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

Federal University of São Paulo1 site in 1 country121 target enrollmentDecember 2015

ConditionsHepatitis C, Chronic

InterventionsDaclatasvir + Sofosbuvir Simeprevir + Sofosbuvir

DrugsDaclatasvir + Sofosbuvir Simeprevir + Sofosbuvir

Overview

Phase: Phase 4
Intervention: Daclatasvir + Sofosbuvir
Conditions: Hepatitis C, Chronic
Sponsor: Federal University of São Paulo
Enrollment: 121
Locations: 1
Primary Endpoint: Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

In this open-label, single-center, head-to-head non-inferiority trial, treatment-naive or pegylated interferon treatment-experienced patients with GT1 infection were randomized to receive once-daily SOF 400 mg plus DCV 60 mg or SIM 150 mg for 12 weeks.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

May 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Federal University of São Paulo

Responsible Party

Principal Investigator

Henrique Pott Junior

Dr. Henrique Pott-Junior

Federal University of São Paulo

Eligibility Criteria

Inclusion Criteria

•Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR Never taken DAAs for HCV Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications No Liver Cirrhosis Liver fibrosis Metavir F3 APRI \> 1,5 FIB4 \> 3,25

Exclusion Criteria

•Infection with HCV other than GT-1 or subjects with mixed infections of any genotype Liver Cirrhosis Evidence of decompensated liver Subjects Infected with HIV-1 Hepatitis B virus (HBV) coinfection Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair Current or known history of cancer Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy Pregnancy or impossibility to use birth control methods by the couple, or breastfeeding Regular use of: erythromycin, clarithromycin, rifampicin, rifabutin, telithromycin, itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole, dexamethasone, cisapride, rifapentine, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), silymarin (Silybum marianum) and some antiarrhythmic drugs such as amiodarone

Arms & Interventions

Daclatasvir + Sofosbuvir

Daclatasvir 60 mg tablet + Sofosbuvir 400 mg tablet oral dosing once daily for 12 weeks

Intervention: Daclatasvir + Sofosbuvir

Simeprevir + Sofosbuvir

Simeprevir 150 mg tablet + Sofosbuvir 400 mg tablet oral dosing once daily for 12 weeks

Intervention: Simeprevir + Sofosbuvir

Outcomes

Primary Outcomes

Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12)

Time Frame: At follow-up Week 12

SVR12 was defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 12 IU/mL at follow-up Week 12

Secondary Outcomes

Percentage of Subjects With Rapid Virologic Response at Week 4 (RVR)(Week 4)
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Non-cirrhotic Subjects With Relapse at Follow-up Week 12 (SVR12)(At follow-up Week 12)
Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment.(From start of study treatment up to 7 days post last dose of study treatment)
Percentage of Subjects With End of Treatment Response (EOTR)(Week 12)