Chronic Hepatitis C VirusPhase 1NCT01740791

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

A Phase 1 study testing Velpatasvir in people with Chronic Hepatitis C Virus, run by Gilead Sciences at 10 sites in 2 countries.

Completed

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

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Hepatitis C Virus
What is being tested?: Velpatasvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 103 participants
Where: 10 sitesin 2 countries
Study dates: 6 Nov 2012to 24 Jan 2014
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

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

Who cannot join

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

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

United States9 sites

West Coast Clinical Trials, LLC
Costa Mesa, California, 92626
Avail Clinical Research, LLC
DeLand, Florida, 32720
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131
New Orleans Center for Clinical Research-Knoxville
Knoxville, Tennessee, 37920
CRI Worldwide, LLC
Marlton, New Jersey, 08053
Orlando Clinical Research Center
Orlando, Florida, 32809
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139
Alamo Medical Research
San Antonio, Texas, 78215
Charles River Clinical Services Northwest, Inc.
Tacoma, Washington, 98418

Other trials in United States

Puerto Rico1 site

Fundacion De Investigacion De Diego
San Juan, 00927

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-5816 in Subjects With Chronic Hepatitis C Virus Infection

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.

Conditions: Chronic Hepatitis C Virus
Being tested: Velpatasvir, Placebo
Keywords: Hepatitis C, HCV, Genotype 1, Genotype 2, Genotype 3, Genotype 4, Genotype 5, Genotype 6, Liver Disease
Medical subject headings: Hepatitis C, Chronic, Hepatitis C, Liver Diseases

What participants receive

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

VelpatasvirDrug
Also called GS-5816
Tablets administered orally
PlaceboDrug
Tablets administered orally

Study groups in NCT01740791
Study group	Role	What they receive
Velpatasvir 5 mg (GT 1a)	Experimental	Participants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir 25 mg (GT 1a)	Experimental	Participants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir 50 mg (GT 1a)	Experimental	Participants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir 100 mg (GT 1a)	Experimental	Participants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir 150 mg (GT 1a)	Experimental	Participants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir 150 mg (GT 1b)	Experimental	Participants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir 150 mg (GT 2)	Experimental	Participants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir 25 mg (GT 3)	Experimental	Participants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir 50 mg (GT 3)	Experimental	Participants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir 150 mg (GT 3)	Experimental	Participants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir 150 mg (GT 4)	Experimental	Participants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo
Velpatasvir up to 400 mg (GT 2)	Experimental	Participants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions. Receives: Drug: Velpatasvir; Drug: Placebo

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
Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing).
Measured: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose.
Measured: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)
Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo.
Measured: Baseline; Days 4, 5, 6, 7, 8, 10, and 17

Secondary outcomes (10)

Absolute HCV RNA Level
Measured: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
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 by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17.
Measured: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected
The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 25 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay.
Measured: Days 4, 5, 6, 7, and 8
Plasma HCV RNA Levels by Treatment and IL28B Genotype
Measured: Days 4, 5, 6, 7, 8, 10, and 17
Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Measured: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1
PK Parameter of Velpatasvir: AUCtau
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measured: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3
PK Parameter of Velpatasvir: Cmax
Cmax is defined as the maximum observed plasma concentration of drug.
Measured: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose.
PK Parameter of Velpatasvir: CL/F
CL/F is defined as the apparent oral clearance following administration of the drug.
Measured: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose
PK Parameter of Velpatasvir: Ctau
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measured: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3
Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints
The full-length NS5A coding region was analyzed pretreatment (baseline) by deep sequencing using MiSeq for all 70 participants who received velpatasvir and for 8 of 17 participants who received placebo prior to and up to 2 weeks (Day 17) after dosing with velpatasvir. Participants were categorized by velpatasvir dose/HCV genotype and presence or absence of NS5A RAVs.
Measured: First dose date up to Day 17

Timeline

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

6 Nov 201224 Jan 2014

First posted4 Dec 2012 (estimated)
Study start6 Nov 2012
Primary completion15 Mar 2013
Study completion24 Jan 2014

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 (4)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis C VirusStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01740791
Sponsor's protocol ID: GS-US-281-0102
Status last verified: Dec 2020
First submitted: 26 Nov 2012
Last updated: 16 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
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.
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.
PubMed 27353271
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.
PubMed 26183611

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

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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 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-5816 in Subjects With Chronic Hepatitis C Virus Infection
ClinicalTrials.gov ID: NCT01740791
Acronym / sponsor ID: GS-US-281-0102
Conditions: Chronic Hepatitis C Virus
Keywords: Hepatitis C, HCV, Genotype 1, Genotype 2, Genotype 3, Genotype 4, Genotype 5, Genotype 6
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 6 Nov 2012 (actual)
Primary completion: 15 Mar 2013 (actual)
Study completion: 24 Jan 2014 (actual)
First posted: 4 Dec 2012 (estimated)
Results: Posted 16 Dec 2020

Clinical summary

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
Velpatasvir 5 mg (GT 1a)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir 25 mg (GT 1a)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir 50 mg (GT 1a)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir 100 mg (GT 1a)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir 150 mg (GT 1a)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir 150 mg (GT 1b)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir 150 mg (GT 2)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir 25 mg (GT 3)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir 50 mg (GT 3)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir 150 mg (GT 3)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir 150 mg (GT 4)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions.
Velpatasvir up to 400 mg (GT 2)	Experimental	Drug: Velpatasvir, Drug: PlaceboParticipants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions.

Who may qualify

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

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

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
VelpatasvirAlso: GS-5816Tablets administered orally	Drug	Velpatasvir 100 mg (GT 1a), Velpatasvir 150 mg (GT 1a), Velpatasvir 150 mg (GT 1b), Velpatasvir 150 mg (GT 2), Velpatasvir 150 mg (GT 3), Velpatasvir 150 mg (GT 4), Velpatasvir 25 mg (GT 1a), Velpatasvir 25 mg (GT 3), Velpatasvir 5 mg (GT 1a), Velpatasvir 50 mg (GT 1a), Velpatasvir 50 mg (GT 3), Velpatasvir up to 400 mg (GT 2)
PlaceboTablets administered orally	Drug	Velpatasvir 100 mg (GT 1a), Velpatasvir 150 mg (GT 1a), Velpatasvir 150 mg (GT 1b), Velpatasvir 150 mg (GT 2), Velpatasvir 150 mg (GT 3), Velpatasvir 150 mg (GT 4), Velpatasvir 25 mg (GT 1a), Velpatasvir 25 mg (GT 3), Velpatasvir 5 mg (GT 1a), Velpatasvir 50 mg (GT 1a), Velpatasvir 50 mg (GT 3), Velpatasvir up to 400 mg (GT 2)

Primary outcome

Percentage of Participants Experiencing Treatment Emergent Adverse Events
Time frame: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)
Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing).
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Time frame: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose.
Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo.

10 secondary outcomes

Absolute HCV RNA Level
Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
Number of Participants Achieving Reductions From Baseline in HCV RNA
Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected
Time frame: Days 4, 5, 6, 7, and 8
Plasma HCV RNA Levels by Treatment and IL28B Genotype
Time frame: Days 4, 5, 6, 7, 8, 10, and 17
Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf
Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1
PK Parameter of Velpatasvir: AUCtau
Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3
PK Parameter of Velpatasvir: Cmax
Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose.
PK Parameter of Velpatasvir: CL/F
Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose
PK Parameter of Velpatasvir: Ctau
Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3
Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints
Time frame: First dose date up to Day 17

Results and safety

Results posted to the registry on 16 Dec 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	22	10
Velpatasvir 5 mg	7	4
Velpatasvir 25 mg	17	11
Velpatasvir 50 mg	14	7
Velpatasvir 100 mg	9	6
Velpatasvir 150 mg	34	23

Primary outcome: Percentage of Participants Experiencing Treatment Emergent Adverse Events

Time frame: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing). Number. Unit: percentage of participants

Measure	Placebo n = 17	Velpatasvir 5 mg n = 4	Velpatasvir 25 mg n = 15	Velpatasvir 50 mg n = 12	Velpatasvir 100 mg n = 8	Velpatasvir 150 mg n = 31
Value	17.6	25.0	26.7	8.3	37.5	29.0

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

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

Time frame: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing). Number. Unit: percentage of participants

Measure	Placebo n = 17	Velpatasvir 5 mg n = 4	Velpatasvir 25 mg n = 15	Velpatasvir 50 mg n = 12	Velpatasvir 100 mg n = 8	Velpatasvir 150 mg n = 31
Grade 1	41.2	25.0	40.0	58.3	62.5	33.3
Grade 2	17.6	0	33.3	8.3	25.0	33.3
Grade 3	11.8	0	13.3	16.7	0	6.7

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

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

Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and 17. Mean (Standard Deviation). Unit: log10 IU/mL

Measure	Placebo n = 17	Velpatasvir 5 mg (GT 1a) n = 4	Velpatasvir 25 mg (GT 1a) n = 8	Velpatasvir 50 mg (GT 1a) n = 8	Velpatasvir 100 mg (GT 1a) n = 8	Velpatasvir 150 mg (GT 1a) n = 7	Velpatasvir 150 mg (GT 1b) n = 8	Velpatasvir 150 mg (GT 2) n = 8	Velpatasvir 25 mg (GT 3) n = 7	Velpatasvir 50 mg (GT 3) n = 4	Velpatasvir 150 mg (GT 3) n = 6	Velpatasvir 150 mg (GT 4) n = 2
Change at Day 4	-0.005 (0.3343)	-3.104 (0.7348)	-3.638 (0.4350)	-3.338 (1.3088)	-3.154 (1.0089)	-3.648 (0.9270)	-3.848 (0.4834)	-4.044 (0.3671)	-2.796 (1.4313)	-2.382 (1.5028)	-2.834 (0.7608)	-3.269 (0.6080)
Change at Day 5	-0.018 (0.2346)	-1.998 (0.8305)	-3.538 (0.7566)	-3.123 (1.5009)	-3.060 (1.1098)	-3.636 (1.0023)	-3.955 (0.3519)	-4.148 (0.5841)	-2.617 (1.3034)	-2.130 (1.4385)	-2.259 (1.1488)	-2.827 (0.5506)
Change at Day 6	-0.037 (0.2119)	-1.244 (0.6135)	-3.140 (0.9786)	-2.704 (1.5100)	-2.713 (1.1206)	-3.221 (1.2323)	-4.021 (0.3681)	-4.109 (0.6408)	-2.193 (1.1060)	-1.737 (1.3854)	-1.869 (1.3270)	-2.243 (0.5919)
Change at Day 7	-0.003 (0.1923)	-1.031 (0.6112)	-2.424 (0.7292)	-2.184 (1.5527)	-2.273 (1.1753)	-2.481 (1.3542)	-4.205 (0.4393)	-3.850 (0.9630)	-1.586 (1.0710)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 17 (0%)	3 of 17 (17.6%)	0 of 17
Velpatasvir 5 mg	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Velpatasvir 25 mg	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15
Velpatasvir 50 mg	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Velpatasvir 100 mg	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Velpatasvir 150 mg	0 of 31 (0%)	6 of 31 (19.4%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationHebner 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.
Results publicationLawitz 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.
Derived from this study: PubMed 27353271Lawitz 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.
Derived from this study: PubMed 26183611Lawitz 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.

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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

10 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 Velpatasvir in people with Chronic Hepatitis C Virus, run by Gilead Sciences at 10 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 2 inclusion and 5 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 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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. 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 16 Dec 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 17 + 2 (Day 19 if Day 17 visit missing)). 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 NCT01740791, which also lists 4 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 16 Dec 2020.