Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection

Phase 2

Completed

Conditions: Hepatitis C Virus Infection

Interventions: Drug: VOX
Drug: SOF/VEL

Registration Number: NCT02378961

Lead Sponsor: Gilead Sciences

Brief Summary: The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

Inclusion Criteria

Individuals with chronic HCV infection
HCV RNA ≥10^4 IU/mL at screening
HCV genotypes 2, 3, 4, 5, or 6
Cirrhosis determination; a liver biopsy may be required
Screening laboratory values within defined thresholds
Use of two contraception methods if female of childbearing potential or sexually active male

Key

Exclusion Criteria

Pregnant or nursing female
Current or prior history of hepatic decompensation
Hepatocellular carcinoma (HCC) or other clinically significant malignancy
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
VOX+SOF/VEL 8 wk,TE, without cirrhosis	VOX	GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis)
VOX+SOF/VEL 8 wk,TE, without cirrhosis	SOF/VEL	GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis)
VOX+SOF/VEL 12 wk, TE, without cirrhosis	VOX	VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
GS-9857+SOF/VEL 8 wk, TE, with cirrhosis	SOF/VEL	GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis)
VOX+SOF/VEL 6 wk, TN, without cirrhosis	VOX	VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
VOX+SOF/VEL 6 wk, TN, without cirrhosis	SOF/VEL	VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
GS-9857+SOF/VEL 6 wk, TN, with cirrhosis	VOX	GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
GS-9857+SOF/VEL 6 wk, TN, with cirrhosis	SOF/VEL	GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL 8 wk, TN, with cirrhosis	VOX	GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL 8 wk, TN, with cirrhosis	SOF/VEL	GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
VOX+SOF/VEL 12 wk, TE, without cirrhosis	SOF/VEL	VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
GS-9857+SOF/VEL 8 wk, TE, with cirrhosis	VOX	GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis)
VOX+SOF/VEL 12 wk, TE, with cirrhosis	VOX	VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
VOX+SOF/VEL 12 wk, TE, with cirrhosis	SOF/VEL	VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 12 Weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ on Treatment	Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
HCV RNA Change From Baseline	Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Percentage of Participants With Virologic Failure	Up to Posttreatment Week 24	* 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.

Trial Locations

Locations (34): Cedars Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Stanford University
🇺🇸
Palo Alto, California, United States
Huntington Memorial Hospital Liver Center
🇺🇸
Pasadena, California, United States
Medical Associates Research Group, Inc.
🇺🇸
San Diego, California, United States
University of Colorado
🇺🇸
Aurora, Colorado, United States
Borland-Groover Clinic
🇺🇸
Jacksonville, Florida, United States
University of Miami
🇺🇸
Miami, Florida, United States
Orlando Immunology center
🇺🇸
Orlando, Florida, United States
South Florida Center of Gastroenterology, P.A.
🇺🇸
Wellington, Florida, United States
Center for Hep C/Atlanta Medical Center
🇺🇸
Atlanta, Georgia, United States
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Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States