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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Sofosbuvir 400 mg tablet + Daclatasvir 60 mg tablet oral dosing once daily for 12 weeks
Sofosbuvir 400 mg tablet + Simeprevir 150 mg tablet oral dosing once daily for 12 weeks
Outpatient Clinic of Viral Hepatitis (NUPAIG)
São Paulo, Brazil
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
Time frame: At follow-up Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: From start of study treatment up to 7 days post last dose of study 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
Time frame: At follow-up Week 12
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