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

Phase 3

Completed

• Conditions: Hepatitis C; Cirrhosis
• Interventions: Drug: Sofosbuvir; Drug: Ledipasvir; Drug: Ribavirin

• Registration Number: NCT02705534
• Lead Sponsor: Tehran University of Medical Sciences

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).

Study Timeline

• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-10
• Study Start: 2016-09
• Status Verified: 2017-02
• Primary Completion: 2017-09
• Study Completion: 2017-10
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Sofosbuvir	Subjects will receive sofosbuvir, ledipasvir and ribavirin
Treatment	Ledipasvir	Subjects will receive sofosbuvir, ledipasvir and ribavirin
Treatment	Ribavirin	Subjects will receive sofosbuvir, ledipasvir and ribavirin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse drug events	week 2, 4, 8, 12, 24	Questionnaire

Trial Locations

Locations (1)

Shariati Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of