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CompletedNCT01768286ION-2Updated Nov 16, 2018Results posted

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

A Phase 3 interventional study of LDV/SOF and RBV in Chronic Hepatitis C Virus, sponsored by Gilead Sciences. Completed at 53 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-16.

Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
441
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Hepatitis C Virus

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
  • Picornaviridae Infections
  • RNA Virus Infections
  • Flaviviridae Infections
  • Antiviral Agents
  • Anti-Infective Agents
  • Therapeutic Uses
  • Pharmacologic Actions
  • Antimetabolites
  • Molecular Mechanisms of Pharmacological Action
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 441 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
441 participants (actual)

Study arms

  • Experimental
    LDV/SOF 12 Weeks

    Participants will receive LDV/SOF FDC for 12 weeks.

    Drug: LDV/SOF

  • Experimental
    LDV/SOF+RBV 12 Weeks

    Participants will receive LDV/SOF FDC plus RBV for 12 weeks.

    Drug: LDV/SOF · Drug: RBV

  • Experimental
    LDV/SOF 24 Weeks

    Participants will receive LDV/SOF FDC for 24 weeks.

    Drug: LDV/SOF

  • Experimental
    LDV/SOF+RBV 24 Weeks

    Participants will receive LDV/SOF FDC plus RBV for 24 weeks.

    Drug: LDV/SOF · Drug: RBV

Interventions

  • DrugLDV/SOF

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

    Also known as: Harvoni®, GS-5885/GS-7997

  • DrugRBV

    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)

06

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, 25 IU/mL) 12 weeks following the last dose of study drug.

    Time frame: 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.

    Time frame: Up to 24 weeks

Secondary outcomes

  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.

    Time frame: Posttreatment Weeks 4 and 24

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

    Time frame: Week 1

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

    Time frame: Week 2

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

    Time frame: Week 4

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

    Time frame: Week 8

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

    Time frame: Week 12

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

    Time frame: Week 24

  8. Change From Baseline in HCV RNA at Week 1

    Time frame: Baseline; Week 1

  9. Change From Baseline in HCV RNA at Week 2

    Time frame: Baseline; Week 2

  10. Change From Baseline in HCV RNA at Week 4

    Time frame: Baseline; Week 4

  11. Change From Baseline in HCV RNA at Week 8

    Time frame: 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.

    Time frame: Baseline to posttreatment Week 24

07

Results

Posted Nov 26, 2014

Participant flow

Participants were enrolled at a total of 64 study sites in the United States. The first participant was screened on 03 January 2013. The last participant observation occurred on 20 February 2014.

Participant flow — Overall Study
MilestoneLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Started109111110111
Completed102107108110
Not completed7421
Withdrew: Randomized but not treated0010
Withdrew: Lack of efficacy7401
Withdrew: Withdrew consent0010

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, 25 IU/mL) 12 weeks following the last dose of study drug.

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 participantsLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)93.696.499.199.1
Statistical analysis
  • LDV/SOF 12 Weeks · Binomial test · p = <0.001 (A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.)
  • LDV/SOF+RBV 12 Weeks · Binomial test · p = <0.001 (A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.)
  • LDV/SOF 24 Weeks · Binomial test · p = <0.001 (A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.)
  • LDV/SOF+RBV 24 Weeks · Binomial test · p = <0.001 (A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.)
PrimaryIncidence 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.

Time frame:
Up to 24 weeks
Reported as:
Number · percentage of participants
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
percentage of participantsLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug0000
SecondaryPercentage 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.

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 participantsLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
SVR494.596.4100.099.1
SVR2493.696.499.199.1
SecondaryPercentage of Participants With HCV RNA < LLOQ at Week 1
Time frame:
Week 1
Reported as:
Number · percentage of participants
Percentage of Participants With HCV RNA < LLOQ at Week 1
percentage of participantsLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Percentage of Participants With HCV RNA < LLOQ at Week 126.633.320.229.7
SecondaryPercentage of Participants With HCV RNA < LLOQ at Week 2
Time frame:
Week 2
Reported as:
Number · percentage of participants
Percentage of Participants With HCV RNA < LLOQ at Week 2
percentage of participantsLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Percentage of Participants With HCV RNA < LLOQ at Week 281.782.981.783.8
SecondaryPercentage of Participants With HCV RNA < LLOQ at Week 4
Time frame:
Week 4
Reported as:
Number · percentage of participants
Percentage of Participants With HCV RNA < LLOQ at Week 4
percentage of participantsLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Percentage of Participants With HCV RNA < LLOQ at Week 4100.099.199.199.1
SecondaryPercentage of Participants With HCV RNA < LLOQ at Week 8
Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants With HCV RNA < LLOQ at Week 8
percentage of participantsLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Percentage of Participants With HCV RNA < LLOQ at Week 8100.0100.0100.0100.0
SecondaryPercentage of Participants With HCV RNA < LLOQ at Week 12
Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With HCV RNA < LLOQ at Week 12
percentage of participantsLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Percentage of Participants With HCV RNA < LLOQ at Week 1299.1100.0100.0100.0
SecondaryPercentage of Participants With HCV RNA < LLOQ at Week 24
Time frame:
Week 24
Reported as:
Number · percentage of participants
Percentage of Participants With HCV RNA < LLOQ at Week 24
percentage of participantsLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Percentage of Participants With HCV RNA < LLOQ at Week 24——100.0100.0
SecondaryChange From Baseline in HCV RNA at Week 1
Time frame:
Baseline; Week 1
Reported as:
Mean · log10 IU/mL
Change From Baseline in HCV RNA at Week 1
log10 IU/mLLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Change From Baseline in HCV RNA at Week 1-4.57 ± 0.501-4.50 ± 0.540-4.47 ± 0.569-4.50 ± 0.575
SecondaryChange From Baseline in HCV RNA at Week 2
Time frame:
Baseline; Week 2
Reported as:
Mean · log10 IU/mL
Change From Baseline in HCV RNA at Week 2
log10 IU/mLLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Change From Baseline in HCV RNA at Week 2-5.08 ± 0.443-4.94 ± 0.520-4.99 ± 0.571-4.99 ± 0.617
SecondaryChange From Baseline in HCV RNA at Week 4
Time frame:
Baseline; Week 4
Reported as:
Mean · log10 IU/mL
Change From Baseline in HCV RNA at Week 4
log10 IU/mLLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Change From Baseline in HCV RNA at Week 4-5.16 ± 0.439-5.02 ± 0.543-5.06 ± 0.571-5.04 ± 0.779
SecondaryChange From Baseline in HCV RNA at Week 8
Time frame:
Baseline; Week 8
Reported as:
Mean · log10 IU/mL
Change From Baseline in HCV RNA at Week 8
log10 IU/mLLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Change From Baseline in HCV RNA at Week 8-5.16 ± 0.439-5.02 ± 0.544-5.06 ± 0.571-5.08 ± 0.605
SecondaryPercentage 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.

Time frame:
Baseline to posttreatment Week 24
Reported as:
Number · percentage of participants
Percentage of Participants With Virologic Failure
percentage of participantsLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
On-Treatment Virologic Failure0000.9
Virologic relapse6.53.600

Adverse events

Collected over Up to 24 weeks plus 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LDV/SOF 12 Weeks—0/109 (0%)73/109 (67%)
LDV/SOF+RBV 12 Weeks—0/111 (0%)96/111 (86.5%)
LDV/SOF 24 Weeks—6/109 (5.5%)87/109 (79.8%)
LDV/SOF+RBV 24 Weeks—3/111 (2.7%)100/111 (90.1%)
Most frequent serious events
Most frequent serious events
EventLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
Angina unstableCardiac disorders0/1090/1111/1090/111
Upper gastrointestinal haemorrhageGastrointestinal disorders0/1090/1111/1090/111
Non-cardiac chest painGeneral disorders0/1090/1111/1090/111
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/1090/1111/1090/111
SpondylolisthesisMusculoskeletal and connective tissue disorders0/1090/1111/1090/111
ConvulsionNervous system disorders0/1090/1111/1090/111
Hepatic encephalopathyNervous system disorders0/1090/1111/1090/111
Cholecystitis acuteHepatobiliary disorders0/1090/1110/1091/111
Wound infectionInfections and infestations0/1090/1110/1091/111
Vaginal prolapseReproductive system and breast disorders0/1090/1110/1091/111
Most frequent other events
Showing 10 of 28
Most frequent other events
EventLDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 Weeks
FatigueGeneral disorders23/10945/11126/10950/111
HeadacheNervous system disorders28/10926/11125/10935/111
NauseaGastrointestinal disorders13/10920/1117/10925/111
InsomniaPsychiatric disorders10/10918/1114/10919/111
DiarrhoeaGastrointestinal disorders7/1095/1119/10917/111
ArthralgiaMusculoskeletal and connective tissue disorders7/10913/1117/10917/111
CoughRespiratory, thoracic and mediastinal disorders5/10916/1115/10916/111
DyspnoeaRespiratory, thoracic and mediastinal disorders0/10916/1113/1099/111
RashSkin and subcutaneous tissue disorders2/10911/1116/10916/111
IrritabilityGeneral disorders2/10913/1114/10912/111

Baseline characteristics

Safety Analysis Set: participants were randomized and received at least one dose of study drug. Participants failed a previous HCV treatment regimen consisting of pegylated interferon alfa-2a (Pegasys) or pegylated interferon alfa-2b (Pegintron) plus ribavirin (RBV), with or without a protease inhibitor (PI).

Age, Continuous
Age, Continuous(years)LDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 WeeksTotal
Mean56 ± 6.957 ± 8.056 ± 8.355 ± 7.856 ± 7.8
Sex: Female, Male
Sex: Female, Male(Participants)LDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 WeeksTotal
Female35403543153
Male74717468287
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)LDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 WeeksTotal
Black or African American2416172077
White84949189358
Asian10001
Hawaiian or Pacific Islander01012
Other00112
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)LDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 WeeksTotal
Hispanic/Latino712111141
Not Hispanic or Latino100999899396
Not Disclosed20013
HCV RNA
HCV RNA(log10 IU/mL)LDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 WeeksTotal
Mean6.5 ± 0.446.4 ± 0.546.4 ± 0.576.5 ± 0.606.5 ± 0.54
HCV RNA Category
HCV RNA Category(participants)LDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 WeeksTotal
< 800,000 IU/mL613161550
≥ 800,000 IU/mL103989396390
HCV Genotype
HCV Genotype(participants)LDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 WeeksTotal
Genotype 1a86888588347
Genotype 1b2323242393
IL28b Status
IL28b Status(participants)LDV/SOF 12 WeeksLDV/SOF+RBV 12 WeeksLDV/SOF 24 WeeksLDV/SOF+RBV 24 WeeksTotal
CC1011161855
CT70776868283
TT29232525102

1 further baseline measures are reported on the registry.

08

Study locations

53 sites
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Englewood, Colorado, United States
  • Washington, District of Columbia, United States
  • Gainesville, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Atlanta, Georgia, United States
  • Marietta, Georgia, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Bowling Green, Kentucky, United States
  • Baton Rouge, Louisiana, United States
  • Baltimore, Maryland, United States
  • Lutherville, Maryland, United States
  • Boston, Massachusetts, United States
  • Springfield, Massachusetts, United States
  • Detroit, Michigan, United States
  • Rochester, Minnesota, United States
  • Saint Louis, Minnesota, United States
  • Saint Paul, Minnesota, United States
  • Kansas City, Missouri, United States
  • Berlin, New Jersey, United States
  • Hillsborough, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Santa Fe, New Mexico, United States
  • Binghamton, New York, United States
  • Manhasset, New York, United States
  • New York, New York, United States
  • Asheville, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Fayetteville, North Carolina, United States
  • Statesville, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Germantown, Tennessee, United States
  • Nashville, Tennessee, United States
  • Arlington, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Fairfax, Virginia, United States
  • Newport News, Virginia, United States
  • Norfolk, Virginia, United States
09

References and documents

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 ↗

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, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01768286
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Jan 15, 2013
Start date
Jan 2013
Primary completion
Nov 2013
Completion
Feb 2014
Results posted
Nov 26, 2014
Last update
Nov 16, 2018

Study contacts

Jenny Yang, PharmD
study director · Gilead Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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