A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis

Gilead Sciences12 sites in 2 countries32 target enrollmentJanuary 23, 2017

ConditionsHepatitis C Virus Infection

InterventionsSOF/VEL RBV

DrugsSOF/VEL RBV

Overview

Phase: Phase 2
Intervention: SOF/VEL
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Enrollment: 32
Locations: 12
Primary Endpoint: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 23, 2017

End Date

December 12, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

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

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

Arms & Interventions

SOF/VEL+ RBV

SOF/VEL FDC plus RBV for 12 weeks

Intervention: SOF/VEL

SOF/VEL+ RBV

SOF/VEL FDC plus RBV for 12 weeks

Intervention: RBV

Outcomes

Primary Outcomes

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

Time Frame: Posttreatment Week 12

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

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

Time Frame: First dose date up to Week 12

Secondary Outcomes

Change From Baseline in HCV RNA(Baseline; Weeks 2, 4, 8, and 12)
Number of Participants With Virologic Failure(Baseline up to Posttreatment Week 24)
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)
Absolute HCV RNA Level Through Week 12(Baseline; Weeks 2, 4, 8, and 12)