Trial Outcomes & Findings for 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 (NCT NCT02349048)

Last Updated: 2017-03-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

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

Results posted on

2017-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Overall Study STARTED	59	9
Overall Study COMPLETED	54	9
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Overall Study Withdrawal by Subject	4	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=59 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.	Total n=68 Participants Total of all reporting groups
Age, Continuous	47 years n=93 Participants	56 years n=4 Participants	50.5 years n=27 Participants
Gender Female	32 Participants n=93 Participants	5 Participants n=4 Participants	37 Participants n=27 Participants
Gender Male	27 Participants n=93 Participants	4 Participants n=4 Participants	31 Participants n=27 Participants
Region of Enrollment CAN	9 participants n=93 Participants	0 participants n=4 Participants	9 participants n=27 Participants
Region of Enrollment USA	50 participants n=93 Participants	9 participants n=4 Participants	59 participants n=27 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=59 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12)	86.4 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=59 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Percentage of Participants With On-treatment Virologic Response Day 2 : >= 15 IU/mL (n = 56, 9)	96.4 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Day 2 : < 100 IU/mL (n = 56, 9)	7.1 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Day 2 : < 15 IU/mL undetect/detectable (n = 56, 9)	3.6 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Day 2 : < 15 IU/mL detectable (n = 56, 9)	3.6 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Day 2: < 15 IU/mL undetectable (n = 56, 9)	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Day 3 : >= 15 IU/mL (n = 58, 9)	94.8 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Day 3 : < 100 IU/mL (n = 58, 9)	19.0 Percentage of Participants	11.1 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Day 3 : < 15 IU/mL undetect/detectable (n = 58, 9)	5.2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Day 3 : < 15 IU/mL detectable (n = 58, 9)	5.2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Day 3 : < 15 IU/mL undetectable (n = 58, 9)	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 1: >= 15 IU/mL (n = 58, 9)	58.6 Percentage of Participants	66.7 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 1: < 100 IU/mL (n = 58, 9)	75.9 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 1: < 15 IU/mL undetect/detectable (n = 58, 9)	41.4 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 1 : < 15 IU/mL detectable (n = 58, 9)	36.2 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 1 : < 15 IU/mL undetectable (n = 58, 9)	5.2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 2 : >= 15 IU/mL (n = 56, 9)	19.6 Percentage of Participants	66.7 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 2: < 100 IU/mL (n = 56, 9)	94.6 Percentage of Participants	77.8 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 2: < 15 IU/mL undetect/detectable (n = 56, 9)	80.4 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 2 : < 15 IU/mL detectable (n = 56, 9)	41.1 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 2: < 15 IU/mL undetectable (vRVR) (n = 56, 9)	39.3 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 3: >= 15 IU/mL (n = 56, 9)	7.1 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 3: < 100 IU/mL (n = 56, 9)	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 3: < 15 IU/mL undetect/detectable (n = 56, 9)	92.9 Percentage of Participants	66.7 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 3 : < 15 IU/mL detectable (n = 56, 9)	21.4 Percentage of Participants	22.2 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 3 : < 15 IU/mL undetectable (n = 56, 9)	71.4 Percentage of Participants	44.4 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 4 : >= 15 IU/mL (n = 58, 9)	3.4 Percentage of Participants	11.1 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 4: < 100 IU/mL (n = 58, 9)	98.3 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 4: < 15 IU/mL undetect/detectable (n = 58, 9)	96.6 Percentage of Participants	88.9 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 4 : < 15 IU/mL detectable ( n = 58, 9)	8.6 Percentage of Participants	33.3 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 4 : < 15 IU/mL undetectable (RVR) (n = 58, 9)	87.9 Percentage of Participants	55.6 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 6 : >= 15 IU/mL (n = 58, 9)	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 6: < 100 IU/mL ( n = 58, 9)	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 6: < 15 IU/mL undetect/detectable (n = 58, 9)	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 6 : < 15 IU/mL detectable (n = 58, 9)	6.9 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 6 : < 15 IU/mL undetectable (n= 58, 9)	93.1 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 8 : >= 15 IU/ml (n = 0, 9)	NA Percentage of Participants HCV RNA values were not collected at week 8 since participants in Arm A ended treatment at week 6.	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 8: < 100 IU/mL (n = 0, 9)	NA Percentage of Participants HCV RNA values were not collected at week 8 since participants in Arm A ended treatment at week 6.	100 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 8: < 15 IU/mL undetect/detectable (n = 0, 9)	NA Percentage of Participants HCV RNA values were not collected at week 8 since participants in Arm A ended treatment at week 6.	100 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 8: < 15 IU/mL detectable (n = 0, 9)	NA Percentage of Participants HCV RNA values were not collected at week 8 since participants in Arm A ended treatment at week 6.	0 Percentage of Participants
Percentage of Participants With On-treatment Virologic Response Week 8: < 15 IU/mL undetectable (n = 0, 9)	NA Percentage of Participants HCV RNA values were not collected at week 8 since participants in Arm A ended treatment at week 6.	100 Percentage of Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=59 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment SVR4	93.2 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment SVR24	84.7 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=59 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Percentage of Participants With On-Treatment Failure	1.7 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=59 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Number of Participants With Viral Relapse	7 Participants	0 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=59 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Number of Participants With Late Viral Relapse	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=59 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR	8 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=25 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 Participants Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR With NS3 Q80K polymorphism at baseline (n=25,9)	88.0 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR Without NS3 Q80K polymorphism at baseline (n=23,9)	78.3 Percentage of Participants	100 Percentage of Participants

Adverse Events

Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=59 participants at risk Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 participants at risk Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
General disorders Chest Pain	1.7% 1/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	0.00% 0/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Nervous system disorders Headache	1.7% 1/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	0.00% 0/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.

Other adverse events

Additional Information

Associate Director, Medical Department

Janssen R&D BE

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks n=59 participants at risk Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 6 weeks.	Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks n=9 participants at risk Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir \[SMV\] 150 milligram (mg)/Daclatasvir \[DCV\] 60mg/Sofosbuvir \[SOF\] 400mg) once daily for 8 weeks.
Eye disorders Cataract	0.00% 0/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	11.1% 1/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Gastrointestinal disorders Constipation	8.5% 5/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	0.00% 0/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Gastrointestinal disorders Diarrhoea	10.2% 6/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	0.00% 0/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Gastrointestinal disorders Dry Mouth	0.00% 0/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	11.1% 1/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Gastrointestinal disorders Nausea	15.3% 9/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	11.1% 1/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
General disorders Fatigue	23.7% 14/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	11.1% 1/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Infections and infestations Nasopharyngitis	6.8% 4/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	0.00% 0/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	11.1% 1/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Injury, poisoning and procedural complications Procedural Pain	10.2% 6/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	0.00% 0/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Musculoskeletal and connective tissue disorders Myalgia	1.7% 1/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	11.1% 1/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Nervous system disorders Dysgeusia	0.00% 0/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	11.1% 1/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Nervous system disorders Headache	25.4% 15/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	11.1% 1/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Skin and subcutaneous tissue disorders Photosensitivity Reaction	1.7% 1/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	11.1% 1/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Skin and subcutaneous tissue disorders Pruritus	5.1% 3/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	0.00% 0/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.
Skin and subcutaneous tissue disorders Pruritus Generalised	1.7% 1/59 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.	11.1% 1/9 • Only adverse events from the Treatment Period (6 weeks in Arm A and 8 weeks in Arm B) are reported.