Sofosbuvir and velpatasvir

Overview

No overview information available.

Background

No background information available.

Indication

1.用于治疗基因1～6型、混合型及未知型慢性丙型肝炎病毒(HCV) 的成人感染患者。 2.美国FDA批准用于治疗6岁及以上或体重超过17千克的6种基因型（GT-1,-2,-3,-4,-5,-6）的HCV儿童感染者（无肝硬化或轻度肝硬化）。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Hepatitis C Treatment in Idaho County Jails	2024/08/01	NCT06533319	Not Applicable	Not yet recruiting	Eastern Idaho Public Health
Eliminating HCV Infection Among PWUD	2022/07/26	NCT05474781	N/A	Recruiting	Vancouver Infectious Diseases Centre
Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%	2022/03/03	NCT05264558	Phase 4	Completed	Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Therapy for Hepatitis C Virus (HCV) in Primary Treatment Failure in Pakistan	2022/02/21	NCT05248919	Not Applicable	ENROLLING_BY_INVITATION	Queen Mary University of London
SOF/VEL±RBV: Efficacy and Safety in GT 3 and 6 HCV Patients	2021/07/02	NCT04948801	N/A	UNKNOWN	Third Affiliated Hospital, Sun Yat-Sen University
HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial	2020/12/04	NCT04653818	Phase 4	Completed	Alexandria University
A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients	2019/09/03	NCT04075916	Phase 2	Active, not recruiting	University of Pennsylvania
Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil	2019/07/31	NCT04039698	Not Applicable	UNKNOWN	Hospital de Clinicas de Porto Alegre
The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study	2019/06/17	NCT03987503	Phase 4	Completed	University of California, San Francisco
Micro-elimination of Hepatitis C Virus Infection in Uremics	2019/03/27	NCT03891550	Phase 3	UNKNOWN	Kaohsiung Medical University Chung-Ho Memorial Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Sofosbuvir and velpatasvir tablets	GILEAD SCIENCES IRELAND UC	国药准字HJ20180024	化学药品	片剂	1/4/2023

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

AbbVie and Gilead Secure EU Approval for Next-Generation Hepatitis C Therapies Targeting Treatment-Resistant Patients

2 months ago

AbbVie's Maviret and Gilead's Vosevi have received EU approval as pan-genotypic hepatitis C treatments covering all six major genotypes with improved dosing schedules.

Gilead Presents New Liver Disease Research at AASLD 2024

9 months ago

• Gilead Sciences is presenting over 40 abstracts at The Liver Meeting 2024, showcasing new data across various liver diseases. • Data from the RESPONSE trial will highlight the efficacy and safety of seladelpar (Livdelzi) in patients with PBC and compensated cirrhosis. • An interim analysis of the Phase 3 MYR301 study will evaluate the long-term efficacy of bulevirtide monotherapy in chronic HDV patients post-treatment. • Safety and tolerability outcomes for velpatasvir/sofosbuvir (Epclusa) in pregnant individuals with chronic HCV will also be presented.

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