Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Filibuvir Plus Pegylated Interferon Alfa-2a And Ribavirin In Treatment-Naive, HCV Genotype 1 Infected Subjects
Brief Summary: The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.


Options:
A: Inclusion Criteria:

* Male or female subjects at least 18 years of age.
* HCV seropositive.
* HCV RNA \>10,000 IU/mL at screening.
* HCV Genotype 1. Subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible.
* Treatment naïve (no prior treatment with IFN alfa +/ RBV regimens or investigational anti-HCV agents).
* Liver biopsy within two years (24 months) of Screening with non-cirrhotic fibrosis classification. For those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization.
* Ultrasound within 6 months of Screening for 1) those subjects with bridging fibrosis or 2) those subjects with AFP \>50 and \<100 ng/mL with no evidence of hepatocellular carcinoma. For those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization.

Exclusion Criteria:

* Co-infection with either HIV or HBV.
* Evidence of severe or decompensated liver disease.
* Subjects with liver disease unrelated to HCV infection.
* Pre-existing medical condition that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling.
* Laboratory abnormality at Screening that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling.
* Abnormal ECG suggestive of clinically significant cardiac disease or QTc\>450msec.
* History of organ transplant.
* Contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent CYP3A4 inhibitors, sensitive CYP3A4 substrates, CYP3A4 substrates with narrow therapeutic range and CYP3A4 inducers.
* Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up.
* Pregnant or nursing females.
* Males whose female partner is pregnant.
B: 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 Pegylated Interferon 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 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)
C: Inclusion Criteria:

* Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
* Naive to previous HCV treatment

Exclusion Criteria:

* Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
* History of any other clinically significant chronic liver disease
D: 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)

Answer: A