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Hepatitis C VirusPhase 3NCT02073656

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection

A Phase 3 study testing LDV/SOF and RBV in people with Hepatitis C Virus and HIV, run by Gilead Sciences at 41 sites in 4 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

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus, HIV
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
335 participants
Where
41 sitesin 4 countries
Study dates
Feb 2014to Dec 2015
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

  • HCV RNA ≥ 10,000 IU/mL at screening
  • HCV genotype 1 or 4
  • HIV-1 infection
  • Cirrhosis determination, a fibroscan or liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male

Who cannot join

  • Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol
  • Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC), or other malignancy (with the exception of certain resolved skin cancers)
  • Hepatitis B virus (HBV) infection
  • Pregnant or nursing female
  • Chronic use of systemically administered immunosuppressive agents

Trial locations and contacts

41 sites in 4 countries.

41 sites in 4 countries

United States34 sites

  • Study site

    Allentown, Pennsylvania, 18102

  • Study site

    Annandale, Virginia, 22003

  • Study site

    Atlanta, Georgia, 30312

  • Study site

    Birmingham, Alabama, 35294-2170

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Bradenton, Florida, 34209

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45267-0595

  • Study site

    Dallas, Texas, 75235

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Denver, Colorado, 80209

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Houston, Texas, 77004

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Los Angeles, California, 90027

  • Study site

    Lutherville, Maryland, 21093

  • Study site

    Miami, Florida, 33136

  • Study site

    New York, New York, 10065

  • Study site

    Newport Beach, California, 92663

  • Study site

    Orlando, Florida, 32803

  • Study site

    Palo Alto, California, 94304-5350

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Richmond, Virginia, 23298-0341

  • Study site

    Sacramento, California, 95817

  • Study site

    San Diego, California, 92103

  • Study site

    San Francisco, California, 94110

  • Study site

    Santa Fe, New Mexico, 87505

  • Study site

    Seattle, Washington, 98104

  • Study site

    Tampa, Florida, 33614

  • Study site

    The Bronx, New York, 10468

  • Study site

    Torrance, California, 90502

  • Study site

    Washington D.C., District of Columbia, 20815

Other trials in United States

Canada4 sites

  • Study site

    Montreal, Quebec, H2L 5B1

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Toronto, Ontario, M5G 2N2

  • Study site

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

New Zealand2 sites

  • Study site

    Auckland, 1142

  • Study site

    Christchurch, 8011

Other trials in New Zealand

Puerto Rico1 site

  • Study site

    San Juan, 00936-5607

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1.

Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.

Being tested
LDV/SOF, RBV
Keywords
genotype 1, genotype 4, HIV
Medical subject headings
Hepatitis C

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-7977

    90/400 mg FDC tablet administered orally once daily

  • RBVDrug

    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 NCT02073656
Study groupRoleWhat they receive
LDV/SOF 12 WeeksExperimentalLDV/SOF for 12 weeks
Receives: Drug: LDV/SOF
Retreatment SubstudyExperimentalLDV/SOF 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) 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 (10)

  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 HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12

    Measured: Weeks 1, 2, 4, 6, 8, 10, and 12

  3. Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8

    Measured: Baseline; Weeks 1, 2, 4, 6, and 8

  4. 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

  5. Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment

    Measured: Weeks 4, 8, and 12

  6. Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24

    Measured: Baseline; Week 12, Posttreatment Weeks 12 and 24

  7. For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)

    SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively.

    Measured: Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy

  8. For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24

    Measured: Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy

  9. For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8

    Measured: Baseline; Weeks 2, 4, and 8 of Retreatment Substudy

  10. For Participants in the Retreatment Substudy, 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 of Retreatment Substudy

Timeline

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

  1. First posted27 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionNov 2014
  4. Study completionDec 2015

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02073656
Sponsor's protocol ID
GS-US-337-0115
Status last verified
Aug 2016
First submitted
25 Feb 2014
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

  • Cooper C, Naggie S, Saag M, Yang JC, Stamm LM, Dvory-Sobol H, et al. Retreatment of Patients Who Failed 12 Weeks of Ledipasvir/Sofosbuvir-Based Regimens with Ledipasvir/Sofosbuvir with Ribavirin for 24 Weeks [Poster Presentation]. 23nd Conference on Retroviruses and Opportunistic Infections (CROI); 2016 February 22-25; Boston, MA.

  • Naggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ, Marks K, Luetkemeyer A, Baden RP, Sax PE, Gane E, Santana-Bagur J, Stamm LM, Yang JC, German P, Dvory-Sobol H, Ni L, Pang PS, McHutchison JG, Stedman CA, Morales-Ramirez JO, Brau N, Jayaweera D, Colson AE, Tebas P, Wong DK, Dieterich D, Sulkowski M; ION-4 Investigators. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):705-13. doi: 10.1056/NEJMoa1501315. Epub 2015 Jul 21.

    PubMed 26196665

  • Naggie S, Cooper C, Saag M, Stamm LM, Yang JC, Pang PS, et al. Ledipasvir/Sofosbuvir for 12 Weeks in Patients Coinfected With HCV and HIV-1 [Oral Presentation]. 22nd Conference on Retroviruses and Opportunistic Infections (CROI); 2015 February 23-26; Seattle, WA.

  • Cooper C, Naggie S, Saag M, Yang JC, Stamm LM, Dvory-Sobol H, Han L, Pang PS, McHutchison JG, Dieterich D, Sulkowski M. Successful Re-treatment of Hepatitis C Virus in Patients Coinfected With HIV Who Relapsed After 12 Weeks of Ledipasvir/Sofosbuvir. Clin Infect Dis. 2016 Aug 15;63(4):528-31. doi: 10.1093/cid/ciw349. Epub 2016 May 25.

    PubMed 27225242

  • Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferriere V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study; Cohen J, Conway B, Cooper C, Cote P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6.

    PubMed 26743093

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LDV/SOF and RBV in people with Hepatitis C Virus and HIV, run by Gilead Sciences at 41 sites in 4 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 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 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 41 sites in United States, Canada, 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 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 21 Oct 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 NCT02073656, which also lists 5 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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