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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04047680
Other study ID # 201509009RINB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date June 2019

Study information

Verified date August 2019
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Description:

Chronic hepatitis C virus (HCV) infection is a major health problem that affects 71 million people worldwide. Patients with chronic HCV infection may present with various hepatic and extrahepatic manifestations which lead to substantial morbidity and mortality. In contrast, the long-term health outcome improves following successful HCV eradication by antiviral therapies.

Owing to the excellent efficacy and safety as well as the short treatment duration, the use of interferon (IFN)-free direct acting antivirals (DAAs) has become the standard-of-care for managing HCV. Sofosbuvir (SOF) is a pyrimidine nucleotide analogue which acts as the HCV ribonucleic acid (RNA) chain terminator by inhibiting HCV non-structural protein 5B (NS5B) RNA-dependent RNA polymerase following intrahepatic activation to uridine triphosphate form. Dephosphorylation results in the formation of inactive metabolite (GS-331007) that undergoes extensive renal excretion. Clinically, SOF is administered once-daily with pangenotypic potency, well tolerability and a high genetic barrier to drug resistance. Furthermore, SOF can be used in combination with NS3/4A protease inhibitors (PIs), NS5A inhibitors, and/or ribavirin (RBV) to achieve high rates of sustained virologic response (SVR). Therefore, applying SOF-based DAAs for HCV is welcome to most treating physicians.

Following the widespread use of SOF-based DAAs for treating HCV in different populations, a large-scale real-world HCV-TARGET study enrolling 1,789 patients indicated that patients with a baseline eGFR ≤ 45 mL/min/1.73m2 were associated with a higher risk of worsening renal function than those with a baseline eGFR > 45 mL/min/1.73m2 following SOF-based DAAs. Moreover, three retrospective studies showed that SOF-based DAAs negatively affected the on-treatment and off-therapy eGFR. On the contrary, other studies showed that the use of SOF-based DAAs did not worsen the eGFR. Because most studies were retrospective in nature without protocol-defined time point for eGFR assessment or patient election, and did not enroll patients receiving SOF-free DAAs as the controls, the investigators thus conducted a prospective study to evaluate the evolution of eGFR in patients with chronic HCV infection receiving SOF-based or SOF-free DAAs.


Recruitment information / eligibility

Status Completed
Enrollment 441
Est. completion date June 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Chronic HCV patients receiving SOF-based or SOF-free DAAs for 12 weeks

Exclusion Criteria:

- Decompensated cirrhosis (Child-Pugh B or C)

- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2

- Active hepatocellular carcinoma (HCC)

- Organ transplantation

- Hepatitis B virus (HBV) co-infection

- Human immunodeficiency virus (HIV) co-infection

- Not received off-therapy follow-up till week 24

Study Design


Intervention

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

Locations

Country Name City State
Taiwan National Taiwan University Hospital, Yun-Lin Branch Douliu
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Slope differences of eGFR Slope differences of eGFR between SOF-based and SOF-free DAAs Baseline to off-therapy week 24
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