Hepatitis C Virus (HCV)
Conditions
Keywords
Hepatitis C Virus (HCV)
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Xiangya Hospital of Central South University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years at the time of enrollment 2. Confirmed chronic hepatitis C virus (HCV) infection 3. Documented virologic relapse after prior direct-acting antiviral (DAA) therapy 4. Detectable HCV RNA at screening 5. Received or planned to receive a 12-week regimen of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) as salvage therapy 6. Willing and able to provide written informed consent
Exclusion criteria
1. Pregnant or breastfeeding women 2. Participation in another interventional clinical study during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virologic Response at 12 Weeks After Treatment (SVR12) | 12 weeks after end of treatment | Proportion of participants with undetectable HCV RNA 12 weeks after completion of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| On-Treatment Virologic Response | During treatment (Week 4 and Week 12) | Proportion of participants with undetectable HCV RNA during treatment. |
| Normalization of Liver Enzymes | Baseline to Week 12 of treatment | Proportion of participants achieving normalization of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. |
| Incidence of Adverse Events | From treatment initiation to 12 weeks after end of treatment | Frequency and type of adverse events observed during treatment and follow-up. |
Countries
China
Contacts
STUDY_DIRECTORHuang Yan, Professor
Xiangya Hospital of Central South University
Outcome results
None listed