Delving into the Latest Updates on Alfosbuvir with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Herbuvir, Holybuvir, 和乐布韦

+ [3]

Target

NS5B polymerase

Mechanism

NS5B polymerase inhibitors(Hepatitis C virus NS5B RNA-dependent RNA polymerase inhibitors)

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis C, Chronic

Inactive Indication-

Originator Organization

Nanjing Sanhome Pharmaceutical Co. Ltd.

Active Organization

Nanjing Sanhome Pharmaceutical Co. Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (12 May 2023),

Hepatitis C, Chronic

RegulationSpecial Review Project (CN), Priority Review (CN)

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Structure

Molecular FormulaC28H33FN3O9P

InChIKeyAGNGNQMSDCXIGL-HDXCYPIWSA-N

CAS Registry2236586-64-2

1.主要目的：评价SH229片在轻度肝功能损害（Child-Pugh A）、中度肝功能损害（Child-Pugh B）和肝功能正常受试者中的药代动力学，为SH229片的临床应用提供依据。 2.次要目的：评价SH229片在轻度肝功能损害（Child-Pugh A）、中度肝功能损害（Child-Pugh B）和肝功能正常受试者中的安全性。

[Translation]

1. Primary objective: To evaluate the pharmacokinetics of SH229 tablets in subjects with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B) and normal hepatic function, and to provide a basis for the clinical application of SH229 tablets. 2. Secondary objective: To evaluate the safety of SH229 tablets in subjects with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B) and normal hepatic function.

Start Date23 Apr 2020

Sponsor / Collaborator

Nanjing Sanhome Pharmaceutical Co. Ltd.

CTR20182539 / CompletedPhase 2/3

评价SH229片联合盐酸达拉他韦片治疗慢性丙型肝炎成人患者的疗效和安全性的开放性、多中心II/III期临床研究

[Translation] An open, multicenter phase II/III clinical study to evaluate the efficacy and safety of SH229 tablets combined with daclatasvir hydrochloride tablets in the treatment of adult patients with chronic hepatitis C

1.探索不同剂量的SH229片联合固定剂量的盐酸达拉他韦（DCV）片治疗12周对慢性丙型肝炎成人患者的疗效和安全性，为药物III期临床试验设计和实施提供依据；2.确证SH229片联合盐酸达拉他韦（DCV）片治疗12周对慢性丙型肝炎成人患者的疗效和安全性，为药物上市注册申请和临床使用提供充分依据。

[Translation]

1. To explore the efficacy and safety of different doses of SH229 tablets combined with a fixed dose of daclatasvir hydrochloride (DCV) tablets for 12 weeks in adult patients with chronic hepatitis C, and provide a basis for the design and implementation of the Phase III clinical trial of the drug; 2. To confirm the efficacy and safety of SH229 tablets combined with daclatasvir hydrochloride (DCV) tablets for 12 weeks in adult patients with chronic hepatitis C, and provide sufficient basis for drug registration application and clinical use.

Start Date29 Mar 2019

Sponsor / Collaborator

Nanjing Sanhome Pharmaceutical Co. Ltd.

NCT04070235 / Unknown statusPhase 2/3

A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C

Phase II: Exploring the efficacy and safety of different doses of SH229 tablets combined with fixed-dose Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials.
Phase III: Confirmation of the efficacy and safety of SH229 tablets combined with Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.

Start Date29 Mar 2019

Sponsor / Collaborator

Nanjing Sanhome Pharmaceutical Co. Ltd.

100 Clinical Results associated with Alfosbuvir

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100 Translational Medicine associated with Alfosbuvir

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100 Patents (Medical) associated with Alfosbuvir

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3

Literatures (Medical) associated with Alfosbuvir

01 Nov 2023·Infectious Diseases and Therapy

Alfosbuvir plus Daclatasvir for Treatment of Chronic Hepatitis C Virus Infection in China

Article

Author: Jiang, Yongfang ; Xie, Wen ; Zhu, Liying ; Ma, Hong ; Shi, Xinsheng ; Wang, Jiefei ; Wen, Xiaofeng ; Deng, Guojiong ; Guan, Yujuan ; Zhao, Yingren ; Hua, Rui ; Li, Dongliang ; Yan, Xuebing ; Li, Guangming ; Wei, Lai ; Mao, Qing ; Mao, Xiaorong ; Meng, Chenxin ; Rao, Huiying ; Sun, Tong ; Chen, Jiayu ; Ma, Yingjie ; Gao, Hainv ; Xin, Yongning ; Yang, Dongliang ; Xu, Bin ; Lian, Jianqi ; Niu, Junqi ; Min, Jie ; Kong, Fei ; Huang, Yan ; Wang, Yifei ; Xiong, Qingfang ; Ye, Yinong ; Su, Minghua ; Wang, Xiaozhong ; Yang, Xingxiang ; Han, Xueji ; Tan, Youwen ; Zhang, Yuexin ; Zhang, Xiaomeng

INTRODUCTIONA pan-genotypic and effective treatment regimen for patients with chronic hepatitis C virus (HCV) infection remains an unmet medical need in China. Alfosbuvir is a novel potent HCV NS5B polymerase inhibitor in development for the treatment of chronic HCV infection. We conducted a phase 3 study to evaluate the efficacy and safety of alfosbuvir in combination with daclatasvir in Chinese patients with HCV infection.METHODSAll patients received 600 mg alfosbuvir tablets plus 60 mg daclatasvir tablets once daily for 12 weeks. The primary endpoint was sustained virological response 12 weeks after the end of treatment (SVR12). A follow-up visit was done at week 4 and 12, and those who achieved SVR12 were followed up at post-treatment week 24.RESULTSOf the 326 patients who received at least one dose of the study drug, 320 (98.2% [95% confidence interval (CI): 96.5%-99.5%]) achieved sustained virological response at post-treatment week 12 (SVR12), which was superior to the historical SVR12 rate of 88% (p < 0.0001). The SVR12 rates were similar regardless of most baseline characteristics. The most common adverse event (AE) (≥ 10%) was hypercholesterolemia. Serious adverse events (SAEs) were reported in 25 (7.7%) patients, none of which was judged to be related to the study drug. The majority of AEs were mild to moderate in severity.CONCLUSIONSAlfosbuvir plus daclatasvir for 12 weeks was highly effective and safe in Chinese patients infected with HCV genotype 1, 2, 3, or 6, suggesting that this regimen could be a promising option for HCV treatment in China irrespective of genotype.TRIAL REGISTRATIONClinicalTrial.gov identifier, NCT04070235.

01 Jun 2022·Journal of Viral HepatitisQ2 · MEDICINE

Efficacy and safety of alfosbuvir plus daclatasvir in Chinese patients with hepatitis C virus genotypes 1, 2, 3, and 6 infection: An open‐label, phase 2 study

Q2 · MEDICINE

Article

Author: Gao, Hainv ; Ma, Hong ; Xin, Yongning ; Guan, Yujuan ; Wu, Qiong ; Niu, Junqi ; Zhang, Yuexin ; Kong, Fei ; Zhang, Xian ; Xiong, Qingfang ; Li, Guangming ; Zhao, Liwen ; Xu, Bin ; Tan, Youwen ; Huang, Yan ; Hua, Rui ; Jiang, Yongfang ; Meng, Chenxin ; Wang, Jiefei ; Li, Cheng ; Wen, Xiaofeng ; Wang, Zhiqiang ; Mao, Xiaorong ; Chen, Jiayu

AbstractAlfosbuvir is a novel potent HCV NS5B polymerase inhibitor in development for the treatment of chronic HCV infection. Our previous studies indicated that alfosbuvir monotherapy was well‐tolerated and druggable in healthy subjects and HCV‐infected patients. Here, we evaluate the efficacy and safety of alfosbuvir in combination with daclatasvir in Chinese patients with HCV genotype 1, 2, 3 or 6. In this open‐label study, patients with chronic HCV infection were randomly assigned with a 1:1:1 ratio to receive 12 weeks of daclatasvir 60 mg plus alfosbuvir at a dose of 400, 600 or 800 mg (Cohort A, B or C) daily. Randomization was stratified by HCV genotype and the presence or absence of cirrhosis at screening. The primary endpoint was a sustained virologic response 12 weeks after the end of treatment (SVR12). A total of 124 patients were enrolled in the study, all of whom were available for post‐treatment week 12 assessments. SVR12 was achieved in 92.7% (38/41), 95.2% (40/42) and 100% (41/41) of patients in Cohort A, B and C respectively. The most common adverse events were hepatic steatosis, upper respiratory tract infection, hypercholesterolaemia, hypertriglyceridaemia, blood bilirubin increased, and total bile acids increased. There were no discontinuations due to adverse events, and no treatment‐related serious adverse events were reported. Once‐daily oral administration of alfosbuvir plus daclatasvir were highly effective and safe in Chinese patients infected with HCV genotype 1, 2, 3 or 6, suggesting this regimen could be a promising drug candidate for HCV treatment irrespective of genotype.(ClinicalTrials.gov number, NCT04070235).

Antimicrobial Agents and Chemotherapy

Single-Ascending-Dose, Food-Effect, and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of the Pangenotypic Anti-Hepatitis C Virus Drug Holybuvir in Healthy Chinese Subjects

Article

Author: Wu, Junzhen ; Zhang, Wenhong ; Cao, Yuran ; Wang, Zhiqiang ; Yang, Haijing ; Huang, Yuxian ; Cao, Guoying ; Zhang, Jing ; Yu, Jicheng ; Wang, Jingjing ; Wu, Xiaojie

Holybuvir is a novel pangenotypic hepatitis C virus NS5B inhibitor. This first in-human study aimed to evaluate the pharmacokinetics (PK), safety, and tolerability of holybuvir and its metabolites and the effect of food on the PK of holybuvir and its metabolites in healthy Chinese subjects.

100 Deals associated with Alfosbuvir

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis C, Chronic	CN	Nanjing Sanhome Pharmaceutical Co. Ltd.	12 May 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04070235 (phase 3 study, Pubmed \| Infect Dis Ther)	Phase 3	Hepatitis C, Chronic	326	Alfosbuvir 600 mg	(kfnxcekulk) = fucfrryzec njlcretorp (rtxplvgdmz, 96.5% - 99.5)	Positive	01 Nov 2023
NCT04070235 (Pubmed \| J Viral Hepat)	Phase 2	Hepatitis C	124	Daclatasvir 60 mg + Alfosbuvir 400 mg	(qqvxtdnhth) = yfjmupquvx cobzirftax (iwvkkmtzko )	Positive	26 Jan 2022
NCT04070235 (Pubmed \| J Viral Hepat)	Phase 2	Hepatitis C	124	Daclatasvir 60 mg + Alfosbuvir 600 mg	(qqvxtdnhth) = hcshywkseh cobzirftax (iwvkkmtzko )	Positive	26 Jan 2022
SH229 (EASL2021)	Phase 3	Hepatitis C, Chronic	327	SH229 plus daclatasvir	oqjrtolhfl(ayptzjcnee) = mnipigmzhc bphsxudnio (dotigdnubx, 96.5% - 99.5%)	Positive	23 Jun 2021
SH229 plus daclatasvir (EASL2020)	Phase 2	Hepatitis C, Chronic	124	SH229 400 mg + Daclatasvir 60 mg	fwbdmmbnaj(flinbucfqi) = ulsibeterf ekehvkvlab (dotppptsvr ) View more	Positive	27 Aug 2020
SH229 plus daclatasvir (EASL2020)	Phase 2	Hepatitis C, Chronic	124	SH229 600 mg + Daclatasvir 60 mg	fwbdmmbnaj(flinbucfqi) = hszezeshsh ekehvkvlab (dotppptsvr ) View more	Positive	27 Aug 2020