Clinical Research Directory

* INCLUSION CRITERIA: Phase I Treatment * Male or female \>= 18 years of age * Either treatment naive or experienced defined as failure of a prior course of interferon-based and ribavirin, DAA plus interferon and DAA only * Confirmation of chronic HCV infection documented by: * A positive HCV RNA or positive HCV genotyping test at least 6-months prior to the Baseline/Day 1 visit * A liver biopsy performed prior to screening visit showing evidence of chronic hepatitis. * Subjects must have the following laboratory parameters at screening: * ALT \<= 10 x the upper limit of normal (ULN) * AST \<= 10 x ULN * Total bilirubin \<2.5 mg/dL, Direct bilirubin \<= 1.5 ULN * Platelets \>= 50,000 K/mm\^3 * HbA1c \<= 8.5% * Hemoglobin \>= 10g/dL * Albumin \>= 3g/dL * INR \<= 1.5 unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR. * HCV RNA positive at screening. * Subjects must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator. Phase II Follow-up * Male or female \>= 18 years of age. * SVR24 following therapy with a direct acting antiviral agent regimen and available liver biopsy performed prior to treatment. * Subject must be of generally good health as determined by the Investigator. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: Phase I Treatment * Pregnancy or lactation * Inability to practice one form of adequate contraction for females of childbearing potential * Prior treatment with a NS5a agent * Current or prior history of any of the following: * Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded * Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug * Decompensated liver disease as defined by serum bilirubin \>= 2.5 mg/dL (with direct bilirubin \>= 1.5 mg/dL), INR \>1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy * Solid organ transplantation * Significant pulmonary disease, significant cardiac disease * History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy \<5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin). * Chronic liver disease of a non-HCV etiology with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis). * Evidence of harmful or hazardous drinking as defined as a score \>= 8 on the AUDIT questionnaire. * Co-infection with HIV defined as the presence of anti-HIV in serum. * Clinically relevant drug abuse based on patient history within 12 months of screening. * Use of medications contraindicated with use of sofosbuvir/velpatasvir within 21 days of the Baseline/Day 1 visit; this washout period does not apply to proton pump inhibitors, which can be taken up to 7 days before baseline Day 1 for the following: * Acid reducing Agents * Antiarrhythmics * Anticancer * Antimycobacterial * HIV antivirals * Herbal supplements * HMG-CoA Reductase Inhibitors * Use of antiviral medications within the last 30 days. * Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent \>= 10 mg/day). * Known hypersensitivity to sofosbuvir and velpatasvir, or formulation excipients. * Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL * Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study. * Presence of conditions that, in the opinion of the investigators, would not allow the subject to n the current study for at least 1 year. Phase II Follow-up * Pregnancy * Current or prior history of any of the following: * Clinically significant illness (other than resolved HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded --Decompensated liver disease as defined by serum bilirubin \>= 2.5 mg/dL (with direct bilirubin \>= 1.5 mg/dL), INR \>1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy. * Solid organ transplantation * Significant pulmonary disease, significant cardiac disease * History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy \<5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin) * Chronic liver disease with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis) * Evidence of harmful or hazardous drinking as defined as a score \>= 8 on the AUDIT questionnaire * Co-infection with HIV defined as the presence of anti-HIV in serum * Clinically relevant drug abuse based on patient history within 12 months of screening * Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent \>= 10 mg/day) * Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL * Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study * Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study for at least 1 year.