Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA

Civil Hospices of Lyon

Status: Completed

Conditions: Hepatitis C

Treatments: Drug: Sofosbuvir/daclatasvir with or without ribavirin

Study type: Observational

Funder types: Other

Identifiers

NCT03318887

CRC_GHN_2016_001

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

130 participants in 1 patient group

Sofosbuvir/daclatasvir

Description:

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

Treatment:

Drug: Sofosbuvir/daclatasvir with or without ribavirin