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

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378935
• Other study ID #: GS-US-367-1168
• Status: Completed
• Phase: Phase 2
• Start date: February 17, 2015
• Est. completion date: April 12, 2016

Study information

• Verified date: November 2017
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 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) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: April 12, 2016
• Est. primary completion date: February 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Individuals with chronic HCV infection

• HCV RNA =10^4 IU/mL at screening

• HCV genotype 1

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

Drug:
• VOX
100 mg tablet(s) administered orally once daily with food
• SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
• RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Locations

Country	Name	City	State
New Zealand	Auckland Clinical Studies	Auckland
New Zealand	Christchurch Clinical Studies Trust	Christchurch
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
United States	Center for Hep C/Atlanta Medical Center	Atlanta	Georgia
United States	Beth Isreal Deconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	University of Colorado	Denver	Colorado
United States	Henry Ford Hospital and Health System	Detroit	Michigan
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Gastro One	Germantown	Tennessee
United States	ID Care	Hillsborough	New Jersey
United States	Indiana University	Indianapolis	Indiana
United States	Indianapolis Gastroenterology & Hepatology, Inc.	Indianapolis	Indiana
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	North Shore/Long Island Jewish PRIME	Manhasset	New York
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	University of Miami	Miami	Florida
United States	Nashville Gastrointestinal Specialists, Inc.	Nashville	Tennessee
United States	Mount Sinai Beth Israel	New York	New York
United States	Orlando Immunology center	Orlando	Florida
United States	Stanford University	Palo Alto	California
United States	Huntington Memorial Hospital Liver Center	Pasadena	California
United States	University of Pennsylvania Health Systems	Philadelphia	Pennsylvania
United States	UPMC Center for Liver Diseases	Pittsburgh	Pennsylvania
United States	Liver Institute of Virginia	Richmond	Virginia
United States	Texas Liver Institute	San Antonio	Texas
United States	Medical Associates Research Group, Inc.	San Diego	California
United States	Southwest Care Center	Santa Fe	New Mexico
United States	Swedish Medical Center	Seattle	Washington
United States	South Florida Center of Gastroenterology, P.A.	Wellington	Florida
United States	Digestive Health Specialists, PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  New Zealand,  Puerto Rico, 

References & Publications (1)

Lawitz E, Reau N, Hinestrosa F, Rabinovitz M, Schiff E, Sheikh A, Younes Z, Herring R Jr, Reddy KR, Tran T, Bennett M, Nahass R, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Pearlman B, Shiffman M, Hawkins T, Curry M, Jacobson I. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 12 Weeks
Secondary	Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.	Posttreatment Weeks 4 and 24
Secondary	Percentage of Participants With HCV RNA < LLOQ on Treatment		Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Secondary	HCV RNA Change From Baseline		Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Secondary	Percentage of Participants With Virologic Failure	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.	Up to Posttreatment Week 24