Randomized Clinical Trial of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus Genotype 1 (TNT)

Phase 4 Completed 121 enrolled Federal University of São Paulo

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to study the combination of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 1.

Timeline

Start: 2015-12
Primary completion: 2017-03
Completion: 2017-05

Outcome

Missed primary endpoint

paper Despite no statistically significant intergroup difference in SVR12 rates, the noninferiority of SOF + SMV to SOF + DCV could not be established PMID 29906601 ↗

Publications

Pott-Junior H, Bricks G, Grandi G, Figueiredo Senise J, Castelo Filho A. Sofosbuvir in combination with daclatasvir or simeprevir for 12 weeks in noncirrhotic subjects chronically infected with hepatitis C virus genotype 1: a randomized clinical trial. Clin Microbiol Infect. 2019 Mar;25(3):365-371. doi: 10.1016/j.cmi.2018.06.007. Epub 2018 Jun 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daclatasvir	Small molecule	60 mg	Oral
Subject	Simeprevir	Small molecule	150 mg	Oral
Subject	Sofosbuvir	Small molecule	400 mg	Oral