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The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL | Experimental | Participants will receive SOF/VEL for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL | Drug | 400/100 mg fixed-dose combination (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 was 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 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 drug, 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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Wyles D, Brau N, Kottilil S, Daar E, Workowski K, Luetkemeyer A, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Patients Co-Infected with HCV and HIV-1: The Phase 3 ASTRAL-5 Study [Abstract PS104]. 2016 European Association for the Study of the Liver (EASL), Barcelona, Spain. | ||
| 28369210 | Derived | Wyles D, Brau N, Kottilil S, Daar ES, Ruane P, Workowski K, Luetkemeyer A, Adeyemi O, Kim AY, Doehle B, Huang KC, Mogalian E, Osinusi A, McNally J, Brainard DM, McHutchison JG, Naggie S, Sulkowski M; ASTRAL-5 Investigators. Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study. Clin Infect Dis. 2017 Jul 1;65(1):6-12. doi: 10.1093/cid/cix260. |
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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.
149 participants were screened.
Participants were enrolled at 17 study sites in the United States. The first participant was screened on 01 July 2015. The last study visit occurred on 22 June 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL 12 Weeks | Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Up to 12 Weeks |
| HCV RNA Change From Baseline/Day 1 | Baseline to Week 12 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to Posttreatment Week 24 |
| Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment | Up to 12 Weeks |
| Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12 | Week 12; Posttreatment Week 12 |
| Los Angeles |
| California |
| United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Torrance | California | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Baltimore | Maryland | United States |
| Lutherville | Maryland | United States |
| Boston | Massachusetts | United States |
| New York | New York | United States |
| The Bronx | New York | United States |
| Durham | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Richmond | Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: Participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1 |
| 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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| HIV RNA category | Participants in the Safety Analysis Set were analyzed by tenofovir disoproxil fumarate(TDF)-containing antiretroviral therapy (ART) at baseline:
| Count of Participants | Participants |
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| Serum Creatinine | Participants in the Safety Analysis Set were analyzed by TDF-containing ART at baseline:
| Mean | Standard Deviation | mg/dL |
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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 was 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 12 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 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, 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 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 Weeks |
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| Secondary | HCV RNA Change From Baseline/Day 1 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline to Week 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 |
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| Secondary | Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment | Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline:
| Posted | Number | percentage of participants | Up to 12 Weeks |
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| Secondary | Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12 | Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline:
| Posted | Mean | Standard Deviation | mg/dL | Week 12; Posttreatment Week 12 |
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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 12 Weeks (Boosted TDF Containing Regimens) | SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group. | 2 | 56 | 34 | 56 | ||
| EG001 | SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens) | SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents). | 0 | 35 | 19 | 35 | ||
| EG002 | SOF/VEL 12 Weeks (Non TDF Containing Regimens) | SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF. | 0 | 15 | 9 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Localised infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Radial nerve palsy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Constipation | 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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| Toothache | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 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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| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue 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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| Flank 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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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Pain in extremity | 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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| Abnormal dreams | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Sinus congestion | 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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| Other |
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| CT |
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| TT |
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| HIV RNA ≥ 50 copies/mL |
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| Non-Boosted TDF Containing Regimens |
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| Non TDF Containing Regimens |
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| Non-Boosted TDF Containing Regimens |
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| Non TDF Containing Regimens |
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| Title | Denominators | Categories |
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| Title | Denominators | Categories | ||||
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| Week 2 |
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| Week 4 |
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| Week 12 |
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| Title | Denominators | Categories |
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| Change at Week 1 |
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| Change at Week 2 |
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| Change at Week 4 |
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| Change at Week 6 |
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| Change at Week 8 |
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| Change at Week 10 |
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| Change at Week 12 |
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SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF. |
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SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF. |
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