Trial Outcomes & Findings for Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis (NCT NCT02114177)

NCT ID: NCT02114177

Last Updated: 2016-04-12

Results Overview

Participants considered to have achieved SVR12, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (\<) lower limit of quantification (LLOQ; 25 international unit per milliliter \[IU/mL\]) detectable or undetectable at 12 weeks after the actual end of study drug treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 310 participants
• Primary outcome timeframe: 12 weeks after the end of treatment (EOT) (Week 20 or Week 24)
• Results posted on: 2016-04-12

Participant Flow

A total of 310 participants were randomly allocated to the 2 treatment arms. All participants received at least 1 dose of study drug and were included in intent to treat (ITT) analysis set.

Participant milestones

Measure	Simeprevir and Sofosbuvir for 8 Weeks Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Overall Study STARTED	155	155
Overall Study COMPLETED	146	151
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Measure	Simeprevir and Sofosbuvir for 8 Weeks Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	6	1
Overall Study Other	2	1

Baseline Characteristics

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

Baseline characteristics by cohort

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=155 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=155 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.	Total n=310 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	56 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	73 Participants n=7 Participants	141 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	82 Participants n=7 Participants	169 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after the end of treatment (EOT) (Week 20 or Week 24)

Population: Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.

Participants considered to have achieved SVR12, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the actual end of study drug treatment.

Outcome measures

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=155 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=155 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)	82.6 Percentage of participants Interval 76.3 to 88.9	96.8 Percentage of participants Interval 93.7 to 99.9

SECONDARY outcome

Timeframe: 4 weeks after the end of treatment (EOT) (Week 12 or Week 16)

Population: Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.

Participants considered to have achieved SVR4, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 4 weeks after the actual end of study drug treatment.

Outcome measures

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=155 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=155 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)	83.9 Percentage of Participants Interval 77.8 to 90.0	96.8 Percentage of Participants Interval 93.7 to 99.9

SECONDARY outcome

Timeframe: 24 weeks after the end of treatment (EOT) (Week 32 or Week 36)

Population: Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.

Participants considered to have achieved SVR24, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 24 weeks after the Actual end of study drug treatment.

Outcome measures

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=155 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=155 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)	82.6 Percentage of participants Interval 76.3 to 88.9	96.8 Percentage of participants Interval 93.7 to 99.9

SECONDARY outcome

Timeframe: Day 14, Day 28, End of treatment (Week 8 or Week 12)

Population: The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, 'n' specifies those participants who were evaluated for this outcome measure at given time point.

Ontreatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment.

Outcome measures

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=155 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=155 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Percentage of Participants Achieving a On-treatment Virologic Response Day 14: < 100 IU/mL (n=154, 152)	90.9 Percentage of participants	93.4 Percentage of participants
Percentage of Participants Achieving a On-treatment Virologic Response Day 14: < 25 IU/mL (n=154, 152)	77.92 Percentage of participants	79.6 Percentage of participants
Percentage of Participants Achieving a On-treatment Virologic Response Day 14: < 25 IU/mL detectable (n=154, 152)	40.26 Percentage of participants	45.4 Percentage of participants
Percentage of Participants Achieving a On-treatment Virologic Response Day 14: < 25 IU/mL undetectable (n=154, 152)	37.66 Percentage of participants	34.2 Percentage of participants
Percentage of Participants Achieving a On-treatment Virologic Response Day 28: < 100 IU/mL (n=154, 153)	100 Percentage of participants	100 Percentage of participants
Percentage of Participants Achieving a On-treatment Virologic Response Day 28: < 25 IU/mL (n=154, 153)	98.7 Percentage of participants	98.7 Percentage of participants
Percentage of Participants Achieving a On-treatment Virologic Response Day 28: < 25 IU/mL detectable (n=154, 153)	16.2 Percentage of participants	11.1 Percentage of participants
Percentage of Participants Achieving a On-treatment Virologic Response Day 28: < 25 IU/mL undetectable (n=154, 153)	82.5 Percentage of participants	87.6 Percentage of participants
Percentage of Participants Achieving a On-treatment Virologic Response EOT: < 100 IU/mL (n=155, 155)	100 Percentage of participants	100 Percentage of participants
Percentage of Participants Achieving a On-treatment Virologic Response EOT: < 25 IU/mL (n=155, 155)	100 Percentage of participants	100 Percentage of participants
Percentage of Participants Achieving a On-treatment Virologic Response EOT: < 25 IU/mL undetectable (n=155, 155)	100 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: The ITT population included all the randomized participants who took at least 1 dose of study drug.

Percentage of participants with greater than 1 log10 IU/mL increase in plasma Hepatitis C virus ribonucleic acid level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been less than 25 IU/mL.

Outcome measures

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=155 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=155 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Percentage of Participants With Viral Breakthrough	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 24

Population: The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.

Percentage of participants who did not achieve sustained virologic response 12, have less than 25 IU/mL undetectable plasma HCV RNA at end of treatment, and greater than or equal to 25 IU/mL plasma HCV RNA during the follow-up phase.

Outcome measures

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=155 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=154 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Percentage of Participants With Viral Relapse	17.4 Percentage of participants	2.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24

Population: The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

HCVSIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively.

Outcome measures

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=146 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=153 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS) Baseline (n=145, 149)	10.8 units on a scale Standard Error 0.94	13.3 units on a scale Standard Error 1.01
Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS) Change at Week 4 (n=145, 146)	-0.4 units on a scale Standard Error 0.83	-0.9 units on a scale Standard Error 0.89
Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS) Change at Week 8 (n=144, 146)	-0.2 units on a scale Standard Error 1.06	-0.4 units on a scale Standard Error 0.90
Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS) Change at Week 12 (n=0, 141)	NA units on a scale Standard Error NA The treatment duration for this Arm is 8 weeks.	0.1 units on a scale Standard Error 0.97
Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS) Change at Follow-up Week 4 (n=142, 148)	-3.5 units on a scale Standard Error 0.88	-3.0 units on a scale Standard Error 0.91
Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS) Change at Follow-up Week 12 (n=141, 145)	-2.0 units on a scale Standard Error 0.86	-3.5 units on a scale Standard Error 0.96
Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS) Change at Follow-up Week 24 (n=133, 143)	-3.6 units on a scale Standard Error 0.99	-4.4 units on a scale Standard Error 0.90

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24

Population: The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue.

Outcome measures

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=146 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=153 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24 Baseline (n=144, 149)	2.9 units on a scale Standard Error 0.13	3.2 units on a scale Standard Error 0.14
Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24 Change at Week 4 (n=142, 142)	-0.1 units on a scale Standard Error 0.09	-0.1 units on a scale Standard Error 0.13
Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24 Change at Week 8 (n=142, 144)	-0.1 units on a scale Standard Error 0.11	-0.2 units on a scale Standard Error 0.14
Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24 Change at Week 12 (n=0, 140)	NA units on a scale Standard Error NA The treatment duration for this Arm is 8 weeks.	-0.1 units on a scale Standard Error 0.15
Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24 Change at Follow-up Week 4 (n=141, 148)	-0.4 units on a scale Standard Error 0.12	-0.4 units on a scale Standard Error 0.13
Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24 Change at Follow-up Week 12 (n=140, 145)	-0.5 units on a scale Standard Error 0.11	-0.4 units on a scale Standard Error 0.15
Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24 Change at Follow-up Week 24 (n=132, 143)	-0.6 units on a scale Standard Error 0.13	-0.5 units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24

Population: The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

The CES-D scale assesses how often during the past week participants experienced 20 symptoms commonly associated with major depression. CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5-7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores greater than or equal to 23 indicate probable major depressive illness.

Outcome measures

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=146 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=153 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores Baseline (n=144, 149)	8.8 units on a scale Standard Error 0.72	10.2 units on a scale Standard Error 0.71
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores Change at Week 4 (n=139, 140)	-0.6 units on a scale Standard Error 0.67	-0.8 units on a scale Standard Error 0.52
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores Change at Week 8 (n=141, 144)	-0.6 units on a scale Standard Error 0.73	-0.3 units on a scale Standard Error 0.66
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores Change at Week 12 (n=141, 144)	NA units on a scale Standard Error NA The treatment duration for this Arm is 8 weeks.	1.0 units on a scale Standard Error 0.72
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores Change at Follow-up Week 4 (n=141, 148)	-2.6 units on a scale Standard Error 0.64	-0.6 units on a scale Standard Error 0.68
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores Change at Follow-up Week 12 (n=140, 145)	-1.5 units on a scale Standard Error 0.62	-0.1 units on a scale Standard Error 0.72
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores Change at Follow-up Week 24 (n=131, 143)	-2.8 units on a scale Standard Error 0.72	-1.0 units on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24

Population: The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening.

Outcome measures

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=146 Participants Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=153 Participants Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale Baseline (N=144, 149)	79.3 units on a scale Standard Error 1.53	76.7 units on a scale Standard Error 1.48
Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale Change at Week 4 (n=142, 141)	4.6 units on a scale Standard Error 1.31	2.4 units on a scale Standard Error 1.05
Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale Change at Week 8 (n=142, 144)	4.0 units on a scale Standard Error 1.21	2.7 units on a scale Standard Error 0.93
Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale Change at Week 12 (n=0, 140)	NA units on a scale Standard Error NA The treatment duration for this Arm is 8 weeks.	2.5 units on a scale Standard Error 1.14
Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale Change at Follow-up Week 4 (n=141, 148)	6.9 units on a scale Standard Error 1.34	4.4 units on a scale Standard Error 1.12
Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale Change at Follow-up Week 12 (n=138, 145)	5.5 units on a scale Standard Error 1.27	3.9 units on a scale Standard Error 1.37
Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale Change at Follow-up Week 24 (n=131, 143)	6.2 units on a scale Standard Error 1.51	5.3 units on a scale Standard Error 1.28

Adverse Events

Simeprevir and Sofosbuvir for 8 Weeks

Serious events: 3 serious events

Other events: 68 other events

Deaths: 0 deaths

Simeprevir and Sofosbuvir for 12 Weeks

Serious events: 2 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=155 participants at risk Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=155 participants at risk Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	0.65% 1/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.65% 1/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	0.00% 0/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Gastrointestinal disorders Gastrooesophageal reflux disease	0.65% 1/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	0.00% 0/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Infections and infestations Clostridium difficile colitis	0.00% 0/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	0.65% 1/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Psychiatric disorders Mania	0.65% 1/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	0.00% 0/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm

Other adverse events

Measure	Simeprevir and Sofosbuvir for 8 Weeks n=155 participants at risk Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.	Simeprevir and Sofosbuvir for 12 Weeks n=155 participants at risk Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Gastrointestinal disorders Nausea	9.0% 14/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	14.8% 23/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Gastrointestinal disorders Diarrhoea	7.7% 12/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	7.1% 11/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Gastrointestinal disorders Constipation	5.2% 8/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	5.8% 9/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Nervous system disorders Headache	16.8% 26/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	14.2% 22/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
General disorders Fatigue	15.5% 24/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	12.3% 19/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Musculoskeletal and connective tissue disorders Arthralgia	5.2% 8/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	5.8% 9/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Psychiatric disorders Insomnia	6.5% 10/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	3.9% 6/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Skin and subcutaneous tissue disorders Pruritus	5.8% 9/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	3.2% 5/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm	5.2% 8/155 • Baseline to End of Treatment (week 8 or week 12) The total number of adverse events listed in the "Other (nonSerious) Adverse Event" table are based on at least 5 percent of participants experiencing the adverse event in any treatment arm

Additional Information

Associate Director Clinical Research

Janssen Infectious Diseases BVBA

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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 in writing, such publication will be withheld for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER