The SIM-SOF Trial for Hepatitis C

Phase 4 Completed 93 enrolled Center For Hepatitis C, Atlanta, GA

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2013-12
Primary completion: 2014-12
Completion: 2015-04

Outcome

Met primary endpoint

paper A significantly greater percentage of patients (93%) given simeprevir and sofosbuvir achieved an SVR12 than those given the interferon-containing regimen (75%) (P = .02). PMID 25557952 ↗

Publications

Results Pearlman BL, Ehleben C, Perrys M. The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related Child's class A cirrhosis. Gastroenterology. 2015 Apr;148(4):762-70.e2; quiz e11-2. doi: 10.1053/j.gastro.2014.12.027. Epub 2014 Dec 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Pegylated interferon alfa-2b	Protein / enzyme biologic	1.5 ug/kg	Subcutaneous
Comparator	Ribavirin	Small molecule	1000 mg	Oral
Comparator	Ribavirin	Small molecule	1200 mg	Oral
Subject	Simeprevir	Small molecule	150 mg	Oral
Background	Sofosbuvir	Small molecule	400 mg	Oral