Treatment of Chronic Hepatitis C Virus Infection With Direct Acting Antivirals in Kidney Transplant Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- SVR12
Study Overview
Brief Summary
Chronic hepatitis C virus (HCV) infection, an important cause of morbidity and mortality worldwide, is a significant problem in kidney transplant recipients (KTRs) given its high prevalence in patients undergoing hemodialysis. Interferon based regimens were cornerstone of treatment of HCV infection in the past; however, due to their low efficacy and high rates of adverse effects, they have been abandoned in the new era of direct acting antivirals (DAAs). Several studies demonstrated the efficacy and safety of DAAs, yet data regarding clinical practice of these agents in KTRs is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of DAAs in KTRs.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Being a kidney transplant recipient.
- •Having a detectable level of HCV RNA.
- •Having direct acting antivirals for 12 or 24 weeks.
Exclusion Criteria
- •Withdrawing or not providing consent.
Outcomes
Primary Outcomes
SVR12
Time Frame: 6 months
Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals.
Secondary Outcomes
- Stable Graft Function(6-12 months)
- Stable Serum Trough Levels of Immunosuppressive Agents(6 months)
Investigators
Safak Mirioglu
Principal Investigator
Istanbul University