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Hepatitis C Virus InfectionPhase 3NCT02472886

Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

A Phase 3 study testing LDV/SOF and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 20 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 ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic 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?
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
153 participants
Where
20 sitesin 2 countries
Study dates
17 Jun 2015to 30 Jun 2016
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

  • Participants who failed treatment in Study GS-US-334-0119 who meet relevant inclusion/exclusion criteria are eligible for retreatment in this study
  • Chronic genotype 1 HCV infection
  • HCV treatment-naive
  • HCV RNA > 10,000 IU/mL at screening
  • Absence of cirrhosis
  • 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
  • Infection with hepatitis B virus (HBV)
  • Current or prior history of clinical hepatic decompensation
  • Chronic use of systemic immunosuppressive agents
  • History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
  • For HIV-1/HCV co-infected individuals:
Show all 10Show fewer
  • Opportunistic infection within 6 months prior to screening
  • Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline
  • Treatment with an antiretroviral (ARV) regimen other than one of those listed in the study protocol
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

Russia18 sites

  • Study site

    Krasnoyarsk, 660049

  • Study site

    Moscow, 105275

  • Study site

    Moscow, 107014

  • Study site

    Moscow, 111123

  • Study site

    Moscow, 115446

  • Study site

    Moscow, 117593

  • Study site

    Moscow, 119435

  • Study site

    Moscow, 119991

  • Study site

    Moscow, 125367

  • Study site

    Moscow, 127015

  • Study site

    Moscow, 129090

  • Study site

    Moscow, 129110

  • Study site

    Saint Petersburg, 190103

  • Study site

    Saint Petersburg, 194044

  • Study site

    Samara, 443063

  • Study site

    Stavropol, 355017

  • Study site

    Tyumen, 625026

  • Study site

    Yekaterinburg, 620102

Other trials in Russia

Estonia2 sites

  • Study site

    Tallinn, 10167

  • Study site

    Tartu, 51014

Other trials in Estonia

About this study

Official title: A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.

Being tested
LDV/SOF, RBV
Keywords
HCV genotype 1, HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, GS-7977, GS-5885, Ribavirin, Sofosbuvir, ledipasvir, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Virus Diseases, Antiviral Agents, HCV/HIV co-infection
Medical subject headings
Hepatitis C, Hepatitis C, Chronic, Liver Diseases, 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-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 NCT02472886
Study groupRoleWhat they receive
LDV/SOFExperimentalTreatment-naive participants with genotype 1 HCV infection without cirrhosis will receive LDV/SOF FDC for 8 weeks.
Receives: Drug: LDV/SOF
LDV/SOF Coinfected with HIV-1ExperimentalTreatment-naive participants with genotype 1 HCV infection without cirrhosis and who are coinfected with HIV-1 will receive LDV/SOF FDC for 8 weeks.
Receives: Drug: LDV/SOF
LDV/SOF+RBV RetreatmentExperimentalParticipants with genotype 1 or 3 HCV infection who failed to achieve SVR12 in Gilead Study GS-US-334-0119 will receive LDV/SOF FDC + RBV for 12 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 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 drug.

    Measured: Posttreatment Week 12

  2. Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)

    Measured: Up to 12 weeks

Secondary outcomes (6)

  1. Percentage of Participants With Sustained Virologic Response (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 on Treatment

    Measured: Up to 12 weeks

  3. HCV RNA Change From Day 1

    Measured: Up to 12 weeks

  4. Percentage of Participants With Virologic Failure

    Virologic failure was defined as

    • On-treatment virologic failure
    • confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),
    • confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)
    • Relapse
    • HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement

    Measured: Up to Posttreatment Week 24

  5. Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4

    Measured: Up to Posttreatment Week 4

  6. For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4

    Measured: Up to Posttreatment Week 4

Timeline

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

  1. First posted16 Jun 2015 (estimated)
  2. Study start17 Jun 2015
  3. Primary completion30 Mar 2016
  4. Study completion30 Jun 2016

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
Parallel groups
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02472886
Sponsor's protocol ID
GS-US-337-1463
Other IDs
2015-000690-13, 2015
Status last verified
Mar 2017
First submitted
12 Jun 2015
Last updated
16 Nov 2018
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 http://www.gilead.com/research/disclosure-and-transparency.

Publications

  • Zhdanov K., Morozov V., Orlova-Morozova E.A., Salupere R., Kozhevnikova G., et al. Preliminary Results of an Evaluation of Ledipasvir/Sofosbuvir in Treatment-Naive Patients with Chronic HCV or HCV/HIV Co-Infection and Retreatment of Sofosbuvir-treated Patients. 8th International Conference of the White Nights of Hepatology. Saint Petersburg, Russia. June 2-3, 2016. Oral presentation.

  • Isakov V, Gankina N, Morozov V, Kersey K, Lu S, Osinusi A, Svarovskaia E, Brainard DM, Salupere R, Orlova-Morozova E, Zhdanov K. Ledipasvir-Sofosbuvir for 8 Weeks in Non-Cirrhotic Patients with Previously Untreated Genotype 1 HCV Infection +/- HIV-1 Co-Infection. Clin Drug Investig. 2018 Mar;38(3):239-247. doi: 10.1007/s40261-017-0606-0.

    PubMed 29177645

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 Infection, run by Gilead Sciences at 20 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 7 inclusion and 10 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 20 sites in Russia, Estonia. 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 10 May 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 NCT02472886, 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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