Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1
Brief Summary: This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly \[QW\]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.


Options:
A: Inclusion Criteria:

* Age between 18 and 60 years;
* Body weight between 45 and 125 kg;
* Documented chronic hepatitis C genotype 1;
* Liver biopsy with histology consistent with chronic hepatitis and no other etiology for chronic liver disease within of 5 years of Day 1;
* Participant and participant's partner(s) must each agree to use acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months after the last dose of study medication;
* Written informed consent.

Exclusion Criteria:

Include, but are not limited to, the following:

* Prior treatment for hepatitis C;
* Co-infection with HIV or hepatitis B virus (HBsAg positive);
* Evidence of decompensated liver disease;
* Diabetic and hypertensive participants with clinically significant ocular exam findings;
* Pre-existing psychiatric condition, including but not limited to:

  * Current moderate or severe depression;
  * History of depression associated with any of the following:

    * Hospitalization for depression;
    * Electroconvulsive therapy for depression;
    * Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions;
  * Suicidal or homicidal ideation and/or attempt;
  * History of severe psychiatric disorders (including but not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania);
  * Past history or current use of lithium;
  * Past history or current use of antipsychotic drugs for listed conditions.
* Substance abuse within protocol specified timeframes;
* Pre-existing medical conditions that could interfere with the participant's participation in and completion of the study, including but not limited to chronic pulmonary disease, cardiac dysfunction or immunologically-mediated disease;
* Active or suspected malignancy or history of malignancy within the past 5 years;
* Participants who are pregnant or nursing; participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.
* Treatment with any investigational drug or participation in any clinical trial 30 days within Screening;
* Hemoglobin \<12 g/dL for females and \<13 g/dL for males;
* Neutrophils \<1500 mm\^3; Blacks: \<1200/mm\^3;
* Platelets \<100,000/mm\^3;
* Other clinically significant laboratory test abnormalities.
B: Inclusion Criteria:

* Chronic genotype 1 Hepatitis (inflammation of the liver) C infection
* Never been treated for Hepatitis C Viral (HCV) infection
* No clinically significant lab abnormalities
* Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry
* Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

Exclusion Criteria:

* Contra-indications for starting anti-HCV therapy
* History or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease
* Any evidence of significant liver disease in addition to Hepatitis C
* Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B
* Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding
C: Inclusion Criteria:

* \>=18 and \<=65 years of age
* Body weight \>=40 and \<=125 kg
* Documented history of HIV infection for greater than 6 months prior to Day 1
* On an optimized anti-retroviral treatment regimen (OTR) with stable HIV disease with CD4 \>=200 cells/µL and HIV-1 RNA viral load \<50 copies/mL
* Documented chronic hepatitis C (CHC) genotype 1 infection (greater than 6 months prior to Day 1)
* Use of acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months or longer after treatment
* Liver biopsy with histology consistent with CHC and no other etiology

Exclusion Criteria:

* Participants who received prior treatment for hepatitis C other than herbal remedies except those with known hepatotoxicity
* Coinfected with hepatitis B virus (Hepatitis B surface antigen (HBsAg) positive) and/or demonstrating signs and symptoms consistent with concomitant infection
* Evidence of decompensated liver disease
* Participants who have changed their anti-retroviral regimen within the last 3 months prior to Day 1 or had first initiated anti-retroviral therapy within the last 6 months prior to Day 1
* Use of certain HIV medications will not be allowed. Medications will be reviewed by the Investigator
* History of clinically significant opportunistic infections (except oral thrush) within the last year prior to Day 1
* Current evidence of substance abuse within 3 years of the Screening Visit
* History of a clinical diagnosis within the past 6 months of substance abuse prior to Day 1
* Participants receiving opiate agonist substitution therapy but not enrolled in an opiate substitution maintenance program
* History of marijuana use deemed excessive by the Investigator
* Infected with HIV-2
* Use of any HIV protease inhibitor without the coadministration of ritonavir within one month of Day 1 and throughout the period of the trial
* Participants receiving any of the following medication(s) within 2 weeks prior to the Day 1 visit: alfuzosin, antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, and quinidine), ergot derivatives, cisapride, lovastatin, simvastatin, pimozide, triazolam, and orally administered midazolam.

Key Laboratory Exclusion Criteria:

* Hematologic, biochemical, and serologic criteria (growth factors may not be used to achieve trial entry requirements):

  * Hemoglobin \<11 g/dL for females and \<12 g/dL for males
  * Neutrophils \<1500/mm\^3 (blacks/African-Americans: \<1200/mm\^3)
  * Platelets \<100,000/mm\^3
  * Direct bilirubin \>1.5 x ULN (upper limit of normal) of the laboratory reference range. Total bilirubin \>1.6 mg/dL unless history of Gilbert's disease or antiretroviral regimen contains atazanavir. If Gilbert's disease is the proposed etiology, this must be documented in the participant's chart
* Alpha fetoprotein (AFP):

  * AFP \>100 ng/mL OR
  * AFP 50 to 100 ng/mL (requires a liver ultrasound and participants with findings suspicious for hepatocellular carcinoma are excluded)
D: Inclusion Criteria:

* Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
* Have been infected with Hepatitis C virus for greater than (\>) 6 months
* Seronegative for hepatitis B surface antigen and human immunodeficiency virus 1 and 2
* Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
* Female subjects must have a negative pregnancy test at all visits before the first dose.

Exclusion Criteria:

* Received any approved or investigational drug or drug regimen for the treatment of hepatitis C.
* Any medical contraindications to Peg-IFN-alfa-2a or Ribavirin therapy
* Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis.
* Diagnosed or suspected hepatocellular carcinoma.
* Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before Study start.
* Alcohol/drug abuse or excessive use in the last 12 months.
* Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).

Answer: A