One hundred and ninety-two weeks treatment of entecavir maleate for Chinese chronic hepatitis B predominantly genotyped B or C.

Background: Entecavir (ETV) is a potent and selective nucleotide analog with significant activity against hepatitis B virus (HBV). ETV maleate is a derivative compound of ETV and was reported to have an efficacy and safety profile that is comparable to ETV (Baraclude) when used in Chinese patients with chronic hepatitis B (CHB) in phase III clinical trials (Clinical Trials.gov number, NCT01926288) at weeks 48, 96, and 144.

240-week entecavir maleate treatment in Chinese chronic hepatitis B predominantly genotype B or C.

This study aimed to evaluate the efficacy and safety of entecavir(ETV) versus ETV maleate in Chinese patients with chronic hepatitis B(CHB). This was a randomized, double-blind, double-dummy, controlled, multicentre study. Patients were randomly assigned to receive 48 weeks of treatment with 0.

Tenofovir disoproxil fumarate in Chinese chronic hepatitis B patients: Results of a multicenter, double-blind, double-dummy, clinical trial at 96 weeks.

Background: Tenofovir disoproxil fumarate (TDF) is a prodrug of a nucleotide analogue. As an antiviral drug, TDF has been proposed in the first-line treatment of chronic hepatitis B (CHB). Qingzhong, a brand name of TDF, commercialized by Jiangsu Chia-tai Tianqing Pharmaceutical Co Ltd.

A randomized, double-blind, double-dummy, controlled, multicenter study of Qingzhong (tenofovir disoproxil fumarate) versus Viread for the treatment of chronic hepatitis B: First-stage results at week 48.

Background: Tenofovir disoproxil fumarate (TDF) has been widely recommended as a first-line antiviral agent to treat chronic hepatitis B (CHB). Qingzhong and Viread, formulations of TDF commercialized by Jiangsu Chia-tai Tianqing Pharmaceutical Co Ltd and GlaxoSmithKline, respectively, have both been approved by the State Food and Drug Administration, China. This study analyzed the efficacy and safety of these 2 TDF agents in Chinese patients with CHB.

Relationship between virological response and FIB-4 index in chronic hepatitis B patients with entecavir therapy.

Aim: To investigate whether long-term low-level hepatitis B virus (HBV) DNA influences dynamic changes of the FIB-4 index in chronic hepatitis B (CHB) patients receiving entecavir (ETV) therapy with partial virological responses.

Methods: We retrospectively analyzed 231 nucleos(t)ide (NA) naïve CHB patients from our previous study (NCT01926288) who received continuous ETV or ETV maleate therapy for three years. The patients were divided into partial virological response (PVR) and complete virological response (CVR) groups according to serum HBV DNA levels at week 48.

[Analysis of a randomized, double-blind, double-dummy, controlled, multicenter study confirmed the similar therapeutic efficacies of entecavir maleate and entecavir for treatment of HBeAg-positive chronic hepatitis B].

Objective: To evaluate the efficacy and safety of entecavir maleate (ETV) versus ETV in Chinese patients with hepatitis B e antigen(HBeAg)-positive chronic hepatitis B(CHB).

Methods: The patient population of this previously published randomized, double-blind, double-dummy, controlled, multicenter study was expanded by patients in the 0.5 mg/day ETV maleate group (total n = 110) and patients in the 0.

[A randomized, double-blind, double-dummy, controlled, multicenter study of entecavir maleate versus entecavir for treatment of HBeAg-negative chronic hepatitis B: results at week 48].

Objective: To evaluate the efficacy and safety of entecavir (ETV) maleate versus ETV in Chinese patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB).

Methods: This was a randomized, double-blind, double-dummy, controlled, multicenter study. Patients were randomly assigned to receive 48 weeks of treatment with 0.

[Variants and quasispecies of reverse transcriptase region in polymerase gene of hepatitis B virus during lamivudine treatment].

Objective: To investigate the variants and quasispecies of reverse transcriptase region in polymerase gene of hepatitis B virus (HBV) during lamivudine treatment and their relationship with genotypes and viral loads.

Methods: HBV DNA of 117 chronic hepatitis B patients treated with lamivudine were amplified by using PCR. The PCR products including the YMDD motif were sequenced by DNA sequencer, of which, HBV DNA viral loads of 99 patients were determined by real-time PCR and 64 samples were sequenced by Pyrosequencing.

[Comparison of lamivudine or interferon monotherapy and sequential therapy in chronic hepatitis B: a random controlled trial].

Objective: To compare the efficacy and safety of lamivudine or interferon monotherapy and sequential therapy in HBeAg positive chronic hepatitis B patients.

Methods: A total of 225 patients with HBeAg positive chronic hepatitis B were randomized into 3 groups: sequential group (group A, 83 patients), lamivudine group (group B, 89 patients) and interferon group (group C, 53 patients). Group A was administrated with lamivudine 100 mg/d for 32 week, and 5 million units of interferon alpha 2b injected subcutaneously every other day lasting for 24 week were added since week 25.

[A clinical study of viral dynamic change in patients with hepatitis B e antigen positive chronic hepatitis B by lamivudine treatment].

Objective: To observe viral dynamic change in patients with HBeAg positive chronic hepatitis B by lamivudine treatment.

Methods: A multi-center clinical trial. Both outpatients and inpatients with HBeAg positive chronic hepatitis B have been administrated lamivudine 100 mg/d for 24 weeks.

Encephalic large arteries narrowness and peripheral neuropathy in a patient with adult-onset Still's disease.

Adult-onset Still's disease (AOSD) is a rare, systemic inflammatory disorder, characterized by spiking high fever, fever-associated evanescent rash, arthritis, myalgia, serositis and hepatosplenomegaly. White blood cell count, neutrophilic cell count, and serum ferritin level are markedly elevated in the active stage of the disease. Neurological complications of AOSD commonly were cranial nerve palsies, seizures, aseptic meningoencephalitis, peripheral neuropathy and Miller-Fisher syndrome.

[Efficacy of antiviral treatment on intrahepatic HBV DNA and histology in HBeAg -positive chronic hepatitis B patients].

Objective: To evaluate the effect of antiviral agents on intrahepatic HBV DNA and histology in HBeAg-positive chronic hepatitis B patients.

Methods: Thirty-five patients were treated with lamivudine, 16 with interferon alfa (INF-alpha), 24 with sequential Lamivudine and INF-alpha. The total duration of therapy was 12 months.

[Effects of antiviral agents on intrahepatic ccc DNA in HBeAg-positive chronic hepatitis B patients].

Objective: To evaluate the effects of antiviral agents on intrahepatic HBV covalently closed circular DNA (cccDNA) in HBeAg-positive chronic hepatitis B patients.

Methods: Seventy-one HBeAg positive chronic hepatitis B patients were enrolled in this study. Lamivudine was administered to 35 patients for 48 weeks, sequential therapy with lamivudine-IFN alpha-2b to 24 of the 71 patients for 48 weeks, and interferon alpha (IFN alpha-2b) was administered to 12 for 24 weeks.

Effects of antiviral agents and HBV genotypes on intrahepatic covalently closed circular DNA in HBeAg-positive chronic hepatitis B patients.

Aim: To evaluate the effects of antiviral agents and HBV genotypes on intrahepatic covalently closed circular DNA (ccc DNA) in HBeAg-positive chronic hepatitis B patients.

Methods: Seventy-one patients received lamivudine (n = 35), or sequential therapy with lamivudine- interferon alpha 2b (IFN-alpha 2b, n = 24) for 48 wk, or IFN-alpha 2b (n = 12) for 24 wk. All subjects were followed up for 24 wk.

[Efficacy of adefovir dipivoxil was not related to genotypes B and C of hepatitis B virus: a randomized, double-blind, multicenter clinical study].

Objective: To determine the relationship between the response to adefovir dipivoxil (ADV) treatment in patients with HBV genotypes B and C of HBeAg positive chronic hepatitis B.

Methods: This clinical trial was a randomized, double-blind, placebo-controlled, multicenter study. A total of 226 eligible patients with HBeAg positive chronic hepatitis B were randomized (in a ratio of 2:1) receiving ADV 10 mg/d for 48 weeks (ADV+ADV group) or placebo for 24 weeks followed by ADV 10 mg/d for 24 weeks (PLB+ADV group).

[Diammonium glycyrrhizinate does not affect efficacy of adefovir dipivoxil therapy in patients with HBeAg-positive chronic hepatitis B].

Objective: To evaluate the effect of diammonium glycyrrhizinate on the antiviral therapy with adefovir dipivoxil (ADV) in patients with HBeAg-positive chronic hepatitis B.

Methods: Patients with HBeAg-positive chronic hepatitis B enrolled in this study were randomized to receive either ADV 10 mg/d fir 48 weeks or placebo for 24 weeks followed by ADV 10 mg/d for 24 weeks. Antiviral activities of diammonium glycyrrhizinate administered during the trial were studied with respect to virological and serologic response, and ALT normalization.

[An analysis of the pathohistology of liver tissues, clinical features and prognostic factors of chronic hepatitis B virus carriers].

Objective: To study the correlations between clinical features and liver pathohistological changes of chronic hepatitis B virus (HBV) carriers and to discuss the factors which may influence the prognosis.

Methods: Ninety HBV carriers who had liver biopsies were enrolled in this study.

Results: (1) The mean follow-up period of the patients was 118 weeks.

[A clinical study of adefovir dipivoxil in treating lamivudine refractory HBeAg-positive chronic hepatitis B].

Objective: To evaluate the efficacy and safety of adefovir dipivoxil (ADV) in treating patients with lamivudine (LAM) refractory HBeAg-positive chronic hepatitis B.

Methods: It is a randomized, double-blind, placebo-controlled, multicenter study. 226 eligible patients with HBeAg-positive chronic hepatitis B were randomized (randomization ratio was 2:1) into two groups.

[Clinical characteristies and distribution of hepatitis B virus genotype and sub-genotype].

Objective: To determine the distribution and virologic characteristics of HBV genotypes, sub-type and possible association with the severity of liver disease.

Methods: 884 patients infected with HBV were enrolled from 8 provinces in China. HBV genotype and sub-type was determined, using PCR-RFLP method.

Intrahepatic HBV DNA as a predictor of antivirus treatment efficacy in HBeAg-positive chronic hepatitis B patients.

Aim: To evaluate the effect of antiviral agents on intrahepatic HBV DNA in HBeAg-positive chronic hepatitis B patients.

Methods: Seventy-one patients received treatment with lamivudine, interferon alpha (IFN-alpha 2b) or sequential therapy with lamivudine-IFN-alpha 2b for 48 wk. All subjects were followed up for 24 wk.

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 clinical study of adefovir dipivoxil, made in China, for treatment of hepatitis B e antigen-positive patients with chronic hepatitis B].

Objective: To evaluate the efficacy and safety of a China made adefovir dipivoxil (ADV) treatment for hepatitis B e antigen-positive patients with chronic hepatitis B.

Methods: Two hundred and thirty patients with chronic hepatitis B who were positive for hepatitis B e antigen (HBeAg) were randomly put into groups A or B, and 58 patients with lamivudine-resistant chronic hepatitis B were randomly put into groups C or D. During the first 12 weeks of the trial, 112 patients in group A and 115 patients in group B received 10 mg of ADV and a placebo once a day; 28 patients in group C received 100 mg of lamivudine (LMV) and 10 mg of ADV; 29 patients in group D received 100 mg of LMV and a placebo once a day.

[Foscarnet sodium for treatment in patients with severe chronic hepatitis B].

Objective: To investigate the effectiveness of foscarnet sodium in the treatment of severe chronic hepatitis B.

Methods: Two hundred and eight patients were enrolled in a multicenter, double-blind, controlled study. The patients received foscarnet sodium (foscarnet group) or saline (control group) injections for 4 weeks, and were then followed for 24 weeks.

[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.