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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daclatasvir + Sofosbuvir

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

Group Type EXPERIMENTAL

Daclatasvir + Sofosbuvir

Intervention Type DRUG

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

Simeprevir + Sofosbuvir

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

Group Type EXPERIMENTAL

Simeprevir + Sofosbuvir

Intervention Type DRUG

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

Interventions

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Daclatasvir + Sofosbuvir

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

Intervention Type DRUG

Simeprevir + Sofosbuvir

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

Intervention Type DRUG

Other Intervention Names

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Solvaldi, Daklinza Sovaldi, Olysio

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes