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A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)

NCT ID: NCT01717326

Last Updated: 2021-02-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

573 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-07

Study Completion Date

2015-05-06

Brief Summary

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This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the treatment arms.

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Detailed Description

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Part A is being done in treatment-naïve (TN), genotype 1 (GT1), interferon eligible, non-cirrhotic (N-C) participants with chronic hepatitis C (CHC). Participants will be assigned randomly to 1 of 2 treatment arms in which they will receive grazoprevir 100 mg once daily (QD) + elbasvir 20 mg or 50 mg QD and twice daily (BID) RBV, or to a treatment arm in which they will receive grazoprevir 100 mg QD + elbasvir 50 mg QD without RBV. Treatment will last 12 weeks.

In Part B, participants with hepatitis C virus (HCV) GT1 and HCV ribonucleic acid (RNA) levels of ≥10,000 IU/mL will be randomly assigned to a study arm, based on absence or presence of cirrhosis (C), whether they are TN or had poor response to previous antiviral therapy (null responders \[NR\]), or whether co-infected with human immunodeficiency virus (HIV); these participants will receive open-label grazoprevir (100 mg) in combination with elbasvir (50 mg) ± RBV. Treatment will last 8 to 18 weeks dependent on arm assignment.

In Part C, TN, N-C participants with HCV GT1b and HCV RNA levels of ≥10,000 IU/mL will be randomly assigned to receive open-label grazoprevir (100 mg) in combination with elbasvir (50 mg) ± RBV. Treatment will last 8 weeks.

In Part D, TN N-C participants with HCV GT3 and HCV RNA levels of ≥10,000 IU/mL will be randomly assigned to receive open-label grazoprevir (100 mg) in combination with elbasvir (50 mg) + RBV for 12 or 18 weeks.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk

GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Placebo to Elbasvir

Intervention Type DRUG

Placebo to Elbasvir 20 or 50 mg capsule, orally, once daily for 12 weeks to maintain blind (Part A only)

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk

GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Placebo to Elbasvir

Intervention Type DRUG

Placebo to Elbasvir 20 or 50 mg capsule, orally, once daily for 12 weeks to maintain blind (Part A only)

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk

GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk

GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk

GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk

GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk

GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk

GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk

GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk

GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight

Group Type EXPERIMENTAL

Grazoprevir

Intervention Type DRUG

100 mg tablet orally QD

Elbasvir

Intervention Type DRUG

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Ribavirin

Intervention Type DRUG

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

Interventions

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Grazoprevir

100 mg tablet orally QD

Intervention Type DRUG

Elbasvir

Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

Intervention Type DRUG

Placebo to Elbasvir

Placebo to Elbasvir 20 or 50 mg capsule, orally, once daily for 12 weeks to maintain blind (Part A only)

Intervention Type DRUG

Ribavirin

Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

Intervention Type DRUG

Other Intervention Names

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MK-5172 MK-8742 Rebetol™ RBV

Eligibility Criteria

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Inclusion Criteria

All participants

* CHC genotype 1 (GT1) virus infection (Parts A, B, and C) or GT3 virus infection (Part D)
* Female participants of childbearing potential or male participant with female partners of childbearing potential, must use two acceptable methods of birth control from ≥2 weeks prior to Day 1 until ≥6 months after last dose of study drug, or longer if dictated by local regulations

Part A - Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis - No evidence of advanced fibrosis, cirrhosis and/or hepatocellular carcinoma by biopsy or noninvasive testing (FibroScan and/or FibroTest)

Parts B, C, and D

* Treatment naïve with or without cirrhosis, or
* Prior treatment failure to Peg-IFN/Ribavirin with or without cirrhosis, or
* Co-infected with human immunodeficiency virus (HIV) without cirrhosis
* Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
* Liver disease staging assessment by liver biopsy or noninvasive testing (FibroScan and/or FibroTest)

Exclusion Criteria

All participants

* Non-GT1 HCV infection (Part A, Part B, and Part C) or a non-GT3 HCV infection (Part D) including a mixed GT infection (with a non-GT1 \[Part A, Part B, and Part C\] or non-GT3 \[Part D\]) or a non-typeable genotype
* Evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
* Currently participating or participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study
* Diabetic and/or hypertensive with clinically significant ocular examination findings
* History of depression associated with hospitalization for depression, electroconvulsive therapy, or resulting in prolonged absence from work and/or significant disruption of daily functions
* Suicidal or homicidal ideations and/or attempt, or history of severe psychiatric disorders
* Clinical diagnosis of substance abuse
* Current history of seizure disorder, stroke, or transient ischemic attack
* Immunologically mediated disease
* Chronic pulmonary disease
* Clinically significant cardiac abnormalities/dysfunction
* Active clinical gout within the last year
* Hemoglobinopathy or myelodysplastic syndromes
* History of organ transplants including hematopoietic stem cell transplants
* Poor venous access
* Indwelling venous catheter
* History of gastric surgery or malabsorption disorders
* Severe concurrent disease
* Evidence of active or suspected malignancy, or a history of malignancy, ≤5 years before
* Pregnant, lactating, expecting to conceive or donate eggs
* Male participant with pregnant female partner
* Member/family member of the investigational study or sponsor staff directly involved with this study
* Evidence or history of chronic hepatitis not caused by HCV

Part A

* Not treatment-naïve
* Documented to be HIV positive
* Taking or planning to take significant inducers or inhibitors of CYP3A4 substrates or herbal supplements 2 weeks prior to start of study medications

Parts B, C, and D

* Previously received any HCV direct-acting antivirals
* Requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
* For participants diagnosed with diabetes mellitus, documented HbA1c \>8.5%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Lawitz E, Gane E, Pearlman B, Tam E, Ghesquiere W, Guyader D, Alric L, Bronowicki JP, Lester L, Sievert W, Ghalib R, Balart L, Sund F, Lagging M, Dutko F, Shaughnessy M, Hwang P, Howe AY, Wahl J, Robertson M, Barr E, Haber B. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. Lancet. 2015 Mar 21;385(9973):1075-86. doi: 10.1016/S0140-6736(14)61795-5. Epub 2014 Nov 11.

Reference Type BACKGROUND
PMID: 25467591 (View on PubMed)

Sulkowski M, Hezode C, Gerstoft J, Vierling JM, Mallolas J, Pol S, Kugelmas M, Murillo A, Weis N, Nahass R, Shibolet O, Serfaty L, Bourliere M, DeJesus E, Zuckerman E, Dutko F, Shaughnessy M, Hwang P, Howe AY, Wahl J, Robertson M, Barr E, Haber B. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial. Lancet. 2015 Mar 21;385(9973):1087-97. doi: 10.1016/S0140-6736(14)61793-1. Epub 2014 Nov 11.

Reference Type BACKGROUND
PMID: 25467560 (View on PubMed)

Gane E, Nahass R, Luketic V, Asante-Appiah E, Hwang P, Robertson M, Wahl J, Barr E, Haber B. Efficacy of 12 or 18 weeks of elbasvir plus grazoprevir with ribavirin in treatment-naive, noncirrhotic HCV genotype 3-infected patients. J Viral Hepat. 2017 Oct;24(10):895-899. doi: 10.1111/jvh.12719. Epub 2017 Jun 23.

Reference Type DERIVED
PMID: 28470815 (View on PubMed)

Jacobson IM, Lawitz E, Kwo PY, Hezode C, Peng CY, Howe AYM, Hwang P, Wahl J, Robertson M, Barr E, Haber BA. Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis. Gastroenterology. 2017 May;152(6):1372-1382.e2. doi: 10.1053/j.gastro.2017.01.050. Epub 2017 Feb 11.

Reference Type DERIVED
PMID: 28193518 (View on PubMed)

Other Identifiers

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2012-003354-89

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

5172-035

Identifier Type: -

Identifier Source: org_study_id

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