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CompletedNCT02081079Updated Nov 19, 2018Results posted

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

A Phase 2 interventional study of LDV/SOF in Chronic Genotype 4 HCV and Chronic Genotype 5 HCV, sponsored by Gilead Sciences. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-19.

Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
85
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

02

Conditions studied

  • Chronic Genotype 4 HCV
  • Chronic Genotype 5 HCV

Keywords

  • HCV GT 4
  • HCV GT 5
03

In context

Lead sponsor

Gilead Sciences is the lead sponsor of 689 studies on the registry; 24 are open to participants now.

Of its 261 completed or terminated interventional studies of FDA-regulated products, 251 (96%) have results posted.

Browse Gilead Sciences studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • HCV RNA ≥ 10\^4 IU/mL at screening
  • Chronic genotype 4 or 5 HCV Infection
  • Individuals may be treatment naive or treatment experienced
  • Presence or absence of cirrhosis, a liver biopsy may be required
  • Healthy according to medical history and physical examination with the exception of HCV diagnosis
  • Agree to use two forms of highly effective contraception for the duration of the study

Exclusion criteria

Exclusion Criteria:

  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
  • Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
  • History of any other clinically significant chronic liver disease
  • Evidence of or history of decompensated liver disease
  • HIV or chronic hepatitis B (HBV) infection
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of immunosuppressive agents or immunomodulatory agents
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Genotype 4

    LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection

    Drug: LDV/SOF

  • Experimental
    Genotype 5

    LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection

    Drug: LDV/SOF

Interventions

  • DrugLDV/SOF

    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Also known as: Harvoni®, GS-5885/GS-7977

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What researchers measure

Primary outcomes

  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.

    Time frame: Posttreatment Week 12

  2. Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event

    Time frame: Up to 12 weeks

Secondary outcomes

  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.

    Time frame: Posttreatment Weeks 4 and 24

  2. Percentage of Patients With Virologic Failure

    Virologic failure was defined as either: * 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); or * Relapse: * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment

    Time frame: Up to posttreatment Week 24

  3. Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12

    Time frame: Baseline; Weeks 2, 4, 8, and 12

07

Results

Posted Jan 14, 2016
Limitations and caveats
There were no limitations affecting the analysis or results.

Participant flow

Participants were enrolled at study sites in France. The first participant was screened on 07 March 2014. The last study visit occurred on 17 February 2015.

Participant flow — Overall Study
MilestoneGenotype 4Genotype 5
Started4441
Completed4039
Not completed42
Withdrew: Lack of efficacy32
Withdrew: Lost to follow-up10

Outcome measures

PrimaryPercentage 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.

Time frame:
Posttreatment Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
percentage of participantsGenotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experienced
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)95.590.995.295.0
PrimaryPercentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event
Time frame:
Up to 12 weeks
Reported as:
Number · percentage of participants
Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event
percentage of participantsGenotype 4Genotype 5
Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event00
SecondaryPercentage 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.

Time frame:
Posttreatment Weeks 4 and 24
Reported as:
Number · percentage of participants
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
percentage of participantsGenotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experienced
SVR495.590.995.295.0
SVR2495.590.995.295.0
SecondaryPercentage of Patients With Virologic Failure

Virologic failure was defined as either: * 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); or * Relapse: * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment

Time frame:
Up to posttreatment Week 24
Reported as:
Number · percentage of participants
Percentage of Patients With Virologic Failure
percentage of participantsGenotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experienced
On-treatment Virologic Failure0000
Relapse4.59.14.85.0
SecondaryChange From Baseline in HCV RNA at Weeks 2, 4, 8, and 12
Time frame:
Baseline; Weeks 2, 4, 8, and 12
Reported as:
Mean · log10 IU/mL
Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12
log10 IU/mLGenotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experienced
Change at Week 2-4.65 ± 0.397-4.77 ± 0.495-4.97 ± 0.479-4.94 ± 0.477
Change at Week 4-4.86 ± 0.396-5.17 ± 0.490-5.07 ± 0.474-5.39 ± 0.381
Change at Week 8-4.88 ± 0.401-5.18 ± 0.484-5.07 ± 0.474-5.45 ± 0.387
Change at Week 12-4.88 ± 0.401-5.18 ± 0.484-5.07 ± 0.474-5.45 ± 0.387

Adverse events

Collected over Up to 12 weeks plus 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Genotype 4—0/44 (0%)31/44 (70.5%)
Genotype 5—1/41 (2.4%)31/41 (75.6%)
Most frequent serious events
Most frequent serious events
EventGenotype 4Genotype 5
DepressionPsychiatric disorders0/441/41
Most frequent other events
Showing 10 of 16
Most frequent other events
EventGenotype 4Genotype 5
AstheniaGeneral disorders10/4416/41
HeadacheNervous system disorders11/4411/41
FatigueGeneral disorders9/444/41
DiarrhoeaGastrointestinal disorders4/443/41
NauseaGastrointestinal disorders4/441/41
Back painMusculoskeletal and connective tissue disorders4/441/41
CoughRespiratory, thoracic and mediastinal disorders4/442/41
Abdominal pain upperGastrointestinal disorders3/443/41
NasopharyngitisInfections and infestations0/443/41
Urinary tract infectionInfections and infestations0/443/41

Baseline characteristics

Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug

Age, Continuous
Age, Continuous(years)Genotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experiencedTotal
Mean52 ± 9.250 ± 8.861 ± 10.464 ± 8.657 ± 10.8
Sex: Female, Male
Sex: Female, Male(Participants)Genotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experiencedTotal
Female115101036
Male1117111049
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Genotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experiencedTotal
Black or African American35008
White1917212077
Region of Enrollment
Region of Enrollment(participants)Genotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experiencedTotal
France2222212085
HCV RNA
HCV RNA(log10 copies/mL)Genotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experiencedTotal
Mean6.0 ± 0.406.3 ± 0.486.2 ± 0.486.6 ± 0.396.3 ± 0.48
HCV Genotype
HCV Genotype(participants)Genotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experiencedTotal
Genotype 422220044
Genotype 500212041
Cirrhosis Status
Cirrhosis Status(participants)Genotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experiencedTotal
Absence2113181466
Presence193619
IL28b Status
IL28b Status(participants)Genotype 4: Treatment-naiveGenotype 4: Treatment-experiencedGenotype 5: Treatment-naiveGenotype 5: Treatment-experiencedTotal
CC7113627
CT111671145
TT451313
08

Study locations

5 sites
  • Clermont-Ferrand, 63003, France
  • Clichy, 92110, France
  • Limoges, 87042, France
  • Toulouse, 31059, France
  • Villejuif, 94800, France
09

References and documents

Publications

  • Abergel A, Metivier S, Samuel D, Jiang D, Kersey K, Pang PS, Svarovskaia E, Knox SJ, Loustaud-Ratti V, Asselah T. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection. Hepatology. 2016 Oct;64(4):1049-56. doi: 10.1002/hep.28706. Epub 2016 Jul 29. PubMed 27351341 ↗
  • Abergel A, Asselah T, Metivier S, Kersey K, Jiang D, Mo H, Pang PS, Samuel D, Loustaud-Ratti V. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: an open-label, multicentre, single-arm, phase 2 study. Lancet Infect Dis. 2016 Apr;16(4):459-64. doi: 10.1016/S1473-3099(15)00529-0. Epub 2016 Jan 21. PubMed 26803446 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: 18 months after study completion

Access criteria: A secured external environment with username, password, and RSA code.

Data sharing details ↗ · www.gilead.com

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02081079
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Mar 7, 2014
Start date
Mar 2014
Primary completion
Nov 2014
Completion
Feb 2015
Results posted
Jan 14, 2016
Last update
Nov 19, 2018

Study contacts

Kathryn Kersey, MSc
study director · Gilead Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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