NCT02705534

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatitis C
• Cirrhosis

Interventions

Type	Name	Description
DRUG	Sofosbuvir	400 mg, included in a combination pill with 90 mg ledipasvir
DRUG	Ledipasvir	90 mg, included in a combination pill with 400 mg sofosbuvir
DRUG	Ribavirin	1000 mg/day if \<75 kg, 1200 mg/day for \>75 kg. Divided into two daily doses

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-09-01
• Completion: 2017-10-01
• First posted: 2016-03-10
• Last updated: 2018-04-30

Locations

1 site across 1 country: Iran