Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female, age greater than or equal to 18 years.
Confirmed chronic HCV infection.
Subjects will have cirrhosis status assessment; liver biopsy may be required.
Genotype 2 subjects must have cirrhosis of the liver to be eligible.
Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event
Infection with HCV genotype 2 or 3 as determined at Screening
Body mass index (BMI) greater than or equal to 18 kg/m\^2
Screening laboratory values within predefined thresholds.
Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.
Subject must be of generally good health as determined by the Investigator.
You may not be if
Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase
Pregnant or nursing female or male with pregnant female partner
History of any other clinically significant chronic liver disease.
HIV or chronic hepatitis B virus (HBV) infection.
Malignancy with the exception of certain resolved skin cancers.
Chronic use of systemically administered immunosuppressive agents.
Clinically-relevant drug or alcohol abuse.
History of solid organ transplantation.
Current or prior history of clinical hepatic decompensation.
History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.
Clareo Health | SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
