Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
Brief Summary: This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).


Options:
A: Inclusion Criteria:

* Males or females aged 18 to 70 years, inclusive, at screening
* Documented chronic genotype 1, 2, or 3 HCV infection
* No previous treatment with HCV antiviral mediations
* Body mass index (BMI) of greater than 18 kg/m2, but not exceeding 36 kg/m2.
* Liver biopsy obtained within 3 years prior to the Day 1 visit, with a fibrosis classification of non-cirrhotic as judged by a local pathologist
* Willing to refrain from beginning any new exercise regimens during the first 3 months of the study
* Fasting blood glucose ≤ 300 mg/dl and/or glycosylated hemoglobin (HbA1c) ≤ 8
* History of hypertension only if managed effectively on a stable regimen of two or fewer antihypertensives for at least three (3) months prior to screening

Exclusion Criteria:

* Females who were breastfeeding
* Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study
* Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
* History of any other clinically significant chronic liver disease
* Treatment with herbal/natural remedies with antiviral activity within 30 days prior to baseline.
* Significant history of immunologically mediated disease, cardiac or pulmonary disease, seizure disorder or anticonvulsant use
* History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease
* Use of medications associated with QT prolongation within 30 days prior to dosing
* Screening electrocardiogram (ECG) QTc value greater than 450 ms and/or clinically significant ECG findings
* Personal or family history of Torsade de pointes.
* Positive results for drugs of abuse test at screening
* Abnormal hematological and biochemical parameters, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5 times the upper limit of the normal range (ULN)
* History of major organ transplantation with an existing functional graft
* History of uncontrolled thyroid disease or abnormal thyroid-stimulating hormone (TSH) levels at screening
* Clinically significant drug allergy to nucleoside/nucleotide analogs
* History or current evidence of psychiatric illness, immunologic disorder, pulmonary, cardiac disease, seizure disorder, cancer or history of malignancy that in the opinion of the investigator makes the patient unsuitable for the study
* History of systemic antineoplastic or immunomodulatory treatment within 6 months prior to dosing, or the expectation of such treatment during the study
B: Inclusion Criteria:

* Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.
* Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening.
* Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).
* No evidence of liver cirrhosis.

Exclusion Criteria:

* Positive screen for drugs or alcohol.
* Significant sensitivity to any drug.
* Use of contraindicated medications within 2 weeks of dosing.
* Certain predefined abnormal laboratory tests.
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
C: 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
D: Inclusion Criteria:

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

Exclusion Criteria:

* Positive screen for drugs or alcohol
* Significant sensitivity to any drug
* Use of contraindicated medications within 2 weeks of dosing
* Certain predefined abnormal laboratory tests
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

Answer: C