Trial Outcomes & Findings for Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021) (NCT NCT02613403)
NCT ID: NCT02613403
Last Updated: 2024-05-22
Results Overview
The percentage of participants achieving SVR12 was determined, defined as having a plasma HCV ribonucleic acid (RNA) level below the lower limit of quantification (LLOQ) 12 weeks after the end of study therapy. Plasma HCV RNA level was measured using the Roche COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay with a LLOQ of 15 IU/mL.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
12 weeks following final dose of study treatment ([MK-3682B + RBV Groups]: Study Week 28; [MK-3682B Groups]: Study Week 36)
Results posted on
2024-05-22
Participant Flow
For study Part A, 94 cirrhotic (C) or non-cirrhotic (NC) participants with chronic hepatitis C virus (HCV) genotype (GT) 1 previously failing a direct-acting antiviral regimen (DAA) were randomized, with 1 participant withdrawing prior to receiving study treatment. The trial was terminated prior to participant enrollment for study Part B.
Participant milestones
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
C or NC HCV GT1 participants previously failing a DAA regimen of sofosbuvir (SOF)/ledipasvir (LDV) receive MK-3682B, a fixed dose combination (FDC) of grazoprevir (GZR; MK-5172 \[50 mg\]) + uprifosbuvir (UPR; MK-3682 \[225 mg\]) + ruzasvir (RZR; MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with ribavirin (RBV) twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/elbasvir (EBR) (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part B] Prior DAA (GT1-6) or SOF/PR (GT3) Failure: MK-3682B
C or NC HCV participants previously failing any all-oral DAA regimen (GT1-6) or SOF/pegylated interferon and ribavirin (PR) regimen (GT 3 only) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
9
|
13
|
0
|
|
Overall Study
Treated
|
35
|
36
|
9
|
13
|
0
|
|
Overall Study
COMPLETED
|
34
|
35
|
9
|
13
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
C or NC HCV GT1 participants previously failing a DAA regimen of sofosbuvir (SOF)/ledipasvir (LDV) receive MK-3682B, a fixed dose combination (FDC) of grazoprevir (GZR; MK-5172 \[50 mg\]) + uprifosbuvir (UPR; MK-3682 \[225 mg\]) + ruzasvir (RZR; MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with ribavirin (RBV) twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/elbasvir (EBR) (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part B] Prior DAA (GT1-6) or SOF/PR (GT3) Failure: MK-3682B
C or NC HCV participants previously failing any all-oral DAA regimen (GT1-6) or SOF/pegylated interferon and ribavirin (PR) regimen (GT 3 only) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 16 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)
Baseline characteristics by cohort
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
58.9 years
STANDARD_DEVIATION 6.6 • n=107 Participants
|
57.3 years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
53.9 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 8.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
80 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 12 weeks following final dose of study treatment ([MK-3682B + RBV Groups]: Study Week 28; [MK-3682B Groups]: Study Week 36)Population: All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
The percentage of participants achieving SVR12 was determined, defined as having a plasma HCV ribonucleic acid (RNA) level below the lower limit of quantification (LLOQ) 12 weeks after the end of study therapy. Plasma HCV RNA level was measured using the Roche COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay with a LLOQ of 15 IU/mL.
Outcome measures
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)
|
97.1 Percentage
Interval 85.1 to 99.9
|
100.0 Percentage
Interval 90.3 to 100.0
|
100.0 Percentage
Interval 66.4 to 100.0
|
100.0 Percentage
Interval 75.3 to 100.0
|
PRIMARY outcome
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)Population: All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE.
Outcome measures
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event
|
31 Participants
|
27 Participants
|
9 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)Population: All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
The number of participants discontinuing study drug due to an AE was assessed.
Outcome measures
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)Population: All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
The number of participants experiencing a serious adverse event (SAE) was assessed. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention.
Outcome measures
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a Serious Adverse Event
|
3 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)Population: All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
The number of participants experiencing a drug-related AE was assessed. A drug-related AE was an AE thought to be possibly, probably, or definitely related to the study drug as determined by the investigator.
Outcome measures
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a Drug-Related Adverse Event
|
23 Participants
|
18 Participants
|
9 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)Population: All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
The number of participants experiencing a serious and drug-related AE was assessed.
Outcome measures
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a Serious and Drug-Related Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)Population: All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
The number of participants experiencing an accidental or intentional overdose without adverse effect was determined. Per study protocol, any occurrence of a participant receiving either MK-3682B or RBV at any dose higher than prescribed was considered an overdose. If this definition of overdose was met without any associated clinical symptoms or abnormal laboratory results, this occurrence of overdose was reported as an accidental or intentional overdose without adverse effect.
Outcome measures
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced an Accidental or Intentional Overdose Without Adverse Effect
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)Population: All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
The number of participants experiencing a non-overdose event of clinical interest (ECI) was determined. Non-overdose ECIs, assessed from initiation of study therapy through 14 days following study treatment cessation, included the following: 1) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>500 IU/L; or 2) AST or ALT \>3x nadir value and \>3X upper limit normal (ULN).
Outcome measures
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a Non-Overdose Event of Clinical Interest
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Study Week 4 up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)Population: All randomized participants in Part A receiving ≥1 dose of study treatment with ≥1 AST/ALT measurement subsequent to study week 4. One participant with prior SOF/LDV failure receiving MK-3682B + RBV withdrew from study before study week 4 and was excluded from analysis. Part B terminated prior to enrollment and was not included for analysis.
The number of participants experiencing AST / ALT \>5 times ULN from study week 4 until 2 weeks following completion of study therapy was determined.
Outcome measures
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=34 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 Participants
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced AST/ALT >5x Upper Limit Normal (ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 participants at risk
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 participants at risk
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 participants at risk
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 participants at risk
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
General disorders
Chest pain
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Nervous system disorders
Hydrocephalus
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Vascular disorders
Deep vein thrombosis
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
Other adverse events
| Measure |
[Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
n=35 participants at risk
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
n=36 participants at risk
C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
[Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
n=9 participants at risk
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
|
[Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
n=13 participants at risk
C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 \[50 mg\]) + UPR (MK-3682 \[225 mg\]) + RZR (MK-8408 \[30 mg\]), administered as 2 tablets once daily for 24 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.6%
3/35 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Cardiac disorders
Palpitations
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Cardiac disorders
Tachycardia
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Ear and labyrinth disorders
Ear pain
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Eye disorders
Vision blurred
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
15.4%
2/13 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
8.3%
3/36 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
2/35 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
8.3%
3/36 • Number of events 4 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
22.2%
2/9 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
15.4%
2/13 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
3/35 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Large intestine polyp
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
5.6%
2/36 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Toothache
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
5.6%
2/36 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
5.6%
2/36 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
General disorders
Asthenia
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
General disorders
Fatigue
|
42.9%
15/35 • Number of events 17 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
19.4%
7/36 • Number of events 7 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
66.7%
6/9 • Number of events 10 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
38.5%
5/13 • Number of events 5 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
General disorders
Influenza like illness
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
General disorders
Malaise
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
General disorders
Oedema peripheral
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
8.3%
3/36 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
General disorders
Pyrexia
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
5.6%
2/36 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Infections and infestations
Cystitis
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
8.3%
3/36 • Number of events 4 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Infections and infestations
Sinusitis
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
5.6%
2/36 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
8.3%
3/36 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
22.2%
2/9 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Investigations
Haemoglobin decreased
|
8.6%
3/35 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
33.3%
3/9 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
5.6%
2/36 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
5.6%
2/36 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
33.3%
3/9 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Nervous system disorders
Dysgeusia
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
13.9%
5/36 • Number of events 5 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
55.6%
5/9 • Number of events 7 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Nervous system disorders
Sciatica
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Nervous system disorders
Syncope
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Nervous system disorders
Tremor
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/35 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Psychiatric disorders
Insomnia
|
8.6%
3/35 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Psychiatric disorders
Irritability
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Psychiatric disorders
Stress
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
5.6%
2/36 • Number of events 4 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
15.4%
2/13 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
2/35 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
5.6%
2/36 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
22.2%
2/9 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.6%
3/35 • Number of events 3 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.4%
4/35 • Number of events 6 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.1%
6/35 • Number of events 8 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
5.6%
2/36 • Number of events 2 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/36 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
11.1%
1/9 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/13 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
|
Vascular disorders
Hypertension
|
0.00%
0/35 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
2.8%
1/36 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
0.00%
0/9 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
7.7%
1/13 • Number of events 1 • Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
|
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