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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hepatitis C, Cirrhosis

Intervention / Treatment
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* Drug: Sofosbuvir
* Drug: Ledipasvir
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subjects will receive sofosbuvir, ledipasvir and ribavirin | Drug: Sofosbuvir<br>* 400 mg, included in a combination pill with 90 mg ledipasvir<br>* Other names: SOF;Drug: Ledipasvir<br>* 90 mg, included in a combination pill with 400 mg sofosbuvir<br>* Other names: LDV;Drug: Ribavirin<br>* 1000 mg/day if <75 kg, 1200 mg/day for >75 kg. Divided into two daily doses<br>* Other names: RBV;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug events | Questionnaire | week 2, 4, 8, 12, 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Cirrhosis, Sofosbuvir, Ledipasvir, Ribavirin