Conditions: Chronic Hepatitis C
Keywords: cirrhosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 93
Healthy volunteers: no

Brief summary:
Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.

Detailed description:
Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.

Must have Child's Class A cirrhosis/compensated and no history of decompensation

Arms:
arm 1: Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks arm 2: (SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks

Interventions: intervention 1: Pegylated Interferon alfa-2b intervention 2: Simeprevir intervention 3: Ribavirin intervention 4: Sofosbuvir
Intervention descriptions: intervention 1: 1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total intervention 2: 150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks intervention 3: 1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir intervention 4: 12 weeks of combination sofosbuvir and simeprevir

Protocol document: