Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.


Options:
A: 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
* Male or female between 18 and 70 years, inclusive, at time of Screening.
* Chronic HCV-infection prior to study enrollment.
* Screening laboratory result indicating HCV genotype 1-infection.
* Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
* Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria:

* Significant liver disease with any cause other than HCV as the primary cause
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
* Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
* Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
* A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.
B: Inclusion Criteria: - Participant has chronic Genotype 4 Hepatitis C infection

* Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level greater than 10,000 International unit per milliliter (IU/mL) at Screening
* Participant never received treatment for HCV
* Participant was to be in good health (besides HCV infection), in the opinion of the Investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram \[ECG\]), with any chronic medical conditions under stable medical control
* Participant had to be willing to refrain from the concomitant use of any medications or substances Exclusion Criteria: - Participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the Investigator's opinion would compromise the participant's safety and/or compliance with study procedures
* Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
* Female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding
* Participant has hypersensitivity to tartrazine
* Participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months
C: 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%
D: Inclusion Criteria:

* Chronic genotype 1 hepatitis C virus (HCV) infection
* Plasma HCV RNA of more than 10,000 IU/mL at screening
* Patients in Cohort 1 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks
* Patients in Cohort 2 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks and could also be HCV treatment-naive, meaning never received treatment with any approved or investigational drug for the treatment of HCV
* Null responders patients in Cohort 1 and Cohort 2 must meet the defined criterion for a null responder, defined as on-treatment less than 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 of the most recent PegIFN/ribavirin therapy
* Patient must have had a liver biopsy within 3 years before screening (or between screening and baseline visit) or patient must have had a liver biopsy at any time in the past which showed Metavir F3 or F4 fibrosis
* Must agree to use 2 forms of effective contraception throughout the study (male and female)

Exclusion Criteria:

* Has evidence of hepatic decompensation
* Has any liver disease of non-HCV etiology
* Has an infection/co-infection with non-genotype 1 HCV
* Has a co-infection with Human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibody test at screening)
* Has a co-infection with hepatitis B virus (hepatitis B surface antigen \[HBsAg\] positive)
* Has a history of malignancy within 5 years of the screening visit

Answer: A