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This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF 8 Weeks (TN) | Experimental | Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks. |
|
| LDV/SOF+RBV 8 Weeks (TN) | Experimental | Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks. |
|
| LDV/SOF 12 Weeks (TN) | Experimental | Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks. |
|
| LDV/SOF 12 Weeks (TE) | Experimental | Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks. |
|
| LDV/SOF+RBV 12 Weeks (TE) | Experimental | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) at 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 after stopping study treatment. | Posttreatment Week 12 |
| Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24) | SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively. | Posttreatment Weeks 2, 4, 8, and 24 |
| Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rob Hyland | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | 78215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24209977 | Derived | Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014 Feb 8;383(9916):515-23. doi: 10.1016/S0140-6736(13)62121-2. Epub 2013 Nov 5. |
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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.
18 months after study completion
A secured external environment with username, password, and RSA code.
116 participants were screened.
Participants were enrolled at 1 study site in the United States. The first participant was screened on 22 October 2012. The last participant observation was on 13 January 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF 8 Weeks (TN) | Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks. |
| FG001 | LDV/SOF+RBV 8 Weeks (TN) | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks. |
| FG002 | LDV/SOF 12 Weeks (TN) | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. |
| FG003 | LDV/SOF 12 Weeks (TE) | Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. |
| FG004 | LDV/SOF+RBV 12 Weeks (TE) | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: participants received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | LDV/SOF 8 Weeks (TN) | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. |
| BG001 | LDV/SOF+RBV 8 Weeks (TN) | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response (SVR) at 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 after stopping study treatment. | Full Analysis Set: participants were randomized and received at least 1 dose of study drug | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
Baseline to Week 12 plus 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LDV/SOF 8 Weeks (TN) | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
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|
| RBV | Drug | 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) |
|
|
| Baseline to Posttreatment Week 24 |
| BG002 | LDV/SOF 12 Weeks (TN) | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. |
| BG003 | LDV/SOF 12 Weeks (TE) | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. |
| BG004 | LDV/SOF+RBV 12 Weeks (TE) | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hepatitis C Virus (HCV) Genotype | There are variations within HCV genotype 1 which are distinct enough to be referred to as genotypes 1a or 1b. | Number | participants |
|
| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
|
| HCV RNA (log10 IU/mL) | Mean | Standard Deviation | log10 IU/mL |
|
| HCV RNA Category | Number | participants |
|
| Prior HCV Treatment and Response | Prior HCV treatment and response was only collected for treatment-experienced participants in the LDV/SOF 12 Weeks (TE) and LDV/SOF+RBV 12 Weeks (TE) groups. | Number | participants |
|
| Cirrhosis | Number | participants |
|
| OG002 | LDV/SOF 12 Weeks (TN) | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. |
| OG003 | LDV/SOF 12 Weeks (TE) | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. |
| OG004 | LDV/SOF+RBV 12 Weeks (TE) | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. |
|
|
| Primary | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized. | Safety Analysis Set | Posted | Number | participants | Baseline to Week 12 |
|
|
|
| Secondary | Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24) | SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively. | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Weeks 2, 4, 8, and 24 |
|
|
|
| Secondary | Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse |
| Posted | Number | percentage of participants | Baseline to Posttreatment Week 24 |
|
|
|
| 0 |
| 20 |
| 9 |
| 20 |
| EG001 | LDV/SOF+RBV 8 Weeks (TN) | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. | 1 | 21 | 12 | 21 |
| EG002 | LDV/SOF 12 Weeks (TN) | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | 1 | 19 | 8 | 19 |
| EG003 | LDV/SOF 12 Weeks (TE) | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | 1 | 19 | 7 | 19 |
| EG004 | LDV/SOF+RBV 12 Weeks (TE) | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. | 1 | 21 | 12 | 21 |
| Peptic ulcer | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
|
| Latent tuberculosis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA Version 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| SVR4 |
|
| SVR8 |
|
| SVR24 |
|
| Viral relapse |
|