLOBE trial, telbivudine demonstrated superior efficacy to lamivudine at 2 years in patients with chronic hepatitis B (CHB).

Aims: To investigate the long-term efficacy and safety of telbivudine in the telbivudine-treated cohort from the GLOBE trial.

Methods: Virological and biochemical responses were assessed in 213 HBeAg-positive and 186 HBeAg-negative CHB patients who continued telbivudine treatment for 3 years.

Natural course of chronic hepatitis B is characterized by changing patterns of programmed death type-1 of CD8-positive T cells.

Aim: To investigate if and how programmed death type-1 (PD-1) expression affects the natural course of hepatitis B virus (HBV) infection.

Methods: Sixty-four patients in different natural stages of chronic HBV infection were enrolled in this study. PD-1 expression in total T cells was detected by flow cytometry.

Early changes of hepatitis B virus quasispecies during lamivudine treatment and the correlation with antiviral efficacy.

Background/aims: To investigate dynamic changes of hepatitis B virus (HBV) quasispecies within the reverse transcriptase (RT) region during the early stage of lamivudine treatment and the correlation with antiviral efficacy.

Methods: Twenty-five chronic hepatitis B patients received lamivudine treatment for 48 weeks. Fourteen patients responded to lamivudine, while eleven patients were non-responders.

[Comparison of immune responses induced by recombinant attenuated Salmonella typhi carrying eukaryotic expression plasmid or prokaryotic expression plasmid of HCV core protein].

Hepatitis C virus (HCV) core protein is considered to be an attractive candidate for development of protective HCV vaccines. However, this protein may attenuate the induction of systemic immune responses due to its immunomodulatory properties. In this study, we constructed a HCV core gene-containing eukaryotic expression plamid pCI-C, and an in vivo-inducible prokaryotic expression plasmid pZW-C, and transformed the recombinant plasmids into an attenuated Salmonella typhimurium aroA strain SL7207.

[The degree of HBV suppression with 24 week telbivudine- or lamivudine-treatment in hepatitis B patients predicts the efficacy of the treatment at week 52].

Objectives: To investigate the possibilities of an association between the degrees of HBV suppression with nucleoside treatments at week 24 and week 52 in hepatitis B patients and to find a useful predictor for treatment efficacy.

Methods: In this phase III, double-blind, multicenter trial, we compared the efficacy of telbivudine treatment with lamivudine treatment in 332 Chinese compensated chronic hepatitis B patients. The patients were randomly assigned to a daily 600 mg telbivudine treatment group or daily 100 mg lamivudine group for 24 weeks.

Genotype B and younger patient age associated with better response to low-dose therapy: a trial with pegylated/nonpegylated interferon-alpha-2b for hepatitis B e antigen-positive patients with chronic hepatitis B in China.

Background: Cost and clinically significant adverse effects are the major limiting factors of interferon (IFN) use in therapy for chronic hepatitis B virus (HBV) infection. A clinical trial was conducted in China to study the efficiency and clinical relevance of low-dose regimen of IFN treatment for chronic HBV infection and to reveal factors predicting sustained combined response.

Methods: During a randomized, open-label control study, hepatitis B e antigen (HBeAg)-positive patients with chronic HBV infection (n=230) were assigned to receive pegylated IFN- alpha -2b (1.

[A multicenter, randomized, open-label study of the safety and effectiveness of pegylated interferon alpha 2b and interferon alpha 2b in treating HBeAg positive chronic hepatitis B patients].

Objective: To compare the efficacy and safety of PEG-IFNalpha-2b (Peg-Intron) with IFNalpha-2b (Intron A) in treating HBeAg positive chronic hepatitis B patients.

Methods: Two hundred thirty chronic hepatitis B (CHB) patients eligible to the following criteria were enrolled into this study: HBsAg and HBeAg(Abbott kit) positive for at least 6 months, serum HBV DNA > or =10(5) copies/ml (real time PCR, LLQ <10(3) copies/ml) and ALT > or =2 x ULN. After 1:1 randomization, the patients received PegIntron (group A: 1.

Prediction of significant fibrosis in HBeAg-positive patients with chronic hepatitis B by a noninvasive model.

A model was constructed consisting of clinical and serum variables to discriminate between hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) patients with and without significant fibrosis (stages 2-4 vs. stages 0-1). Consecutive treatment-naive CHB patients who underwent liver biopsy were divided into 2 sequential groups: a training group (n = 200) and a validation group (n = 172).

Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B.

Aim: To study the efficacy and safety of Fuzhenghuayu capsule (FZHY capsule, a capsule for strengthening body resistance to remove blood stasis) against liver fibrosis due to chronic hepatitis B.

Methods: Multicenter, randomized, double blinded and parallel control experiment was conducted in patients (aged from 18 to 65 years) with liver fibrosis due to chronic hepatitis B. Hepatic histologic changes and HBV markers were examined at wk 0 and 24 during treatment.

[Therapeutic effect of Bushen Rougan Recipe on hepatic fibrosis in rats].

Objective: To study the therapeutic effect of Bushen Rougan Recipe (BSRGR) on hepatic fibrosis in rats.

Methods: Forty male Wistar rats were randomly divided into normal control group (n=10), model group (n=15), and BSRGR-treated group (n=15). Rats in the model and BSRGR-treated groups were administered intraperitoneally with 0.

[Oxymatrine in the treatment of chronic hepatitis B for one year: a multicenter random double-blind placebo-controlled trial].

Objective: To evaluate the efficacy and safety of oxymatrine in the treatment of chronic hepatitis B.

Methods: A multicenter randomized double-blind placebo-controlled trial was conducted. A total of 144 patients with chronic hepatitis B entered the study for 52 weeks; of them 72 received oxymatrine, and 72 received a placebo.

Capsule oxymatrine in treatment of hepatic fibrosis due to chronic viral hepatitis: a randomized, double blind, placebo-controlled, multicenter clinical study.

Aim: To evaluate the efficacy and safety of oxymatrine capsule in treatment of hepatic fibrosis in patients with chronic viral hepatitis.

Methods: It was a randomized, double blind, placebo-controlled, multicenter clinical study. One hundred and forty-four patients were divided into oxymatrine capsule group(group A) and placebo group (group B).

[Multicenter clinical study about the action of Fuzheng Huayu Capsule against liver fibrosis with chronic hepatitis B].

Objective: To study the efficacy and safety of Fuzheng Huayu Capsule (FZHY Capsule) against liver fibrosis with chronic hepatitis B.

Methods: Multicentric, randomized, double blinded and paralleled control led trial was conducted on patients (aged between 18 and 65) with liver fibrosis in chronic hepatitis B Indexes observed: (1) hepatic histological changes and HBV markers were observed at 0 and 24th week during the treatment; serological indexes (HA, LN, P-III-P, IV-C) were determined and B ultrasound examination of spleen and liver was taken at 0, 12th, 24th week; liver function (during the period of follow-up, liver function and serological indexes for liver fibrosis were evaluated) were observed at 0, 6th, 12th, 18th, 24th week; (2) indexes for safety: blood and urine routine tests, renal function and ECG were examined.

Results: (1) Enrollment and demographic data: There was no significant difference between the trial (110 cases) and control group (106 cases) in demographic feature, vital signs, course of illness, history for drug anaphylaxis, history of previous therapy, liver function, serological indexes for liver fibrosis, liver histological examination (99 cases for test group, 96 cases for control group), HBV markers, and renal function, etc.

[Expression of TIMP-1 and TGF-beta1 mRNA in hepatic fibrosis rats and the therapeutic effects of Bushen Rougan Recipe].

Objective: To study the expression of TIMP-1 and TGF-beta1 mRNA in hepatic fibrosis rats and the therapeutic effects of Bushen Rougan Recipe (BSRGR).

Methods: Hepatic fibrosis was induced in rats by dimethylnitrosamine (DMN). The rats' hepatic tissue was studied by HE staining and Sirius red staining.