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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003167-10 | EudraCT Number |
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The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL/VOX | Experimental | SOF/VEL/VOX for 12 weeks |
|
| SOF/VEL | Experimental | SOF/VEL for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL/VOX | Drug | 400/100/100 mg FDC tablet administered orally once daily with food |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinue Study Drug 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 SVR24 were 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 |
|---|---|---|---|---|---|---|
| Long Beach | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28564569 | Derived | Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512. |
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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.
397 participants were screened.
Participants were enrolled across 101 study sites in North America, Europe, and Asia Pacific. The first participant was screened on 23 December 2015. The last study visit occurred on 18 January 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL/VOX 12 Weeks | Sofosbuvir/veltapasvir/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 12 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| SOF/VEL | Drug | 400/100 mg FDC tablet administered orally once daily without regard to food |
|
|
| Weeks 1, 2, 4, 8 and 12 |
| Change From Baseline in HCV RNA | Weeks 1, 2, 4, 8, and 12 |
| Percentage of Participants With Virologic Failure |
| Up to Posttreatment Week 24 |
| Los Angeles |
| California |
| United States |
| Palo Alto | California | United States |
| Pasadena | California | United States |
| Rialto | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Aurora | Colorado | United States |
| Englewood | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Gainesville | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Wellington | Florida | United States |
| Atlanta | Georgia | United States |
| Marietta | Georgia | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| Bastrop | Louisiana | United States |
| Baltimore | Maryland | United States |
| Catonsville | Maryland | United States |
| Boston | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Detroit | Michigan | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| Hillsborough | New Jersey | United States |
| New York | New York | United States |
| Asheville | North Carolina | United States |
| Fayetteville | North Carolina | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Providence | Rhode Island | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Murray | Utah | United States |
| Falls Church | Virginia | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| Madison | Wisconsin | United States |
| Camperdown | New South Wales | Australia |
| Darlinghurst | New South Wales | Australia |
| Herston | Queensland | Australia |
| Clayton | Victoria | Australia |
| Melbourne | Victoria | Australia |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Vancouver | British Columbia | Canada |
| Brampton | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Clermont-Ferrand | France |
| Clichy | France |
| Grenoble | France |
| Lille | France |
| Limoges | France |
| Lyon | France |
| Marseille | France |
| Montpellier | France |
| Nice | France |
| Paris | France |
| Pessac | France |
| Toulouse | France |
| Vandœuvre-lès-Nancy | France |
| Villejuif | France |
| Berlin | Germany |
| Bonn | Germany |
| Cologne | Germany |
| Frankfurt am Main | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Grafton | Auckland | New Zealand |
| San Juan | Puerto Rico |
| London | United Kingdom |
| Oxford | United Kingdom |
Sofosbuvir/Velpatasvir (Epclusa®; SOF/VEL) (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
| COMPLETED |
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| NOT COMPLETED |
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|
Safety Analysis Set: all randomized or enrolled participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL/VOX 12 Weeks | SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks |
| BG001 | SOF/VEL 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene | Count of Participants | Participants |
| |||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Count of Participants | Participants |
|
| 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 Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. | Full Analysis Set: all randomized or enrolled participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 12 |
|
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| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event | Safety Analysis Set | Posted | Number | percentage of participants | Up to 12 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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 after stopping study treatment, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participcants | Posttreatment Weeks 4 and 24 |
|
| |||||||||||||||||||||||||||||
| 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 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA | 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 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure |
| Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
|
Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received 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 12 Weeks | SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks | 4 | 182 | 111 | 182 | ||
| EG001 | SOF/VEL 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks | 4 | 151 | 88 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (19.0) | 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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| 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 |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000654129 | sofosbuvir velpatasvir voxilaprevir drug combination |
| C000611331 | sofosbuvir-velpatasvir drug combination |
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| Male |
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| Black or African American |
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| Asian |
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| Other |
|
| American Indian or Alaska Native |
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| Native Hawaiian or Pacific Islander |
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| Not Hispanic or Latino |
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| Australia |
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| Canada |
|
| France |
|
| Germany |
|
| New Zealand |
|
| United Kingdom |
|
| CT |
|
| TT |
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| ≥ 800,000 IU/mL |
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