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Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial.
- Source :
-
Journal of Viral Hepatitis . Feb2015, Vol. 22 Issue 2, p83-93. 9p. - Publication Year :
- 2015
-
Abstract
- 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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 13520504
- Volume :
- 22
- Issue :
- 2
- Database :
- Academic Search Index
- Journal :
- Journal of Viral Hepatitis
- Publication Type :
- Academic Journal
- Accession number :
- 100488337
- Full Text :
- https://doi.org/10.1111/jvh.12313