An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets
Intervention description: MK-5172A FDC tablet: MK-5172 (100 mg)/MK-8742 (50 mg)
Intervention MeSH terms: Grazoprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100
      mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus
      (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The
      primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir
      and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater
      than 70%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented chronic HCV genotype (GT) 1, GT4, or GT6 infection with no evidence of
             non-typeable or mixed GT infection (positive for anti-HCV antibody, HCV RNA, or any of
             the listed GTs at least 6 months prior to screening must be confirmed by screening lab
             results)

          -  Treatment naïve for all anti-HCV treatments

          -  HIV-1 infection documented by laboratory test

          -  Currently naïve to treatment with any antiretroviral therapy (ART) and have no plans
             to initiate ART during this study OR on a HIV ART for at least 8 weeks prior to study
             entry

          -  Has not experienced any alteration(s) in HIV therapy within 4 weeks of randomization

          -  Has at least one viable antiretroviral regimen alternative beyond the current regimen
             in the event of HIV virologic failure or the development of anti-retroviral drug
             resistance

          -  Participants of reproductive potential must agree to remain abstinent from
             heterosexual activity OR use (or have their partner use) acceptable contraception
             during heterosexual activity while receiving study drug and for 14 days after last
             dose of study drug.

        Exclusion Criteria:

          -  Evidence of decompensated liver disease manifested by the presence or history of
             ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other
             signs of symptoms of advanced liver disease

          -  Co-infected with hepatitis B virus

          -  History of malignancy <=5 years prior to study start except for adequately treated
             basal cell or squamous cell skin cancer or in situ cervical cancer or is under
             evaluation for other active or suspected malignancy

          -  Taking or planning to take any HIV therapy that includes a ritonavir-boosted or
             unboosted protease inhibitor, efavirenz or etravirine

          -  Currently participating or has participated in a study with an investigational
             compound within 30 days of study start and is not willing to refrain from
             participating in another study during this study

          -  Clinically-relevant drug or alcohol abuse within 12 months of study start

          -  Pregnant, breast feeding, or expecting to conceive or donate eggs from Day 1 of the
             study throughout treatment and 14 days after the last dose of study medication, or
             longer if dictated by local regulations

          -  Organ transplants (including hematopoietic stem cell transplants) other than cornea
             and hair

          -  Poor venous access

          -  History of gastric surgery (e.g., stapling, bypass) or history of malabsorption
             disorders (e.g., celiac sprue disease)

          -  Medical condition requiring, or likely to require, chronic systemic administration of
             corticosteroids during this study

          -  History of opportunistic infection in the 6 months prior to study start

          -  Use of HIV drugs other than a dual nucleoside reverse transcriptase inhibitor (NRTI)
             backbone of tenofovir or abacavir and either emtricitibine or lamivudine PLUS
             raltegravir (or dolutegravir or rilpivirine)