Dataset Information

Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial.

ABSTRACT:

Introduction

Chronic hepatitis B (CHB) remains a major worldwide public health concern. Besifovir dipivoxil maleate (BSV) is a new promising treatment for CHB. However, long-term efficacy and safety have not yet been evaluated. Therefore, the goal of the study is to determine the antiviral efficacy and safety of BSV treatment over a 144-week duration (BSV-BSV) in comparison with those of a sequential treatment with tenofovir disoproxil fumarate (TDF) followed by a 96-week duration BSV administration (TDF-BSV).

Methods

After 48 weeks of a double-blind comparison between BSV and TDF treatments, patients continued the open-label BSV study. We evaluated antiviral efficacy and drug safety up to 144 weeks for BSV-BSV and TDF-BSV groups. The primary endpoint was a virological response (hepatitis B virus DNA < 69 IU/mL).

Results

Among the 197 patients enrolled, 170 and 158 patients entered the second-year and third-year open-label phase extensional study, respectively, whereas 153 patients completed the 144-week follow-up. The virological response rate over the 144-week period was 87.7% and 92.1% in BSV-BSV and TDF-BSV groups, respectively (P = 0.36). The rates of ALT normalization and HBeAg seroconversion were similar between the groups. No drug-resistant mutations to BSV were noted. Bone mineral density and renal function were well preserved in the BSV-BSV group and were significantly improved after switching therapy in TDF-BSV patients.

Discussion

This extensional study of a phase 3 trial (NCT01937806) suggests that BSV treatment is efficacious and safe for long-term use in treatment-naïve and TDF-experienced patients with CHB.

SUBMITTER: Yim HJ

PROVIDER: S-EPMC7402376 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Publications

Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial.

Yim Hyung Joon HJ Kim Won W Ahn Sang Hoon SH Yang Jin Mo JM Jang Jae Young JY Kweon Yong Oh YO Cho Yong Kyun YK Kim Yoon Jun YJ Hong Gun Young GY Kim Dong Joon DJ Jung Young Kul YK Um Soon Ho SH Sohn Joo Hyun JH Lee Jin Woo JW Park Sung Jae SJ Lee Byung Seok BS Kim Ju Hyun JH Kim Hong Soo HS Yoon Seung Kew SK Kim Moon Young MY Lee Kwan Sik KS Lim Young Suk YS Lee Wan Sik WS Han Kwang-Hyub KH

The American journal of gastroenterology 20200801 8

<h4>Introduction</h4>Chronic hepatitis B (CHB) remains a major worldwide public health concern. Besifovir dipivoxil maleate (BSV) is a new promising treatment for CHB. However, long-term efficacy and safety have not yet been evaluated. Therefore, the goal of the study is to determine the antiviral efficacy and safety of BSV treatment over a 144-week duration (BSV-BSV) in comparison with those of a sequential treatment with tenofovir disoproxil fumarate (TDF) followed by a 96-week duration BSV ad ...[more]

PMID: 32355123

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Dataset Information

Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial.

Introduction

Methods

Results

Discussion

Publications

Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial.

Similar Datasets

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