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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002996-12 | EudraCT Number |
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The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL/VOX | Experimental | SOF/VEL/VOX tablet for 8 weeks |
|
| SOF/VEL | Experimental | SOF/VEL tablet 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 |
|---|---|---|---|
| Result | Foster GR, Thompson AJ, Ruane PJ, Borgia SM, Dore G, Workowski K, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients with Genotype 3 HCV Infection and Cirrhosis: The POLARIS-3 Study [Abstract 258]. J Hepatology 2016;63 (1S):135A | ||
| 28390869 | Result | Jacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgia SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Brau N, Berg T, Agarwal K, Bhandari BR, Davis M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017 Jul;153(1):113-122. doi: 10.1053/j.gastro.2017.03.047. Epub 2017 Apr 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 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.
315 participants were screened.
Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 23 December 2015. The last study visit occurred on 02 January 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL/VOX 8 Weeks | Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 8 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 | Virologic failure was defined as:
| Up to Posttreatment Week 24 |
| Los Angeles |
| California |
| United States |
| Palo Alto | California | United States |
| Rialto | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Aurora | Colorado | United States |
| Miami | Florida | United States |
| Wellington | Florida | United States |
| Atlanta | Georgia | 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 |
| Hillsborough | New Jersey | United States |
| New York | New York | United States |
| The Bronx | New York | United States |
| Asheville | North Carolina | United States |
| Fayetteville | North Carolina | United States |
| Pittsburgh | Pennsylvania | United States |
| Providence | Rhode Island | United States |
| Nashville | Tennessee | United States |
| San Antonio | Texas | United States |
| Murray | Utah | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| Camperdown | New South Wales | Australia |
| Darlinghurst | New South Wales | Australia |
| Herston | Queensland | Australia |
| Clayton | Victoria | Australia |
| Fitzroy | Victoria | Australia |
| Melbourne | Victoria | Australia |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Vancouver | British Columbia | Canada |
| Brampton | Ontario | Canada |
| Toronto | Ontario | Canada |
| Bobigny | France |
| Clermont-Ferrand | France |
| Clichy | France |
| Créteil | France |
| Limoges | France |
| Lyon | France |
| Marseille | France |
| Montpellier | France |
| Nice | France |
| Orléans | France |
| Paris | France |
| Pessac | France |
| Rennes | France |
| Strasbourg | France |
| Vandœuvre-lès-Nancy | France |
| Berlin | Germany |
| Bonn | Germany |
| Cologne | Germany |
| Frankfurt am Main | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Grafton | Auckland | New Zealand |
| Christchurch | New Zealand |
| San Juan | Puerto Rico |
| London | United Kingdom |
| Manchester | United Kingdom |
| Nottingham | United Kingdom |
| Oxford | United Kingdom |
| Portsmouth | 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 participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL/VOX 8 Weeks | SOF/VEL/VOX (400/100/100 mg) tablet orally once daily with food for 8 weeks |
| BG001 | SOF/VEL 12 Weeks | SOF/VEL (400/100 mg) 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 |
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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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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| IL28b Status | 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/enrolled participants who took at least 1 dose of the 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 |
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| 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 participants | Posttreatment Weeks 4 and 24 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ On Treatment | Percentage of participants in Full Analysis Set with on-treatment data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 2, 4, 8 and 12 |
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| 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 |
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| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
|
Up to 12 weeks plus 30 days
Safety Analysis Set
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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 8 Weeks | SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks | 2 | 110 | 68 | 110 | ||
| EG001 | SOF/VEL 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks | 3 | 109 | 61 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Hypertensive crisis | Vascular 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 |
| |
| Abdominal pain upper | Gastrointestinal 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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| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | 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 |
| 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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| Asian |
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| American Indian or Alaska Native |
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| Black or African American |
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| Native Hawaiian or Pacific Islander |
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| Other |
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| Not Hispanic or Latino |
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| Canada |
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| United States |
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| United Kingdom |
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| Australia |
|
| France |
|
| Germany |
|
| CT |
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| TT |
|
| ≥ 800,000 IU/mL |
|
| 2-sided exact 1-sample binomial test |
| <0.001 |
The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level. |
| Superiority |
The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%. |
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