Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03063879

Acronym

SD-CRF

Enrollment

Registered

2017-02-24

Start date

2017-04-01

Completion date

2019-02-01

Last updated

2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure, Hepatitis C, Chronic

Keywords

hepatitis C, renal failure, sofosbuvir, daclatasvir

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.

Interventions

DRUGSofosbuvir 400 mg and daclatasvir 60 mg

Daily fixed dose combination pill (Sovodak) containing 400 mg sofosbuvir and 60 mg daclatasvir for 12 weeks if not cirrhotic (liver stiffness \< 12 KPa) or 24 weeks if cirrhotic

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Sustained Viral Response (SVR12)	12 weeks after end of treatment	Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment

Secondary

Measure	Time frame	Description
Safety as assessed by adverse drug events	From start of treatment to 12 weeks after end of treatment	Adverse drug events recorded by direct questioning

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026