Title
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
Phase
Phase 4Lead Sponsor
Center For Hepatitis C, Atlanta, GAStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Chronic Hepatitis CIntervention/Treatment
ribavirin sofosbuvir simeprevir interferon alpha-2b ...Study Participants
93Randomized 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
1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total
150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
12 weeks of combination sofosbuvir and simeprevir
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
(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks
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
| Event Type | Organ System | Event Term | All Oral | Interferon-containing |
|---|
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy
