The Efficacy of Vosevi in Treating DAA-experienced Patients

Launched by THE THIRD AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Dec 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Vosevi for patients with chronic Hepatitis C who have already tried other antiviral medications but did not achieve the desired results. The goal is to see how effective Vosevi is in helping these patients clear the virus from their bodies and to compare its safety and effectiveness with another treatment that combines Sofosbuvir and Velpatasvir with ribavirin. The researchers will track participants for three years to gather information on how well the treatments work and any side effects.

To be eligible for the trial, participants must be between 20 and 70 years old, have previously received antiviral therapy, and still test positive for the Hepatitis C virus. They should also be able to take the medication as directed. However, people with certain other infections, serious liver disease, or those who are pregnant cannot join. If you participate, you can expect to receive either Vosevi or the combination therapy and will be monitored closely for changes in your health and liver function over the study period.

Gender

ALL

Eligibility 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.