Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096)

NCT ID: NCT03111108

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2018-10-15

Brief Summary

The purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A) as assessed by the percentage of participants with hepatitis C virus (HCV) genotype (GT) 4 infection that achieve sustained virologic response (HCV ribonucleic acid [RNA] < Lower Limit of Quantification [LLOQ]) 12 weeks after the end of study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.

Conditions

Hepatitis C Virus (HCV) Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: EBR/GZR for 8 Weeks

Treatment-naïve participants with stage 0-2 fibrosis (F0-F2) receive FDC of EBR/GZR (50 mg/100 mg) for 8 weeks, with 24 weeks of follow-up.

Group Type: EXPERIMENTAL

EBR/GZR (50 mg/100 mg) FDC

Intervention Type: DRUG

One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.

Arm 2: EBR/GZR for 12 Weeks

Treatment-naïve participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis receive FDC of EBR/GZR (50 mg/100 mg) for 12 weeks, with 24 weeks of follow-up.

Group Type: EXPERIMENTAL

EBR/GZR (50 mg/100 mg) FDC

Intervention Type: DRUG

One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.

Interventions

EBR/GZR (50 mg/100 mg) FDC

One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.

Intervention Type: DRUG

Other Intervention Names

MK-5172A

Eligibility Criteria

Inclusion Criteria

• Be a current resident of France
• Have HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
• Have documented chronic HCV GT4 (with no evidence of non-typeable or mixed genotype) infection
• Have liver biopsy performed within 24 months of Day 1 of this study (if participant has cirrhosis, there is no time restriction on biopsy), or have FibroScan® performed within 12 months of Day 1 of this study with interpretable result in kilopascals (kPa) as follows: Fibrosis score of F0-F2, Fibrosis score of F3, or Cirrhosis (F4)
• Have a prior treatment history of either HCV TN or HCV TE with interferon (IFN) +/- ribavirin (RBV) +/- Sofosbuvir (SOF) (on-treatment failure, relapser, or other/intolerant)
• 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
• If Human Immunodeficiency Virus (HIV) co-infected, then have HIV-1 infection documented prior to screening

Exclusion Criteria

• Had prior treatment (defined as 1 dose or more) with direct-acting antiviral (DAA) therapy
• Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of active advanced liver disease
• Classified as Child-Pugh B or C or has a Child Pugh-Turcotte score (CPT) > 6
• Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
• Hepatitis B virus surface antigen (HBsAg) positive at screening. Participants who are HBsAg negative and hepatitis B core antibody (anti-HBc) positive at screening may be included
• Under evaluation for active or suspected malignancy, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer Currently participating or has 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 such study during the course of this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

CHU Amiens-Picardie - Hopital Sud ( Site 0217)

Amiens, , France

CHU Jean Minjoz ( Site 0213)

Besançon, , France

CHU Henri Mondor ( Site 0206)

Créteil, , France

CHU de Grenoble - Hopital Michallon ( Site 0208)

Genoble, , France

CHU Dupuytren ( Site 0209)

Limoges, , France

Hopital Saint Eloi ( Site 0207)

Montpellier, , France

C.H.U. de Nice Hopital de l Archet 2 ( Site 0215)

Nice, , France

Centre Hospitalier Regional du Orleans ( Site 0212)

Orléans, , France

Hopital Beaujon ( Site 0201)

Paris, , France

Hopital Cochin ( Site 0211)

Paris, , France

Hopital Saint Antoine ( Site 0200)

Paris, , France

CHU de Toulouse - Hopital Purpan ( Site 0216)

Toulouse, , France

CHU de Nancy Hopital Brabois Adultes ( Site 0204)

Vandœuvre-lès-Nancy, , France

Countries

France

References

Asselah T, Pol S, Hezode C, Loustaud-Ratti V, Leroy V, Ahmed SNS, Ozenne V, Bronowicki JP, Larrey D, Tran A, Alric L, Nguyen-Khac E, Robertson MN, Hanna GJ, Brown D, Asante-Appiah E, Su FH, Hwang P, Hall JD, Guidoum A, Hagen K, Haber BA, Talwani R, Serfaty L. Efficacy and safety of elbasvir/grazoprevir for 8 or 12 weeks for hepatitis C virus genotype 4 infection: A randomized study. Liver Int. 2020 May;40(5):1042-1051. doi: 10.1111/liv.14313. Epub 2020 Mar 22.

Reference Type: RESULT

PMID: 31765046 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-001159-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-5172-096

Identifier Type: OTHER

Identifier Source: secondary_id

5172-096

Identifier Type: -

Identifier Source: org_study_id