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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)

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Daclatasvir + Sofosbuvir

Simeprevir + Sofosbuvir

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Outpatient Clinic of Viral Hepatitis (NUPAIG)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Daclatasvir + Sofosbuvir

Simeprevir + Sofosbuvir

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

Percentage of Subjects With Rapid Virologic Response at Week 4 (RVR)

RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 12 IU/mL at Week 4.

Percentage of Subjects With End of Treatment Response (EOTR)

EOTR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 12 IU/mL at the end of treatment.

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.

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

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

Full Information

NCT ID

NCT02624063

First Posted

December 2, 2015

Last Updated

July 28, 2017

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02624063

Brief Title

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)

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

December 2015 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daclatasvir + Sofosbuvir

Arm Type

Experimental

Arm Description

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

Arm Title

Simeprevir + Sofosbuvir

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Daclatasvir + Sofosbuvir

Other Intervention Name(s)

Solvaldi, Daklinza

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Simeprevir + Sofosbuvir

Other Intervention Name(s)

Sovaldi, Olysio

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

At follow-up Week 12

Secondary Outcome Measure Information:

Title

Percentage of Subjects With Rapid Virologic Response at Week 4 (RVR)

Description

RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 12 IU/mL at Week 4.

Time Frame

Week 4

Title

Percentage of Subjects With End of Treatment Response (EOTR)

Description

EOTR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 12 IU/mL at the end of treatment.

Time Frame

Week 12

Title

Time Frame

From start of study treatment up to 7 days post last dose of study treatment

Title

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

Description

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

Time Frame

At follow-up Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Outpatient Clinic of Viral Hepatitis (NUPAIG)

City

São Paulo

ZIP/Postal Code

04025-001

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29906601

Citation

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.

Results Reference

derived

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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)

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