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Efficacy and Safety of Besifovir Dipivoxil Maleate Compared With Tenofovir Disoproxil Fumarate in Treatment of Chronic Hepatitis B Virus Infection

Ahn, Sang Hoon ; Kim, Won ; Jung, Young Kul ; [et al.]

Elsevier BV ; 2019

In: Clinical Gastroenterology and Hepatology Vol. 17, No. 9 ( 2019-08), p. 1850-1859.e4

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In: Clinical Gastroenterology and Hepatology, Elsevier BV, Vol. 17, No. 9 ( 2019-08), p. 1850-1859.e4

Type of Medium: Online Resource

ISSN: 1542-3565

URL: Article

DOI: 10.1016/j.cgh.2018.11.001

Language: English

Publisher: Elsevier BV

Publication Date: 2019

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FRI-215-Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: 144 weeks results of phase 3 trial

Yim, Hyung Joon ; Ahn, Sang Hoon ; Kim, Won ; [et al.]

Elsevier BV ; 2019

In: Journal of Hepatology Vol. 70, No. 1 ( 2019-04), p. e489-

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In: Journal of Hepatology, Elsevier BV, Vol. 70, No. 1 ( 2019-04), p. e489-

Type of Medium: Online Resource

ISSN: 0168-8278

URL: Article

DOI: 10.1016/S0618-8278(19)30960-0

Language: English

Publisher: Elsevier BV

Publication Date: 2019

detail.hit.zdb_id: 2027112-8

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

Yim, Hyung Joon ; Kim, Won ; Ahn, Sang Hoon ; [et al.]

Ovid Technologies (Wolters Kluwer Health) ; 2020

In: American Journal of Gastroenterology Vol. 115, No. 8 ( 2020-08), p. 1217-1225

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In: American Journal of Gastroenterology, Ovid Technologies (Wolters Kluwer Health), Vol. 115, No. 8 ( 2020-08), p. 1217-1225

Abstract: 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.

Type of Medium: Online Resource

ISSN: 0002-9270 , 1572-0241

URL: Article

DOI: 10.14309/ajg.0000000000000605

RVK:

XA 18920

Language: English

Publisher: Ovid Technologies (Wolters Kluwer Health)

Publication Date: 2020

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Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial

Song, Do Seon ; Kim, Won ; Ahn, Sang Hoon ; [et al.]

The Korean Association for the Study of the Liver ; 2021

In: Clinical and Molecular Hepatology Vol. 27, No. 2 ( 2021-04-01), p. 346-359

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In: Clinical and Molecular Hepatology, The Korean Association for the Study of the Liver, Vol. 27, No. 2 ( 2021-04-01), p. 346-359

Abstract: Background/Aims: Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus. Our previous 48-week trial revealed that BSV has comparable antiviral efficacy to tenofovir disoproxil fumarate (TDF) and better safety profiles in terms of improved renal and bone safety. This extension study evaluated the prolonged efficacy and safety of BSV in treatment-naive chronic hepatitis B patients.Methods: Patients continued to participate in an open-label BSV study after an initial 48-week double-blind comparison of BSV and TDF treatment. The antiviral efficacy and drug safety was evaluated up to 192 weeks in two groups: patients continuing BSV treatment (BSV-BSV) and patients switching from TDF to BSV after 48 weeks (TDF-BSV).Results: Among 197 patients receiving randomized treatments, 170 (86%) entered the open-label phase and 152 (77%) entered the 192-week extension study. Virological response rates over 192 weeks were 92.50% and 93.06% in the BSV-BSV and TDF-BSV groups, respectively (P=0.90). Hepatitis B envelop antigen seroconversion and alanine aminotransferase normalization rates were similar between the groups (P=0.75 and P=0.36, respectively). There were no drug-resistant mutations to BSV. Bone mineral density and renal function were well preserved in the BSV-BSV group, whereas these initially worsened then recovered after switching therapy in the TDF-BSV group.Conclusions: BSV maintained potent antiviral efficacy after 192 weeks and showed no evidence of drug resistance. BSV was safe, well tolerated, and effective in patients who switched from TDF to BSV. Trial Registration Number: NCT01937806 (date: 10 Sep 2013).

Type of Medium: Online Resource

ISSN: 2287-2728 , 2287-285X

URL: Article

DOI: 10.3350/cmh.2020.0307

Language: English

Publisher: The Korean Association for the Study of the Liver

Publication Date: 2021

detail.hit.zdb_id: 2672531-9

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