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Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection

NCT ID: NCT01740791

Last Updated: 2020-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-06

Study Completion Date

2014-01-24

Brief Summary

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The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.

Detailed Description

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Conditions

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Chronic Hepatitis C Virus

Keywords

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Hepatitis C HCV Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6 Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Velpatasvir 5 mg (GT 1a)

Participants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir 25 mg (GT 1a)

Participants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir 50 mg (GT 1a)

Participants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir 100 mg (GT 1a)

Participants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir 150 mg (GT 1a)

Participants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir 150 mg (GT 1b)

Participants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir 150 mg (GT 2)

Participants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir 25 mg (GT 3)

Participants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir 50 mg (GT 3)

Participants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir 150 mg (GT 3)

Participants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir 150 mg (GT 4)

Participants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Velpatasvir up to 400 mg (GT 2)

Participants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions.

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Tablets administered orally

Placebo

Intervention Type DRUG

Tablets administered orally

Interventions

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Velpatasvir

Tablets administered orally

Intervention Type DRUG

Placebo

Tablets administered orally

Intervention Type DRUG

Other Intervention Names

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GS-5816

Eligibility Criteria

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Inclusion Criteria

* HCV treatment-naive adult participants (18-65 years of age) with chronic HCV infection and plasma HCV RNA ≥ 5 log10 IU/mL at screening
* Agree to use protocol defined precautions against pregnancy

Exclusion Criteria

* Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
* Evidence of cirrhosis
* Evidence of current drug abuse
* Screening laboratory results outside the protocol specified requirements
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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West Coast Clinical Trials, LLC

Costa Mesa, California, United States

Site Status

Avail Clinical Research, LLC

DeLand, Florida, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Kansas City Gastroenterology and Hepatology

Kansas City, Missouri, United States

Site Status

CRI Worldwide, LLC

Marlton, New Jersey, United States

Site Status

CRI Worldwide, LLC

Philadelphia, Pennsylvania, United States

Site Status

New Orleans Center for Clinical Research-Knoxville

Knoxville, Tennessee, United States

Site Status

Alamo Medical Research

San Antonio, Texas, United States

Site Status

Charles River Clinical Services Northwest, Inc.

Tacoma, Washington, United States

Site Status

Fundacion De Investigacion De Diego

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Hebner C, Gontcharova V, Chodavarapu RK, Rodriguez-Torres M, Lawitz E, Yang C, et al. Deep Sequencing of HCV NS5A From a 3-Day Study of GS-5816 Monotherapy Confirms the Potency of GS-5816 Against Pre-Existing Genotype 1-3 NS5A Resistance-Associated Variants [Abstract 470]. The Liver Meeting The 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2013 November 1-5; Washington, D.C.

Reference Type RESULT

Lawitz E, Glass SJ, Gruener D, Freilich B, Hill JM, Link JO, et al. GS-5816, a Once-Daily NS5A Inhibitor, Demonstrates Potent Antiviral Activity in Patients with Genotype 1, 2, 3, or 4 HCV Infection in a 3-Day Monotherapy Study [Abstract 1082]. The Liver Meeting The 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2013 November 1-5; Washington, D.C.

Reference Type RESULT

Lawitz EJ, Dvory-Sobol H, Doehle BP, Worth AS, McNally J, Brainard DM, Link JO, Miller MD, Mo H. Clinical Resistance to Velpatasvir (GS-5816), a Novel Pan-Genotypic Inhibitor of the Hepatitis C Virus NS5A Protein. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5368-78. doi: 10.1128/AAC.00763-16. Print 2016 Sep.

Reference Type DERIVED
PMID: 27353271 (View on PubMed)

Lawitz E, Freilich B, Link J, German P, Mo H, Han L, Brainard DM, McNally J, Marbury T, Rodriguez-Torres M. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. J Viral Hepat. 2015 Dec;22(12):1011-9. doi: 10.1111/jvh.12435. Epub 2015 Jul 16.

Reference Type DERIVED
PMID: 26183611 (View on PubMed)

Other Identifiers

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GS-US-281-0102

Identifier Type: -

Identifier Source: org_study_id