Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects With Chronic Hepatitis C Virus Infection
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Infection with HCV genotype 1, 4, 5, or 6
* Cirrhosis determination
* Subject met the following classifications:

  * Treatment-naive
  * Screening laboratory values within defined thresholds
  * Not treated with any investigational drug or device within 30 days of screening
* Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
* Pregnant or nursing female, or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation
* History of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol
* Excessive alcohol ingestion or significant drug abuse
B: 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%
C: Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
* Subject has never received antiviral treatment for hepatitis C infection
* No evidence of liver cirrhosis

Exclusion Criteria:

* Significant liver disease with any cause other than HCV as the primary cause
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Positive screen for drugs or alcohol
* Significant sensitivity to any drug
* Use of contraindicated medications within 2 weeks of dosing
* Abnormal laboratory tests
D: Key Inclusion Criteria:

* Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
* No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin
* Body mass index (BMI) of 18 to 35 kg/m\^2, inclusive. BMI=weight (kg)/height (m)\^2
* Males and females, 18 - 70 years of age

Key Exclusion Criteria:

* Liver transplant recipients
* Documented or suspected hepatocellular carcinoma
* Evidence of decompensated cirrhosis
* History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
* Current or known history of cancer
* Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug
* Inability to tolerate oral medication
* Poor venous access
* Severe psychiatric disease
* History of chronic pulmonary disease
* History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease
* History of or current electrocardiogram findings indicative of cardiovascular instability
* Preexisting ophthalmologic disorders considered clinically significant on eye
* History of uncontrolled diabetes mellitus
* Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.
* Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
* Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)
* Exposure to any investigational drug or placebo

Answer: B