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)
Condition: Hepatitis C Virus (HCV) Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Intervention: EBR/GZR (50 mg/100 mg) FDC
Intervention description: One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.
Intervention MeSH terms: Grazoprevir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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