NCT07316842

SVR12 in Genotype 3 HCV (F0-F2) Treated With RDV + SOF

Prospective, Single-cohort, Observational Clinical Study Evaluating the Rate of Achieving SVR12 in Patients With Chronic Hepatitis C Genotype 3 With Fibrosis Stage F0-F2 Who Received Ravidasvir + Sofosbuvir Therapy.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Center of target therapy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will follow a group of people with chronic hepatitis C infection of genotype 3 who have mild to moderate liver fibrosis (stages F0-F2, measured by a liver stiffness test). All participants will be receiving the antiviral drugs ravidasvir and sofosbuvir as part of their regular medical care. Only patients who start this treatment, meet the study's eligibility criteria, and give written consent for their medical data to be used in research will take part. They will be monitored during their routine clinic visits while receiving the two-drug therapy. After 8 weeks of treatment, researchers will check how many patients have cleared the virus from their blood. Those who achieve this response will continue to be followed for another 4 and 12 weeks after treatment to see if the virus remains undetectable.

Detailed description

An observational, prospective, single-cohort study will be conducted in patients with chronic hepatitis C virus infection of genotype 3 and fibrosis stage F0-F2 according to the METAVIR score based on liver elastography data, who have initiated antiviral therapy with ravidasvir and sofosbuvir as part of routine clinical practice. Patients who have initiated antiviral therapy with ravidasvir and sofosbuvir, meet the inclusion criteria, and have signed informed consent for the use of their data in scientific research will be enrolled in the study. Patients will be followed in the clinic in accordance with routine medical practice during the course of ravidasvir and sofosbuvir antiviral therapy. After 8 weeks of therapy, the rate of viral eradication in peripheral blood will be determined. Patients who achieve a virological response will continue to be followed to assess the maintenance of virological response at 4 and 12 weeks after completion of antiviral therapy.

Conditions

• Viral Hepatitis C

Timeline

• Start date: 2025-09-17
• Primary completion: 2026-02-02
• Completion: 2026-02-02
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

1 site across 1 country: Russia