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)

Federal University of São Paulo

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: Daclatasvir + Sofosbuvir; Drug: Simeprevir + Sofosbuvir

Study type: Interventional

Funder types: Other

Identifiers

NCT02624063

TNT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

Daclatasvir + Sofosbuvir

Experimental group

Description:

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

Treatment:

Drug: Daclatasvir + Sofosbuvir

Simeprevir + Sofosbuvir

Experimental group

Description:

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

Treatment:

Drug: Simeprevir + Sofosbuvir