Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA

NCT03318887 | Completed

• 1 other identifier: CRC_GHN_2016_001
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Cirrhosis; Direct acting antiviral agents; Hepatitis C; Pharmacological monitoring

Outcome Measures

Primary Outcomes (1)

• Sofosbuvir/daclatasvir plasma concentration

  Sofosbuvir/daclatasvir plasma concentrations were measured at week 4, 8, 12 and 24 during therapy

Secondary Outcomes (1)

• HCV viral load

  At treatment initiation, at week 4, 8, 12 and 24 of therapy and 12 weeks after the end of treatment

Study Arms (1)

Sofosbuvir/daclatasvir

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

Drug: Sofosbuvir/daclatasvir with or without ribavirin

Interventions

Sofosbuvir/daclatasvir with or without ribavirin DRUG

Direct-acting antiviral treatment for hepatitis C virus infection

Also known as: Combination of sofosbuvir and daclatasvir with or without ribavirin

Sofosbuvir/daclatasvir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All HCV infected patients from the Department of Hepatology, Croix-Rousse Hospital, Lyon, France receiving sofosbuvir/daclatasvir with or without ribavirin between February and September 2014 were considered

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, France

Location

MeSH Terms

Conditions

Hepatitis C; Fibrosis

Interventions

Sofosbuvir; daclatasvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Study Officials

• Fabien Zoulim, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: February 1, 2014
• Primary Completion: September 30, 2014
• Study Completion: June 30, 2015
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)