Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Grazoprevir/Elbasvir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02251990

5172-067

Details and patient eligibility

About

This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination [FDC]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype (GT) 1, 4 or 6 infection. The primary hypothesis is that the percentage of participants receiving grazoprevir/elbasvir FDC in the Immediate Treatment Group (ITG) achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to the historical reference rate of 73%.

Enrollment: 489 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has documented chronic HCV GT1, GT4, or GT6 (with no evidence of non-typeable or mixed genotype) infection
• Meets clinical criteria for presence or absence of cirrhosis based on liver disease staging assessment
• Is abstinent or uses acceptable method(s) of contraception

Exclusion criteria

• Has evidence of decompensated liver disease
• Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV)
• Shows evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
• Has a clinically-relevant drug or alcohol abuse within 12 months of screening
• Is pregnant or breast-feeding
• Has any condition or abnormality that might confound the results of the trial or pose an additional risk to the participant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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489 participants in 2 patient groups, including a placebo group

Immediate Treatment Group (ITG): Grazoprevir/Elbasvir

Experimental group

Description:

Participants receive a grazoprevir/elbasvir FDC tablet once daily (q.d.) by mouth during a 12-week Active Treatment period (Week 1 to Week 12) and are followed-up for 24 weeks to Week 36.

Treatment:

Drug: Grazoprevir/Elbasvir

Deferred Treatment Group (DTG): Placebo > Grazoprevir/Elbasvir

Placebo Comparator group

Description:

Participants receive a placebo tablet q.d. by mouth for 12 weeks (placebo treatment period). After a 4-week Follow-Up period, participants receive open-label grazoprevir/elbasvir FDC during a 12-week Active Treatment period (Week 16 to Week 28). Participants are then followed-up for 24 weeks to Week 52.

Treatment:

Drug: Placebo