eGFR Evolution in HCV Patients Receiving SOF-based or SOF-free DAAs

Sponsor
National Taiwan University Hospital
Study ID
NCT04047680
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sofosbuvir / Velpatasvir Oral Tablet — DRUG
    Sofosbuvir/velpatasvir for 12 weeks
  • Sofosbuvir and Ledipasvir — DRUG
    Sofosbuvir and ledipasvir for 12 weeks
  • Sofosbuvir Tablets — DRUG
    Sofosbuvir plus ribavirin (RBV) or daclatasvir (DCV) for 12 weeks
  • Ombitasvir/paritaprevir/ritonavir — DRUG
    Ombitasvir/paritaprevir/ritonavir for 12 weeks
  • Elbasvir / Grazoprevir Oral Tablet — DRUG
    Elbasvir/grazoprevir for 12 weeks
  • Glecaprevir and Pibrentasvir — DRUG
    Glecaprevir/pibrentasvir for 12 weeks

Study Details

Data regarding the nephrotoxicity of sofosbuvir (SOF) remain controversial. The investigators compared the changes of estimated glomerular filtration rate (eGFR) in patients with chronic hepatitis C virus (HCV) infection receiving SOF-based or SOF-free direct acting antivirals (DAAs).

Key Dates

Start date
Feb 28, 2015
Status verified
Aug 2019
Primary completion
Dec 31, 2018
Completion
Jun 30, 2019

Study Design

Enrollment
441 participants (actual)

Arms

  • Arm: SOF-based DAAs
    Patients receiving sofosbuvir (SOF)-based direct acting antiviral agents (DAAs) for 12 weeks
  • Arm: SOF-free DAAs
    Patients receiving sofosbuvir (SOF)-free direct acting antiviral agents (DAAs) for 12 weeks

Primary Outcome Measure

Slope differences of eGFR [ Time Frame: Baseline to off-therapy week 24 ]

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