Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir (SD-CRF)

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic; Chronic Renal Failure

Treatments: Drug: Sofosbuvir 400 mg and daclatasvir 60 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03063879

96-04-37-37348

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

Sovodak

Experimental group

Description:

Sofosbuvir 400 mg and daclatasvir 60 mg

Treatment:

Drug: Sofosbuvir 400 mg and daclatasvir 60 mg