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

NCT ID: NCT02994056

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-23
• Study Completion Date: 2018-12-12

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis.

Conditions

Hepatitis C Virus Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOF/VEL+ RBV

SOF/VEL FDC plus RBV for 12 weeks

Group Type: EXPERIMENTAL

SOF/VEL

Intervention Type: DRUG

400/100 mg FDC tablet administered orally once daily

RBV

Intervention Type: DRUG

Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice daily.

Interventions

SOF/VEL

400/100 mg FDC tablet administered orally once daily

Intervention Type: DRUG

RBV

Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice daily.

Intervention Type: DRUG

Other Intervention Names

Epclusa®; GS-7977/GS-5816

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Adults under evaluation for possible malignancy are not eligible
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Tampa General Medical Group

Tampa, Florida, United States

Northwestern Memorial Hospital; Clinical Research Unit

Chicago, Illinois, United States

Digestive Disease Associates, PA

Catonsville, Maryland, United States

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

American Research Corporation at Texas Liver Institute

San Antonio, Texas, United States

Intermountain Liver Disease and Transplant Center

Murray, Utah, United States

Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia

Richmond, Virginia, United States

University of Washington/ Harborview Medical Center

Seattle, Washington, United States

Hopital Henri Mondor

Créteil, , France

Hopital Paul Brousse

Villejuif, , France

Countries

United States; France

References

Flamm S, Lawitz E, Borg B, Charlton M, Landis C, Reddy R, et al. High Efficacy and Improvement in CPT Class With Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks in Patients With CPT C Decompensated Cirrhosis [Poster THU-138]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria.

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-003066-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-342-4022

Identifier Type: -

Identifier Source: org_study_id