Viral Hepatitis C
Conditions
Keywords
Ravidasvir, Sofosbuvir
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.
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.
Interventions
None listed
Sponsors
Center of target therapy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the rate of achieving sustained virological response (SVR12) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | The absence of detectable hepatitis C virus (HCV) RNA in a patient's blood 4 weeks after completing antiviral treatment |
| 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). | The amount of hepatitis C virus RNA present in a milliliter of a patient's blood (IU/mL). |
| 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) | The frequency and nature of side effects associated with the combination of ravidasvir and sofosbuvir. |
Countries
Russia
Outcome results
None listed