Trial Outcomes & Findings for An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus (HCV) Genotype (GT)1, 4, or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (MK-5172-062) (NCT NCT02105688)

Last Updated: 2019-12-05

Results Overview

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (\<LLOQ) at 12 weeks after the end of all study therapy for baseline infection, or HCV RNA≥ LLOQ demonstrated to be due to reinfection (after clearance of baseline infection). The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR12 rate. The primary efficacy analysis for Part A was the percentage of participants in the immediate treatment arm (ITA) who achieved SVR12. SVR12 was also calculated for the Deferred Treatment Arm.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

301 participants

Primary outcome timeframe

12 weeks after end of all therapy (Study Week 24 for Immediate Treatment Arm and Study Week 40 for Deferred Treatment Arm)

Results posted on

2019-12-05

Participant Flow

301 participants were randomized to either the Immediate Treatment Arm or to the Deferred Treatment Arm during Part A. 199 participants who completed Part A were enrolled in Part B; of these, 142 participants completed the study.

Participant milestones

Participant milestones
Measure	Immediate Treatment Arm: Grazoprevir/Elbasvir In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).	Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Part A: Double-Blind STARTED	201	100
Part A: Double-Blind COMPLETED	181	83
Part A: Double-Blind NOT COMPLETED	20	17
Part B: Observational Follow-up STARTED	131	68
Part B: Observational Follow-up COMPLETED	94	48
Part B: Observational Follow-up NOT COMPLETED	37	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Immediate Treatment Arm: Grazoprevir/Elbasvir In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).	Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Part A: Double-Blind Adverse Event	1	0
Part A: Double-Blind Death	0	1
Part A: Double-Blind Lost to Follow-up	15	11
Part A: Double-Blind Physician Decision	0	1
Part A: Double-Blind Status Unknown	0	2
Part A: Double-Blind Withdrawal by Subject	4	2
Part B: Observational Follow-up Death	2	1
Part B: Observational Follow-up Lost to Follow-up	23	15
Part B: Observational Follow-up Withdrawal by Subject	9	3
Part B: Observational Follow-up Physician Decision	3	1

Baseline Characteristics

An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus (HCV) Genotype (GT)1, 4, or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (MK-5172-062)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Treatment Arm: Grazoprevir/Elbasvir n=201 Participants In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).	Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir n=100 Participants In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).	Total n=301 Participants Total of all reporting groups
Age, Continuous	47.4 years STANDARD_DEVIATION 9.9 • n=5 Participants	46.4 years STANDARD_DEVIATION 9.9 • n=7 Participants	47.1 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	23 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	153 Participants n=5 Participants	77 Participants n=7 Participants	230 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after end of all therapy (Study Week 24 for Immediate Treatment Arm and Study Week 40 for Deferred Treatment Arm)

Population: Modified FAS (mFAS): All randomized participants receiving ≥1 dose of active study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or BL genotype (GT)2, GT3, or GT5. The primary efficacy hypothesis was evaluated within participants of the Immediate Treatment Arm.

Outcome measures

Outcome measures
Measure	Immediate Treatment Arm: Grazoprevir/Elbasvir n=198 Participants In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).	Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir n=88 Participants In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)	95.5 Percentage of Participants Interval 91.5 to 97.9	96.6 Percentage of Participants Interval 90.4 to 99.3

PRIMARY outcome

Timeframe: DB Treatment period plus first 14 follow-up days (up to Study Week 14)

Population: All randomized participants who received at least one dose of study treatment during the Part A DB period.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants experiencing an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period.

Outcome measures

Outcome measures
Measure	Immediate Treatment Arm: Grazoprevir/Elbasvir n=201 Participants In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).	Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir n=100 Participants In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Double-Blind (DB) Treatment Period and First 14 Follow-up Days	83.1 Percentage of Participants	83.0 Percentage of Participants

PRIMARY outcome

Timeframe: DB Treatment period (up to Study Week 12)

Population: All randomized participants who received at least one dose of study treatment during the Part A DB period.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants discontinuing study therapy due to an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period.

Outcome measures

Outcome measures
Measure	Immediate Treatment Arm: Grazoprevir/Elbasvir n=201 Participants In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).	Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir n=100 Participants In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Percentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period	0.5 Percentage of Participants	1.0 Percentage of Participants

SECONDARY outcome

Timeframe: 24 weeks after end of all therapy (Study Week 36 for Immediate Treatment Arm and Study Week 52 for Deferred Treatment Arm)

Population: Modified FAS (mFAS): All randomized participants receiving ≥1 dose of active study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or BL genotype (GT)2, GT3, or GT5. The secondary efficacy analysis was evaluated within participants of the Immediate Treatment Arm.

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA \<LLOQ at 24 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR24 rate. The secondary efficacy analysis for Part A evaluated the percentage of participants in the immediate treatment arm (ITA) who achieved SVR24. SVR24 was also calculated for the Deferred Treatment Arm.

Outcome measures

Outcome measures
Measure	Immediate Treatment Arm: Grazoprevir/Elbasvir n=186 Participants In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).	Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir n=85 Participants In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)	94.1 Percentage of Participants Interval 89.7 to 97.0	96.5 Percentage of Participants Interval 90.0 to 99.3

Adverse Events

Immediate Treatment Arm: Grazoprevir/Elbasvir

Serious events: 16 serious events

Other events: 108 other events

Deaths: 3 deaths

Deferred Treatment Arm: Placebo

Serious events: 4 serious events

Other events: 46 other events

Deaths: 1 deaths

Deferred Treatment Arm: Grazoprevir/Elbasvir

Serious events: 7 serious events

Other events: 36 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Immediate Treatment Arm: Grazoprevir/Elbasvir n=201 participants at risk In Part A, participants received grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).	Deferred Treatment Arm: Placebo n=100 participants at risk In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up.	Deferred Treatment Arm: Grazoprevir/Elbasvir n=95 participants at risk In Part A, participants received placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).
Gastrointestinal disorders Abdominal pain	5.5% 11/201 • Number of events 12 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	4.0% 4/100 • Number of events 4 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	3.2% 3/95 • Number of events 3 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
Gastrointestinal disorders Constipation	8.5% 17/201 • Number of events 17 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	4.0% 4/100 • Number of events 5 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	2.1% 2/95 • Number of events 2 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
Gastrointestinal disorders Diarrhoea	10.0% 20/201 • Number of events 22 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	9.0% 9/100 • Number of events 11 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	8.4% 8/95 • Number of events 8 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
Gastrointestinal disorders Nausea	11.4% 23/201 • Number of events 23 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	9.0% 9/100 • Number of events 9 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	8.4% 8/95 • Number of events 8 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
Gastrointestinal disorders Vomiting	4.0% 8/201 • Number of events 8 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	7.0% 7/100 • Number of events 7 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	4.2% 4/95 • Number of events 5 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
General disorders Fatigue	15.9% 32/201 • Number of events 32 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	20.0% 20/100 • Number of events 22 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	13.7% 13/95 • Number of events 14 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
Injury, poisoning and procedural complications Accidental overdose	3.5% 7/201 • Number of events 7 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	4.0% 4/100 • Number of events 5 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	5.3% 5/95 • Number of events 5 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
Metabolism and nutrition disorders Decreased appetite	4.0% 8/201 • Number of events 8 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	6.0% 6/100 • Number of events 6 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	3.2% 3/95 • Number of events 3 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
Nervous system disorders Headache	12.9% 26/201 • Number of events 31 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	14.0% 14/100 • Number of events 20 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	12.6% 12/95 • Number of events 15 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.
Psychiatric disorders Insomnia	6.5% 13/201 • Number of events 13 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	6.0% 6/100 • Number of events 6 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.	0.00% 0/95 • Up to approximately 4 years (Study Week 208) All-Cause Mortality reported for all randomized participants. AEs reported for all randomized participants receiving ≥1 dose of study treatment. AEs were reported by the treatment that participants were receiving at the time of the event; AEs and deaths for Deferred Group reported separately for placebo (N=100) and active (N=95) treatment periods.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER