Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
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ClinicalTrials.gov Identifier: NCT01851330 |
Recruitment Status :
Completed
First Posted : May 10, 2013
Results First Posted : December 30, 2014
Last Update Posted : November 16, 2018
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Condition or disease | Intervention/treatment | Phase |
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Chronic Hepatitis C Virus | Drug: LDV/SOF Drug: RBV | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 647 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection |
Study Start Date : | May 2013 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
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Experimental: LDV/SOF 8 Week
Participants will receive LDV/SOF FDC for 8 weeks.
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Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
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Experimental: LDV/SOF+RBV 8 Week
Participants will receive LDV/SOF FDC plus RBV for 8 weeks.
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Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
Drug: RBV 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) |
Experimental: LDV/SOF 12 Week
Participants will receive LDV/SOF FDC for 12 weeks.
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Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
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- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]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.
- Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug [ Time Frame: Up to 12 weeks ]The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
- Percentage of Participants With HCV RNA < LLOQ at Week 2 [ Time Frame: Week 2 ]
- Percentage of Participants With HCV RNA < LLOQ at Week 4 [ Time Frame: Week 4 ]
- Percentage of Participants With HCV RNA < LLOQ at Week 8 [ Time Frame: Week 8 ]
- Change From Baseline in HCV RNA at Week 2 [ Time Frame: Baseline; Week 2 ]
- Change From Baseline in HCV RNA at Week 4 [ Time Frame: Baseline; Week 4 ]
- Change From Baseline in HCV RNA at Week 8 [ Time Frame: Baseline; Week 8 ]
- Percentage of Participants Experiencing Virologic Failure [ Time Frame: Baseline to posttreatment Week 24 ]
Virologic failure was defined as on-treatment virologic failure or virologic relapse.
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18, with chronic genotype 1 HCV infection
- HCV treatment-naive
- HCV RNA > 10,000 IU/mL at screening
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
- Pregnant or nursing female or male with pregnant female partner
- Presence of cirrhosis
- Coinfection with HIV or 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 subject treatment, assessment or compliance with the protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851330

Study Director: | Robert H. Hyland, DPhil | Gilead Sciences |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01851330 |
Other Study ID Numbers: |
GS-US-337-0108 |
First Posted: | May 10, 2013 Key Record Dates |
Results First Posted: | December 30, 2014 |
Last Update Posted: | November 16, 2018 |
Last Verified: | December 2014 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | 18 months after study completion |
Access Criteria: | A secured external environment with username, password, and RSA code. |
URL: | http://www.gilead.com/research/disclosure-and-transparency |
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 |
Hepatitis C Hepatitis C, Chronic Hepatitis Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases RNA Virus Infections |
Blood-Borne Infections Communicable Diseases Flaviviridae Infections Hepatitis, Chronic Sofosbuvir Ledipasvir, sofosbuvir drug combination Ledipasvir Antiviral Agents Anti-Infective Agents |