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Hepatitis CPhase 2NCT01858766

Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

A Phase 2 study testing SOF, VEL and RBV in people with Hepatitis C, run by Gilead Sciences at 51 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 objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 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
What is being tested?
SOF, VEL and RBV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
379 participants
Where
51 sitesin 2 countries
Study dates
Apr 2013to Aug 2014
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

  • Chronic HCV infection
  • Body mass index (BMI) ≥ 18 kg/m^2
  • HCV RNA ≥ 10000 IU/mL at screening
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male
  • Must not have cirrhosis

Who cannot join

  • Current or prior history of clinically significant illness other than HCV
  • Screening ECG with clinically significant abnormalities
  • Prior exposure to HCV specific direct acting antiviral agent
  • Prior treatment of HCV with interferon or ribavirin
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of non-HCV etiology
Show all 9Show fewer
  • Hepatitis B
  • Active drug abuse
  • Use of any prohibited concomitant medications

Trial locations and contacts

51 sites in 2 countries.

51 sites in 2 countries

United States50 sites

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • Center For Hepatitis C/Atlanta Medical Center

    Atlanta, Georgia, 30344

  • Mercy Medical Ctr

    Baltimore, Maryland, 21202

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Northwestern University

    Chicago, Illinois, 60611

  • Methodist Transplant Physicians

    Dallas, Texas, 75203

  • University of Colorado

    Denver, Colorado, 80220

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • INOVA Institute of Research & Education

    Falls Church, Virginia, 22042

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28303

  • University of Florida Center for Clinical Trials Research

    Gainesville, Florida, 32610

  • Gastro One

    Germantown, Tennessee, 38138

  • ID Care

    Hillsborough, New Jersey, 08844

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Indianapolis Gastroenterology & Hepatology, Inc.- ARC

    Indianapolis, Indiana, 46237

  • Borland-Groover Clinic

    Jacksonville, Florida, 32216

  • UCSD

    La Jolla, California, 92037

  • University of California San Diego Medical Center

    La Jolla, California, 92093

  • North Shore/Long Island Jewish PRIME

    Lake Success, New York, 11041

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Los Angeles Medical Center

    Los Angeles, California, 90027

  • Ruane Peter J MD Incorporated

    Los Angeles, California, 90036

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • National Research Institute

    Los Angeles, California, 90057

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • University of Miami

    Miami, Florida, 33136

  • Nashville Gastrointestinal Specialists Inc.

    Nashville, Tennessee, 37211

  • Weill Cornell Medical College-New York Presbyterian Hospital

    New York, New York, 10021

  • The Liver Institute of Virginia

    Newport News, Virginia, 23602

  • Digestive and Liver Disease Specialists, Ltd.

    Norfolk, Virginia, 23502

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Huntington Medical Research Institutes Liver Center

    Pasadena, California, 91105

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • UPMC Center For Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Alamo Medical Research, LTD d/b/a American Research Corporation

    San Antonio, Texas, 78215

  • Kaiser Permanente Medical Grp

    San Diego, California, 92120

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • Kaiser Permante

    San Francisco, California, 94080

  • Southwest C.A.R.E. Center

    Santa Fe, New Mexico, 87505

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Tampa General Hospital

    Tampa, Florida, 33606

  • South Florida Center of Gastroenterology, P.A

    Wellington, Florida, 33414

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico1 site

  • Fundacion de Investigacion de Diego

    Santurce, 00909

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.

Conditions
Hepatitis C
Being tested
SOF, VEL, RBV
Keywords
Hepatitis, HCV Genotype 1, HCV Genotype 2, HCV Genotype 3, HCV Genotype 4, HCV Genotype 5, HCV Genotype 6, treatment naive
Medical subject headings
Hepatitis C, Hepatitis

What participants receive

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

  • SOFDrug

    Also called GS-7977, PSI-7977, Sovaldi®

    400 mg tablet administered orally once daily

  • VELDrug

    Also called GS-5816

    Tablet administered orally once daily

  • RBVDrug

    Also called Ribasphere®

    200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Study groups in NCT01858766
Study groupRoleWhat they receive
SOF+VEL 25 mg 12 Weeks (GT1)ExperimentalParticipants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Receives: Drug: SOF; Drug: VEL
SOF+VEL 100 mg 12 Weeks (GT1)ExperimentalParticipants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Receives: Drug: SOF; Drug: VEL
SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)ExperimentalParticipants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Receives: Drug: SOF; Drug: VEL
SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)ExperimentalParticipants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Receives: Drug: SOF; Drug: VEL
SOF+VEL 25 mg 12 Weeks (GT3)ExperimentalParticipants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Receives: Drug: SOF; Drug: VEL
SOF+VEL 100 mg 12 Weeks (GT3)ExperimentalParticipants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Receives: Drug: SOF; Drug: VEL
SOF+VEL 25 mg 8 Weeks (GT1)ExperimentalParticipants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
Receives: Drug: SOF; Drug: VEL
SOF+VEL 25 mg + RBV 8 Weeks (GT1)ExperimentalParticipants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
Receives: Drug: SOF; Drug: VEL; Drug: RBV
SOF+VEL 100 mg 8 Weeks (GT1)ExperimentalParticipants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
Receives: Drug: SOF; Drug: VEL
SOF+VEL 100 mg + RBV 8 Weeks (GT1)ExperimentalParticipants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
Receives: Drug: SOF; Drug: VEL; Drug: RBV
SOF+VEL 25 mg 8 Weeks (GT2)ExperimentalParticipants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
Receives: Drug: SOF; Drug: VEL
SOF+VEL 25 mg + RBV 8 Weeks (GT2)ExperimentalParticipants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
Receives: Drug: SOF; Drug: VEL; Drug: RBV
SOF+VEL 100 mg 8 Weeks (GT2)ExperimentalParticipants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
Receives: Drug: SOF; Drug: VEL
SOF+VEL 100 mg + RBV 8 Weeks (GT2)ExperimentalParticipants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
Receives: Drug: SOF; Drug: VEL; Drug: RBV

What is being measured

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

  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

    Measured: Posttreatment Week 12

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

    Measured: Up to 12 weeks

Secondary outcomes (2)

  1. Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

    Measured: Posttreatment Weeks 4 and 24

  2. Percentage of Participants With Virologic Failure

    Virologic failure was defined as:

    • 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.

  1. First posted21 May 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMay 2014
  4. Study completionAug 2014

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
379 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01858766
Sponsor's protocol ID
GS-US-342-0102
Status last verified
Jul 2016
First submitted
10 May 2013
Last updated
14 Nov 2018
Data monitoring committee
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 http://www.gilead.com/research/disclosure-and-transparency.

Publications

  • Everson GT, Tran TT, Towner WJ , Davis MN, Wyles D, Nahass R, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, Symonds WT, McHutchison JG, Morgan T, Chung RT. Safety and Efficacy of Treatment with the Interferon-Free, Ribavirin-Free Combination of Sofosbuvir + GS-5816 for 12 Weeks in Treatment Naive Patients with Genotype 1-6 HCV Infection. Journal of Hepatology, Volume 60, Issue 1, Supplement, Page S46. April 2014 (EASL 2014).

  • Tran TT, Morgan TR, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Chung RT, Everson GT. Safety and Efficacy of Treatment with Sofosbuvir+ GS-5816±Ribavirin for 8 or 12 Weeks in Treatment Naïve Patients with Genotype 1-6 HCV Infection. Hepatology (2014), 60: 4 (suppl) 237A.

  • Doehle B, Gontcharova V, Chodavarapu1 RK, McNally J, Chung RT, Everson GT, McHutchison JG, Miller MD, Mo H. Resistance Analysis of Treatment-Naive HCV Genotype 1-6 Infected Patients Treated with Sofosbuvir in Combination with GS-5816 for 12 Weeks. Hepatology (2014), 60: 4 (suppl) 1138A.

  • Everson GT, Towner WJ, Davis MN, Wyles DL, Nahass RG, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, Rabinovitz M, McNally J, Brainard DM, Han L, Doehle B, McHutchison JG, Morgan T, Chung RT, Tran TT. Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection: A Randomized Trial. Ann Intern Med. 2015 Dec 1;163(11):818-26. doi: 10.7326/M15-1000. Epub 2015 Nov 10.

    PubMed 26551051

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOF, VEL and RBV in people with Hepatitis C, run by Gilead Sciences at 51 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 5 inclusion and 9 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 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 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 2016). 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 (SVR) 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 NCT01858766, 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 14 Nov 2018.

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