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Efficacy and Safety of Uprifosbuvir (MK-3682) + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)

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ClinicalTrials.gov Identifier: NCT02956629
Recruitment Status : Terminated (The study was terminated based on review of Phase 2 efficacy data)
First Posted : November 6, 2016
Results First Posted : December 26, 2018
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Uprifosbuvir
Drug: Ruzasvir
Drug: Ribavirin
Enrollment 282
Recruitment Details Males and females of at least 18 years of age, with chronic Hepatitis C Virus (HCV) infection were enrolled in this study.
Pre-assignment Details  
Arm/Group Title HCV Genotype (GT) 1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + Ruzasvir (RZR) 180 mg for 12 weeks. Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Period Title: Overall Study
Started 78 47 61 56 18 22
Completed 73 41 57 55 18 21
Not Completed 5 6 4 1 0 1
Reason Not Completed
Adverse Event             0             0             1             0             0             0
Lost to Follow-up             2             5             3             1             0             1
Withdrawal by Subject             3             1             0             0             0             0
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6 Total
Hide Arm/Group Description Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 78 47 61 56 18 22 282
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 47 participants 61 participants 56 participants 18 participants 22 participants 282 participants
47.9  (12.6) 52.7  (11.9) 48.4  (10.1) 46.4  (13.0) 57.4  (12.4) 53.3  (11.0) 49.5  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 47 participants 61 participants 56 participants 18 participants 22 participants 282 participants
Female
35
  44.9%
24
  51.1%
27
  44.3%
23
  41.1%
11
  61.1%
6
  27.3%
126
  44.7%
Male
43
  55.1%
23
  48.9%
34
  55.7%
33
  58.9%
7
  38.9%
16
  72.7%
156
  55.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 47 participants 61 participants 56 participants 18 participants 22 participants 282 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.6%
2
   4.3%
2
   3.3%
0
   0.0%
1
   5.6%
22
 100.0%
29
  10.3%
Native Hawaiian or Other Pacific Islander
2
   2.6%
1
   2.1%
0
   0.0%
1
   1.8%
0
   0.0%
0
   0.0%
4
   1.4%
Black or African American
4
   5.1%
0
   0.0%
1
   1.6%
8
  14.3%
9
  50.0%
0
   0.0%
22
   7.8%
White
69
  88.5%
44
  93.6%
57
  93.4%
47
  83.9%
4
  22.2%
0
   0.0%
221
  78.4%
More than one race
1
   1.3%
0
   0.0%
1
   1.6%
0
   0.0%
4
  22.2%
0
   0.0%
6
   2.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Completing Study Therapy (SVR12)
Hide Description Plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR12 is the absence of detectable RNA of the hepatitis C virus, (<lower limit of quantification [LLOQ] of 15 IU/mL) for at least 12 weeks after completing treatment.
Time Frame 12 weeks after completing study therapy (Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were assigned to treatment, and received at least one dose of study medication.
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description:
Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Number of Participants Analyzed 78 47 61 56 18 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
92.3
(84.0 to 97.1)
91.5
(79.6 to 97.6)
73.8
(60.9 to 84.2)
98.2
(90.4 to 100.0)
100.0
(81.5 to 100.0)
90.9
(70.8 to 98.9)
2.Primary Outcome
Title Percentage of Participants Experiencing an Adverse Event (AE)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time Frame Up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment.
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description:
Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Number of Participants Analyzed 78 47 61 56 18 22
Measure Type: Number
Unit of Measure: Percentage of participants
60.3 61.7 57.4 55.4 77.8 77.3
3.Primary Outcome
Title Percentage of Participants Experiencing an AE of Clinical Importance (ECI)
Hide Description Adverse events of clinical importance, excluding overdoses include, but is not limited to, significant changes in alanine aminotransferase, aspartate aminotransferase, blood creatinine, glomerular filtration rate or hepatitis B reactivation.
Time Frame Up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description:
Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Number of Participants Analyzed 78 47 61 56 18 22
Measure Type: Number
Unit of Measure: Percentage of participants
1.3 2.1 1.6 3.6 0 0
4.Primary Outcome
Title Percentage of Participants Experiencing a Serious Adverse Event (SAE)
Hide Description A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose.
Time Frame Up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment.
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description:
Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Number of Participants Analyzed 78 47 61 56 18 22
Measure Type: Number
Unit of Measure: Percentage of participants
3.8 2.1 1.6 3.6 0 0
5.Primary Outcome
Title Percentage of Participants Experiencing a Drug-related AE
Hide Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE is determined by the investigator to be related to the use of the drug.
Time Frame Up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment.
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description:
Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Number of Participants Analyzed 78 47 61 56 18 22
Measure Type: Number
Unit of Measure: Percentage of participants
37.2 27.7 36.1 28.6 50.0 22.7
6.Primary Outcome
Title Percentage of Participants Experiencing a Drug-related SAE
Hide Description A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose. A drug-related SAE is determined by the investigator to be related to the use of the drug.
Time Frame Up to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment.
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description:
Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Number of Participants Analyzed 78 47 61 56 18 22
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0 0 0 0
7.Primary Outcome
Title Percentage of Participants Discontinuing Study Therapy Due to an AE
Hide Description An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment.
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description:
Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Number of Participants Analyzed 78 47 61 56 18 22
Measure Type: Number
Unit of Measure: Percentage of participants
1.3 2.1 1.6 1.8 0 4.5
8.Secondary Outcome
Title Percentage of Participants With SVR 24 Weeks After Completing Study Therapy (SVR24)
Hide Description Plasma levels of HCV RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR24 is the absence of detectable RNA of the hepatitis C virus (<LLOQ of 15 IU/mL), for at least 24 weeks after completing treatment.
Time Frame 24 weeks after completing study therapy (Week 36)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were assigned to treatment, and received at least one dose of study medication.
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description:
Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Number of Participants Analyzed 78 47 61 56 18 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
89.7
(80.8 to 95.5)
85.1
(71.7 to 93.8)
72.1
(59.2 to 82.9)
96.4
(87.7 to 99.6)
100.0
(81.5 to 100.0)
81.8
(59.7 to 94.8)
9.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description Virologic failure is the detection of HCV RNA among participants who do not discontinue study for non-treatment-related reasons, either due to on-treatment failure defined as either non-response where HCV RNA is detected at end of treatment without HCV RNA <LLOQ having been achieved while on treatment; rebound defined as >1 log10 IU/mL increase in HCV RNA from nadir while on treatment and confirmed from a separate blood draw within 2 weeks; or virologic breakthrough which is confirmed HCV RNA ≥LLOQ (target detected, quantifiable [TD(q)]) after being <LLOQ previously while on treatment. Confirmation is defined as an HCV RNA ≥LLOQ from a separate blood draw repeated within 2 weeks; or relapse post-treatment. where there is a confirmed HCV RNA ≥LLOQ [TD(q)] following end of all study therapy, after becoming undetectable (target not detected [TND]) at end of treatment. Confirmation is defined as an HCV RNA ≥LLOQ from a separate blood draw repeated within 2 weeks.
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who followed the protocol sufficiently to allow the analysis of the results. Participants who deviated substantially from the protocol were excluded.
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description:
Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
Overall Number of Participants Analyzed 78 47 61 56 18 22
Measure Type: Number
Unit of Measure: Percentage of participants
3.8 2.1 23.0 0 0 13.6
Time Frame Up to Week 14
Adverse Event Reporting Description All participants who received at least one dose of study treatment.
 
Arm/Group Title HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Hide Arm/Group Description Male and female participants with HCV GT1a or GT1b infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT2 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT3 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT4 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT5 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks. Male and female participants with HCV GT6 infection take uprifosbuvir 450 mg + RZR 180 mg for 12 weeks.
All-Cause Mortality
HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)      0/47 (0.00%)      0/61 (0.00%)      0/56 (0.00%)      0/18 (0.00%)      0/22 (0.00%)    
Hide Serious Adverse Events
HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/78 (3.85%)      1/47 (2.13%)      1/61 (1.64%)      2/56 (3.57%)      0/18 (0.00%)      0/22 (0.00%)    
Cardiac disorders             
Acute coronary syndrome  1  1/78 (1.28%)  1 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Gastrointestinal disorders             
Diarrhoea  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 1/56 (1.79%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Infections and infestations             
Abscess limb  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 1/56 (1.79%)  2 0/18 (0.00%)  0 0/22 (0.00%)  0
Cellulitis  1  1/78 (1.28%)  1 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Sinusitis  1  1/78 (1.28%)  2 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Injury, poisoning and procedural complications             
Fall  1  0/78 (0.00%)  0 0/47 (0.00%)  0 1/61 (1.64%)  2 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Investigations             
Ammonia increased  1  0/78 (0.00%)  0 0/47 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Blood creatinine increased  1  0/78 (0.00%)  0 0/47 (0.00%)  0 1/61 (1.64%)  2 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Glomerular filtration rate decreased  1  0/78 (0.00%)  0 0/47 (0.00%)  0 1/61 (1.64%)  2 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Rhabdomyolysis  1  0/78 (0.00%)  0 0/47 (0.00%)  0 1/61 (1.64%)  2 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Renal and urinary disorders             
Acute kidney injury  1  0/78 (0.00%)  0 0/47 (0.00%)  0 1/61 (1.64%)  2 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Reproductive system and breast disorders             
Ovarian cyst  1  0/78 (0.00%)  0 1/47 (2.13%)  2 0/61 (0.00%)  0 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HCV GT1 HCV GT2 HCV GT3 HCV GT4 HCV GT5 HCV GT6
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/78 (35.90%)      20/47 (42.55%)      30/61 (49.18%)      22/56 (39.29%)      14/18 (77.78%)      10/22 (45.45%)    
Gastrointestinal disorders             
Abdominal pain  1  1/78 (1.28%)  1 1/47 (2.13%)  1 1/61 (1.64%)  2 2/56 (3.57%)  2 2/18 (11.11%)  2 1/22 (4.55%)  1
Constipation  1  2/78 (2.56%)  2 1/47 (2.13%)  1 1/61 (1.64%)  1 1/56 (1.79%)  1 0/18 (0.00%)  0 2/22 (9.09%)  2
Diarrhoea  1  3/78 (3.85%)  3 2/47 (4.26%)  2 2/61 (3.28%)  2 3/56 (5.36%)  3 2/18 (11.11%)  2 1/22 (4.55%)  1
Gastrooesophageal reflux disease  1  1/78 (1.28%)  1 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Nausea  1  7/78 (8.97%)  9 1/47 (2.13%)  1 4/61 (6.56%)  5 5/56 (8.93%)  6 1/18 (5.56%)  1 1/22 (4.55%)  1
Toothache  1  1/78 (1.28%)  5 1/47 (2.13%)  1 0/61 (0.00%)  0 0/56 (0.00%)  0 0/18 (0.00%)  0 2/22 (9.09%)  2
Vomiting  1  4/78 (5.13%)  4 0/47 (0.00%)  0 2/61 (3.28%)  2 1/56 (1.79%)  1 1/18 (5.56%)  1 1/22 (4.55%)  1
General disorders             
Asthenia  1  5/78 (6.41%)  5 1/47 (2.13%)  1 6/61 (9.84%)  6 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Fatigue  1  14/78 (17.95%)  16 5/47 (10.64%)  5 5/61 (8.20%)  5 4/56 (7.14%)  4 0/18 (0.00%)  0 1/22 (4.55%)  1
Oedema peripheral  1  0/78 (0.00%)  0 0/47 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Infections and infestations             
Influenza  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Rhinitis  1  1/78 (1.28%)  1 0/47 (0.00%)  0 0/61 (0.00%)  0 3/56 (5.36%)  3 0/18 (0.00%)  0 0/22 (0.00%)  0
Upper respiratory tract infection  1  2/78 (2.56%)  3 3/47 (6.38%)  3 2/61 (3.28%)  2 2/56 (3.57%)  2 3/18 (16.67%)  3 1/22 (4.55%)  2
Urinary tract infection  1  3/78 (3.85%)  3 1/47 (2.13%)  1 0/61 (0.00%)  0 0/56 (0.00%)  0 1/18 (5.56%)  1 1/22 (4.55%)  1
Injury, poisoning and procedural complications             
Accidental overdose  1  2/78 (2.56%)  3 0/47 (0.00%)  0 0/61 (0.00%)  0 2/56 (3.57%)  2 1/18 (5.56%)  1 0/22 (0.00%)  0
Contusion  1  1/78 (1.28%)  1 1/47 (2.13%)  1 0/61 (0.00%)  0 1/56 (1.79%)  1 1/18 (5.56%)  2 0/22 (0.00%)  0
Joint injury  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Meniscus injury  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 1/18 (5.56%)  2 0/22 (0.00%)  0
Traumatic haemorrhage  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Investigations             
Blood creatine phosphokinase increased  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 1/56 (1.79%)  1 3/18 (16.67%)  3 0/22 (0.00%)  0
Blood pressure increased  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Metabolism and nutrition disorders             
Decreased appetite  1  3/78 (3.85%)  3 2/47 (4.26%)  2 3/61 (4.92%)  3 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Hyperkalaemia  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  3/78 (3.85%)  3 0/47 (0.00%)  0 1/61 (1.64%)  1 2/56 (3.57%)  4 2/18 (11.11%)  3 0/22 (0.00%)  0
Muscle spasms  1  1/78 (1.28%)  1 0/47 (0.00%)  0 1/61 (1.64%)  1 0/56 (0.00%)  0 2/18 (11.11%)  2 0/22 (0.00%)  0
Nervous system disorders             
Dizziness  1  3/78 (3.85%)  3 0/47 (0.00%)  0 4/61 (6.56%)  4 3/56 (5.36%)  4 0/18 (0.00%)  0 0/22 (0.00%)  0
Headache  1  7/78 (8.97%)  11 5/47 (10.64%)  6 10/61 (16.39%)  13 8/56 (14.29%)  10 2/18 (11.11%)  2 1/22 (4.55%)  1
Somnolence  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Psychiatric disorders             
Depression  1  0/78 (0.00%)  0 0/47 (0.00%)  0 1/61 (1.64%)  2 0/56 (0.00%)  0 1/18 (5.56%)  2 0/22 (0.00%)  0
Insomnia  1  0/78 (0.00%)  0 1/47 (2.13%)  1 3/61 (4.92%)  3 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  2/78 (2.56%)  2 0/47 (0.00%)  0 1/61 (1.64%)  2 2/56 (3.57%)  2 0/18 (0.00%)  0 2/22 (9.09%)  2
Oropharyngeal pain  1  1/78 (1.28%)  1 2/47 (4.26%)  3 1/61 (1.64%)  1 1/56 (1.79%)  1 0/18 (0.00%)  0 2/22 (9.09%)  3
Rhinitis allergic  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 1/56 (1.79%)  1 1/18 (5.56%)  1 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders             
Pruritus  1  0/78 (0.00%)  0 0/47 (0.00%)  0 1/61 (1.64%)  1 2/56 (3.57%)  2 0/18 (0.00%)  0 2/22 (9.09%)  2
Psoriasis  1  0/78 (0.00%)  0 0/47 (0.00%)  0 0/61 (0.00%)  0 0/56 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Rash  1  0/78 (0.00%)  0 3/47 (6.38%)  4 3/61 (4.92%)  3 0/56 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02956629    
Other Study ID Numbers: 3682-041
2016-003227-37 ( EudraCT Number )
MK-3682-041 ( Other Identifier: Merck Protocol Number )
First Submitted: November 2, 2016
First Posted: November 6, 2016
Results First Submitted: December 3, 2018
Results First Posted: December 26, 2018
Last Update Posted: June 25, 2019