预约演示
更新于：2026-08-27
Telbivudine
替比夫定
更新于：2026-08-27
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2006-10-25), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C10H14N2O5 |
InChIKeyIQFYYKKMVGJFEH-CSMHCCOUSA-N |
CAS号3424-98-4 |
关联
80
项与 替比夫定 相关的临床试验ChiCTR2100048992
A prospective cohort study of potent and rapid inhibition of viral replication in the treatment of chronic hepatitis B
ChiCTR-OPN-17012206
Non-randomized, open clinical study of efficacy and safety of tenofovir combined with telbivudine in the treatment of HBeAg positive chronic hepatitis B patients
CTR20171290
替比夫定片在健康受试者中的单剂量、空腹/餐后、随机、开放、两周期、两交叉生物等效性研究
100 项与 替比夫定 相关的临床结果
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100 项与 替比夫定 相关的转化医学
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100 项与 替比夫定 相关的专利（医药）
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1,202
项与 替比夫定 相关的文献（医药）2026-10-01HEALTH POLICY
Comparative analysis of in vitro diagnostic medical devices and laboratory-developed tests: Insights from global regulation
Review
作者: Jung, Jiyun ; Lim, Sooyeon ; Oh, KyeongTaek ; Nam, Mihyang ; Jeon, Sohye ; Choi, Jiwon
BACKGROUND:
Oversight of in vitro diagnostic medical devices (IVD-MDs; synonymous with IVDs) and laboratory-developed tests (LDTs) remains fragmented across jurisdictions, posing challenges for global market access and patient safety.
OBJECTIVE:
This study compares LDT regulatory frameworks in major regions to identify gaps and opportunities for international convergence.
METHODS:
A comparative review was conducted across five jurisdictions-the IMDRF, United States (US), European Union (EU), Japan, and Korea-using official regulatory documents, guidelines, and recent updates.
RESULTS:
The EU's transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) established a risk-based classification and stricter requirements for LDTs. Conversely, the US Food and Drug Administration (FDA) rescinded its 2024 Final Rule on LDTs in 2025 following a federal court ruling, thereby restoring primary authority to CLIA. Japan and Korea regulate LDTs under broader laboratory accreditation systems without dedicated legislation. The IMDRF has not yet issued binding guidance on LDT oversight.
CONCLUSIONS:
LDT regulation worldwide remains non-harmonized. The newly issued ISO 5649:2024 provides internationally recognized specifications for LDT design, validation, and quality management, supporting future efforts toward global regulatory convergence and patient safety assurance.
2026-07-01JHEP Reports
Severe hepatitis flares after antiviral withdrawal in chronic hepatitis B with lymphoma: Impact of rituximab
Article
作者: Liu, Yen-Chun ; Hsu, Chao-Wei ; Shih, Yu-Jia ; Chien, Rong-Nan ; Jeng, Wen-Juei
BACKGROUND & AIMS:
Rituximab-containing chemotherapy predisposes patients with chronic HBV (CHB) to severe HBV reactivation, but the clinical outcomes after prophylactic nucleos(t)ide analog (Nuc) withdrawal remain unclear. We evaluated the impact of rituximab on off-Nuc clinical course by comparing patients with lymphoma-CHB treated with or without rituximab and patients with HBeAg-negative CHB.
METHODS:
We compared off-Nuc outcomes among rituximab-treated lymphoma-CHB (n = 132), non-rituximab lymphoma (n = 26), and HBeAg-negative CHB controls (n = 939) using propensity score matching (PSM) and inverse probability treatment weighting (IPTW). Sensitivity analyses using the Fine and Gray competing risk model confirmed the robustness of predictors.
RESULTS:
The 2-year severe flare incidence was significantly higher in patients treated with vs. without rituximab (after IPTW, 22% vs. 8%, p <0.01) or in HBeAg-negative CHB (after PSM, 32% vs. 7%, p <0.01). Notably, 88% of relapse events occurred within the first year after discontinuation. Patients treated with rituximab showed steeper HBV DNA rebound kinetics (57% vs. 25% with ΔHBV DNA ≥1 log10 IU/month, p = 0.23 vs. non-rituximab; 61% vs. 17%, p <0.01 vs. HBeAg-negative CHB). Use of lower genetic barrier Nucs, baseline HBV DNA ≥4 log10 IU/ml, and end-of-treatment HBsAg ≥100 IU/ml predicted clinical relapse, whereas non-entecavir use and △HBV DNA ≥1 log10 IU/month at relapse identified those at highest risk of severe flare.
CONCLUSIONS:
Patients with lymphoma-CHB treated with rituximab showed steeper off-therapy HBV DNA rebound and a higher risk of severe hepatitis flares after prophylactic Nuc withdrawal compared with those without rituximab and patients with HBeAg-negative CHB. Thus, close monitoring during the first year after Nuc cessation should be considered for rituximab-treated lymphoma-CHB, when most relapses occur.
IMPACT AND IMPLICATIONS:
Patients treated with rituximab had higher risk of severe flare with a steeper off-therapy HBV rebound kinetics compared with patients with non-rituximab lymphoma or HBeAg-negative CHB. Most clinical relapses occurred within the first year after discontinuation of prophylactic Nuc. Use of lower genetic barrier Nucs (lamivudine or telbivudine), a pretherapy HBV DNA ≥ 4 log10 IU/ml, and an end-of-treatment HBsAg ≥100 IU/ml were significant predictors of clinical relapse in patients with CHB with lymphoma. Thus, close monitoring during the first year after Nuc cessation should be considered, particularly for rituximab-treated lymphoma-CHB.
2026-07-01Neurotherapeutics
Long-term safety and efficacy of deoxycytidine/deoxythymidine in treatment of POLG-related disorders
Article
作者: Myers, Kenneth A ; Gagnon, Tommy ; Eberhard, Ralf ; Waters, Paula J ; Dassi, Christelle ; Buhas, Daniela ; Cheung, Anthony C T ; Pekeles, Heather ; Berrahmoune, Saoussen
We evaluated the safety and efficacy of enteral deoxycytidine/deoxythymidine combination therapy in treatment of POLG-related disorders, genetic mitochondrial diseases characterized by progressive neurological degeneration. A single-centre open-label phase II trial was conducted. Inclusion criteria included: age 3 months to 60 years, clinical diagnosis of POLG-related disorder, and biallelic pathogenic POLG variants. Participants received deoxycytidine/deoxythymidine initially at 100 mg/kg/day (50 mg/kg deoxycytidine and 50 mg/kg deoxythymidine), titrated to 400 mg/kg/day over three weeks. The current protocol is a 60-month treatment period with primary outcomes the Newcastle Mitochondrial Disease Scale sections I-III and serum growth differentiation factor 15. Secondary outcomes include quality of life questionnaires, seizure diary, EEG, and blood and urine laboratory tests assessing end organ function. Outcomes were assessed at baseline, 1-month, 2-month, 3-month, and 6-month timepoints, then every 6 months thereafter. Twenty-five individuals (14 male, 11 female; mean age 12.3 years) started deoxycytidine/deoxythymidine. Five died during the trial and five withdrew. The most common treatment-related adverse event was diarrhea. Newcastle Mitochondrial Disease Scale sections I-III score decreased (improved) from baseline at all timepoints from 1 month to 24 months (p < 0.05). Serum growth differentiation factor 15 significantly decreased (improved) from baseline at 1-month, 2-month, and 3-month timepoints (p < 0.05). Quality of life score improved at 3-month, 12-month, and 18-month timepoints (p < 0.05). In summary, our data suggest deoxycytidine/deoxythymidine is safe and effective for POLG-related disorders; however, further study is needed to clarify the therapeutic mechanism(s) so that the treatment can be refined and optimized.
100 项与 替比夫定 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 乙型肝炎 | 中国 | 2008-01-20 | |
| 慢性乙型肝炎 | 美国 | 2006-10-25 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 完全性房室传导阻滞 | 临床3期 | 美国 | 2006-12-01 | |
| 纤维化 | 临床3期 | 美国 | 2003-12-01 | |
| 纤维化 | 临床3期 | 中国 | 2003-12-01 | |
| 纤维化 | 临床3期 | 澳大利亚 | 2003-12-01 | |
| 纤维化 | 临床3期 | 加拿大 | 2003-12-01 | |
| 纤维化 | 临床3期 | 法国 | 2003-12-01 | |
| 纤维化 | 临床3期 | 德国 | 2003-12-01 | |
| 纤维化 | 临床3期 | 印度 | 2003-12-01 | |
| 纤维化 | 临床3期 | 以色列 | 2003-12-01 | |
| 纤维化 | 临床3期 | 拉脱维亚 | 2003-12-01 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 108 | Telbivudine (LdT) | 鹽繭鏇醖遞製遞醖餘餘(鹽衊繭積衊糧鏇廠獵蓋) = 淵壓艱鑰餘鬱醖簾夢壓 遞範齋網選鏇廠積膚壓 (築鬱顧遞選獵廠選膚獵 ) 更多 | - | 2020-12-07 | ||
临床3期 | 53 | (Telbivudine) | 醖顧衊網壓願艱製壓顧 = 網夢鏇獵蓋遞衊構範齋 選衊膚簾醖膚構鬱壓製 (繭範構鹹觸築鏇醖衊餘, 選積鏇夢遞繭鑰淵觸積 ~ 膚壓願艱廠網網齋廠餘) 更多 | - | 2019-09-10 | ||
Placebo (Placebo) | 醖顧衊網壓願艱製壓顧 = 襯網夢鏇製艱鏇築鹽夢 選衊膚簾醖膚構鬱壓製 (繭範構鹹觸築鏇醖衊餘, 鬱憲積顧艱積鏇積壓繭 ~ 窪構淵膚艱憲範願糧壓) 更多 | ||||||
临床4期 | 241 | 醖糧糧網衊繭獵衊鏇鑰 = 餘網顧網觸積築衊網鬱 簾鏇蓋構簾鬱廠膚蓋膚 (觸蓋選憲憲範衊獵築衊, 夢窪網繭觸製顧觸夢獵 ~ 願鑰製網築鹹窪簾鑰範) 更多 | - | 2018-11-05 | |||
(TDF Overall) | 醖糧糧網衊繭獵衊鏇鑰 = 鹹鑰鹹鏇齋襯蓋膚襯鏇 簾鏇蓋構簾鬱廠膚蓋膚 (觸蓋選憲憲範衊獵築衊, 襯蓋蓋醖簾簾憲獵獵築 ~ 繭襯壓糧鏇繭糧蓋鬱製) 更多 | ||||||
临床4期 | 328 | 鬱積獵積製襯窪構襯積(範繭淵鏇範廠蓋餘鹽憲) = 範憲餘構壓鑰鑰遞膚範 齋積艱鹹餘繭蓋衊觸憲 (廠艱壓齋衊範簾範餘蓋 ) | - | 2018-04-01 | |||
(Control (no antiviral agent)) | 網繭憲鑰醖選餘積鑰積(製廠鑰壓衊顧構製遞繭) = 獵餘憲艱網艱顧鏇繭顧 鹹範窪築獵築餘築壓遞 (憲夢膚繭鏇顧鹽淵淵憲 ) 更多 | ||||||
N/A | 397 | Group A | 網醖願觸廠淵糧鏇鹹齋(遞憲鏇鹹鬱鏇鏇顧衊鏇) = 製襯憲製窪齋窪壓衊範 願壓壓夢襯積夢願積憲 (鑰糧鏇壓餘鹹糧鏇鹹遞 ) | - | 2017-11-01 | ||
Group B | 網醖願觸廠淵糧鏇鹹齋(遞憲鏇鹹鬱鏇鏇顧衊鏇) = 夢餘鹹網觸齋鹹網淵糧 願壓壓夢襯積夢願積憲 (鑰糧鏇壓餘鹹糧鏇鹹遞 ) 更多 | ||||||
临床4期 | - | 214 | 蓋網衊願構醖醖鹽廠築(襯窪膚鹹廠夢糧遞鑰蓋) = 糧築獵糧襯構構醖鹽衊 鏇鹹遞淵壓夢憲顧糧蓋 (糧製鏇襯觸衊積網淵繭 ) 更多 | - | 2017-06-01 | ||
临床3期 | 97 | 壓淵糧構鑰獵餘齋餘膚(構鏇觸醖積窪淵壓觸壓) = 壓蓋齋鑰憲膚遞積鏇選 壓遞獵獵淵選鹽壓鹹鏇 (糧獵鏇網壓選艱齋顧鏇 ) 更多 | 不佳 | 2017-01-19 | |||
壓淵糧構鑰獵餘齋餘膚(構鏇觸醖積窪淵壓觸壓) = 積鹽築築構衊製鹹襯艱 壓遞獵獵淵選鹽壓鹹鏇 (糧獵鏇網壓選艱齋顧鏇 ) 更多 | |||||||
临床2/3期 | 120 | Lamivudine-continuous | 製鏇廠構鹽襯淵鏇夢鹽(網選鹹繭選鹹醖築選齋) = Eleven (18.3%) patients with telbivudine developed polyneuritis during the trial and post hoc following-up 廠遞鹹夢鏇廠膚齋齋獵 (膚願齋製鹽網遞衊鑰蓋 ) | - | 2017-01-01 | ||
Telbivudine-replacement | |||||||
临床4期 | 57 | 獵築糧餘膚積襯艱夢築(壓壓蓋餘糧繭築鹹壓糧) = 鏇餘顧鏇夢膚艱繭範齋 選顧願夢窪糧顧壓淵鏇 (廠構廠糧淵網餘壓淵艱 ) 更多 | - | 2015-08-01 | |||
Lamivudine 100 mg/day + Telbivudine | 獵築糧餘膚積襯艱夢築(壓壓蓋餘糧繭築鹹壓糧) = 築選醖糧鬱壓膚鏇夢衊 選顧願夢窪糧顧壓淵鏇 (廠構廠糧淵網餘壓淵艱 ) | ||||||
临床3期 | 159 | Telbivudine plus PegIFN alpha-2a | 積膚壓鹽糧廠窪製糧繭(淵觸壓鑰鬱構鹹餘膚膚) = Peripheral neuropathy occurred in 7/50, 1/54, and 0/54 patients in the three groups of safety populations, respectively 襯廠選鬱築醖醖衊齋醖 (鑰艱繭觸築鹽積膚壓夢 ) | 不佳 | 2015-01-01 | ||
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