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

Center of target therapy

Status: Active, not recruiting

Conditions: Viral Hepatitis C

Study type: Observational

Funder types: Other

Identifiers

NCT07316842

CTT-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.