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The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL+RBV | Experimental | Participants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL | Drug | 400/100 mg FDC tablet administered orally once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 24 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 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug. | 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 |
|---|---|---|---|---|---|---|
| San Diego | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Gane EJ, Shiffman ML, Etzkorn K, Morelli G, Stedman C, Davis MN, et al. Sofosbuvir/Velpatasvir in Combination With Ribavirin for 24 Weeks is Effective Retreatment for Patients Who Failed Prior NS5A Containing DAA Regimens: Results of the GS-US-342-1553 Study [Abstract PS024]. J Hepatology 2016;64:S147-S8. |
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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.
74 participants were screened.
Participants were enrolled at 31 study sites in North America and Asia Pacific. The first participant was screened on 01 December 2014. The last study visit occurred on 15 September 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL+RBV | Sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) (400/100mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 mg or 1200 mg) for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RBV | Drug | Tablet (s) 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 Week 24 |
| HCV RNA Change From Baseline | Baseline to Week 24 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to Posttreatment Week 24 |
| San Marcos |
| California |
| United States |
| Aurora | Colorado | United States |
| Gainesville | Florida | United States |
| Jacksonville | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Wellington | Florida | United States |
| Baltimore | Maryland | United States |
| Boston | Massachusetts | United States |
| Hillsborough | New Jersey | United States |
| Manhasset | New York | United States |
| Durham | North Carolina | United States |
| Fayetteville | North Carolina | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Falls Church | Virginia | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Darlinghurst | New South Wales | Australia |
| Fitzroy | Victoria | Australia |
| Melbourne | Victoria | Australia |
| Murdoch | Western Australia | Australia |
| Auckland | New Zealand |
| Christchurch | New Zealand |
| San Juan | Puerto Rico |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL+RBV | SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks |
| 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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| Region of Enrollment | 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 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | Full Analysis Set: all enrolled participants who received at least one 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 Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set | Posted | Number | percentage of participants | Up to 24 weeks |
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| Secondary | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug. | 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 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Week 24 |
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| 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 to Week 24 |
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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 |
|
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Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date 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+RBV | SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks | 0 | 69 | 1 | 69 | 55 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspepsia | 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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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | 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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| Irritability | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue 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 |
| 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 |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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| Asian |
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| Native Hawaiian or Pacific Islander |
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| Australia |
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| TT |
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| SVR24 |
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