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CompletedNCT02105688C-EDGE CO-STARUpdated Dec 5, 2019Results posted

An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus (HCV) Genotype (GT)1, 4, or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (MK-5172-062)

A Phase 3 interventional study of Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet (MK-5172A) and Placebo to Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet in Chronic Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-05.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
301
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a 2-part study. The purpose of Part A is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg for 12 weeks in the treatment of chronic HCV GT1, GT4, or GT6 infection in treatment-naïve participants who are on opiate substitution therapy (OST). The primary hypothesis is that the percentage of participants who receive grazoprevir/elbasvir fixed-dose combination (FDC) in the Immediate Treatment Arm and achieve a Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to 67%. In addition, participants who received at least 1 dose of grazoprevir/elbasvir in Part A will be eligible to participate in Part B, which is a 3-year observational follow-up.

02

Conditions studied

  • Chronic Hepatitis C
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 301 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Part A

  • Documented chronic HCV GT1, GT4, or GT6 infection with no evidence of GT2, GT3, GT5 or non-typeable genotypes and HCV ribonucleic acid (RNA) confirmed by screening lab results prior to randomization
  • On opiate substitution therapy (OST; methadone, levamethadone, buprenorphine, naloxone, naltrexone) for at least 3 months prior to screening
  • Treatment naïve to all HCV therapies
  • Human Immunodeficiency Virus (HIV)-infected participants enrolled in this study must meet following criteria:
  • Documented HIV infection
  • Naïve to treatment with any antiretroviral therapy (ART) OR on HIV ART for at least 8 weeks prior to study entry using a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir (or dolutegravir or rilpivirine). Dose modifications or changes in ART during the 4 weeks prior to study entry (Day 1) are not permitted
  • Cluster of differentiation 4 (CD4+) T-cell count >200 cells/mm\^3 if on ART or >500 cell/mm\^3 if ART treatment naïve
  • Undetectable plasma HIV-1 RNA at least 8 weeks prior to screening if on ART or \<50,000 copies/mL if ART treatment naïve
  • Participants with HIV-1 infection and on ART must have at least one viable antiretroviral regimen alternative beyond their current regimen in the event of HIV virologic failure or the development of anti-retroviral drug resistance
  • Females who are of reproductive potential must agree to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity

Part B

  • Received at least one dose of grazoprevir in combination with elbasvir in Part A. Receiving OST and keeping >80% of scheduled appointments while on OST were not required for Part B.

Exclusion criteria

Exclusion Criteria:

Part A

  • Evidence of decompensated liver disease
  • For participants with cirrhosis, participants who are Child-Pugh Class B or C or who have a Pugh-Turcotte (CPT) score >6
  • Is co-infected with hepatitis B virus
  • Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
  • Currently using or intends to use barbiturates during the treatment period of this study
  • Is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from Day 1 or anytime during treatment, and 14 days after the last dose of study medication, or longer if dictated by local regulations
  • Any medical condition requiring or likely to require chronic systemic administration of corticosteroids, Tumor Necrosis Factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial
  • Evidence or history of chronic hepatitis not caused by HCV

Part B

  • Mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures
  • Has a medical condition or personal circumstance which, in the opinion of the investigator and/or Sponsor, places the participant at unnecessary risk through continued participation in the trial or does not allow the participant to adhere to the requirements of the protocol
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
301 participants (actual)

Study arms

  • Experimental
    Immediate Treatment Arm: Grazoprevir/Elbasvir

    In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).

    Drug: Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet (MK-5172A)

  • Placebo comparator
    Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir

    In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants received 12 weeks of open-label treatment with the MK-5172A FDC and were followed-up for 24 weeks. In Part B, participants could enroll in a 3-year follow-up period where they were followed every 6 months for 3 years in an observational cohort (no treatment was administered during Part B).

    Drug: Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet (MK-5172A) · Drug: Placebo to Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet

Interventions

  • DrugGrazoprevir 100 mg/Elbasvir 50 mg FDC tablet (MK-5172A)

    Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet, taken once daily by mouth for 12 weeks.

    Also known as: MK-5172A

  • DrugPlacebo to Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet

    Placebo Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet, taken once daily by mouth for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)

    Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (\<LLOQ) at 12 weeks after the end of all study therapy for baseline infection, or HCV RNA≥ LLOQ demonstrated to be due to reinfection (after clearance of baseline infection). The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR12 rate. The primary efficacy analysis for Part A was the percentage of participants in the immediate treatment arm (ITA) who achieved SVR12. SVR12 was also calculated for the Deferred Treatment Arm.

    Time frame: 12 weeks after end of all therapy (Study Week 24 for Immediate Treatment Arm and Study Week 40 for Deferred Treatment Arm)

  2. Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Double-Blind (DB) Treatment Period and First 14 Follow-up Days

    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants experiencing an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period.

    Time frame: DB Treatment period plus first 14 follow-up days (up to Study Week 14)

  3. Percentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period

    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants discontinuing study therapy due to an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period.

    Time frame: DB Treatment period (up to Study Week 12)

Secondary outcomes

  1. Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)

    Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA \<LLOQ at 24 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR24 rate. The secondary efficacy analysis for Part A evaluated the percentage of participants in the immediate treatment arm (ITA) who achieved SVR24. SVR24 was also calculated for the Deferred Treatment Arm.

    Time frame: 24 weeks after end of all therapy (Study Week 36 for Immediate Treatment Arm and Study Week 52 for Deferred Treatment Arm)

07

Results

Posted Jul 11, 2016

Participant flow

Part A: Double-Blind
Participant flow — Part A: Double-Blind
MilestoneImmediate Treatment Arm: Grazoprevir/ElbasvirDeferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Started201100
Completed18183
Not completed2017
Withdrew: Adverse event10
Withdrew: Death01
Withdrew: Lost to follow-up1511
Withdrew: Physician decision01
Withdrew: Status unknown02
Withdrew: Withdrawal by subject42
Part B: Observational Follow-up
Participant flow — Part B: Observational Follow-up
MilestoneImmediate Treatment Arm: Grazoprevir/ElbasvirDeferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Started13168
Completed9448
Not completed3720
Withdrew: Death21
Withdrew: Lost to follow-up2315
Withdrew: Withdrawal by subject93
Withdrew: Physician decision31

Outcome measures

PrimaryPercentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (\<LLOQ) at 12 weeks after the end of all study therapy for baseline infection, or HCV RNA≥ LLOQ demonstrated to be due to reinfection (after clearance of baseline infection). The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR12 rate. The primary efficacy analysis for Part A was the percentage of participants in the immediate treatment arm (ITA) who achieved SVR12. SVR12 was also calculated for the Deferred Treatment Arm.

Time frame:
12 weeks after end of all therapy (Study Week 24 for Immediate Treatment Arm and Study Week 40 for Deferred Treatment Arm)
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
Percentage of ParticipantsImmediate Treatment Arm: Grazoprevir/ElbasvirDeferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)95.5 (91.5 to 97.9)96.6 (90.4 to 99.3)
Statistical analysis
  • Immediate Treatment Arm: Grazoprevir/Elbasvir · One-sided exact test · p = <0.001
PrimaryPercentage of Participants Experiencing at Least One Adverse Event (AE) During the Double-Blind (DB) Treatment Period and First 14 Follow-up Days

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants experiencing an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period.

Time frame:
DB Treatment period plus first 14 follow-up days (up to Study Week 14)
Reported as:
Number · Percentage of Participants
Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Double-Blind (DB) Treatment Period and First 14 Follow-up Days
Percentage of ParticipantsImmediate Treatment Arm: Grazoprevir/ElbasvirDeferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Double-Blind (DB) Treatment Period and First 14 Follow-up Days83.183.0
Statistical analysis
  • Immediate Treatment Arm: Grazoprevir/Elbasvir vs Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir · Difference in percentage: 0.2 · 95% CI -8.3 to 10.0
PrimaryPercentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, 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 pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants discontinuing study therapy due to an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period.

Time frame:
DB Treatment period (up to Study Week 12)
Reported as:
Number · Percentage of Participants
Percentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period
Percentage of ParticipantsImmediate Treatment Arm: Grazoprevir/ElbasvirDeferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Percentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period0.51.0
Statistical analysis
  • Immediate Treatment Arm: Grazoprevir/Elbasvir vs Deferred Treatment Arm: Placebo > Grazoprevir/Elbasvir · Difference in percentage: -0.5 · 95% CI -5.0 to 1.9
SecondaryPercentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA \<LLOQ at 24 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR24 rate. The secondary efficacy analysis for Part A evaluated the percentage of participants in the immediate treatment arm (ITA) who achieved SVR24. SVR24 was also calculated for the Deferred Treatment Arm.

Time frame:
24 weeks after end of all therapy (Study Week 36 for Immediate Treatment Arm and Study Week 52 for Deferred Treatment Arm)
Reported as:
Number · Percentage of Participants
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)
Percentage of ParticipantsImmediate Treatment Arm: Grazoprevir/ElbasvirDeferred Treatment Arm: Placebo > Grazoprevir/Elbasvir
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)94.1 (89.7 to 97.0)96.5 (90.0 to 99.3)

Adverse events

Collected over Up to approximately 4 years (Study Week 208). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Immediate Treatment Arm: Grazoprevir/Elbasvir3/201 (1.5%)16/201 (8%)108/201 (53.7%)
Deferred Treatment Arm: Placebo1/100 (1%)4/100 (4%)46/100 (46%)
Deferred Treatment Arm: Grazoprevir/Elbasvir1/95 (1.1%)7/95 (7.4%)36/95 (37.9%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventImmediate Treatment Arm: Grazoprevir/ElbasvirDeferred Treatment Arm: PlaceboDeferred Treatment Arm: Grazoprevir/Elbasvir
CellulitisInfections and infestations1/2010/1001/95
Accidental overdoseInjury, poisoning and procedural complications0/2010/1001/95
OverdoseInjury, poisoning and procedural complications1/2010/1001/95
Road traffic accidentInjury, poisoning and procedural complications0/2010/1001/95
Skin lacerationInjury, poisoning and procedural complications0/2010/1001/95
Squamous cell carcinoma of the oral cavityNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2010/1001/95
DepressionPsychiatric disorders0/2010/1001/95
Drug abusePsychiatric disorders1/2010/1001/95
Skin ulcerSkin and subcutaneous tissue disorders0/2011/1001/95
BacteraemiaInfections and infestations0/2011/1000/95
Most frequent other events
Most frequent other events
EventImmediate Treatment Arm: Grazoprevir/ElbasvirDeferred Treatment Arm: PlaceboDeferred Treatment Arm: Grazoprevir/Elbasvir
FatigueGeneral disorders32/20120/10013/95
HeadacheNervous system disorders26/20114/10012/95
NauseaGastrointestinal disorders23/2019/1008/95
DiarrhoeaGastrointestinal disorders20/2019/1008/95
ConstipationGastrointestinal disorders17/2014/1002/95
VomitingGastrointestinal disorders8/2017/1004/95
InsomniaPsychiatric disorders13/2016/1000/95
Decreased appetiteMetabolism and nutrition disorders8/2016/1003/95
Abdominal painGastrointestinal disorders11/2014/1003/95
Accidental overdoseInjury, poisoning and procedural complications7/2014/1005/95

Baseline characteristics

Baseline (BL) characteristics were reported for the Full Analysis Set (FAS): all randomized participants receiving ≥1 dose of study treatment.

Age, Continuous
Age, Continuous(years)Immediate Treatment Arm: Grazoprevir/ElbasvirDeferred Treatment Arm: Placebo > Grazoprevir/ElbasvirTotal
Mean47.4 ± 9.946.4 ± 9.947.1 ± 9.9
Sex: Female, Male
Sex: Female, Male(Participants)Immediate Treatment Arm: Grazoprevir/ElbasvirDeferred Treatment Arm: Placebo > Grazoprevir/ElbasvirTotal
Female482371
Male15377230
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Dore GJ, Altice F, Litwin AH, Dalgard O, Gane EJ, Shibolet O, Luetkemeyer A, Nahass R, Peng CY, Conway B, Grebely J, Howe AY, Gendrano IN, Chen E, Huang HC, Dutko FJ, Nickle DC, Nguyen BY, Wahl J, Barr E, Robertson MN, Platt HL; C-EDGE CO-STAR Study Group. Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial. Ann Intern Med. 2016 Nov 1;165(9):625-634. doi: 10.7326/M16-0816. Epub 2016 Aug 9. PubMed 27537841 ↗
  • Grebely J, Dore GJ, Altice FL, Conway B, Litwin AH, Norton BL, Dalgard O, Gane EJ, Shibolet O, Nahass R, Luetkemeyer AF, Peng CY, Iser D, Gendrano IN, Kelly MM, Hwang P, Asante-Appiah E, Haber BA, Barr E, Robertson MN, Platt H. Reinfection and Risk Behaviors After Treatment of Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy : A Cohort Study. Ann Intern Med. 2022 Sep;175(9):1221-1229. doi: 10.7326/M21-4119. Epub 2022 Aug 9. PubMed 35939812 ↗
  • Asselah T, Reesink H, Gerstoft J, de Ledinghen V, Pockros PJ, Robertson M, Hwang P, Asante-Appiah E, Wahl J, Nguyen BY, Barr E, Talwani R, Serfaty L. Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis. Liver Int. 2018 Sep;38(9):1583-1591. doi: 10.1111/liv.13727. Epub 2018 Mar 31. PubMed 29461687 ↗
  • Reau N, Robertson MN, Feng HP, Caro L, Yeh WW, Nguyen BT, Wahl J, Barr E, Hwang P, Klopfer SO. Concomitant proton pump inhibitor use does not reduce the efficacy of elbasvir/grazoprevir: A pooled analysis of 1,322 patients with hepatitis C infection. Hepatol Commun. 2017 Aug 22;1(8):757-764. doi: 10.1002/hep4.1081. eCollection 2017 Oct. PubMed 29404492 ↗

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02105688
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Apr 7, 2014
Start date
Sep 2, 2014
Primary completion
Jun 10, 2015
Completion
Dec 4, 2018
Results posted
Jul 11, 2016
Last update
Dec 5, 2019

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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