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CompletedNCT02185794Updated Sep 17, 2020Results posted

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

A Phase 1 interventional study of Voxilaprevir and Placebo to match voxilaprevir in Hepatitis C Virus Infection, sponsored by Gilead Sciences. Completed at 11 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-17.

Sponsored by Gilead Sciences · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. All participants will be monitored for up to 48 weeks after the last dose.

02

Conditions studied

  • 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
  • RNA Virus Infections
  • Flaviviridae Infections
  • Antiviral Agents
  • Anti-Infective Agents
  • Therapeutic Uses
  • Pharmacologic Actions
  • Antimetabolites
  • Molecular Mechanisms of Pharmacological Action
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 101 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • 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:

  • 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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
101 participants (actual)

Study arms

  • Placebo comparator
    Placebo (GT 1a, Cohort 1)

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

    Drug: Placebo to match voxilaprevir

  • Experimental
    Voxilaprevir 50 mg (GT 1a, Cohort 1)

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

    Drug: Voxilaprevir

  • Experimental
    Voxilaprevir 100 mg (GT 1a, Cohort 1)

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

    Drug: Voxilaprevir

  • Experimental
    Voxilaprevir 300 mg (GT 1a, Cohort 1)

    Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.

    Drug: Voxilaprevir

  • Placebo comparator
    Placebo (GT 3, Cohort 2)

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

    Drug: Placebo to match voxilaprevir

  • Experimental
    Voxilaprevir 50 mg (GT 3, Cohort 2)

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

    Drug: Voxilaprevir

  • Experimental
    Voxilaprevir 100 mg (GT 3, Cohort 2)

    Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.

    Drug: Voxilaprevir

  • Experimental
    Voxilaprevir 300 mg (GT 3, Cohort 2)

    Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions.

    Drug: Voxilaprevir

  • Placebo comparator
    Placebo (GT 2, Cohort 3)

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

    Drug: Placebo to match voxilaprevir

  • Experimental
    Voxilaprevir 100 mg (GT 2, Cohort 3)

    Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.

    Drug: Voxilaprevir

  • Experimental
    Voxilaprevir 100 mg (GT 4, Cohort 4)

    Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.

    Drug: Voxilaprevir

  • Experimental
    Voxilaprevir 100 mg (GT 1b, Cohort 5)

    Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions.

    Drug: Voxilaprevir

  • Experimental
    Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)

    Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions.

    Drug: Voxilaprevir

  • Experimental
    Voxilaprevir 600 mg (Cohorts 7-9)

    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.

    Drug: Voxilaprevir

  • Experimental
    Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10)

    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.

    Drug: Voxilaprevir · Drug: SOF/VEL

  • Experimental
    Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10)

    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.

    Drug: Voxilaprevir · Drug: SOF/VEL

Interventions

  • DrugVoxilaprevir

    Voxilaprevir tablets administered orally once daily

    Also known as: GS-9857

  • DrugPlacebo to match voxilaprevir

    Placebo to match voxilaprevir tablets administered orally once daily

  • DrugSOF/VEL

    400 mg/100 mg FDC tablet administered orally once daily

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Experiencing Treatment Emergent Adverse Events

    Time frame: First dose date up to Day 3 plus 30 days

  2. 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.

    Time frame: First dose date up to Day 3 plus 30 days

  3. 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.

    Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48

Secondary outcomes

  1. 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).

    Time frame: Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48

  2. 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).

    Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48

  3. 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).

    Time frame: Days 4, 5, 6, 7, 8, 10, and Week 48

07

Results

Posted Aug 21, 2020

Participant flow

Participants were enrolled at study sites in United States and Puerto Rico. The first participant was screened on 13 June 2014. The last study visit occurred on 28 September 2015.

Participant flow — Overall Study
MilestonePlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mg
Started9203316716
Completed4717840
Not completed513168316
Withdrew: Enrolled but never dosed163110
Withdrew: Investigator's discretion1012215
Withdrew: Withdrew consent2510200
Withdrew: Lost to follow-up122301

Outcome measures

PrimaryPercentage of Participants Experiencing Treatment Emergent Adverse Events
Time frame:
First dose date up to Day 3 plus 30 days
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing Treatment Emergent Adverse Events
percentage of participantsPlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mg
Percentage of Participants Experiencing Treatment Emergent Adverse Events25.014.316.713.333.312.5
PrimaryPercentage 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.

Time frame:
First dose date up to Day 3 plus 30 days
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
percentage of participantsPlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mg
Grade 137.528.626.720.050.062.5
Grade 225.028.633.313.3012.5
Grade 3014.310.026.733.30
Grade 4003.3000
PrimaryAntiviral 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.

Time frame:
Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
Reported as:
Mean · log10 IU/mL
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
log10 IU/mLPlacebo (GT 1a, Cohort 1)Voxilaprevir 50 mg (GT 1a, Cohort 1)Voxilaprevir 100 mg (GT 1a, Cohort 1)Voxilaprevir 300 mg (GT 1a, Cohort 1)Placebo (GT 3, Cohort 2)Voxilaprevir 50 mg (GT 3, Cohort 2)Voxilaprevir 100 mg (GT 3, Cohort 2)Voxilaprevir 300 mg (GT 3, Cohort 2)Placebo (GT 2, Cohort 3)Voxilaprevir 100 mg (GT 2, Cohort 3)Voxilaprevir 100 mg (GT 4, Cohort 4)Voxilaprevir 100 mg (GT 1b, Cohort 5)Voxilaprevir 100 mg Fed (GT 3a, Cohort 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 ± 0.4830.00 ± 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 70.01 ± 0.340-3.15 ± 0.973-3.88 ± 0.729-3.48 ± 0.6950.02 ± 0.089-0.76 ± 0.352-2.00 ± 0.378-2.89 ± 0.763-0.05 ± 0.058-2.80 ± 0.494-3.70 ± 0.877-3.42 ± 0.710-1.74 ± 0.885
Change at Day 80.13 ± 0.260-2.92 ± 1.069-3.54 ± 0.663-3.23 ± 0.726-0.14 ± 0.158-0.53 ± 0.379-1.79 ± 0.627-2.74 ± 0.916-0.05 ± 0.090-2.48 ± 0.355-3.53 ± 0.637-3.27 ± 0.627-1.43 ± 0.987
Change at Day 10-0.06 ± 0.091-2.69 ± 1.116-3.33 ± 0.756-2.97 ± 0.918-0.23 ± 0.180-0.28 ± 0.330-1.18 ± 1.055-2.17 ± 1.394-0.13 ± 0.022-2.28 ± 0.469-3.61 ± 0.674-3.08 ± 0.740-0.62 ± 1.085
Change at Week 480.41 ± 0.8730.08 ± 0.337-0.80 ± 2.094-0.73 ± 2.3520.41-0.03 ± 0.2210.540.06 ± 0.370-0.02-0.020.18 ± 0.247-0.57 ± 2.3890.16 ± 0.044
SecondaryAntiviral 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).

Time frame:
Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48
Reported as:
Mean · log10 IU/mL
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
log10 IU/mLPlacebo (GT 1a, Cohort 1)Voxilaprevir 50 mg (GT 1a, Cohort 1)Voxilaprevir 100 mg (GT 1a, Cohort 1)Voxilaprevir 300 mg (GT 1a, Cohort 1)Placebo (GT 3, Cohort 2)Voxilaprevir 50 mg (GT 3, Cohort 2)Voxilaprevir 100 mg (GT 3, Cohort 2)Voxilaprevir 300 mg (GT 3, Cohort 2)Placebo (GT 2, Cohort 3)Voxilaprevir 100 mg (GT 2, Cohort 3)Voxilaprevir 100 mg (GT 4, Cohort 4)Voxilaprevir 100 mg (GT 1b, Cohort 5)Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
Pre Day 1 Dose6.73 ± 0.3076.30 ± 0.4976.35 ± 0.5266.05 ± 0.5586.11 ± 0.4805.61 ± 0.6126.75 ± 0.3466.01 ± 0.7736.71 ± 0.0596.24 ± 0.3946.16 ± 0.7306.23 ± 0.6086.01 ± 0.866
Day 46.62 ± 0.3782.56 ± 0.7052.38 ± 0.7592.72 ± 0.9435.87 ± 0.3324.22 ± 0.8783.54 ± 0.4552.44 ± 0.6936.71 ± 0.1642.83 ± 0.6112.65 ± 0.5332.67 ± 0.5002.95 ± 0.505
Day 56.53 ± 0.4262.73 ± 1.2032.33 ± 0.6432.67 ± 0.9475.94 ± 0.1954.19 ± 1.1043.75 ± 0.4552.73 ± 0.7806.59 ± 0.2102.87 ± 0.6032.55 ± 0.5492.63 ± 0.7643.56 ± 0.273
Day 66.52 ± 0.3202.85 ± 1.0002.57 ± 1.0282.57 ± 0.8186.05 ± 0.5324.55 ± 1.2034.23 ± 0.6042.88 ± 0.8826.68 ± 0.1993.02 ± 0.7542.46 ± 0.3002.85 ± 0.6853.98 ± 0.413
Day 76.74 ± 0.0593.15 ± 1.2682.47 ± 0.8212.56 ± 0.7146.13 ± 0.5694.85 ± 0.8864.75 ± 0.2683.12 ± 0.9916.67 ± 0.0013.44 ± 0.6132.45 ± 0.3592.82 ± 1.1114.27 ± 0.485
Day 86.86 ± 0.1443.38 ± 1.0192.81 ± 0.9012.81 ± 0.6715.97 ± 0.3235.08 ± 0.6554.96 ± 0.5313.27 ± 1.1006.66 ± 0.0313.76 ± 0.4972.62 ± 0.2782.96 ± 1.1114.59 ± 0.528
Day 106.68 ± 0.2633.61 ± 1.0413.03 ± 0.8573.07 ± 0.8875.88 ± 0.3005.43 ± 0.8035.56 ± 0.9873.83 ± 1.4176.58 ± 0.0813.96 ± 0.5552.54 ± 0.5533.15 ± 1.2105.40 ± 0.697
Week 486.97 ± 0.4886.29 ± 0.8255.55 ± 2.0075.20 ± 2.0856.185.13 ± 0.2077.296.38 ± 1.4796.656.136.34 ± 0.6965.65 ± 2.4735.98 ± 0.891
SecondaryAntiviral 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).

Time frame:
Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
Reported as:
Count of participants · Participants
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
ParticipantsPlacebo (GT 1a, Cohort 1)Voxilaprevir 50 mg (GT 1a, Cohort 1)Voxilaprevir 100 mg (GT 1a, Cohort 1)Voxilaprevir 300 mg (GT 1a, Cohort 1)Placebo (GT 3, Cohort 2)Voxilaprevir 50 mg (GT 3, Cohort 2)Voxilaprevir 100 mg (GT 3, Cohort 2)Voxilaprevir 300 mg (GT 3, Cohort 2)Placebo (GT 2, Cohort 3)Voxilaprevir 100 mg (GT 2, Cohort 3)Voxilaprevir 100 mg (GT 4, Cohort 4)Voxilaprevir 100 mg (GT 1b, Cohort 5)Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
Day 4 — Missing HCV RNA0100011000000
Day 4 — < 1 log10 IU/mL decrease in HCV RNA4000200020000
Day 4 — ≥1 and <2 log10 IU/mL decrease in HCV RNA0001040000000
Day 4 — ≥2 and <3 log10 IU/mL decrease in HCV RNA0010011101103
Day 4 — ≥3 log10 IU/mL decrease in HCV RNA0777004605363
Day 5 — Missing HCV RNA0001001000000
Day 5 — < 1 log10 IU/mL decrease in HCV RNA4000210020000
Day 5 — ≥1 and <2 log10 IU/mL decrease in HCV RNA0101040000001
Day 5 — ≥2 and <3 log10 IU/mL decrease in HCV RNA0100012202103
Day 5 — ≥3 log10 IU/mL decrease in HCV RNA0686003504362
Day 6 — Missing HCV RNA0001001000010
Day 6 — < 1 log10 IU/mL decrease in HCV RNA4000220020000
Day 6 — ≥1 and <2 log10 IU/mL decrease in HCV RNA0101041100003
Day 6 — ≥2 and <3 log10 IU/mL decrease in HCV RNA0010003102112
Day 6 — ≥3 log10 IU/mL decrease in HCV RNA0776001504341
Day 7 — Missing HCV RNA0001001000000
Day 7 — < 1 log10 IU/mL decrease in HCV RNA4000240020001
Day 7 — ≥1 and <2 log10 IU/mL decrease in HCV RNA0200023100002
Day 7 — ≥2 and <3 log10 IU/mL decrease in HCV RNA0011002203123
Day 7 — ≥3 log10 IU/mL decrease in HCV RNA0676000403340
Day 8 — Missing HCV RNA0001001000000
Day 8 — < 1 log10 IU/mL decrease in HCV RNA4000260120003
Day 8 — ≥1 and <2 log10 IU/mL decrease in HCV RNA0200004000002
Day 8 — ≥2 and <3 log10 IU/mL decrease in HCV RNA0213001206121
Day 8 — ≥3 log10 IU/mL decrease in HCV RNA0474000400340
Day 10 — Missing HCV RNA0001011000000
Day 10 — < 1 log10 IU/mL decrease in HCV RNA4000252120004
Day 10 — ≥1 and <2 log10 IU/mL decrease in HCV RNA0311002202011
Day 10 — ≥2 and <3 log10 IU/mL decrease in HCV RNA0203001104011
Day 10 — ≥3 log10 IU/mL decrease in HCV RNA0373000300440
Week 48 — Missing HCV RNA2412135515012
Week 48 — < 1 log10 IU/mL decrease in HCV RNA2465131211444
Week 48 — ≥1 and <2 log10 IU/mL decrease in HCV RNA0000000000000
Week 48 — ≥2 and <3 log10 IU/mL decrease in HCV RNA0000000000000
Week 48 — ≥3 log10 IU/mL decrease in HCV RNA0011000000010
SecondaryPercentage 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).

Time frame:
Days 4, 5, 6, 7, 8, 10, and Week 48
Reported as:
Number · participants
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
participantsPlacebo (GT 1a, Cohort 1)Voxilaprevir 50 mg (GT 1a, Cohort 1)Voxilaprevir 100 mg (GT 1a, Cohort 1)Voxilaprevir 300 mg (GT 1a, Cohort 1)Placebo (GT 3, Cohort 2)Voxilaprevir 50 mg (GT 3, Cohort 2)Voxilaprevir 100 mg (GT 3, Cohort 2)Voxilaprevir 300 mg (GT 3, Cohort 2)Placebo (GT 2, Cohort 3)Voxilaprevir 100 mg (GT 2, Cohort 3)Voxilaprevir 100 mg (GT 4, Cohort 4)Voxilaprevir 100 mg (GT 1b, Cohort 5)Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
Day 4 < LLOQ detected0011000000000
Day 5 < LLOQ detected0001000100000
Day 6 < LLOQ TND0001000000000
Day 7 < LLOQ detected0000000000010
Day 8 < LLOQ detected0000000000010
Day 10 < LLOQ TND0000000000010
Week 48 < LLOQ TND0011000000000

Adverse events

Collected over Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/8 (0%)0/8 (0%)2/8 (25%)
Voxilaprevir 50 mg0/14 (0%)0/14 (0%)2/14 (14.3%)
Voxilaprevir 100 mg0/30 (0%)0/30 (0%)2/30 (6.7%)
Voxilaprevir 300 mg0/15 (0%)0/15 (0%)2/15 (13.3%)
Voxilaprevir 100 mg Fed0/6 (0%)1/6 (16.7%)1/6 (16.7%)
Voxilaprevir 100 mg + SOF/VEL 400/100 mg0/16 (0%)0/16 (0%)2/16 (12.5%)
Most frequent serious events
Most frequent serious events
EventPlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mg
Atrial fibrillationCardiac disorders0/80/140/300/151/60/16
Most frequent other events
Most frequent other events
EventPlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mg
HeadacheNervous system disorders2/80/141/300/151/61/16
DizzinessNervous system disorders0/80/140/300/151/60/16
ConstipationGastrointestinal disorders1/80/140/300/150/60/16
DiarrhoeaGastrointestinal disorders1/80/142/301/150/61/16
ContusionInjury, poisoning and procedural complications0/81/140/300/150/60/16
ArthralgiaMusculoskeletal and connective tissue disorders0/81/140/300/150/60/16
Pain in extremityMusculoskeletal and connective tissue disorders0/81/140/300/150/60/16
Dermatitis contactSkin and subcutaneous tissue disorders0/80/140/301/150/60/16

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)PlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mgTotal
Mean52 ± 6.149 ± 7.752 ± 8.043 ± 9.451 ± 6.256 ± 5.251 ± 8.4
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mgTotal
Female15952729
Male7921104960
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mgTotal
Black or African American241231022
White610181251667
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mgTotal
Hispanic or Latino271286944
Not Hispanic or Latino671870745
HCV Genotype
HCV Genotype(Participants)PlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mgTotal
1a48880937
1b0060039
20000011
2a/2c0020002
2b2040028
3a26676128
40020002
4a/4c/4d0020002
HCV RNA
HCV RNA(log10 IU/mL)PlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mgTotal
Mean6.6 ± 0.396.0 ± 0.646.4 ± 0.536.0 ± 0.646.0 ± 0.876.2 ± 0.836.2 ± 0.65
HCV RNA Category
HCV RNA Category(Participants)PlaceboVoxilaprevir 50 mgVoxilaprevir 100 mgVoxilaprevir 300 mgVoxilaprevir 100 mg FedVoxilaprevir 100 mg + SOF/VEL 400/100 mgTotal
< 800,000 IU/mL17664428
≥ 800,000 IU/mL7724921261
08

Study locations

11 sites
  • Costa Mesa, California, United States
  • DeLand, Florida, United States
  • Orlando, Florida, United States
  • Kansas City, Missouri, United States
  • Saint Louis, Missouri, United States
  • Berlin, New Jersey, United States
  • Marlton, New Jersey, United States
  • Philadelphia, Pennsylvania, United States
  • Knoxville, Tennessee, United States
  • San Antonio, Texas, United States
  • San Juan, Puerto Rico
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02185794
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Jul 10, 2014
Start date
Jun 13, 2014
Primary completion
Dec 22, 2014
Completion
Sep 28, 2015
Results posted
Aug 21, 2020
Last update
Sep 17, 2020

Study contacts

Gilead Study Director
study director · Gilead Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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