Trial Outcomes & Findings for Study of Efficacy and Safety of Grazoprevir (MK-5172)/Elbasvir (MK-8742) Combination Regimen for Treatment-Naïve Participants With Chronic Hepatitis C Virus Genotypes 1, 4, and 6 (MK-5172-060) (NCT NCT02105467)
NCT ID: NCT02105467
Last Updated: 2018-10-02
Results Overview
Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR12 was defined as HCV RNA \<Lower Limit of Quantification (\<15 IU/mL) 12 weeks after the end of all study therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
421 participants
Primary outcome timeframe
Week 24 (12 weeks after the end of treatment)
Results posted on
2018-10-02
Participant Flow
For Subject Disposition, Period 1 covers Day 1 through Week 12 for both treatment groups. Period 2 covers Week 12 through Week 36 for the Immediate Treatment Group (ITG) and Week 12 through Week 28 for the Deferred Treatment Group (DTG). Period 3 covers Week 28 through Week 52 for the DTG; the ITG completed the study with Period 2.
A total of 469 participants were screened and 421 were randomized.
Participant milestones
| Measure |
Immediate Treatment Group
Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks (Period 1), followed by a 24-week follow-up period (Period 2)
|
Deferred Treatment Group
Participants received blinded placebo tablet orally once daily for 12 weeks (Period 1), followed by a 4-week unblinding/washout period and 12 weeks of open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily (Period 2), followed by a 24-week follow-up period (Period 3).
|
|---|---|---|
|
Period 1
STARTED
|
316
|
105
|
|
Period 1
COMPLETED
|
314
|
105
|
|
Period 1
NOT COMPLETED
|
2
|
0
|
|
Period 2
STARTED
|
314
|
104
|
|
Period 2
COMPLETED
|
312
|
102
|
|
Period 2
NOT COMPLETED
|
2
|
2
|
|
Period 3
STARTED
|
0
|
103
|
|
Period 3
COMPLETED
|
0
|
102
|
|
Period 3
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Immediate Treatment Group
Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks (Period 1), followed by a 24-week follow-up period (Period 2)
|
Deferred Treatment Group
Participants received blinded placebo tablet orally once daily for 12 weeks (Period 1), followed by a 4-week unblinding/washout period and 12 weeks of open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily (Period 2), followed by a 24-week follow-up period (Period 3).
|
|---|---|---|
|
Period 1
Lost to Follow-up
|
1
|
0
|
|
Period 1
Death
|
1
|
0
|
|
Period 2
Lost to Follow-up
|
1
|
0
|
|
Period 2
Death
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
2
|
|
Period 3
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study of Efficacy and Safety of Grazoprevir (MK-5172)/Elbasvir (MK-8742) Combination Regimen for Treatment-Naïve Participants With Chronic Hepatitis C Virus Genotypes 1, 4, and 6 (MK-5172-060)
Baseline characteristics by cohort
| Measure |
Immediate Treatment Group
n=316 Participants
Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
|
Deferred Treatment Group
n=105 Participants
Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
|
Total
n=421 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.2 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
53.8 Years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
52.6 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 1a
|
157 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 1b
|
131 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 4
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 6
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24 (12 weeks after the end of treatment)Population: The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.
Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR12 was defined as HCV RNA \<Lower Limit of Quantification (\<15 IU/mL) 12 weeks after the end of all study therapy.
Outcome measures
| Measure |
Immediate Treatment Group
n=316 Participants
Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
|
Deferred Treatment Group
Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)
|
94.6 Percentage of participants
Interval 91.5 to 96.8
|
—
|
PRIMARY outcome
Timeframe: Up to Week 14 (14 days after the Blinded Treatment was completed)Population: The All Subjects as Treated population included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the blinded treatment period.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Outcome measures
| Measure |
Immediate Treatment Group
n=316 Participants
Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
|
Deferred Treatment Group
n=105 Participants
Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
|
|---|---|---|
|
Percentage of Participants Experiencing at Least One Adverse Event
|
67.4 Percentage of participants
|
68.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 12 (end of Blinded Treatment)Population: The All Subjects as Treated population included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the blinded treatment period.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Outcome measures
| Measure |
Immediate Treatment Group
n=316 Participants
Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
|
Deferred Treatment Group
n=105 Participants
Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
|
|---|---|---|
|
Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event
|
0.9 Percentage of participants
|
1.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 36 (24 weeks after the end of treatment)Population: The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.
Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR24 was defined as HCV RNA \<Lower Limit of Quantitation (\<15 IU/mL) 24 weeks after the end of all study therapy.
Outcome measures
| Measure |
Immediate Treatment Group
n=316 Participants
Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
|
Deferred Treatment Group
Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks After the End of Treatment (SVR24)
|
94.3 Percentage of participants
Interval 91.1 to 96.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 16 (4 weeks after the end of treatment)Population: The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.
Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR4 was defined as HCV RNA \<Lower Limit of Quantitation (\<15 IU/mL) 4 weeks after the end of all study therapy.
Outcome measures
| Measure |
Immediate Treatment Group
n=316 Participants
Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
|
Deferred Treatment Group
Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response at 4 Weeks After the End of Treatment (SVR4)
|
97.2 Percentage of participants
Interval 94.7 to 98.7
|
—
|
Adverse Events
Immediate Treatment Group
Serious events: 15 serious events
Other events: 147 other events
Deaths: 0 deaths
Deferred Treatment Group (Blinded Treatment)
Serious events: 4 serious events
Other events: 60 other events
Deaths: 0 deaths
Deferred Treatment Group (Open-label Treatment)
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Treatment Group
n=316 participants at risk
Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period. Adverse event reporting covers Day 1 through Week 36.
|
Deferred Treatment Group (Blinded Treatment)
n=105 participants at risk
Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Day 1 through Week 16.
|
Deferred Treatment Group (Open-label Treatment)
n=103 participants at risk
Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Week 16 through Week 52.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.95%
1/105 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/316 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.95%
1/105 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Gastrointestinal disorders
Hiatus hernia strangulated
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/316 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.95%
1/105 • Number of events 2 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Renal and urinary disorders
Renal colic
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/316 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.97%
1/103 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
General disorders
Asthenia
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
General disorders
Chest pain
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/316 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.97%
1/103 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Infections and infestations
Tooth abscess
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/316 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.95%
1/105 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/316 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.97%
1/103 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Vascular disorders
Hypotension
|
0.32%
1/316 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/105 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
Other adverse events
| Measure |
Immediate Treatment Group
n=316 participants at risk
Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period. Adverse event reporting covers Day 1 through Week 36.
|
Deferred Treatment Group (Blinded Treatment)
n=105 participants at risk
Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Day 1 through Week 16.
|
Deferred Treatment Group (Open-label Treatment)
n=103 participants at risk
Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Week 16 through Week 52.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
14/316 • Number of events 15 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
6.7%
7/105 • Number of events 7 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
4.9%
5/103 • Number of events 5 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Gastrointestinal disorders
Nausea
|
9.2%
29/316 • Number of events 32 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
7.6%
8/105 • Number of events 8 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
7.8%
8/103 • Number of events 8 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
General disorders
Fatigue
|
15.5%
49/316 • Number of events 53 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
17.1%
18/105 • Number of events 19 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
11.7%
12/103 • Number of events 13 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Infections and infestations
Nasopharyngitis
|
6.3%
20/316 • Number of events 23 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
6.7%
7/105 • Number of events 8 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
6.8%
7/103 • Number of events 8 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
20/316 • Number of events 22 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
5.7%
6/105 • Number of events 6 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
2.9%
3/103 • Number of events 3 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Nervous system disorders
Dizziness
|
2.8%
9/316 • Number of events 9 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
6.7%
7/105 • Number of events 9 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.00%
0/103 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Nervous system disorders
Headache
|
16.1%
51/316 • Number of events 61 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
17.1%
18/105 • Number of events 19 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
16.5%
17/103 • Number of events 19 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Psychiatric disorders
Insomnia
|
1.9%
6/316 • Number of events 6 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
5.7%
6/105 • Number of events 6 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
2.9%
3/103 • Number of events 3 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
7/316 • Number of events 7 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
7.6%
8/105 • Number of events 9 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
0.97%
1/103 • Number of events 1 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
17/316 • Number of events 18 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
1.9%
2/105 • Number of events 2 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
4.9%
5/103 • Number of events 6 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
10/316 • Number of events 10 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
2.9%
3/105 • Number of events 3 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
6.8%
7/103 • Number of events 7 • Immediate Treatment Group: Up to Week 36; Deferred Treatment Group (Blinded Treatment): Up to Week 16; Deferred Treatment Group (Open-label Treatment): Week 16 to Week 52
|
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.
- Publication restrictions are in place
Restriction type: OTHER