Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1

Sustained Viral Response Rate in 50 Subjects With Cirrhosis Due to Hepatitis C, Genotype 1, Treated With 12 Weeks of Sofosbuvir, Ledipasvir and Ribavirin

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02705534

Acronym

SL50

Enrollment

Registered

2016-03-10

Start date

2016-09-30

Completion date

2017-10-31

Last updated

2018-04-30

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

Conditions

Cirrhosis, Hepatitis C

Keywords

Hepatitis C, Cirrhosis, Sofosbuvir, Ledipasvir, Ribavirin

Brief summary

The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with sofosbuvir 400 mg daily, ledipasvir 90 mg daily and weight-based ribavirin (1000 mg/d if \<75 kg, 1200 mg/d if \>75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

Detailed description

Cirrhosis due to Hepatitis C virus (HCV) presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of care. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and ledipasvir (LDV) 90 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks only for HCV genotype 1 patients. The current recommendation for cirrhotics (genotype 1) is SOF/LDV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/LDV/RBV the investigators decided to treat 50 HCV genotype 1 cirrhotics with this combination for 12 weeks. Patients with MELD score \> 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Interventions

DRUGSofosbuvir

400 mg, included in a combination pill with 90 mg ledipasvir

DRUGLedipasvir

90 mg, included in a combination pill with 400 mg sofosbuvir

DRUGRibavirin

1000 mg/day if \<75 kg, 1200 mg/day for \>75 kg. Divided into two daily doses

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Positive qualitative hepatitis C RNA polymerase chain reaction assay on two occasions at least 6 months apart

Exclusion criteria

* Renal failure \[estimated glomerular filtration rate (eGFR) \< 30 cc/min\], * Model or End stage Liver Disease (MELD) score \> 20, * Child's class C (score \> 12), * Heart rate \< 50/min, * Taking amiodarone

Design outcomes

Primary

Measure	Time frame	Description
The sustained viral response rate	week 24 (12 weeks after end of treatment)	Qualitative polymerase chain reaction assay for Hepatitis C RNA

Secondary

Measure	Time frame	Description
Adverse drug events	week 2, 4, 8, 12, 24	Questionnaire

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026