Using Vosevi to treat patients with chronic Hepatitis C who have tried other medications
A Prospective Cohort Study: the Efficacy of Vosevi in Treating Direct Antiviral Agent Therapy Failure Patients
This study is testing if Vosevi can help people with chronic Hepatitis C who haven't had success with other treatments feel better and clear the virus from their system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | The Third Affiliated Hospital of Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06180590 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy of Vosevi, a combination of Sofosbuvir, Velpatasvir, and Voxilaprevir, in treating patients with chronic Hepatitis C who have previously experienced treatment with direct antiviral agents (DAAs). Participants aged 20-70 with persistent HCV-RNA despite prior DAA therapy will receive Vosevi or a combination of Sofosbuvir/Velpatasvir and ribavirin. The study aims to assess the sustained virologic response (SVR) rates among these patients, contributing to the understanding of treatment options for DAA-experienced individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-70 who have previously received direct antiviral agents and still have positive HCV-RNA.
Not a fit: Patients with concurrent infections, significant comorbidities, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for patients with chronic Hepatitis C who have not responded to previous antiviral therapies.
How similar studies have performed: Other studies have shown promising results with similar antiviral combinations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of 20-70 years. * Accepted the standard direct antiviral agent before * HCV-RNA still positive * Patients are administrated with once-daily oral Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir: 400mg/100mg/100mg) or Sofosbuvir/Velpatasvir (400mg/100mg) combined with ribavirin（500mg）twice a day treatment for rescue therapy. * The good compliance of patients. Exclusion Criteria: * Patients with antibodies against HIV, HBV, HDV, concretion or other forms of infectious disease. * Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity. * Concurrent treatment with glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators. * Pregnancy.
Where this trial is running
Guangzhou, Guangdong
- The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xingfei Pan, PhD
- Email: panxf0125@163.com
- Phone: 13662517686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.