Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sofosbuvir/daclatasvir with or without ribavirin

Drug

Direct-acting antiviral treatment for hepatitis C virus infection

Other names: Combination of sofosbuvir and daclatasvir with or without ribavirin

Primary outcomes

Sofosbuvir/daclatasvir plasma concentration

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

Secondary outcomes

HCV viral load

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2015
First posted: Oct 24, 2017
Registry last updated: Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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