Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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