Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients

Treatment of Chronic Hepatitis C Virus Infection With Direct Acting Antivirals in Kidney Transplant Recipients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03880682

Enrollment

Registered

2019-03-19

Start date

2018-11-01

Completion date

2019-10-31

Last updated

2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic, Kidney Transplant; Complications

Keywords

kidney transplant recipients, chronic hepatitis c virus infection, direct acting antivirals, sofosbuvir/ledipasvir

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
SVR12	6 months	Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals.

Secondary

Measure	Time frame	Description
Stable Graft Function	6-12 months	Stability of serum creatinine and proteinuria levels of kidney transplant recipients during and after the treatment with direct acting antivirals.
Stable Serum Trough Levels of Immunosuppressive Agents	6 months	Stability of serum trough levels of calcineurin and mTOR inhibitors during the treatment with direct acting antivirals.

Countries

Turkey (Türkiye)

Outcome results