Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable at 12 weeks after the end of study drug treatment.

Time frame: 12 weeks after end of study drug treatment (week 18 for Arm A and week 20 for Arm B)

Population: The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).

Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify preexisting sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR.

Time frame: Up to Week 30 for Arm A and up to Week 32 for Arm B

Population: The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).

Late Viral Relapse: Participant who achieved SVR12 and the post treatment HCV RNA measurement fulfilled 1 the following conditions: a) at least 2 consecutive measurements not lesser than (\<)15 IU/mL undetectable, of which at least the second measurement was \>=15 IU/mL quantifiable or b) the last available measurement was \>=15 IU/mL quantifiable.

Time frame: From Week 18 to Week 30 (for Arm A), From Week 20 to Week 32 (for Arm B)

Population: The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).

Viral Relapse: Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (\>=) LLOQ during followup.

Time frame: From Week 6 to Week 18 (for Arm A) and From Week 8 to Week 20 (for Arm B)

Population: The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).

Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. Includes participants with: 1) viral breakthrough, defined as a confirmed increase of greater than (\>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA 2) confirmed detectable HCV RNA at the actual end of treatment (example, completed treatment, discontinued due to adverse events, withdrawal of consent) of \>100 IU/mL in participants whose HCV RNA had previously been \<LLOQ while on treatment.

Time frame: Baseline up to End of Treatment (Week 6 for Arm A and Week 8 for Arm B)

Population: The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).

On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold. The following thresholds were considered at any time point: \<LLOQ undetectable, \<LLOQ detectable, and \<LLOQ undetectable or detectable. The LLOQ value was 15 IU/mL. Very rapid virologic response (vRVR) is undetectable HCV RNA at Week 2 while on treatment and Rapid virologic response (RVR) is undetectable HCV RNA at Week 4 while on treatment.

Time frame: Day 2, Day 3, Week 1, 2, 3, 4, 6 (for Arm A) and 8 (for Arm B only)

Population: The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV). Here 'n' signifies number of participants who were evaluable at each specified time point, for each arm, respectively.

The Q80K polymorphism, associated with low level SMV in vitro resistance. Percentage of participants who achieved SVR with or without an NS3 Q80K polymorphism at baseline were reported.

Time frame: up to Week 30 for Arm A and Week 32 for Arm B

Population: The ITT analysis set is defined as all enrolled participants who took at least 1 dose of SMV, SOF or DCV. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' signifies number of participants evaluable for this outcome measure at specific time point.

Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was \<LLOQ detectable or undetectable at 4 weeks and 24 weeks respectively after the end of study drug treatment. The LLOQ value was 15 IU/mL.

Time frame: 4 weeks after end of study drug treatment (week 10 for Arm A and 12 for Arm B); 24 weeks after end of study drug treatment (week 30 for Arm A and 32 for Arm B)

Population: The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).