Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Sustained Viral Response (SVR12)
Study Overview
Brief Summary
Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
- •Renal failure (eGFR < 30 cc/min) or under hemodialysis
Exclusion Criteria
- •Model for End-stage Liver Disease (MELD) score > 20,
- •Child's C (CTP score > 12),
- •Heart rate < 50/min,
- •Taking amiodarone
Arms & Interventions
Sovodak
Sofosbuvir 400 mg and daclatasvir 60 mg
Intervention: Sofosbuvir 400 mg and daclatasvir 60 mg (Drug)
Outcomes
Primary Outcomes
Sustained Viral Response (SVR12)
Time Frame: 12 weeks after end of treatment
Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment
Secondary Outcomes
- Safety as assessed by adverse drug events(From start of treatment to 12 weeks after end of treatment)