Hepatitis C Virus InfectionPhase 2NCT02378961
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
A Phase 2 study testing VOX and SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 34 sites in 3 countries.
Trial summary
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- VOX and SOF/VEL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 16 Feb 2015to 26 Jan 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with chronic HCV infection
- HCV RNA ≥10^4 IU/mL at screening
- HCV genotypes 2, 3, 4, 5, or 6
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two contraception methods if female of childbearing potential or sexually active male
Who cannot join
- Pregnant or nursing female
- Current or prior history of hepatic decompensation
- Hepatocellular carcinoma (HCC) or other clinically significant malignancy
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
United States31 sites
Center for Hep C/Atlanta Medical Center
Atlanta, Georgia
University of Colorado
Aurora, Colorado
Beth Isreal Deconess Medical Center
Boston, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts
Medical University of South Carolina
Charleston, South Carolina
University of Chicago
Chicago, Illinois
Henry Ford Hospital and Health System
Detroit, Michigan
Cumberland Research Associates, LLC
Fayetteville, North Carolina
Gastro One
Germantown, Tennessee
ID Care
Hillsborough, New Jersey
Indiana University School of Medicine
Indianapolis, Indiana
Indianapolis Gastroenterology & Hepatology, Inc.
Indianapolis, Indiana
Borland-Groover Clinic
Jacksonville, Florida
Cedars Sinai Medical Center
Los Angeles, California
North Shore/Long Island Jewish PRIME
Manhasset, New York
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia
University of Miami
Miami, Florida
Nashville Gastrointestinal Specialists Inc.
Nashville, Tennessee
Mount Sinai Beth Israel
New York, New York
Orlando Immunology center
Orlando, Florida
Stanford University
Palo Alto, California
Huntington Memorial Hospital Liver Center
Pasadena, California
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania
Liver Institute of Virginia
Richmond, Virginia
Texas Liver Institute
San Antonio, Texas
Medical Associates Research Group, Inc.
San Diego, California
Southwest Care Center
Santa Fe, New Mexico
Swedish Medical
Seattle, Washington
South Florida Center of Gastroenterology, P.A.
Wellington, Florida
Digestive Health Specialists, PA
Winston-Salem, North Carolina
New Zealand2 sites
Christchurch Clinical Studies Trust
Christchurch
Auckland Clinical Studies
Grafton
About this study
Official title: A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Non-Genotype 1 HCV Infection
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- VOX, SOF/VEL
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOXDrug
Also called GS-9857
100 mg tablet(s) administered orally once daily with food
SOF/VELDrug
Also called GS-7977/GS-5816, Epclusa®
400/100 mg FDC tablet administered orally once daily with food
| Study group | Role | What they receive |
|---|---|---|
| VOX+SOF/VEL 6 wk, TN, without cirrhosis | Experimental | VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL |
| GS-9857+SOF/VEL 6 wk, TN, with cirrhosis | Experimental | GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL |
| VOX+SOF/VEL 8 wk, TN, with cirrhosis | Experimental | GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL |
| VOX+SOF/VEL 8 wk,TE, without cirrhosis | Experimental | GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL |
| VOX+SOF/VEL 12 wk, TE, without cirrhosis | Experimental | VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL |
| GS-9857+SOF/VEL 8 wk, TE, with cirrhosis | Experimental | GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL |
| VOX+SOF/VEL 12 wk, TE, with cirrhosis | Experimental | VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) Receives: Drug: VOX; Drug: SOF/VEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Measured: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Measured: Up to 12 Weeks
Secondary outcomes (4)
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.
Measured: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Measured: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
HCV RNA Change From Baseline
Measured: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Percentage of Participants With Virologic Failure
- On-treatment virologic failure:
- Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
- Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
- Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
- Virologic relapse:
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Measured: Up to Posttreatment Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start16 Feb 2015
- Primary completion21 Sep 2015
- Study completion26 Jan 2016
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 (1)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378961
- Sponsor's protocol ID
- GS-US-367-1169
- Status last verified
- Oct 2017
- First submitted
- 27 Feb 2015
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Publications
Gane EJ, Kowdley KV, Pound D, Stedman CA, Davis M, Etzkorn K, Gordon SC, Bernstein D, Everson G, Rodriguez-Torres M, Tsai N, Khalid O, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Tong M, Chung RT, Beavers K, Poulos JE, Kwo PY, Nguyen MH. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-Label, Phase 2 Trial. Gastroenterology. 2016 Nov;151(5):902-909. doi: 10.1053/j.gastro.2016.07.038. Epub 2016 Jul 30.
PubMed 27486033
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Non-Genotype 1 HCV Infection
- ClinicalTrials.gov ID
- NCT02378961
- Acronym / sponsor ID
- GS-US-367-1169
- Conditions
- Hepatitis C Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2015 (actual)
- Primary completion
- 21 Sep 2015 (actual)
- Study completion
- 26 Jan 2016 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Posted 15 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| VOX+SOF/VEL 6 wk, TN, without cirrhosis | Experimental | Drug: VOX, Drug: SOF/VELVOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) |
| GS-9857+SOF/VEL 6 wk, TN, with cirrhosis | Experimental | Drug: VOX, Drug: SOF/VELGS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) |
| VOX+SOF/VEL 8 wk, TN, with cirrhosis | Experimental | Drug: VOX, Drug: SOF/VELGS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) |
| VOX+SOF/VEL 8 wk,TE, without cirrhosis | Experimental | Drug: VOX, Drug: SOF/VELGS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis) |
| VOX+SOF/VEL 12 wk, TE, without cirrhosis | Experimental | Drug: VOX, Drug: SOF/VELVOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) |
| GS-9857+SOF/VEL 8 wk, TE, with cirrhosis | Experimental | Drug: VOX, Drug: SOF/VELGS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis) |
| VOX+SOF/VEL 12 wk, TE, with cirrhosis | Experimental | Drug: VOX, Drug: SOF/VELVOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals with chronic HCV infection
- HCV RNA ≥10^4 IU/mL at screening
- HCV genotypes 2, 3, 4, 5, or 6
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
Key exclusion criteria (6 listed)
- Pregnant or nursing female
- Current or prior history of hepatic decompensation
- Hepatocellular carcinoma (HCC) or other clinically significant malignancy
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
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 |
|---|---|---|
| VOXAlso: GS-9857100 mg tablet(s) administered orally once daily with food | Drug | GS-9857+SOF/VEL 6 wk, TN, with cirrhosis, GS-9857+SOF/VEL 8 wk, TE, with cirrhosis, VOX+SOF/VEL 12 wk, TE, with cirrhosis, VOX+SOF/VEL 12 wk, TE, without cirrhosis, VOX+SOF/VEL 6 wk, TN, without cirrhosis, VOX+SOF/VEL 8 wk, TN, with cirrhosis, VOX+SOF/VEL 8 wk,TE, without cirrhosis |
| SOF/VELAlso: GS-7977/GS-5816, Epclusa®400/100 mg FDC tablet administered orally once daily with food | Drug | GS-9857+SOF/VEL 6 wk, TN, with cirrhosis, GS-9857+SOF/VEL 8 wk, TE, with cirrhosis, VOX+SOF/VEL 12 wk, TE, with cirrhosis, VOX+SOF/VEL 12 wk, TE, without cirrhosis, VOX+SOF/VEL 6 wk, TN, without cirrhosis, VOX+SOF/VEL 8 wk, TN, with cirrhosis, VOX+SOF/VEL 8 wk,TE, without cirrhosis |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 12 Weeks
4 secondary outcomes
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
HCV RNA Change From Baseline
Time frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)
Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27486033Gane EJ, Kowdley KV, Pound D, Stedman CA, Davis M, Etzkorn K, Gordon SC, Bernstein D, Everson G, Rodriguez-Torres M, Tsai N, Khalid O, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Tong M, Chung RT, Beavers K, Poulos JE, Kwo PY, Nguyen MH. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-Label, Phase 2 Trial. Gastroenterology. 2016 Nov;151(5):902-909. doi: 10.1053/j.gastro.2016.07.038. Epub 2016 Jul 30.
- Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
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
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VOX and SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 34 sites in 3 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 6 inclusion and 6 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, New Zealand, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Sep 2017). 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 With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (time frame: Posttreatment Week 12). The study lists 2 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 NCT02378961, which also lists 1 linked publication.
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 3 Mar 2020.