Sofosbuvir Plus Daclatasvir With or Without Ribavirin for Chronic Hepatitis C Infection: Impact of Drug Concentration on Viral Load Decay

Hospices Civils de Lyon1 site in 1 country130 target enrollmentFebruary 1, 2014

ConditionsHepatitis C

InterventionsSofosbuvir/daclatasvir with or without ribavirin

DrugsSofosbuvir/daclatasvir with or without ribavirin

Overview

Phase: Not Applicable
Intervention: Sofosbuvir/daclatasvir with or without ribavirin
Conditions: Hepatitis C
Sponsor: Hospices Civils de Lyon
Enrollment: 130
Locations: 1
Primary Endpoint: Sofosbuvir/daclatasvir plasma concentration
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. The objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics.

Registry

clinicaltrials.gov

Start Date

February 1, 2014

End Date

June 30, 2015

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with hepatitis C virus infection treated with sofosbuvir/daclatasvir
•Patients with at least one measurement of sofosbuvir or daclatasvir plasma concentration
•Follow-up of at least 3 months after the end of treatment

Exclusion Criteria

•Patients with severe renal failure (estimated glomerular filtration rate (eGFR)\<30ml/min/1.73m2)
•Patients with liver transplantation during therapy

Arms & Interventions

Sofosbuvir/daclatasvir

Patients with hepatitis C virus (HCV) infection treated with sofosbuvir/daclatasvir combination therapy with or without ribavirin between February and September 2014

Intervention: Sofosbuvir/daclatasvir with or without ribavirin