Trial Outcomes & Findings for Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection (NCT NCT02250807)

NCT ID: NCT02250807

Last Updated: 2016-11-17

Results Overview

SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 12 weeks after actual EOT.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

12 weeks after EOT

Results posted on

2016-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	SMV+SOF 12 Weeks Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SMV+SOF 12 Weeks n=40 Participants Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after EOT

Population: Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).

SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 12 weeks after actual EOT.

Outcome measures

Outcome measures
Measure	SMV+SOF 12 Weeks n=40 Participants Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)	100 percentage of participants Interval 91.2 to 100.0

SECONDARY outcome

Timeframe: 4 weeks after EOT

Population: ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).

SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 4 weeks after actual EOT.

Outcome measures

Outcome measures
Measure	SMV+SOF 12 Weeks n=40 Participants Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)	100 percentage of participants Interval 91.2 to 100.0

SECONDARY outcome

Timeframe: At 24 weeks after EOT

Population: ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).

Participants were considered to have reached SVR24, if at the time point of SVR24 (that is \[i.e.\], 24 weeks after the end of treatment \[EOT\]) the following condition has been met: HCV RNA \< lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable.

Outcome measures

Outcome measures
Measure	SMV+SOF 12 Weeks n=40 Participants Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)	100 percentage of participants Interval 91.2 to 100.0

SECONDARY outcome

Timeframe: Week 2, 3, 4, 12 and EOT

Population: ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).

Percentage of participants with HCV RNA less than (\<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed.

Outcome measures

Outcome measures
Measure	SMV+SOF 12 Weeks n=40 Participants Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 2: < 100 IU/mL	87.5 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 2: < 15 IU/mL undetectable/detectable	40.0 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 2: < 15 IU/mL undetectable	17.5 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 3: < 100 IU/mL	100.0 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 3: < 15 IU/mL undetectable/detectable	82.5 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 3: < 15 IU/mL undetectable	40.0 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 4: < 100 IU/mL	100.0 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 4: < 15 IU/mL undetectable/detectable	87.5 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 4: < 15 IU/mL undetectable (RVR)	65.0 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 12: < 100 IU/mL	100.0 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 12: < 15 IU/mL undetectable/detectable	100.0 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Week 12: < 15 IU/mL undetectable	100.0 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) End of Treatment (EOT): < 100 IU/mL	100.0 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) EOT: < 15 IU/mL undetectable/detectable	100.0 percentage of participants
Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) EOT: < 15 IU/mL undetectable	100.0 percentage of participants

SECONDARY outcome

Timeframe: through 12 weeks (EOT)

Population: ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).

Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., \<LLOQ detectable or \>=LLOQ.

Outcome measures

Outcome measures
Measure	SMV+SOF 12 Weeks n=40 Participants Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
Percentage of Participants With On-Treatment Failure	0 percentage of participants

SECONDARY outcome

Timeframe: Up to follow-up Week 24

Population: ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).

Participants with confirmed \>1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA \>100 IU/mL in participants who had previously achieved HCV RNA \<LLOQ.

Outcome measures

Outcome measures
Measure	SMV+SOF 12 Weeks n=40 Participants Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
Percentage of Participants With Viral Breakthrough	0 percentage of participants

SECONDARY outcome

Timeframe: Up to follow-up week 24

Population: ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).

Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (\<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (\>=)LLOQ.

Outcome measures

Outcome measures
Measure	SMV+SOF 12 Weeks n=40 Participants Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
Percentage of Participants With Viral Relapse	0 percentage of participants

Adverse Events

SMV+SOF 12 Weeks

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SMV+SOF 12 Weeks n=40 participants at risk Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
Nervous system disorders Headache	20.0% 8/40 • Up to EOT (Week 12)
Skin and subcutaneous tissue disorders Erythema	5.0% 2/40 • Up to EOT (Week 12)
Skin and subcutaneous tissue disorders Rash	5.0% 2/40 • Up to EOT (Week 12)
General disorders Asthenia	7.5% 3/40 • Up to EOT (Week 12)
Respiratory, thoracic and mediastinal disorders Catarrh	7.5% 3/40 • Up to EOT (Week 12)
Gastrointestinal disorders Constipation	5.0% 2/40 • Up to EOT (Week 12)

Additional Information

Trial Physician

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