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更新于：2025-08-26
Valganciclovir Hydrochloride
盐酸缬更昔洛韦
更新于：2025-08-26
概要
基本信息
药物类型 小分子化药 |
别名 Cymeval、Valganciclovir、Valganciclovir hydrochloride (JAN/USP) + [21] |
作用方式 抑制剂 |
作用机制 DNA-指导DNA聚合酶抑制剂 |
在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2001-03-29), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (日本)、孤儿药 (韩国) |
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结构/序列
分子式C14H23ClN6O5 |
InChIKeyZORWARFPXPVJLW-MTFPJWTKSA-N |
CAS号175865-59-5 |
关联
113
项与 盐酸缬更昔洛韦 相关的临床试验NCT07138989
Efficacy and Safety of EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent/Metastatic Nasopharyngeal Carcinoma: a Single-center, Single-arm Phase II Trial
NCT06798909
Kidney Transplant Preemptive Therapy or Prophylaxis (KPoP) for CMV Prevention in D+R- Recipients
CTRI/2025/06/088638
Open-label, prospective, multi-center, single-arm, academic clinical trial of oral Valganciclovir (VGCV) as pre-emptive therapy for low-risk cytomegalovirus reactivation following alloHCT in children - VALOR
100 项与 盐酸缬更昔洛韦 相关的临床结果
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100 项与 盐酸缬更昔洛韦 相关的转化医学
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100 项与 盐酸缬更昔洛韦 相关的专利（医药）
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1,931
项与 盐酸缬更昔洛韦 相关的文献（医药）2025-12-31Journal of Pharmaceutical Policy and Practice
Cost-utility and budget impact analyses of valganciclovir for cytomegalovirus retinitis in patients with human immunodeficiency virus in Thailand
Article
作者: Hemapanpairoa, Jatapat ; Kulthanachairojana, Nattanichcha ; Wongwian, Tippawan
Background:
Cytomegalovirus retinitis (CMVR) is an opportunistic infection frequently seen in people living with HIV (PLHIV) and can cause blindness. Intravenous (IV) ganciclovir is a typical CMVR treatment in Thailand, but oral valganciclovir is a more convenient alternative. However, its cost-effectiveness and budget impact remain unclear. Therefore, this study aimed to analyse the cost-utility and budget impact of oral valganciclovir compared with IV ganciclovir for CMVR treatment in PLHIV in Thailand.
Methods:
A hybrid decision tree/Markov model was developed to estimate costs, quality-adjusted life years (QALYs), and life years (LYs). Cost, utility, and probability parameters were obtained from the published literature and national databases. A cost-utility analysis was performed to estimate the incremental cost-effectiveness ratios, whereas a budget impact analysis (BIA) was performed to assess the financial implications. Sensitivity analyses were performed to assess model uncertainty.
Results:
Oral valganciclovir was the dominant treatment, providing higher QALYs (3.50 vs. 3.23) and LYs (4.78 vs. 4.75) and lower total costs (133,630 THB vs. 163,024 THB) than IV ganciclovir. One-way sensitivity analysis revealed that retinal detachment probability, drug cost, and inpatient service cost were the most influential parameters. Probabilistic sensitivity analysis revealed that 94.3% of the simulations placed oral valganciclovir in the dominant quadrant. BIA revealed an annual cost reduction of 6,408,714 THB when replacing IV ganciclovir with oral valganciclovir.
Conclusion:
Oral valganciclovir was cost-effective and demonstrated budget reduction compared with IV ganciclovir. These findings provide valuable insights into enhancing CMVR management and ensuring efficient healthcare resource allocation.
2025-09-01PEDIATRIC TRANSPLANTATION
Letermovir and Tacrolimus Drug–Drug Interaction in a Pediatric Kidney Transplant Patient: A Case Report and Review of the Literature
Review
作者: Haubrich, Kathryn ; Berger, Iona ; Matsuda‐Abedini, Mina
ABSTRACT:
Background:
Cytomegalovirus (CMV) viremia is one of the most common opportunistic infections following solid organ transplant (SOT) in pediatric patients and can be associated with significant morbidity. Valganciclovir is the preferred antiviral medication used for CMV prophylaxis in high‐risk kidney transplant recipients, but its use is limited by myelosuppression. Letermovir is an alternative antiviral medication with lower rates of neutropenia. Letermovir has been implicated in many potential drug–drug interactions, including in combination with tacrolimus.
Methods:
This report describes the case of a 6‐year‐old girl, 2 months post‐kidney transplant, at risk for CMV, who received letermovir for CMV prophylaxis after developing neutropenia while receiving valganciclovir. Her maintenance immunosuppression included tacrolimus. This report describes the drug–drug interaction of letermovir and tacrolimus, the dose adjustments required, and summarizes the available literature on the interaction.
Results:
While on concurrent letermovir and tacrolimus, the patient required a 36% tacrolimus dose reduction and additional therapeutic drug level monitoring.
Conclusion:
This case adds to the current limited data on the interaction of letermovir and tacrolimus in the pediatric SOT population.
2025-09-01INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY
The effect of (val)ganciclovir on hearing in children with congenital cytomegalovirus infection
Article
作者: Keymeulen, Annelies ; Desloovere, Christian ; Boudewyns, An ; Schatteman, Isabelle ; De Leenheer, Els ; Van Hoecke, Helen ; Kuhweide, Rudolf ; Muylle, Marie ; Gilles, Annick ; Dhooge, Ingeborg ; Royackers, Liesbeth ; Verstreken, Margriet ; Acke, Frederic ; De Cuyper, Elise
OBJECTIVES:
To assess the effect of (val)ganciclovir on long-term hearing outcome.
METHODS:
This matched cohort study presents multicentric data of the Flemish CMV registry (Belgium) collected over 16 years. Treated and untreated cCMV-infected children with a minimal four-year audiological follow-up were included. Primary outcome was hearing evolution. Exact matching for risk factors of spontaneous hearing evolution was performed between the treated and untreated group. The average marginal treatment effect was calculated using a pooled regression model.
RESULTS:
Of the 525 children, 98 (18.7 %) were treated. Antiviral therapy did not significantly result in more hearing improvement (RR,1.56; 95 % CI,0.48 to 4.93) or less hearing deterioration (RR,0.89; 95 % CI,0.61 to 1.25). Treatment of children with unilateral congenital hearing loss with valganciclovir for six weeks prevented contralateral late-onset hearing loss compared to untreated children (RR,2.49∗10-8; 95 % CI,9.19∗10-9 to 7.71∗10-8). Similarly, late-onset hearing loss could be prevented in symptomatic children with bilateral normal hearing treated with ganciclovir for six weeks (RR,3.65∗10-7; 95 % CI,2.16∗10-7 to 6.21∗10-7). Prolongation from six weeks to six months showed no beneficial effect on hearing improvement (RR,4.61∗10-8; 95 % CI,1.07∗10-8 to 2.32∗10-7), hearing deterioration (RR,1.21; 95 % CI,0.43 to 2.25), or late-onset hearing loss (RR,1.95; 95 % CI,0.63 to 5.93).
CONCLUSIONS:
(Val)ganciclovir for six weeks prevented late-onset hearing loss. No additional benefit of a six-month therapy was found. These novel findings can aid in treatment decision making. Future studies with a larger sample size and investigation on the effect of valganciclovir on long-term neurological outcome are needed.
100 项与 盐酸缬更昔洛韦 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 |
|---|---|---|---|
| 病毒感染 | 中国 | 2005-12-13 | |
| 获得性免疫缺陷综合征 | 日本 | 2004-11-05 | |
| 巨细胞病毒感染 | 澳大利亚 | 2002-06-17 | |
| 巨细胞病毒视网膜炎 | 美国 | 2001-03-29 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 造血干细胞移植 | 临床3期 | 美国 | 2001-11-01 | |
| HIV感染 | 临床3期 | 加拿大 | 1997-01-01 | |
| 神经性听力损失 | 临床2期 | 美国 | 2018-08-31 | |
| 慢性淋巴细胞白血病 | 临床2期 | 美国 | 2003-09-01 | |
| 人类疱疹病毒8型感染 | 临床2期 | 美国 | 2002-12-01 | |
| 特发性肺纤维化 | 临床1期 | 美国 | 2018-01-03 | |
| 囊性纤维化 | 临床1期 | 美国 | 2004-12-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 137 | 觸窪膚膚製鹹窪齋獵餘(淵壓繭鹽鑰築製窪範構) = 繭鹹襯糧願窪鏇蓋簾糧 範壓淵觸構淵蓋願鹽網 (獵夢顧窪觸簾遞鬱範觸 ) 更多 | 积极 | 2024-06-01 | |||
Valganciclovir | 觸窪膚膚製鹹窪齋獵餘(淵壓繭鹽鑰築製窪範構) = 範鏇製膚選鬱鏇顧繭膚 範壓淵觸構淵蓋願鹽網 (獵夢顧窪觸簾遞鬱範觸 ) 更多 | ||||||
临床3期 | - | Valganciclovir (dose-adjusted for renal clearance) | 襯築淵製醖鏇蓋鑰構醖(網廠鹽鏇窪鏇選艱鬱餘) = 餘襯艱艱壓夢築顧餘鹽 鬱蓋顧襯壓鑰顧壓廠夢 (築獵壓糧繭願繭廠築壓 ) 更多 | 不佳 | 2023-11-30 | ||
N/A | 33 | 夢夢壓簾獵窪網夢窪獵(鹹壓窪蓋衊構窪夢衊鑰) = 積壓窪繭壓鬱製構膚選 觸夢壓淵築獵糧鹹範夢 (積齋膚簾襯鹽膚繭餘廠, 311.24–826.25) | - | 2023-06-15 | |||
AACR2023 人工标引  | 临床1期 | 15 | 鑰憲簾窪艱鏇衊製糧衊(繭築築襯蓋夢繭鬱製鬱) = 願網繭顧糧淵淵簾積衊 糧壓齋襯廠積鏇願夢餘 (鬱鹹構願壓廠夢鏇鹽餘 ) 更多 | 积极 | 2023-04-14 | ||
N/A | 140 | 窪積鹹膚鏇鹽網壓鬱構(鏇顧選繭憲鏇鹹遞構餘) = 簾顧艱鏇網鑰選衊夢願 鹽網鑰壓鹽膚鏇鹹鬱顧 (糧鹹蓋構積窪繭鹹鹽壓 ) 更多 | - | 2023-02-02 | |||
Preemptive therapy | 窪積鹹膚鏇鹽網壓鬱構(鏇顧選繭憲鏇鹹遞構餘) = 繭鬱憲築願願壓簾顧憲 鹽網鑰壓鹽膚鏇鹹鬱顧 (糧鹹蓋構積窪繭鹹鹽壓 ) 更多 | ||||||
临床2期 | 7 | 願夢窪選衊選獵願淵壓 = 壓遞構遞顧積窪觸鹹簾 艱糧膚鬱膚製鏇餘繭繭 (遞衊築願鏇遞製觸築鹽, 鏇齋憲構廠鬱網夢廠選 ~ 鏇簾繭網衊鹹衊衊襯憲) 更多 | - | 2023-01-26 | |||
临床1期 | 31 | (Valganciclovir) | 糧鏇鬱製齋糧遞築艱觸 = 觸鬱壓遞網廠鹽觸衊構 鹽艱襯蓋鏇網鏇觸衊築 (淵觸窪築窪願積範獵壓, 衊鏇觸構襯鹹鹽選繭簾 ~ 淵窪鏇繭糧願選網壓窪) 更多 | - | 2022-04-29 | ||
Placebo (Placebo) | 糧鏇鬱製齋糧遞築艱觸 = 鬱窪簾製鹽醖積鹹鬱積 鹽艱襯蓋鏇網鏇觸衊築 (淵觸窪築窪願積範獵壓, 顧憲蓋膚醖淵醖築廠鑰 ~ 艱鹹築衊淵糧壓鏇艱積) 更多 | ||||||
临床2期 | 54 | Placebo (Placebo) | 鹽鹽範簾顧構壓壓鹹築 = 餘蓋選夢遞夢齋廠衊齋 簾鑰繭淵衊憲範膚繭遞 (襯淵齋鑰窪網鹽襯醖製, 獵鏇鏇糧蓋壓獵鹹遞網 ~ 鏇範願餘獵衊獵夢糧繭) 更多 | - | 2021-06-02 | ||
(Active) | 鹽鹽範簾顧構壓壓鹹築 = 願衊憲築艱淵淵憲餘鹽 簾鑰繭淵衊憲範膚繭遞 (襯淵齋鑰窪網鹽襯醖製, 構糧網膚襯範顧繭窪餘 ~ 艱鹽憲齋積蓋構醖願繭) 更多 | ||||||
临床1期 | 特发性肺纤维化 追加 | 31 | 顧願鑰願壓顧獵構繭衊(醖鹽築觸鹹衊齋廠廠製) = 糧齋憲選選艱築鏇築簾 夢選膚鹽膚夢醖構製簾 (壓鏇簾簾鏇繭構蓋構鑰 ) | - | 2021-03-19 | ||
Placebo | 顧願鑰願壓顧獵構繭衊(醖鹽築觸鹹衊齋廠廠製) = 鏇廠膚網艱範夢壓築襯 夢選膚鹽膚夢醖構製簾 (壓鏇簾簾鏇繭構蓋構鑰 ) | ||||||
临床3期 | 299 | 廠築鑰窪衊醖鹽築構願 = 醖簾簾築鹽夢繭艱範蓋 願鑰憲願鬱積憲蓋憲廠 (壓遞艱衊憲網衊夢範窪, 齋壓願淵製獵積廠範鹹 ~ 膚製餘衊選遞窪鏇糧獵) 更多 | - | 2020-03-11 |
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