Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
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Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A body mass index (BMI) of ≥ 18 kg/m\^2
Chronic HCV infection (≥ 6 months) as documented by either prior medical history or liver biopsy
Quantifiable HCV RNA at screening
Individuals may be non-transplanted or with recurrent HCV post-liver transplant.
* If listed for liver transplant, then the projected date of transplant must be ≥12 weeks after Day1 of treatment
* If post-liver transplant, then Day1 must be ≥ 6 months from date of transplant
CPT score of 10 to 12, inclusive, as determined at screening
Liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma (HCC)
If treatment-experienced, the most recent HCV treatment must have been completed at least 8 weeks prior to Screening
Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to randomization
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Females must agree to refrain from egg donation and in vitro fertilization during treatment until at least 30 days after the last dose of SOF/VEL or 6 months after the last dose of RBV, whichever occurs last
Lactating females must agree to discontinue nursing before the study drugs are administered
Males must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV or 30 days after the last dose of SOF/VEL, whichever occurs last
Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
You may not be if
Current or prior history of any of the following:
* Clinically significant medical or psychiatric illness or individual is currently under evaluation for a potentially clinically significant illness
* Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
* Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
* Significant pulmonary disease, significant cardiac disease or porphyria
* Significant drug allergy (such as anaphylaxis or hepatotoxicity)
Any history of organ transplant other than liver or kidney
Chronic liver disease of a non-HCV etiology
Inability to exclude HCC by imaging within 6 months of Day 1
Alpha-fetoprotein (AFP) \> 50 unless negative imaging for hepatic masses within the last 6 months or during screening
Active spontaneous bacterial peritonitis at screening
Infection requiring systemic antibiotics at the time of screening
Evidence of fibrosing cholestatic hepatitis at screening
Life threatening serious adverse event (SAE) during screening
Active variceal bleeding within 6 months of screening
Prior placement of a portosystemic shunt (such as TIPS)
ECG with clinically significant abnormalities
Laboratory parameters with clinically significant abnormalities
Hepatitis B surface antigen positive at screening
Infection with human immunodeficiency virus (HIV)
Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug screen will exclude individuals unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the Investigator
Prior exposure to any HCV Non-structural Protein 5A (NS5A) inhibitor
Current use of corticosteroids at any dose \>10 mg of prednisone/day (or equivalent dose of corticosteroid)
Use of any prohibited concomitant medications
Use of granulocyte macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other hematopoietic stimulating agents within 2 weeks of screening
Male with pregnant female partner
History of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia)
Contraindications to RBV therapy
Known hypersensitivity to VEL, RBV, SOF, the metabolites, or formulation excipients
Participation in a clinical study with an investigational drug or biologic within 3 months prior to Day 1
Clareo Health | Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
