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Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Primary Purpose

Hepatitis C Virus Infection

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SOF/VEL/VOX

RBV

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Individuals with chronic HCV genotype 1 infection
Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response
Absence of cirrhosis or presence of compensated cirrhosis
Screening laboratory values within defined thresholds
Must use specific contraceptive methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

Co-infection with HIV or hepatitis B virus (HBV)
Current or prior history of clinical hepatic decompensation
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
Pregnant or a nursing female

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

The Texas Liver Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SOF/VEL/VOX

SOF/VEL/VOX + RBV

Arm Description

SOF/VEL/VOX for 12 weeks

SOF/VEL/VOX + RBV for 12 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)

SVR12 is 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 SOF/VEL/VOX Due to an Adverse Event

Secondary Outcome Measures

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Percentage of Participants With HCV RNA < LLOQ on Treatment

HCV RNA Change From Baseline/Day 1 Through Week 12

Percentage of Participants With Virologic Failure

Virologic failure is defined as: On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

Full Information

NCT ID

NCT02536313

First Posted

August 27, 2015

Last Updated

February 8, 2019

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02536313

Brief Title

Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Official Title

A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

July 29, 2015 (Actual)

Primary Completion Date

March 28, 2016 (Actual)

Study Completion Date

June 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Virus Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SOF/VEL/VOX

Arm Type

Experimental

Arm Description

SOF/VEL/VOX for 12 weeks

Arm Title

SOF/VEL/VOX + RBV

Arm Type

Experimental

Arm Description

SOF/VEL/VOX + RBV for 12 weeks

Intervention Type

Drug

Intervention Name(s)

SOF/VEL/VOX

Other Intervention Name(s)

GS-7977/GS-5816/GS-9857, Vosevi®

Intervention Description

400/100/100 mg FDC tablet administered orally once daily with food

Intervention Type

Drug

Intervention Name(s)

RBV

Intervention Description

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Primary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)

Description

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

Time Frame

Posttreatment Week 12

Title

Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event

Time Frame

Up to 12 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

Description

SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Time Frame

Posttreatment Weeks 4 and 24

Title

Percentage of Participants With HCV RNA < LLOQ on Treatment

Time Frame

Weeks 1, 2, 4, 8 and 12

Title

HCV RNA Change From Baseline/Day 1 Through Week 12

Time Frame

Weeks 1, 2, 4, 8, and 12

Title

Percentage of Participants With Virologic Failure

Description

Time Frame

Up to Posttreatment Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Individuals with chronic HCV genotype 1 infection Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response Absence of cirrhosis or presence of compensated cirrhosis Screening laboratory values within defined thresholds Must use specific contraceptive methods if female of childbearing potential or sexually active male Key Exclusion Criteria: Co-infection with HIV or hepatitis B virus (HBV) Current or prior history of clinical hepatic decompensation Chronic use of systemic immunosuppressive agents History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol Pregnant or a nursing female Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilead Study Director

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

Facility Name

The Texas Liver Institute

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing URL

https://www.gilead.com/about/ethics-and-code-of-conduct/policies

Citations:

PubMed Identifier

28220512

Citation

Lawitz E, Poordad F, Wells J, Hyland RH, Yang Y, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Landaverde C, Gutierrez J. Sofosbuvir-velpatasvir-voxilaprevir with or without ribavirin in direct-acting antiviral-experienced patients with genotype 1 hepatitis C virus. Hepatology. 2017 Jun;65(6):1803-1809. doi: 10.1002/hep.29130. Epub 2017 May 3.

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