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Hou J.L.,Southern Medical University | Gao Z.L.,Sun Yat Sen University | Xie Q.,Ruijin Hospital | Zhang J.M.,Huashan Hospital | And 22 more authors.
Journal of Viral Hepatitis | Year: 2015

Tenofovir disoproxil fumarate (TDF) has demonstrated long-term efficacy and a high barrier to resistance in multiple chronic hepatitis B (CHB) populations outside of China. This study aimed to evaluate the efficacy and safety of TDF compared with adefovir dipivoxil (ADV) in Chinese patients with CHB during 48 weeks of treatment (ClinicalTrial.gov number, NCT01300234). A Phase 3, multicentred, randomized, double-blind, controlled trial compared the efficacy and safety of TDF with ADV in Chinese patients with CHB. The primary endpoint was the proportion of patients with HBV DNA <400 copies/mL in each treatment group at Week 48, using an unpooled Z-test for superiority. Secondary endpoints included viral suppression, serologic response, histological improvement, normalization of alanine aminotransferase (ALT) levels and the emergence of resistance mutations. A total of 509 patients, 202 hepatitis B e antigen (HBeAg)-positive and 307 HBeAg-negative, with HBV DNA ≥105 copies/mL received either TDF 300 mg od or ADV 10 mg od. At Week 48, TDF demonstrated superior viral suppression compared with ADV in both HBeAg-positive (76.7% vs 18.2%, P < 0.0001) and HBeAg-negative (96.8% vs 71.2%, P < 0.0001) patients. The majority of patients in both treatment arms achieved ALT normalization (>85%). No resistance to TDF was observed. The frequency of adverse events was comparable between treatment arms (TDF 3.9% vs ADV 4.8%). In this double-blind, randomized, clinical trial, TDF demonstrated superiority over ADV with respect to viral suppression in Chinese patients with CHB at 48 weeks of treatment and without the development of resistance. © 2014 John Wiley & Sons Ltd.


Chen J.,Liver Diseases Research Center | Zheng Q.,Liver Diseases Research Center | Jiang J.,Liver Diseases Research Center | Zheng J.,Fujian Medical University
Journal of Central South University (Medical Sciences) | Year: 2012

Objective: To investigate the factors that influence the curative effect in patients with HBeAgpositive chronic hepatitis B (CHB) treated with peg-interferon α-2a, and to explore whether such factors might predict the therapeutic effect. Methods: HBeAg-positive CHB patients treated with peg-interferon α-2a (180 μg once a week) were divided into a standard therapy group (48 weeks) and an extended therapy group (>48 weeks). The rates of HBsAg loss, HBeAg loss, HBeAg seroconversion, HBV DNA clearance, and ALT normalization were all evaluated in the two groups at the end of treatment and after 24 weeks follow up. Results: A total of 81 patients were enrolled in the study. The standard therapy group included 37 patients, and the extended therapy group included 44 cases, with durations ranging from 52 to 92 (median 72) weeks. The baseline clinical data were comparable between the two groups (P>0.05). At the end of treatment and at 24 weeks of follow-up, the HBeAg seroconversion rate of the extended therapy group was significantly higher than that of the standard therapy group (54.5% vs 29.7%, P=0.025, at 24 weeks; 76.9% vs 52.9%, P=0.008, after follow-up). In the standard therapy group, age and half-quantification of HBeAg at 24 weeks of treatment were the predictive factors for HBeAg seroconversion at 24 weeks of follow-up. Using a logistic regression model, the area under the receiver operating characteristic curve was 0.872, taking the optimum cut-off point of -1.299, with 100.0% sensitivity at 66.7% specificity. COX multi-factor analysis (of the two groups) showed that age and therapy duration were predictive factors for HBeAg seroconversion at 24 weeks of follow-up. Conclusion: HBeAg-positive CHB patients treated with peg-interferon a-2a may have a better curative effect at a young age or with extended therapy. Age and half-quantification of HBeAg at 24 weeks of treatment may predict HBeAg seroconversion at 24 weeks of follow-up after completion of the standard therapy.

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