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: Key Inclusion Criteria:

* HCV treatment-naive adult participants (18-65 years of age) with chronic HCV infection and plasma HCV RNA ≥ 5 log10 IU/mL at screening
* Agree to use protocol defined precautions against pregnancy

Key Exclusion Criteria:

* Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
* Evidence of cirrhosis
* Evidence of current drug abuse
* Screening laboratory results outside the protocol specified requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
B: 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.
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:

* Documented chronic (at least 6 months) HCV GT 1 infection (with no evidence of mixed genotypes or genotype that cannot be assigned a type)
* Evidence or no evidence of liver cirrhosis based on one of the following:
* Liver biopsy performed within 24 months of Day 1 (if participant is cirrhotic then there is no time restriction on biopsy)
* Fibroscan performed within 12 months of Day 1 of this study
* Fibrosure™ (Fibrotest™) plus aspartate aminotransferase to platelet Ratio Index \[APRI\] obtained during the screening period)
* Has HCV status that is one of the following:
* Treatment naïve
* Prior interferon or pegylated interferon with or without ribavarin failures (null responder, partial responder, or relapser)
* Intolerant to prior interferon or pegylated intereferon with or without ribavarin regimen
* Chronic kidney disease (defined as glomerular filtration rate \[eGFR\] \<=29) non-dialysis dependent or on hemodialysis for at least 3 months, including individuals awaiting kidney transplant and those with failed kidney transplants but no longer on immunosuppressant therapy)
* Female participant of reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of contraception from at least 2 weeks prior to Day 1 through 14 days after the last dose of study drugs, or longer if dictated by local regulations

Exclusion Criteria:

* Evidence of decompensated liver disease
* On peritoneal dialysis for management of kidney disease
* Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
* History of malignancy \<=5 years prior to signing informed consent
* Clinical diagnosis of substance abuse
* Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from Day 1 through 14 days after the last study dose, or longer if dictated by local regulations
* Organ transplant (including hematopoietic stem cell transplant) other than kidney, cornea, and hair
* Conditions requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
* Uncontrolled or poorly controlled hypertension
* Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) or cardiovascular procedure within 3 months prior to signing informed consent
* New or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent
* Severe active peripheral vascular disease
* Recent (within 3 months prior to signing informed consent) episode or recurrence of stroke, transient ischemic attack (TIA) or neurological disorder, including but not limited to seizures
* Evidence or history of chronic hepatitis not caused by HCV

Answer: C