Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 (SL50)

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Cirrhosis; Hepatitis C

Treatments: Drug: Ribavirin; Drug: Sofosbuvir; Drug: Ledipasvir

Study type: Interventional

Funder types: Other

Identifiers

NCT02705534

94-04-37-31023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment

Experimental group

Description:

Subjects will receive sofosbuvir, ledipasvir and ribavirin

Treatment:

Drug: Ledipasvir

Drug: Ribavirin

Drug: Sofosbuvir