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The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL/VOX | Experimental | SOF/VEL/VOX for 12 weeks |
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| SOF/VEL/VOX + RBV | Experimental | SOF/VEL/VOX + RBV for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL/VOX | Drug | 400/100/100 mg FDC tablet administered orally once daily with food |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12) | SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants With HCV RNA < LLOQ on Treatment |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28220512 | Background | Lawitz E, Poordad F, Wells J, Hyland RH, Yang Y, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Landaverde C, Gutierrez J. Sofosbuvir-velpatasvir-voxilaprevir with or without ribavirin in direct-acting antiviral-experienced patients with genotype 1 hepatitis C virus. Hepatology. 2017 Jun;65(6):1803-1809. doi: 10.1002/hep.29130. Epub 2017 May 3. |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.
18 months after study completion
A secured external environment with username, password, and RSA code.
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Participants were enrolled at 1 study site in the United States. The first participant was screened on 29 July 2015. The last study visit occurred on 28 June 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL/VOX | Sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX ) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 12 weeks |
| FG001 | SOF/VEL/VOX + RBV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RBV | Drug | Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) |
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| Weeks 1, 2, 4, 8 and 12 |
| HCV RNA Change From Baseline/Day 1 Through Week 12 | Weeks 1, 2, 4, 8, and 12 |
| Percentage of Participants With Virologic Failure | Virologic failure is defined as:
| Up to Posttreatment Week 24 |
SOF/VEL/VOX (400/100/100 mg) FDC tablet + Ribavirin (RBV) (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
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| NOT COMPLETED |
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Safety Analysis Set: participants who took at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL/VOX | SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks |
| BG001 | SOF/VEL/VOX + RBV | SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene. | Count of Participants | Participants |
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| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
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| HCV RNA Category | Count of Participants | Participants |
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| 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) 12 Weeks After Cessation of Treatment (SVR12) | SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. | Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of particpants | Posttreatment Week 12 |
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| Primary | Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event | Safety Analysis Set: participants who took at least 1 dose of study drug | Posted | Number | percentage of participants | Up to 12 weeks |
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| Secondary | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4 and 24 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 2, 4, 8 and 12 |
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| Secondary | HCV RNA Change From Baseline/Day 1 Through Week 12 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Weeks 1, 2, 4, 8, and 12 |
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| Secondary | Percentage of Participants With Virologic Failure | Virologic failure is defined as:
| Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
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Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
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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 | SOF/VEL/VOX | SOF/VEL/VOX (400/100/100 mg) tablet orally once daily for 12 weeks | 0 | 24 | 1 | 24 | 6 | 24 |
| EG001 | SOF/VEL/VOX + RBV | SOF/VEL/VOX (400/100/100 mg) tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily for 12 weeks | 0 | 25 | 0 | 25 | 11 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000654129 | sofosbuvir velpatasvir voxilaprevir drug combination |
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| Male |
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| White |
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| Not Hispanic or Latino |
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| CT |
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| TT |
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| ≥ 800,000 IU/mL |
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