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

NCT07316842 | Active Not Recruiting

• 1 other identifier: CTT-004
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Viral Hepatitis C

Keywords

Ravidasvir; Sofosbuvir

Outcome Measures

Primary Outcomes (1)

• Evaluation of the rate of achieving sustained virological response (SVR12)

  Absence of detectable hepatitis C virus (HCV) RNA in a patient's blood 12 weeks after completing antiviral treatment

  20 weeks after enrollment to the study (8 weeks of antiviral treatment + 12 week of post-treatment follow up)

Secondary Outcomes (3)

• Evaluation of the rate of achieving aviremia 4 weeks after completion of antiviral therapy (SVR-4)

  12 weeks after enrollment (8 weeks of antiviral treatment + 4 weeks of post-treatment follow up)

• Assessment of the dynamics of viral load changes during treatment

  At Week 4 after enrollment (therapy initiation), at Week 8 after enrollment (end of antiviral treatment), at Week 12 and Week 20 after enrollment (post-treatment follow up).

• Assessment of the safety and tolerability of therapy.

  20 weeks after enrollment (8 weeks of antiviral therapy and 12 weeks of post-treatment follow up)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic hepatitis C virus infection genotype 3 with fibrosis stage F0-F2 were selected for this non-interventional study. These patients represent an important group with a high probability of successful therapy response and relatively low risk of complications, making them ideal candidates for studying the efficacy and safety of a short-term treatment regimen with ravidasvir and sofosbuvir. A similar patient population showed a high rate of sustained virological response (93.42%) in the EASE clinical trial (NCT05757700) with an 8-week therapy regimen. Despite the presence of significant data on treatment of chronic hepatitis C overall, detailed descriptions of disease epidemiology depending on virus genotype, fibrosis stage, and treatment efficacy in patients at early disease stages in real clinical practice are limited.

You may qualify if:

• Patient informed consent for the collection and use of data in scientific research.
• Diagnosed chronic hepatitis C (genotype 3).
• Fibrosis stage F0-F2 according to METAVIR, confirmed by liver biopsy or liver elastography (results of performed studies must be no older than 3 months at the start of antiviral therapy).
• Signed informed consent.
• Age ≥18 years.
• Antiviral therapy with ravidasvir and sofosbuvir initiated as part of routine clinical practice.

You may not qualify if:

• Significant concomitant liver diseases considered relevant by the investigator (hepatitis B, hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hepatocellular carcinoma).
• Presence of other active viral infections (e.g., hepatitis B, HIV).
• If the patient has received other antiviral treatment for hepatitis C within the last 6 months.
• Pregnancy or breastfeeding.
• Alcohol or drug dependence that may interfere with adherence to the treatment regimen.

Sponsors & Collaborators

• Center of target therapy: lead

Study Sites (1)

Center of Target Therapy LLC.

Moscow, 125008, Russia

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Pavel Bogomolov, Prof., PhD, MD

  Center of target therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 5, 2026
• Study Start: September 17, 2025
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)