Long-Term Follow-Up Of Subjects With CHC Who Achieved A Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Background: Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why.
Objective: To study the course and complications of liver disease after cure of hepatitis C infection.
Eligibility: Adults 18 years and older infected with chronic hepatitis C virus who were never treated or were treated and not cured and those who were cured
Design: Participants will be screened with: Blood and urine tests Questionnaires Liver ultrasound Fibroscan. A probe vibrates the liver, testing stiffness. In Phase 1, people with chronic hepatitis C will: Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A small piece of liver is removed by needle passed through the skin. Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks. Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional visits in the next 24 weeks with more blood work collected. Phase 1 participants who test negative for hepatitis C and all other eligible participants will enter Phase 2. Phase 2 participants will have a visit every 24 weeks for 10 years. These may include: Repeats of screening tests Questionnaires Scans Stool tests Chest x-ray Heart function test Endoscopy. A tube guides a camera into the upper digestive system. At about 5 years, participants will have another liver biopsy. Some participants will give separate consent for genetic testing and a special blood procedure.
∙ 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.