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临床试验/NCT07565948
NCT07565948进行中(未招募)不适用

A Multicenter Study Evaluating the Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir in Chronic Hepatitis C Patients With Relapse After Direct-Acting Antiviral Therapy

Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
Sustained Virologic Response at 12 Weeks After Treatment (SVR12)

研究概览

简要总结

This multicenter study evaluates the effectiveness and safety of a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C who relapsed after prior direct-acting antiviral therapy. The study assesses the rate of sustained virologic response after treatment, along with changes in liver function and overall safety. It also explores whether clinical factors such as liver cirrhosis, viral genotype, and the use of ribavirin influence treatment outcomes, aiming to better define this regimen as a salvage therapy option.

详细描述

Despite the high cure rates achieved with direct-acting antiviral (DAA) therapies, a subset of patients with chronic hepatitis C virus (HCV) infection experience virologic relapse after treatment. Optimal retreatment strategies for these patients, particularly those with advanced liver disease or genotype 3 infection, remain an important clinical concern. This multicenter observational study was conducted across 24 academic centers in Hunan and Shanxi Provinces, China, to evaluate the real-world effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) as a salvage therapy. Adult patients with confirmed chronic HCV infection who relapsed following prior DAA therapy were enrolled and received a 12-week course of SOF/VEL/VOX. The use of ribavirin was permitted at the discretion of the treating physician. Virologic response was assessed by measuring HCV RNA levels during treatment and at 12 weeks after treatment completion to determine sustained virologic response (SVR12). Laboratory parameters, including liver function tests and hematologic indices, were monitored to evaluate treatment response and safety. Subgroup analyses were performed to explore the potential impact of baseline characteristics such as age, sex, liver cirrhosis status, viral genotype, and treatment regimen on treatment outcomes. Safety was assessed by recording adverse events throughout treatment and follow-up. This study aims to provide real-world evidence to support the use of SOF/VEL/VOX as an effective and well-tolerated retreatment option for patients with prior DAA failure, with particular attention to populations that are more difficult to treat.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years at the time of enrollment
  • Confirmed chronic hepatitis C virus (HCV) infection
  • Documented virologic relapse after prior direct-acting antiviral (DAA) therapy
  • Detectable HCV RNA at screening
  • Received or planned to receive a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) as salvage therapy
  • Willing and able to provide written informed consent

排除标准

  • Pregnant or breastfeeding women
  • Participation in another interventional clinical study during the study period

研究组 & 干预措施

Hepatitis C salvage therapy group

结局指标

主要结局

Sustained Virologic Response at 12 Weeks After Treatment (SVR12)

时间窗: 12 weeks after end of treatment

Proportion of participants with undetectable HCV RNA 12 weeks after completion of treatment.

次要结局

  • On-Treatment Virologic Response(During treatment (Week 4 and Week 12))
  • Normalization of Liver Enzymes(Baseline to Week 12 of treatment)
  • Incidence of Adverse Events(From treatment initiation to 12 weeks after end of treatment)

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang Yan

Professor

Xiangya Hospital of Central South University

研究点 (1)

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