Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Collaborators: Ahvaz Jundishapur University of Medical Sciences; Hamadan University of Medical Science; Shiraz University of Medical Sciences
• Treatments: Sofosbuvir

Criteria

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