Hepatitis C Virus InfectionPhase 1NCT02185794

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection

A Phase 1 study testing Voxilaprevir and SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hepatitis C Virus Infection
What is being tested?: Voxilaprevir and SOF/VEL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 101 participants
Where: 11 sitesin 2 countries
Study dates: 13 Jun 2014to 28 Sep 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic genotype 1-4 HCV infection
For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for Cohort 10)
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Who cannot join

Pregnant or nursing female or male with pregnant female partner
Presence of cirrhosis
Prior exposure to approved or experimental HCV Protease Inhibitors
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 participant's treatment, assessment or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States10 sites

Study site
Berlin, New Jersey
Study site
Costa Mesa, California
Study site
DeLand, Florida
Study site
Kansas City, Missouri
Study site
Knoxville, Tennessee
Study site
Marlton, New Jersey
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
San Antonio, Texas
Study site
St Louis, Missouri

Other trials in United States

Puerto Rico1 site

Study site
San Juan

Other trials in Puerto Rico

About this study

Official title: Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection

Conditions: Hepatitis C Virus Infection
Being tested: Voxilaprevir, Placebo to match voxilaprevir, SOF/VEL
Keywords: Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections, Flaviviridae Infections, Antiviral Agents, Anti-Infective Agents, Therapeutic Uses, Pharmacologic Actions, Antimetabolites, Molecular Mechanisms of Pharmacological Action
Medical subject headings: Hepatitis C, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Enterovirus Infections, Picornaviridae Infections, RNA Virus Infections, Flaviviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VoxilaprevirDrug
Also called GS-9857
Voxilaprevir tablets administered orally once daily
Placebo to match voxilaprevirDrug
Placebo to match voxilaprevir tablets administered orally once daily
SOF/VELDrug
400 mg/100 mg FDC tablet administered orally once daily

Study groups in NCT02185794
Study group	Role	What they receive
Placebo (GT 1a, Cohort 1)	Placebo comparator	Participants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions. Receives: Drug: Placebo to match voxilaprevir
Voxilaprevir 50 mg (GT 1a, Cohort 1)	Experimental	Participants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions. Receives: Drug: Voxilaprevir
Voxilaprevir 100 mg (GT 1a, Cohort 1)	Experimental	Participants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. Receives: Drug: Voxilaprevir
Voxilaprevir 300 mg (GT 1a, Cohort 1)	Experimental	Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions. Receives: Drug: Voxilaprevir
Placebo (GT 3, Cohort 2)	Placebo comparator	Participants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions. Receives: Drug: Placebo to match voxilaprevir
Voxilaprevir 50 mg (GT 3, Cohort 2)	Experimental	Participants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions. Receives: Drug: Voxilaprevir
Voxilaprevir 100 mg (GT 3, Cohort 2)	Experimental	Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. Receives: Drug: Voxilaprevir
Voxilaprevir 300 mg (GT 3, Cohort 2)	Experimental	Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions. Receives: Drug: Voxilaprevir
Placebo (GT 2, Cohort 3)	Placebo comparator	Participants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions. Receives: Drug: Placebo to match voxilaprevir
Voxilaprevir 100 mg (GT 2, Cohort 3)	Experimental	Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. Receives: Drug: Voxilaprevir
Voxilaprevir 100 mg (GT 4, Cohort 4)	Experimental	Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. Receives: Drug: Voxilaprevir
Voxilaprevir 100 mg (GT 1b, Cohort 5)	Experimental	Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. Receives: Drug: Voxilaprevir
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)	Experimental	Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions. Receives: Drug: Voxilaprevir
Voxilaprevir 600 mg (Cohorts 7-9)	Experimental	Participants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days. Receives: Drug: Voxilaprevir
Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)	Experimental	Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal. Receives: Drug: Voxilaprevir; Drug: SOF/VEL
Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)	Experimental	Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. Receives: Drug: Voxilaprevir; Drug: SOF/VEL

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Experiencing Treatment Emergent Adverse Events
Measured: First dose date up to Day 3 plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.
Measured: First dose date up to Day 3 plus 30 days
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.
Measured: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48

Secondary outcomes (3)

Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).
Measured: Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Categorical declines from baseline were summarized by the number of participants with a < 1, ≥ 1 to <2, ≥ 2 to <3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).
Measured: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).
Measured: Days 4, 5, 6, 7, 8, 10, and Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 201428 Sep 2015

First posted10 Jul 2014 (estimated)
Study start13 Jun 2014
Primary completion22 Dec 2014
Study completion28 Sep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02185794
Sponsor's protocol ID: GS-US-338-1121
Status last verified: Aug 2020
First submitted: 7 Jul 2014
Last updated: 17 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Rodriguez-Torres M, Glass S, Hill J, Freilich B, Hassman D, Di Bisceglie A, Taylor J, Kirby B, Yang J, An D, Stamm L, Brainard D, Kim S, Krefetz D, Smith W, Marbury T, Lawitz E. The Pangenotypic NS3/4A Protease Inhibitor GS-9857 Demonstrates Potent Antiviral Activity in Patients Infected With HCV Genotype 1, 2, 3, or 4 in a 3-Day Monotherapy Study [Poster P0901]. Presented at the European Association for the Study of the Liver (EASL) 50th International Liver Congress 2015, April 22-26, 2015, Vienna, Austria.
Lawitz E, Yang JC, Stamm LM, Taylor JG, Cheng G, Brainard DM, Miller MD, Mo H, Dvory-Sobol H. Characterization of HCV resistance from a 3-day monotherapy study of voxilaprevir, a novel pangenotypic NS3/4A protease inhibitor. Antivir Ther. 2018;23(4):325-334. doi: 10.3851/IMP3202.
PubMed 29063860

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection
ClinicalTrials.gov ID: NCT02185794
Acronym / sponsor ID: GS-US-338-1121
Conditions: Hepatitis C Virus Infection
Keywords: Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Enterovirus Infections, Picornaviridae Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 13 Jun 2014 (actual)
Primary completion: 22 Dec 2014 (actual)
Study completion: 28 Sep 2015 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Posted 21 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 16

Arm	Type	Receives
Placebo (GT 1a, Cohort 1)	Placebo comparator	Drug: Placebo to match voxilaprevirParticipants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions.
Voxilaprevir 50 mg (GT 1a, Cohort 1)	Experimental	Drug: VoxilaprevirParticipants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg (GT 1a, Cohort 1)	Experimental	Drug: VoxilaprevirParticipants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir 300 mg (GT 1a, Cohort 1)	Experimental	Drug: VoxilaprevirParticipants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.
Placebo (GT 3, Cohort 2)	Placebo comparator	Drug: Placebo to match voxilaprevirParticipants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions.
Voxilaprevir 50 mg (GT 3, Cohort 2)	Experimental	Drug: VoxilaprevirParticipants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg (GT 3, Cohort 2)	Experimental	Drug: VoxilaprevirParticipants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir 300 mg (GT 3, Cohort 2)	Experimental	Drug: VoxilaprevirParticipants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.
Placebo (GT 2, Cohort 3)	Placebo comparator	Drug: Placebo to match voxilaprevirParticipants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg (GT 2, Cohort 3)	Experimental	Drug: VoxilaprevirParticipants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg (GT 4, Cohort 4)	Experimental	Drug: VoxilaprevirParticipants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg (GT 1b, Cohort 5)	Experimental	Drug: VoxilaprevirParticipants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)	Experimental	Drug: VoxilaprevirParticipants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions.
Voxilaprevir 600 mg (Cohorts 7-9)	Experimental	Drug: VoxilaprevirParticipants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days.
Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)	Experimental	Drug: Voxilaprevir, Drug: SOF/VELParticipants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal.
Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)	Experimental	Drug: Voxilaprevir, Drug: SOF/VELParticipants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Chronic genotype 1-4 HCV infection
For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for Cohort 10)
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male

Key exclusion criteria (8 listed)

Pregnant or nursing female or male with pregnant female partner
Presence of cirrhosis
Prior exposure to approved or experimental HCV Protease Inhibitors
Co-infection with HIV or hepatitis B virus (HBV)
Current or prior history of clinical hepatic decompensation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VoxilaprevirAlso: GS-9857Voxilaprevir tablets administered orally once daily	Drug	Voxilaprevir 100 mg (GT 1a, Cohort 1), Voxilaprevir 100 mg (GT 1b, Cohort 5), Voxilaprevir 100 mg (GT 2, Cohort 3), Voxilaprevir 100 mg (GT 3, Cohort 2), Voxilaprevir 100 mg (GT 4, Cohort 4), Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10), Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10), Voxilaprevir 100 mg Fed (GT 3a, Cohort 6), Voxilaprevir 300 mg (GT 1a, Cohort 1), Voxilaprevir 300 mg (GT 3, Cohort 2), Voxilaprevir 50 mg (GT 1a, Cohort 1), Voxilaprevir 50 mg (GT 3, Cohort 2), Voxilaprevir 600 mg (Cohorts 7-9)
Placebo to match voxilaprevirPlacebo to match voxilaprevir tablets administered orally once daily	Drug	Placebo (GT 1a, Cohort 1), Placebo (GT 2, Cohort 3), Placebo (GT 3, Cohort 2)
SOF/VEL400 mg/100 mg FDC tablet administered orally once daily	Drug	Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10), Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)

Primary outcome

Percentage of Participants Experiencing Treatment Emergent Adverse Events
Time frame: First dose date up to Day 3 plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Time frame: First dose date up to Day 3 plus 30 days
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.

3 secondary outcomes

Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
Time frame: Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
Time frame: Days 4, 5, 6, 7, 8, 10, and Week 48

Results and safety

Results posted to the registry on 21 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	9	4
Voxilaprevir 50 mg	20	7
Voxilaprevir 100 mg	33	17
Voxilaprevir 300 mg	16	8
Voxilaprevir 100 mg Fed	7	4
Voxilaprevir 100 mg + SOF/VEL 400/100 mg	16	0

Primary outcome: Percentage of Participants Experiencing Treatment Emergent Adverse Events

Time frame: First dose date up to Day 3 plus 30 days. Number. Unit: percentage of participants

Measure	Placebo n = 8	Voxilaprevir 50 mg n = 14	Voxilaprevir 100 mg n = 30	Voxilaprevir 300 mg n = 15	Voxilaprevir 100 mg Fed n = 6	Voxilaprevir 100 mg + SOF/VEL 400/100 mg n = 16
Value	25.0	14.3	16.7	13.3	33.3	12.5

Population analysed: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.

Primary outcome: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

Time frame: First dose date up to Day 3 plus 30 days. Number. Unit: percentage of participants

Measure	Placebo n = 8	Voxilaprevir 50 mg n = 14	Voxilaprevir 100 mg n = 30	Voxilaprevir 300 mg n = 15	Voxilaprevir 100 mg Fed n = 6	Voxilaprevir 100 mg + SOF/VEL 400/100 mg n = 16
Grade 1	37.5	28.6	26.7	20.0	50.0	62.5
Grade 2	25.0	28.6	33.3	13.3	0	12.5
Grade 3	0	14.3	10.0	26.7	33.3	0
Grade 4	0	0	3.3	0	0	0

Population analysed: Participants in the Safety Analysis Set were analyzed. Data were summarized by dose.

Primary outcome: Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA

Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48. Mean (Standard Deviation). Unit: log10 IU/mL

Measure	Placebo (GT 1a, Cohort 1) n = 4	Voxilaprevir 50 mg (GT 1a, Cohort 1) n = 8	Voxilaprevir 100 mg (GT 1a, Cohort 1) n = 8	Voxilaprevir 300 mg (GT 1a, Cohort 1) n = 8	Placebo (GT 3, Cohort 2) n = 2	Voxilaprevir 50 mg (GT 3, Cohort 2) n = 6	Voxilaprevir 100 mg (GT 3, Cohort 2) n = 6	Voxilaprevir 300 mg (GT 3, Cohort 2) n = 7	Placebo (GT 2, Cohort 3) n = 2	Voxilaprevir 100 mg (GT 2, Cohort 3) n = 6	Voxilaprevir 100 mg (GT 4, Cohort 4) n = 4	Voxilaprevir 100 mg (GT 1b, Cohort 5) n = 6	Voxilaprevir 100 mg Fed (GT 3a, Cohort 6) n = 6
Change at Day 4	-0.12 (0.136)	-3.81 (0.516)	-3.97 (0.608)	-3.33 (0.902)	-0.24 (0.813)	-1.47 (0.416)	-3.20 (0.364)	-3.57 (0.483)	0.00 (0.104)	-3.41 (0.444)	-3.50 (0.677)	-3.57 (0.227)	-3.06 (0.752)
Change at Day 5	-0.20 (0.519)	-3.58 (1.104)	-4.03 (0.594)	-3.37 (0.894)	-0.17 (0.285)	-1.43 (0.606)	-3.00 (0.470)	-3.28 (0.515)	-0.12 (0.151)	-3.37 (0.480)	-3.61 (0.702)	-3.60 (0.390)	-2.45 (0.664)
Change at Day 6	-0.21 (0.479)	-3.45 (0.829)	-3.78 (0.710)	-3.47 (0.763)	-0.06 (0.051)	-1.06 (0.632)	-2.52 (0.739)	-3.13 (0.736)	-0.04 (0.139)	-3.22 (0.689)	-3.69 (0.879)	-3.61 (0.601)	-2.04 (0.706)
Change at Day 7	0.01 (0.340)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Voxilaprevir 50 mg	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Voxilaprevir 100 mg	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30
Voxilaprevir 300 mg	0 of 15 (0%)	2 of 15 (13.3%)	0 of 15
Voxilaprevir 100 mg Fed	1 of 6 (16.7%)	1 of 6 (16.7%)	0 of 6
Voxilaprevir 100 mg + SOF/VEL 400/100 mg	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationRodriguez-Torres M, Glass S, Hill J, Freilich B, Hassman D, Di Bisceglie A, Taylor J, Kirby B, Yang J, An D, Stamm L, Brainard D, Kim S, Krefetz D, Smith W, Marbury T, Lawitz E. The Pangenotypic NS3/4A Protease Inhibitor GS-9857 Demonstrates Potent Antiviral Activity in Patients Infected With HCV Genotype 1, 2, 3, or 4 in a 3-Day Monotherapy Study [Poster P0901]. Presented at the European Association for the Study of the Liver (EASL) 50th International Liver Congress 2015, April 22-26, 2015, Vienna, Austria.
Results publication: PubMed 29063860Lawitz E, Yang JC, Stamm LM, Taylor JG, Cheng G, Brainard DM, Miller MD, Mo H, Dvory-Sobol H. Characterization of HCV resistance from a 3-day monotherapy study of voxilaprevir, a novel pangenotypic NS3/4A protease inhibitor. Antivir Ther. 2018;23(4):325-334. doi: 10.3851/IMP3202.

Related trials for Hepatitis C Virus Infection

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Voxilaprevir and SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing Treatment Emergent Adverse Events (time frame: First dose date up to Day 3 plus 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02185794, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.