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NCT Number: NCT07316842

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center of Target Therapy LLC.

Moscow, 125008, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluation of the rate of achieving sustained virological response (SVR12)

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

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

Secondary outcomes

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

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

    The absence of detectable hepatitis C virus (HCV) RNA in a patient's blood 4 weeks after completing antiviral treatment

  2. Assessment of the dynamics of viral load changes during treatment

    Time frame: 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).

    The amount of hepatitis C virus RNA present in a milliliter of a patient's blood (IU/mL).

  3. Assessment of the safety and tolerability of therapy.

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

    The frequency and nature of side effects associated with the combination of ravidasvir and sofosbuvir.

Sponsors and collaborators

Lead sponsor

Center of target therapy

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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