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The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOX+SOF/VEL 6 wk, TN, without cirrhosis | Experimental | VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) |
|
| GS-9857+SOF/VEL 6 wk, TN, with cirrhosis | Experimental | GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) |
|
| VOX+SOF/VEL 8 wk, TN, with cirrhosis | Experimental | GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) |
|
| VOX+SOF/VEL 8 wk,TE, without cirrhosis | Experimental | GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis) |
|
| VOX+SOF/VEL 12 wk, TE, without cirrhosis | Experimental | VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) |
|
| GS-9857+SOF/VEL 8 wk, TE, with cirrhosis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOX | Drug | 100 mg tablet(s) administered orally once daily with food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 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 following the last dose of 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 |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | United States | |||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27486033 | Result | Gane EJ, Kowdley KV, Pound D, Stedman CA, Davis M, Etzkorn K, Gordon SC, Bernstein D, Everson G, Rodriguez-Torres M, Tsai N, Khalid O, Yang JC, Lu S, Dvory-Sobol H, Stamm LM, Brainard DM, McHutchison JG, Tong M, Chung RT, Beavers K, Poulos JE, Kwo PY, Nguyen MH. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-Label, Phase 2 Trial. Gastroenterology. 2016 Nov;151(5):902-909. doi: 10.1053/j.gastro.2016.07.038. Epub 2016 Jul 30. |
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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/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
18 months after study completion
A secured external environment with username, password, and RSA code.
171 participants were screened. Enrollment was sequential, with the longer treatment duration groups enrolled, treated, and evaluated for Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) prior to enrollment of the shorter treatment duration groups, which were not enrolled, at the discretion of the Sponsor.
Participants were enrolled at study sites in United States and New Zealand. The first participant was screened on 16 February 2015. The last study visit occurred on 26 January 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | Voxilaprevir (VOX) 100 mg tablet + sofosbuvir/veltapasvir (Epclusa® ; SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis |
| FG001 | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Experimental |
GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis) |
|
| VOX+SOF/VEL 12 wk, TE, with cirrhosis | Experimental | VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) |
|
|
| SOF/VEL | Drug | 400/100 mg FDC tablet administered orally once daily with food |
|
|
| Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) |
| HCV RNA Change From Baseline | Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) |
| Percentage of Participants With Virologic Failure |
| Up to Posttreatment Week 24 |
| Palo Alto |
| California |
| United States |
| Huntington Memorial Hospital Liver Center | Pasadena | California | United States |
| Medical Associates Research Group, Inc. | San Diego | California | United States |
| University of Colorado | Aurora | Colorado | United States |
| Borland-Groover Clinic | Jacksonville | Florida | United States |
| University of Miami | Miami | Florida | United States |
| Orlando Immunology center | Orlando | Florida | United States |
| South Florida Center of Gastroenterology, P.A. | Wellington | Florida | United States |
| Center for Hep C/Atlanta Medical Center | Atlanta | Georgia | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | United States |
| University of Chicago | Chicago | Illinois | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | United States |
| Indianapolis Gastroenterology & Hepatology, Inc. | Indianapolis | Indiana | United States |
| Beth Isreal Deconess Medical Center | Boston | Massachusetts | United States |
| Massachusetts General Hospital | Boston | Massachusetts | United States |
| Henry Ford Hospital and Health System | Detroit | Michigan | United States |
| ID Care | Hillsborough | New Jersey | United States |
| Southwest Care Center | Santa Fe | New Mexico | United States |
| North Shore/Long Island Jewish PRIME | Manhasset | New York | United States |
| Mount Sinai Beth Israel | New York | New York | United States |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | United States |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | United States |
| University of Pennsylvania Health Systems | Philadelphia | Pennsylvania | United States |
| UPMC Center for Liver Diseases | Pittsburgh | Pennsylvania | United States |
| Medical University of South Carolina | Charleston | South Carolina | United States |
| Gastro One | Germantown | Tennessee | United States |
| Nashville Gastrointestinal Specialists Inc. | Nashville | Tennessee | United States |
| Texas Liver Institute | San Antonio | Texas | United States |
| Liver Institute of Virginia | Richmond | Virginia | United States |
| Swedish Medical | Seattle | Washington | United States |
| Christchurch Clinical Studies Trust | Christchurch | New Zealand |
| Auckland Clinical Studies | Grafton | New Zealand |
| Fundacion de Investigacion de Diego | San Juan | Puerto Rico |
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis |
| FG002 | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis |
| FG003 | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis |
| BG001 | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis |
| BG002 | VOX+SOF/VEL 12 Weeks, Treatment-Experienced, Non Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis |
| BG003 | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
| BG004 | 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 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. | Full Analysis Set (FAS): participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 12 |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set | Posted | Number | percentage of participants | Up to 12 Weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 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 following the last dose of study treatment, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4 and 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment | Participants in the Full Analysis Set with available data were analyzed | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | HCV RNA Change From Baseline | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) |
| |||||||||||||||||||||||||||||||||||||
| 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
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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 | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | 0 | 33 | 22 | 33 | ||
| EG001 | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | 0 | 30 | 14 | 30 | ||
| EG002 | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis | 0 | 36 | 25 | 36 | ||
| EG003 | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis | 1 | 29 | 23 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.1) | 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 |
| 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 |
|---|---|
| C000619503 | voxilaprevir |
| C000611331 | sofosbuvir-velpatasvir drug combination |
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| Male |
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| White |
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| Asian |
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| American Indian or Alaska Native |
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| Native India or Pacific Islander |
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| Other |
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| Not Hispanic or Latino |
|
| United States |
|
| CT |
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| TT |
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| ≥ 800,000 IU/mL |
|
|
|
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
|
|
|
|
|
|
| OG003 | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
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