Hepatitis C
Conditions
Keywords
Cirrhosis, Direct acting antiviral agents, Hepatitis C, Pharmacological monitoring
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.
Interventions
DRUGSofosbuvir/daclatasvir with or without ribavirin
Direct-acting antiviral treatment for hepatitis C virus infection
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sofosbuvir/daclatasvir plasma concentration | Sofosbuvir/daclatasvir plasma concentrations were measured at week 4, 8, 12 and 24 during therapy |
Secondary
| Measure | Time frame |
|---|---|
| HCV viral load | At treatment initiation, at week 4, 8, 12 and 24 of therapy and 12 weeks after the end of treatment |
Countries
France
Outcome results
None listed