Micro-elimination of Hepatitis C Virus Infection in Uremics

• Status: Active, not recruiting
• Trial end date: 2024-04-15
• Target enrollment: 0
• Participant gender: All

Summary

There is a huge gap between the clinical efficacy and community effectiveness in the treatment of chronic hepatitis C in Taiwan. HCV infection prevails in uremic patients with the prevalence of > 10 % in Taiwan.The current study will be executed in each participating hemodialysis centers by an outreach team of HCV treaters, treating all of the HCV-viremic uremia patients and HD staffs at the same time (group therapy) in each individual HD center (Erase-C campaign) with all oral directly-acting antivirals, to ensure the rates of diagnosis, accessibility, treatment and follow-up.The purpose of the study is to demonstrate a model of care using outreach HCV treaters by implementing the concept of "group therapy" with one-size-fit-all pangenotypic DAA regimen, 12 weeks of sofosbuvir/velpatasvir, in each individual hemodialysis center (Erase-C campaign) to achieve HCV micro-elimination.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Treatments: Sofosbuvir-velpatasvir drug combination

Criteria

Inclusion Criteria:

• Medical staffs and patients on HD, with age 20 years or more at the time of screening, agree to participate the study and provide informed consent.

• A negative serum pregnancy test is required for female subjects (unless permanently sterile or greater than two years post-menopausal)

• Subjects and their partners are considered childbearing potential must agree to use acceptable contraceptive method during treatment till SVR12.

• Ability to participate and willingness to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

Medical staffs or uremic patients who are seropositive for HCV RNA and have contraindication to or unwilling to receive SOF/VEL, or who failed to prior IFN-free direct antiviral agents (DAA) regimens