Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
Brief Summary: This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and tolerability of each regimen as assessed by review of the accumulated safety data. Approximately 150 participants with genotype 1 HCV infection, who have previously received treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will be randomized to 1 of 2 groups.

Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks

Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks

Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b; mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy treatment response (never achieved HCV RNA \< the lower limit of quantitation (LLOQ), or achieved HCV RNA \< LLOQ).


Options:
A: Inclusion Criteria:

* Age between 18 and 85
* Receiving no treatment before diagnosis
* Establishing Diagnosis according to the Asian Pacific Association for the Study of Liver(APASL) criteria

Exclusion Criteria:

* Clinical data missing
* Laboratory tests information missing
* Serum samples doesn't qualified
* Obstructive jaundice patients
* Medical history of taking warfarin
B: Inclusion Criteria:

* Age at entry at least 18 years.
* Positive for Hepatitis C.
* Previous treatment with any interferon or interferon and ribavirin for at least 3 months.
* Documented non-response to treatment with interferon.
* A liver biopsy demonstrating significant liver scarring.

Exclusion Criteria:

* No other liver disease.
* No unstable major medical diseases or conditions.
* No major complications of cirrhosis.
* No recent abuse of alcohol or illicit drugs.
C: Inclusion Criteria:

* Age equal to or greater than 18 years, with chronic genotype 1 HCV infection
* HCV RNA ≥ 10,000 IU/mL at screening
* Prior virological failure after treatment with pegylated interferon (PEG-IFN), RBV and a protease inhibitor following documented prior virology failure after treatment with a PEG-IFN + RBV regimen
* Evidence of cirrhosis
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation
* Prior exposure to approved or experimental HCV specific direct-acting antivirals other than a nonstructural protein (NS)3/4A protease inhibitor
* History of solid organ transplantation, including liver transplant
* Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
D: Inclusion Criteria:

* liver biopsy or clinical diagnosis compatible with advanced liver fibrosis or cirrhosis
* potential candidate for treatment of HCC
* imaging study involving the liver in the last 12 months without evidence for HCC
* must be a veteran in VISN 23

Exclusion Criteria:

* active or untreated malignancy other than non-melanoma skin cancer
* patients with advanced medical conditions such as severe cardiovascular disease, COPD, or severe end-stage liver disease
* patients unable to receive intravenous contrast due to advanced kidney disease or severe allergy
* history of liver mass identified on imaging study

Answer: C