한빛사논문
- 조회1,374
Hyung Joon Yim, MD1, Won Kim, MD2, Sang Hoon Ahn, MD3, Jin Mo Yang, MD4, Jae Young Jang, MD5, Yong Oh Kweon, MD6, Yong Kyun Cho, MD7, Yoon Jun Kim, MD8, Gun Young Hong, MD9, Dong Joon Kim, MD10, Young Kul Jung, MD1, Soon Ho Um, MD1, Joo Hyun Sohn, MD11, Jin Woo Lee, MD12, Sung Jae Park, MD13, Byung Seok Lee, MD14, Ju Hyun Kim, MD15, Hong Soo Kim, MD16, Seung Kew Yoon, MD17, Moon Young Kim, MD18, Kwan Sik Lee, MD3, Young Suk Lim, MD19, Wan Sik Lee, MD20 and Kwang-Hyub Han, MD3,*
1Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea;
2Department of Internal Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Boramae Medical Center, Seoul, Korea;
3Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea;
4Department of Internal Medicine, Catholic University Medical College St. Vincent, Suwon, Korea;
5Department of Internal Medicine, College of Medicine, Soonchunhyang University, Seoul, Korea;
6Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea;
7Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea;
8Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea;
9Department of Internal Medicine, Gwangju Christian Hospital, Gwangju, Korea; 10Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea;
11Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea;
12Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea;
13Department of Internal Medicine, Paik Hospital, Inje University, Busan, Korea;
14Department of Gastroenterology and Hepatology, Chungnam National University School of Medicine, Daejeon, Korea;
15Department of Internal Medicine, Gacheon University College of Medicine, Incheon, Korea;
16Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea;
17Department of Internal Medicine, Catholic University of Korea, Seoul, Korea;
18Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea;
19Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea;
20Department of Internal Medicine, Chonnam University Medical School, Gwangju, Korea.
*Correspondence: Kwang-Hyub Han
Abstract
OBJECTIVES: 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 openlabel 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 TDFBSV 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-na¨ıve and TDF-experienced patients with CHB.
논문정보
- Research article
- 2020년 05월 (BRIC 등록일 2020-06-11)
- 국내 연구진
- 의약학 > 응용의학
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