Trial | NCT02705534  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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 Started
Sep 30
2016
Primary Completion
Sep 30
2017
Study Completion
Oct 31
2017
Last Update
Apr 30
2018

Drug Sofosbuvir

400 mg, included in a combination pill with 90 mg ledipasvir

  • Other names: SOF

Drug Ledipasvir

90 mg, included in a combination pill with 400 mg sofosbuvir

  • Other names: LDV

Drug Ribavirin

1000 mg/day if <75 kg, 1200 mg/day for >75 kg. Divided into two daily doses

  • Other names: RBV

Treatment Experimental

Subjects will receive sofosbuvir, ledipasvir and ribavirin

Criteria 

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
No Results Posted