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

NCT02994056 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: GS-US-342-40222016-003066-10
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

  SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

  Posttreatment Week 12

• Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event

  First dose date up to Week 12

Secondary Outcomes (8)

• Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

  Posttreatment Week 4

• Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)

  Posttreatment Week 24

• Percentage of Participants With HCV RNA < LLOQ While on Study Treatment

  Weeks 2, 4, 8, and 12

• Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class

  Baseline to Posttreatment Week 24

• Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score

  Baseline to Posttreatment Week 24

Study Arms (1)

SOF/VEL+ RBV

EXPERIMENTAL

SOF/VEL FDC plus RBV for 12 weeks

Drug: SOF/VEL; Drug: RBV

Interventions

SOF/VEL DRUG

400/100 mg FDC tablet administered orally once daily

Also known as: Epclusa®, GS-7977/GS-5816

SOF/VEL+ RBV

RBV 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.

SOF/VEL+ RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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
• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (12)

Tampa General Medical Group

Tampa, Florida, 33606, United States

Location

Northwestern Memorial Hospital; Clinical Research Unit

Chicago, Illinois, 60611, United States

Location

Digestive Disease Associates, PA

Catonsville, Maryland, 21228, United States

Location

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, 39216, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

American Research Corporation at Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Intermountain Liver Disease and Transplant Center

Murray, Utah, 84107, United States

Location

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

Richmond, Virginia, 23226, United States

Location

University of Washington/ Harborview Medical Center

Seattle, Washington, 98105, United States

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

Hopital Paul Brousse

Villejuif, 94800, France

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 15, 2016
• Study Start: January 23, 2017
• Primary Completion: September 25, 2018
• Study Completion: December 12, 2018
• Last Updated: March 2, 2020
• Results First Posted: October 8, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

FR (2); US (10)