Trial Outcomes & Findings for Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074) (NCT NCT02133131)
NCT ID: NCT02133131
Last Updated: 2021-02-05
Results Overview
The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) \<15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2021-02-05
Participant Flow
The current interim disclosure covers data up to 12 weeks after completing study treatment. The cutoff date for this initial disclosure is 12-Feb-2015. GT3 participants have completed treatment but are ongoing in follow-up.
Participant milestones
| Measure |
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
|
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
20
|
21
|
15
|
14
|
12
|
|
Overall Study
COMPLETED
|
26
|
25
|
19
|
15
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
1
|
6
|
15
|
14
|
12
|
Reasons for withdrawal
| Measure |
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
|
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Status not recorded
|
4
|
5
|
1
|
4
|
0
|
0
|
0
|
|
Overall Study
Ongoing in study
|
0
|
0
|
0
|
0
|
15
|
14
|
11
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)
Baseline characteristics by cohort
| Measure |
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks
n=31 Participants
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
|
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks
n=30 Participants
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks
n=20 Participants
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks
n=21 Participants
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks
n=15 Participants
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks
n=14 Participants
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks
n=12 Participants
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.1 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
51.2 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
55.7 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
56.8 Years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
51.3 Years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
42.2 Years
STANDARD_DEVIATION 11.7 • n=8 Participants
|
55.3 Years
STANDARD_DEVIATION 5.3 • n=8 Participants
|
52.3 Years
STANDARD_DEVIATION 9.9 • n=24 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
49 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
94 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: The Per Protocol (PP) population includes all randomized and treated participants who did not have protocol deviations that may substantially affect the results of the primary and secondary endpoints.
The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) \<15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.
Outcome measures
| Measure |
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks
n=30 Participants
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
|
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks
n=28 Participants
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks
n=20 Participants
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks
n=19 Participants
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks
n=15 Participants
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks
n=14 Participants
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks
n=11 Participants
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)
|
33.3 Percentage of participants
Interval 17.3 to 52.8
|
89.3 Percentage of participants
Interval 71.8 to 97.7
|
80.0 Percentage of participants
Interval 56.3 to 94.3
|
89.5 Percentage of participants
Interval 66.9 to 98.7
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
100.0 Percentage of participants
Interval 76.8 to 100.0
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
PRIMARY outcome
Timeframe: Up to Week 14Population: The All Participants as Treated (APaT) population consists of all participants who received ≥1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks
n=31 Participants
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
|
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks
n=30 Participants
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks
n=20 Participants
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks
n=21 Participants
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks
n=15 Participants
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks
n=14 Participants
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks
n=12 Participants
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing at Least 1 Adverse Event (AE)
|
5 Number of participants
|
7 Number of participants
|
7 Number of participants
|
4 Number of participants
|
4 Number of participants
|
3 Number of participants
|
3 Number of participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: The APaT population consists of all participants who received ≥1 dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks
n=31 Participants
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
|
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks
n=30 Participants
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks
n=20 Participants
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks
n=21 Participants
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks
n=15 Participants
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks
n=14 Participants
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks
n=12 Participants
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing Study Therapy Due to an AE
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: Analysis of SVR4 is ongoing and results will be indicated in a future report.
The percentage of participants achieving SVR4, defined as HCV ribonucleic acid (RNA) \<15 IU/mL 4 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.
Outcome measures
Outcome data not reported
Adverse Events
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks
n=31 participants at risk
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
|
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks
n=30 participants at risk
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks
n=20 participants at risk
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks
n=21 participants at risk
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks
n=15 participants at risk
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks
n=14 participants at risk
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks
n=12 participants at risk
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.0%
1/20 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.3%
1/12 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.7%
1/15 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.0%
1/20 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
Other adverse events
| Measure |
GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks
n=31 participants at risk
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
|
GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks
n=30 participants at risk
HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks
n=20 participants at risk
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
|
GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks
n=21 participants at risk
HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks
n=15 participants at risk
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
|
GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks
n=14 participants at risk
HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks
n=12 participants at risk
HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
7.1%
1/14 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.7%
1/15 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.3%
1/12 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
3.3%
1/30 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
4.8%
1/21 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
7.1%
1/14 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.3%
1/12 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
General disorders
Fatigue
|
3.2%
1/31 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
3.3%
1/30 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.7%
1/15 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.3%
1/12 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 2 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.0%
1/20 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
7.1%
1/14 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.7%
1/15 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
7.1%
1/14 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
5.0%
1/20 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
9.5%
2/21 • Number of events 2 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.7%
1/15 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
8.3%
1/12 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
6.7%
1/15 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/14 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/31 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/30 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/20 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/21 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/15 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
7.1%
1/14 • Number of events 1 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
0.00%
0/12 • Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
|
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.
- Publication restrictions are in place
Restriction type: OTHER