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Chronic Hepatitis C VirusPhase 3ION-2NCT01768286

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection

A Phase 3 study testing LDV/SOF and RBV in people with Chronic Hepatitis C Virus, run by Gilead Sciences at 53 sites in United States.

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

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic 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
Chronic Hepatitis C Virus
What is being tested?
LDV/SOF and RBV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
441 participants
Where
53 sitesUnited States
Study dates
Jan 2013to Feb 2014
Phase
Phase 3
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

  • Age > 18, with chronic genotype 1 HCV infection
  • HCV treatment-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen
  • HCV RNA > 10,000 IU/mL at screening
  • Cirrhosis determination; a liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Who cannot join

  • Pregnant or nursing female or male with pregnant female partner
  • Coinfection with HIV or hepatitis B virus
  • Current or prior history of clinical hepatic decompensation
  • Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of systemic immunosuppressive agents
  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

United States53 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Arlington, Texas

  • Study site

    Asheville, North Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Berlin, New Jersey

  • Study site

    Binghamton, New York

  • Study site

    Boston, Massachusetts

  • Study site

    Bowling Green, Kentucky

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Dallas, Texas

  • Study site

    Detroit, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    Englewood, Colorado

  • Study site

    Fairfax, Virginia

  • Study site

    Fayetteville, North Carolina

  • Study site

    Gainesville, Florida

  • Study site

    Germantown, Tennessee

  • Study site

    Hillsborough, New Jersey

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    La Jolla, California

  • Study site

    Los Angeles, California

  • Study site

    Lutherville, Maryland

  • Study site

    Manhasset, New York

  • Study site

    Marietta, Georgia

  • Study site

    Miami, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Newport News, Virginia

  • Study site

    Norfolk, Virginia

  • Study site

    Orlando, Florida

  • Study site

    Palo Alto, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Providence, Rhode Island

  • Study site

    Rochester, Minnesota

  • Study site

    Saint Louis, Minnesota

  • Study site

    Saint Paul, Minnesota

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Santa Fe, New Mexico

  • Study site

    Springfield, Massachusetts

  • Study site

    Statesville, North Carolina

  • Study site

    Tucson, Arizona

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.

Being tested
LDV/SOF, RBV
Keywords
HCV genotype 1 (GT-1), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, GS-7977, GS-5885, Ribavirin, Open Label, Sofosbuvir, Additional relevant MeSH terms:, Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases, Enterovirus Infections
Medical subject headings
Hepatitis C, Chronic, Hepatitis, Hepatitis, Chronic, Hepatitis C, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, Virus Diseases

What participants receive

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

  • LDV/SOFDrug

    Also called Harvoni®, GS-5885/GS-7997

    Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily

  • RBVDrug

    Ribavirin (RBV) 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 NCT01768286
Study groupRoleWhat they receive
LDV/SOF 12 WeeksExperimentalParticipants will receive LDV/SOF FDC for 12 weeks.
Receives: Drug: LDV/SOF
LDV/SOF+RBV 12 WeeksExperimentalParticipants will receive LDV/SOF FDC plus RBV for 12 weeks.
Receives: Drug: LDV/SOF; Drug: RBV
LDV/SOF 24 WeeksExperimentalParticipants will receive LDV/SOF FDC for 24 weeks.
Receives: Drug: LDV/SOF
LDV/SOF+RBV 24 WeeksExperimentalParticipants will receive LDV/SOF FDC plus RBV for 24 weeks.
Receives: Drug: LDV/SOF; 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, 25 IU/mL) 12 weeks following the last dose of study drug.

    Measured: Posttreatment Week 12

  2. Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug

    The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.

    Measured: Up to 24 weeks

Secondary outcomes (12)

  1. Percentage of Participants With SVR at 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 drug, respectively.

    Measured: Posttreatment Weeks 4 and 24

  2. Percentage of Participants With HCV RNA < LLOQ at Week 1

    Measured: Week 1

  3. Percentage of Participants With HCV RNA < LLOQ at Week 2

    Measured: Week 2

  4. Percentage of Participants With HCV RNA < LLOQ at Week 4

    Measured: Week 4

  5. Percentage of Participants With HCV RNA < LLOQ at Week 8

    Measured: Week 8

  6. Percentage of Participants With HCV RNA < LLOQ at Week 12

    Measured: Week 12

  7. Percentage of Participants With HCV RNA < LLOQ at Week 24

    Measured: Week 24

  8. Change From Baseline in HCV RNA at Week 1

    Measured: Baseline; Week 1

  9. Change From Baseline in HCV RNA at Week 2

    Measured: Baseline; Week 2

  10. Change From Baseline in HCV RNA at Week 4

    Measured: Baseline; Week 4

  11. Change From Baseline in HCV RNA at Week 8

    Measured: Baseline; Week 8

  12. Percentage of Participants With Virologic Failure

    Virologic failure was defined as on-treatment virologic failure or virologic relapse.

    • On-Treatment Virologic Failure was defined as
    • 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 was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

    Measured: Baseline 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 posted15 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionNov 2013
  4. Study completionFeb 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01768286
Sponsor's protocol ID
GS-US-337-0109
Acronym
ION-2
Status last verified
Nov 2014
First submitted
10 Jan 2013
Last updated
16 Nov 2018
Data monitoring committee
Yes
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

  • Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ. Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials. Clin Infect Dis. 2016 Dec 1;63(11):1405-1411. doi: 10.1093/cid/ciw580. Epub 2016 Aug 23.

    PubMed 27553375

  • Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11.

    PubMed 24725238

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LDV/SOF and RBV in people with Chronic Hepatitis C Virus, run by Gilead Sciences at 53 sites in United States.

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 16 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 53 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Nov 2014). 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 NCT01768286, which also lists 2 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.

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