A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Simeprevir (SMV); Ledipasvir (LDV); Sofosbuvir (SOF)
Intervention description: Participants will receive 150 milligram (mg) of SMV (Treatment A) once daily in Panel 1 and Panel 2.; Participants will receive 90 mg of LDV once daily as FDC tablet with SOF (Treatment B) in Panel 1 and Panel 2.; Participants will receive 400 mg of SOF alone (Treatment C) in Panel 1 and as FDC tablet with LDV (Treatment B) once daily in Panel 2.
Intervention MeSH terms: Sofosbuvir; Ledipasvir; Simeprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; Simeprevir; Ledipasvir; Sofosbuvir

Summary:

      The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir
      and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and
      ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV)
      genotype 1 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with Body Mass Index (weight in kilogram [kg] divided by the square of
             height in meters) of 18.0 to 35.0 kilogram per square meter kg/m^2, extremes included

          -  Participants must be treatment-naive (that is, have not received prior treatment with
             any approved or investigational drug)

          -  Participants with HCV ribonucleic acid (RNA) plasma levels greater than (>) 10,000
             international unit per milliliter (IU/ml) and lower than 6,000,000 international unit
             per milliliter (IU/ml) at screening

          -  Participants with absence of cirrhosis confirmed by FibroTest/Fibrosure score less or
             equal to 0.75 and an aspartate aminotransferase to platelet ration index less or equal
             to 2 or a Fibroscan less or equal to 14.6 kilopascale (kPA), performed within 6 months
             prior or during the screening period

          -  Participants with documented chronic HCV infection: diagnosis of HCV infection >6
             months prior to screening, either by detectable HCV RNA, an HCV positive antibody test
             or presence of histological changes consistent with chronic hepatitis in a liver
             biopsy

        Exclusion Criteria:

          -  Participant has infection/co-infection with HCV of a genotype other than genotype 1,
             human immunodeficiency virus (HIV) type 1 or 2

          -  Participant has any evidence of liver disease of non-HCV etiology. This includes, but
             is not limited to acute hepatitis A, active hepatitis B, drug- or alcohol-related
             liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1
             antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or
             any other non-HC liver disease considered clinically significant by the investigator

          -  Participant with significant co-morbidities, conditions or clinical significant
             findings during screening assessments that in the opinion of the investigator could
             compromise the participants' safety or could interfere with the Participant
             participating in and completing the study

          -  Participant received an organ transplant (other than cornea or hair transplant or skin
             graft)

          -  Participants have key protocol defined laboratory abnormalities