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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of the rate of achieving sustained virological response (SVR12)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluation of the rate of achieving sustained virological response (SVR12)
时间窗: 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
次要结局
- 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).)
- 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 safety and tolerability of therapy.(20 weeks after enrollment (8 weeks of antiviral therapy and 12 weeks of post-treatment follow up))