Trial Outcomes & Findings for An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061) (NCT NCT02105662)
NCT ID: NCT02105662
Last Updated: 2021-02-05
Results Overview
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (\<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy.
COMPLETED
PHASE3
218 participants
12 weeks after end of all therapy (Study Week 24)
2021-02-05
Participant Flow
218 participants were enrolled and treated on study, 212 participants completed 24 weeks of follow-up.
Participant milestones
| Measure |
Grazoprevir+Elbasvir
Participants received a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
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|---|---|
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Overall Study
STARTED
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218
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Overall Study
COMPLETED
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212
|
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
Grazoprevir+Elbasvir
Participants received a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
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|---|---|
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Overall Study
Lost to Follow-up
|
5
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)
Baseline characteristics by cohort
| Measure |
Grazoprevir+Elbasvir
n=218 Participants
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
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|---|---|
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Age, Continuous
|
48.7 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
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35 Participants
n=5 Participants
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Sex: Female, Male
Male
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183 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 12 weeks after end of all therapy (Study Week 24)Population: Full Analysis Set (FAS); all allocated participants who received at least 1 dose of study treatment.
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (\<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy.
Outcome measures
| Measure |
Grazoprevir+Elbasvir
n=218 Participants
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
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|---|---|
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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
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96.3 percentage of participants
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PRIMARY outcome
Timeframe: Treatment Period plus first 14 follow-up days (up to 14 weeks)Population: All Participants as Treated (APaT) Population; all participants who received at least one dose of study treatment.
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 in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Grazoprevir+Elbasvir
n=218 Participants
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
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|---|---|
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Percentage of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days
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73.9 percentage of participants
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PRIMARY outcome
Timeframe: Treatment Period (up to 12 weeks)Population: APaT Population; all participants who received at least one dose of study treatment.
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 in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Grazoprevir+Elbasvir
n=218 Participants
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
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|---|---|
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Percentage of Participants Discontinuing Study Therapy Due to AEs During the Treatment Period
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0.0 percentage of participants
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SECONDARY outcome
Timeframe: 24 weeks after end of all therapy (Study Week 36)Population: FAS; all allocated participants who received at least 1 dose of study treatment.
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (\<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy.
Outcome measures
| Measure |
Grazoprevir+Elbasvir
n=218 Participants
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
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|---|---|
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Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)
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93.1 percentage of participants
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Adverse Events
Grazoprevir + Elbasvir
Serious adverse events
| Measure |
Grazoprevir + Elbasvir
n=218 participants at risk
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
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|---|---|
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Infections and infestations
Erysipelas
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0.46%
1/218 • Number of events 1 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
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|
Infections and infestations
Peritonitis bacterial
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0.46%
1/218 • Number of events 1 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
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0.46%
1/218 • Number of events 1 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
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|
Injury, poisoning and procedural complications
Ulna fracture
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0.46%
1/218 • Number of events 1 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
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|
Nervous system disorders
Seizure
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0.46%
1/218 • Number of events 1 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
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|
Psychiatric disorders
Acute psychosis
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0.46%
1/218 • Number of events 1 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
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Renal and urinary disorders
Urinary retention
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0.46%
1/218 • Number of events 1 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
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0.46%
1/218 • Number of events 1 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
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0.46%
1/218 • Number of events 1 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
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Other adverse events
| Measure |
Grazoprevir + Elbasvir
n=218 participants at risk
Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
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|---|---|
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Gastrointestinal disorders
Abdominal pain upper
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5.0%
11/218 • Number of events 11 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
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Gastrointestinal disorders
Diarrhoea
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8.3%
18/218 • Number of events 19 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
|
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Gastrointestinal disorders
Nausea
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9.2%
20/218 • Number of events 20 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
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13.3%
29/218 • Number of events 31 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
14/218 • Number of events 14 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
17/218 • Number of events 18 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
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Nervous system disorders
Headache
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12.4%
27/218 • Number of events 33 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
|
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Psychiatric disorders
Insomnia
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7.3%
16/218 • Number of events 16 • 12 week treatment period plus 24 week follow-up period (up to 36 weeks)
APaT Population; all participants who received at least one dose of study treatment.
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Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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