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Trial record 30 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)

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ClinicalTrials.gov Identifier: NCT02358044
Recruitment Status : Completed
First Posted : February 6, 2015
Results First Posted : January 11, 2017
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Sofosbuvir
Biological: PegIntron
Drug: Ribavirin
Drug: Grazoprevir/Elbasvir (100 mg/50 mg) FDC
Enrollment 257
Recruitment Details  
Pre-assignment Details A total of 257 participants were randomized to treatment: 129 to Grazoprevir + Elbasvir arm and 128 to Sofosbuvir plus Pegylated Interferon/Ribavirin (SOF + PR) arm. Two participants in the SOF + PR arm withdrew from study prior to treatment.
Arm/Group Title Grazoprevir + Elbasvir SOF + PR
Hide Arm/Group Description Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up. Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
Period Title: Overall Study
Started 129 128
Treated 129 126
Completed 127 [1] 121 [1]
Not Completed 2 7
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             2             1
Physician Decision             0             1
Withdrawal by Subject             0             4
[1]
Completed = Completed Follow-up Week 24 (end of study)
Arm/Group Title Grazoprevir + Elbasvir SOF + PR Total
Hide Arm/Group Description Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up. Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up. Total of all reporting groups
Overall Number of Baseline Participants 129 126 255
Hide Baseline Analysis Population Description
Full Analysis Set (FAS); all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants 126 participants 255 participants
47.6  (12.4) 48.2  (12.4) 47.9  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 126 participants 255 participants
Female
74
  57.4%
64
  50.8%
138
  54.1%
Male
55
  42.6%
62
  49.2%
117
  45.9%
1.Primary Outcome
Title Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12)
Hide Description Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (<LLOQ) at 12 weeks after the end of all study therapy. The primary efficacy hypothesis for this study was that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was non-inferior to the percentage in the SOF plus PR arm. A secondary statistical analysis was performed to determine whether the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was superior to the percentage in the SOF plus PR arm.
Time Frame 12 weeks after end of all therapy (Study Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.
Arm/Group Title Grazoprevir + Elbasvir SOF + PR
Hide Arm/Group Description:
Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
Overall Number of Participants Analyzed 129 126
Measure Type: Number
Unit of Measure: percentage of participants
99.2 90.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir, SOF + PR
Comments

Primary Analysis Approach: Non-Inferiority

Analyses of the percentage of participants achieving SVR12 was conducted using the Miettinen & Nurminen (M&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Miettinen & Nurminen Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Difference in Percentage
Estimated Value 8.8
Confidence Interval (2-Sided) 95%
3.6 to 15.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir, SOF + PR
Comments

Secondary Analysis Approach: Superiority

Analyses of the percentage of participants achieving SVR12 was conducted using the M&N method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir +elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% CIs and p-values were provided.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Miettinen & Nurminen Method
Comments The lower bound of 95% CIs was compared to zero to evaluate superiority. The M=F approach was used to handle missing values.
Method of Estimation Estimation Parameter Adjusted Difference in Percentage
Estimated Value 8.8
Confidence Interval (2-Sided) 95%
3.6 to 15.3
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could 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 of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm.
Time Frame Treatment + First 14 days of follow-up (Up to Week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects as Treated (ASaT) population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.
Arm/Group Title Grazoprevir + Elbasvir SOF + PR
Hide Arm/Group Description:
Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
Overall Number of Participants Analyzed 129 126
Measure Type: Number
Unit of Measure: percentage of participants
51.9 93.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir, SOF + PR
Comments The percentage of participants with an event were assessed via point estimates with 95% CIs provided for between-group comparisons.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -41.7
Confidence Interval (2-Sided) 95%
-51.1 to -31.9
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Discontinuing Study Treatment Due to an AE
Hide Description

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could 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 of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE.

The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial.

Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ASaT population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.
Arm/Group Title Grazoprevir + Elbasvir SOF + PR
Hide Arm/Group Description:
Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
Overall Number of Participants Analyzed 129 126
Measure Type: Number
Unit of Measure: percentage of participants
0.8 0.8
4.Secondary Outcome
Title Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days
Hide Description Tier 1 safety events were pre-specified by the protocol to evaluate safety and test the safety superiority hypothesis. Tier 1 safety events were chosen to assess broad tolerability, hematological side effects and liver-related laboratory abnormalities. For this study, Tier 1 safety events included: any serious drug-related AE, any drug-related AE leading to permanent discontinuation (DC) of all study drugs, neutrophil count <0.75 x 10^9/L, hemoglobin <10 g/dL, severe depression, hepatic events of clinical interest (defined by abnormal increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]), or events meeting stopping rule criteria for DC from trial (due to abnormal increases of ALT, AST, or ALP with/without pre-specified related AEs). The percentage of participants who experienced each individual event that was defined as a Tier 1 safety event during the study treatment period was reported for each treatment arm.
Time Frame Treatment + First 14 days of follow-up (Up to Week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
ASaT population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.
Arm/Group Title Grazoprevir + Elbasvir SOF + PR
Hide Arm/Group Description:
Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
Overall Number of Participants Analyzed 129 126
Measure Type: Number
Unit of Measure: percentage of participants
Total Tier 1 AEs 0.8 27.8
Tier 1 AE: Serious drug-related AE 0.0 2.4
Tier 1 AE: DC due to drug-related AE 0.0 0.8
Tier 1 AE: Neutrophil count <0.75 x 10^9/L 0.0 12.7
Tier 1 AE: Hemoglobin <10 g/dL 0.8 14.3
Tier 1 AE: Severe depression 0.0 0.0
Tier 1 AE: Hepatic event of clinical interest 0.0 0.0
Tier 1 AE: Trial DC due to stopping rule 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir, SOF + PR
Comments

Total Tier 1 AEs:

If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments % of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.
Method Miettinen & Nurminen Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -27.0
Confidence Interval (2-Sided) 95%
-35.5 to -19.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir, SOF + PR
Comments

Serious drug-related AEs:

If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments % of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.
Method Miettinen & Nurminen Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-6.8 to 0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir, SOF + PR
Comments

DC due to drug-related AE:

If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.312
Comments % of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.
Method Miettinen & Nurminen Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-4.4 to 2.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir, SOF + PR
Comments

Neutrophil count <0.75 x 10^9/L:

If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments % of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.
Method Miettinen & Nurminen Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -12.7
Confidence Interval (2-Sided) 95%
-19.7 to -8.0
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir, SOF + PR
Comments

Hemoglobin <10 g/dL:

If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments % of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.
Method Miettinen & Nurminen Method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -13.5
Confidence Interval (2-Sided) 95%
-20.8 to -7.9
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)
Hide Description HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy.
Time Frame 24 weeks after end of all therapy (Study Week 36)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.
Arm/Group Title Grazoprevir + Elbasvir SOF + PR
Hide Arm/Group Description:
Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
Overall Number of Participants Analyzed 129 126
Measure Type: Number
Unit of Measure: percentage of participants
98.4 89.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Grazoprevir + Elbasvir, SOF + PR
Comments Analyses of the percentage of participants achieving SVR24 was conducted using the Miettinen & Nurminen (M&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.
Method of Estimation Estimation Parameter Adjusted Difference in Percentage
Estimated Value 8.8
Confidence Interval (2-Sided) 95%
3.3 to 15.7
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4)
Hide Description HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR4 was defined as HCV RNA <LLOQ at 4 weeks after the end of all study therapy.
Time Frame 4 weeks after end of all therapy (Study Week 16)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.
Arm/Group Title Grazoprevir + Elbasvir SOF + PR
Hide Arm/Group Description:
Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
Overall Number of Participants Analyzed 129 126
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.2
(95.8 to 100.0)
92.1
(85.9 to 96.1)
Time Frame Up to Follow-up Week 24
Adverse Event Reporting Description ASaT population; all randomized participants who received at least one dose of study treatment. Two randomized participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.
 
Arm/Group Title Grazoprevir + Elbasvir SOF + PR
Hide Arm/Group Description Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up. Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
All-Cause Mortality
Grazoprevir + Elbasvir SOF + PR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Grazoprevir + Elbasvir SOF + PR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/129 (0.78%)      6/126 (4.76%)    
Blood and lymphatic system disorders     
Anaemia  1  0/129 (0.00%)  0 1/126 (0.79%)  1
Cardiac disorders     
Angina pectoris  1  0/129 (0.00%)  0 1/126 (0.79%)  1
Gastrointestinal disorders     
Proctitis  1  0/129 (0.00%)  0 1/126 (0.79%)  1
Infections and infestations     
Infection  1  0/129 (0.00%)  0 1/126 (0.79%)  1
Influenza  1  0/129 (0.00%)  0 1/126 (0.79%)  1
Proctitis infectious  1  0/129 (0.00%)  0 1/126 (0.79%)  1
Tooth abscess  1  1/129 (0.78%)  1 0/126 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/129 (0.00%)  0 1/126 (0.79%)  1
Nervous system disorders     
Cerebrovascular accident  1  0/129 (0.00%)  0 1/126 (0.79%)  1
Psychiatric disorders     
Drug dependence  1  0/129 (0.00%)  0 1/126 (0.79%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Grazoprevir + Elbasvir SOF + PR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/129 (34.11%)      114/126 (90.48%)    
Blood and lymphatic system disorders     
Anaemia  1  1/129 (0.78%)  1 15/126 (11.90%)  15
Neutropenia  1  0/129 (0.00%)  0 11/126 (8.73%)  15
Gastrointestinal disorders     
Dyspepsia  1  1/129 (0.78%)  1 8/126 (6.35%)  10
Nausea  1  8/129 (6.20%)  9 13/126 (10.32%)  23
General disorders     
Asthenia  1  8/129 (6.20%)  10 30/126 (23.81%)  36
Chills  1  2/129 (1.55%)  4 21/126 (16.67%)  27
Fatigue  1  9/129 (6.98%)  9 32/126 (25.40%)  48
Influenza like illness  1  1/129 (0.78%)  1 23/126 (18.25%)  40
Pyrexia  1  2/129 (1.55%)  2 68/126 (53.97%)  191
Injury, poisoning and procedural complications     
Accidental overdose  1  0/129 (0.00%)  0 8/126 (6.35%)  12
Metabolism and nutrition disorders     
Decreased appetite  1  1/129 (0.78%)  1 16/126 (12.70%)  16
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/129 (3.88%)  5 14/126 (11.11%)  25
Back pain  1  3/129 (2.33%)  4 8/126 (6.35%)  8
Myalgia  1  4/129 (3.10%)  6 19/126 (15.08%)  47
Nervous system disorders     
Dizziness  1  4/129 (3.10%)  5 7/126 (5.56%)  10
Headache  1  17/129 (13.18%)  31 50/126 (39.68%)  97
Psychiatric disorders     
Irritability  1  0/129 (0.00%)  0 10/126 (7.94%)  11
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/129 (0.00%)  0 13/126 (10.32%)  27
Dyspnoea  1  3/129 (2.33%)  3 10/126 (7.94%)  10
Skin and subcutaneous tissue disorders     
Alopecia  1  1/129 (0.78%)  1 18/126 (14.29%)  18
Pruritus  1  2/129 (1.55%)  2 8/126 (6.35%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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. Sponsor review can be expedited to meet publication timelines.
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: NCT02358044     History of Changes
Other Study ID Numbers: 5172-077
2014-003836-38 ( EudraCT Number )
First Submitted: February 3, 2015
First Posted: February 6, 2015
Results First Submitted: September 15, 2016
Results First Posted: January 11, 2017
Last Update Posted: October 3, 2018