Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection
Brief Summary: The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).


Options:
A: Inclusion criteria:

* Has chronic HCV genotype 1 infection
* Is treatment-experienced
* For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.

Exclusion criteria:

* Has not tolerated previous course peg-IFN and RBV
* Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV
* Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B
* Consumes excessive amounts of alcohol
* Has a history of drug or alcohol abuse
* If female, participant is pregnant or breastfeeding
* Has been in a clinical trail with an investigational drug in the last 30 days
* Has used IFN/Peg-IFN and RBV in the last 3 months
B: Inclusion Criteria:

* Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
* HCV RNA viral load of ≥100,000 IU/mL
* No previous exposure to interferon, pegIFNα, or RBV
* Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
* Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
* Body mass index of 18 to 35 kg/m\^2

Exclusion Criteria:

* Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
* Evidence of a medical condition associated with chronic liver disease other than HCV
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
C: 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
D: Inclusion Criteria:

* Chronically infected with Hepatitis C Virus (HCV) genotype 1
* Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or Hepatitis B Virus
* HCV RNA viral load of ≥10\*5 IU/mL
* BMI 18 to 35kg/m²

Exclusion Criteria:

* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with Hepatitis C Virus infection
* HIV and/or HBV positive
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

WOCBP will be enrolled as in-patient for 16 days

Answer: A