Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA
Completed
- Conditions
- Hepatitis C
- Interventions
- Drug: Sofosbuvir/daclatasvir with or without ribavirin
- Registration Number
- NCT03318887
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
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
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Exclusion Criteria
- Patients with severe renal failure (estimated glomerular filtration rate (eGFR)<30ml/min/1.73m2)
- Patients with liver transplantation during therapy
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir with or without ribavirin Patients with hepatitis C virus (HCV) infection treated with sofosbuvir/daclatasvir combination therapy with or without ribavirin between February and September 2014
- Primary Outcome Measures
Name Time Method Sofosbuvir/daclatasvir plasma concentration Sofosbuvir/daclatasvir plasma concentrations were measured at week 4, 8, 12 and 24 during therapy
- Secondary Outcome Measures
Name Time Method HCV viral load At treatment initiation, at week 4, 8, 12 and 24 of therapy and 12 weeks after the end of treatment
Trial Locations
- Locations (1)
Croix-Rousse Hospital, Hospices Civils de Lyon
🇫🇷Lyon, France