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

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	Peginterferon 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

The SIM-SOF Trial for Hepatitis C

Summary

Timeline

Publications

Drugs

Indications