Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)

January 15, 2021 updated by: Merck Sharp & Dohme LLC

A Phase II Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172, MK-8742, and Sofosbuvir in Treatment-Naïve Subjects With Chronic HCV GT1 or GT3 Infection

This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (SVR12).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is an open-label, single-center, multiple-arm investigation of a fixed-dose combination [FDC] of grazoprevir 100mg + elbasvir 50mg, and SOF 400mg, in treatment-naive participants with chronic HCV GT1 or GT3. The impact of study treatment regimens of varying duration on SVR12 (undetectable HCV ribonucleic acid [RNA] 12 weeks after ending study treatment) in cirrhotic (C) participants and non-cirrhotic (NC) participants will be determined (Part A). Any HCV GT1 participant from study Arms 1-4 in Part A who experienced virologic relapse will be offered retreatment consisting of 12 additional weeks of treatment with MK-5172/MK-8742 + SOF + ribavirin and 24 weeks of follow-up in Part B.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • has HCV RNA ≥10,000 IU/mL in peripheral blood at the time of screening
  • has documented chronic HCV GT1 or GT3 infection
  • has either negative or positive history of liver cirrhosis based on liver biopsy, Fibroscan, or FibroSure ® (Fibrotest®)
  • is treatment naïve to all anti-HCV treatment

Exclusion Criteria:

  • has evidence of decompensated liver disease
  • is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or human immunodeficiency virus
  • has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
  • has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
  • has clinically-relevant drug or alcohol abuse within 12 months of screening
  • has any of the following conditions: organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
  • has a history of chronic hepatitis not caused by HCV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GT1:NC Grazoprevir/Elbasvir+SOF 4wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC with SOF 400mg once daily (q.d.) by mouth for 4 weeks (n=30 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Names:
  • MK-5172A, Zepatier
Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.
Experimental: GT1:NC Grazoprevir/Elbasvir+SOF 6wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=30 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Names:
  • MK-5172A, Zepatier
Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.
Experimental: GT1:C Grazoprevir/Elbasvir+SOF 6wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=20 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Names:
  • MK-5172A, Zepatier
Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.
Experimental: GT1:C Grazoprevir/Elbasvir+SOF 8wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=20 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Names:
  • MK-5172A, Zepatier
Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.
Experimental: GT3:NC Grazoprevir/Elbasvir+SOF 8wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=15 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Names:
  • MK-5172A, Zepatier
Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.
Experimental: GT3:NC Grazoprevir/Elbasvir+SOF 12wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=15 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Names:
  • MK-5172A, Zepatier
Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.
Experimental: GT3:C Grazoprevir/Elbasvir+SOF 12wk
Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=10 planned).
Drug: Grazoprevir/Elbasvir FDC
FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
Other Names:
  • MK-5172A, Zepatier
Drug: Sofosbuvir
Sofosbuvir 400mg tablet taken q.d. by mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)
Time Frame: Up to 24 weeks
The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.
Up to 24 weeks
Number of Participants Experiencing at Least 1 Adverse Event (AE)
Time Frame: Up to Week 14
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.
Up to Week 14
Number of Participants Discontinuing Study Therapy Due to an AE
Time Frame: Up to Week 12
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.
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4)
Time Frame: Up to 16 weeks
The percentage of participants achieving SVR4, defined as HCV ribonucleic acid (RNA) <15 IU/mL 4 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2014

Primary Completion (Actual)

November 2, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5172-074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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