Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial. (August 2020)

• Record Type: Journal Article
• Authors: Yim, Hyung Joon; Kim, Won; Ahn, Sang Hoon; Yang, Jin Mo; Jang, Jae Young; Kweon, Yong Oh; Cho, Yong Kyun; Kim, Yoon Jun; Hong, Gun Young; Kim, Dong Joon; Jung, Young Kul; Um, Soon Ho; Sohn, Joo Hyun; Lee, Jin Woo; Park, Sung Jae; Lee, Byung Seok; Kim, Ju Hyun; Kim, Hong Soo; Yoon, Seung Kew; Kim, Moon Young; Lee, Kwan Sik; Lim, Young Suk; Lee, Wan Sik; Han, Kwang-Hyub
• Is Part Of: American journal of gastroenterology. Volume 115:Number 8(2020)
• Publication Date: 2020-08
• Subjects: Stomach -- Diseases -- Periodicals; Intestines -- Diseases -- Periodicals; Gastroenterology -- Periodicals; Gastrointestinal Diseases -- Periodicals; Electronic journals; Periodicals; 616.33
• DOI: 10.14309/ajg.0000000000000605
• Languages: English
• ISSNs: 0002-9270

Abstract

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.