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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
400 mg, included in a combination pill with 90 mg ledipasvir
90 mg, included in a combination pill with 400 mg sofosbuvir
1000 mg/day if \<75 kg, 1200 mg/day for \>75 kg. Divided into two daily doses
Shariati Hospital
Tehran, Iran
The sustained viral response rate
Qualitative polymerase chain reaction assay for Hepatitis C RNA
Time frame: week 24 (12 weeks after end of treatment)
Adverse drug events
Questionnaire
Time frame: week 2, 4, 8, 12, 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.