Continuing besifovir dipivoxil maleate versus switching from tenofovir disoproxil fumarate for treatment of chronic hepatitis B: Results of 192-week phase 3 trial
| Autor: | Kyun-Hwan Kim, Hyung Joon Yim, Kwan Sik Lee, Gun Young Hong, Sang Hoon Ahn, Young-Suk Lim, Byung Seok Lee, Yoon Jun Kim, Jin-Woo Lee, Do Seon Song, Joo Hyun Sohn, Ju-Hyun Kim, Jae Young Jang, Yong Kyun Cho, Moon Young Kim, Hong Soo Kim, Soon Ho Um, Young Kul Jung, Dong Joon Kim, Sung Jae Park, Won Kim, Wan Sik Lee, Young Oh Kweon, Kwang Hyub Han, Jin Mo Yang, Seung Kew Yoon |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Drug Hepatitis B virus medicine.medical_specialty Guanine Tenofovir media_common.quotation_subject Organophosphonates Renal function Drug resistance medicine.disease_cause Antiviral Agents Gastroenterology Nephrotoxicity 03 medical and health sciences Hepatitis B Chronic 0302 clinical medicine Internal medicine Bone mineral density medicine Humans lcsh:RC799-869 Seroconversion Molecular Biology media_common Hepatology business.industry Maleates Hepatitis B medicine.disease Besifovir 030104 developmental biology lcsh:Diseases of the digestive system. Gastroenterology Original Article 030211 gastroenterology & hepatology business medicine.drug |
| Zdroj: | Clinical and Molecular Hepatology Clinical and Molecular Hepatology, Vol 27, Iss 2, Pp 346-359 (2021) |
| ISSN: | 2287-285X 2287-2728 |
| DOI: | 10.3350/cmh.2020.0307 |
| Popis: | Background/aims Besifovir dipivoxil maleate (BSV), an acyclic nucleotide phosphonate, shows potent antiviral activity against hepatitis B virus (HBV). 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: September 10, 2013). |
| Databáze: | OpenAIRE |
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