Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA

Hospices Civils de Lyon130 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Hepatitis C

Interventions

Sofosbuvir/daclatasvir with or without ribavirinDRUG

Direct-acting antiviral treatment for hepatitis C virus infection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, France

Outcomes

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

Data from ClinicalTrials.gov

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