The SIM-SOF Trial for Hepatitis C

The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis

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.

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

Inclusion Criteria:

• chronic hepatitis c,
• cirrhosis biopsy-proven, or via fibrotest,
• CPT score less than 7,
• genotype 1a,
• INR 2.3 or less,
• serum albumin greater than 2.7 gm/dL,
• total bilirubin less than 3 gm/dL,
• platelet count 50,000 per cubic milliliter or more
• GFR >50 ml/min

Exclusion Criteria:

• non genotype 1a,
• history of CPT class B or C or decompensation or history of same,
• HIV or HBV coinfection,
• prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent,
• uncontrolled psychiatric or cardiopulmonary disorders,
• planning pregnancy or unwilling/unable to practice contraception