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The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL 12 weeks | Experimental | Participants will receive SOF/VEL FDC for 12 weeks. |
|
| SOF/VEL+RBV 12 weeks | Experimental | Participants will receive SOF/VEL FDC plus RBV for 12 weeks. |
|
| SOF/VEL 24 weeks | Experimental | Participants will receive SOF/VEL FDC for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL | Drug | 400/100 mg tablets administered orally once daily |
|
| 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) 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 plus 30 days |
| 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 at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anu M Osinusi, MD, MPH | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Charlton MR, O'Leary JG, Bzowej NH, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir/Velapatasvir Fixed Dose Combination for the Treatment of HCV in Patients with Decompensated Liver Disease: The Phase 3 ASTRAL-4 Study. Hepatology 2015; 62 (6): 1387A-1388A. | ||
| 26569658 | Result | Curry MP, O'Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, Reddy KR, Lawitz E, Flamm SL, Schiano T, Teperman L, Fontana R, Schiff E, Fried M, Doehle B, An D, McNally J, Osinusi A, Brainard DM, McHutchison JG, Brown RS Jr, Charlton M; ASTRAL-4 Investigators. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. N Engl J Med. 2015 Dec 31;373(27):2618-28. doi: 10.1056/NEJMoa1512614. Epub 2015 Nov 16. | |
| Result | Asselah T, Charlton M, Feld J, Foster GR, McNally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single-Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015; 62:S855-S6. |
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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.
438 participants were screened.
Participants were enrolled at a total of 47 study sites in the United States. The first participant was screened on 31 July 2014. The last study visit occurred on 25 November 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL 12 Weeks (Group 1) | SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks |
| FG001 | SOF/VEL+RBV 12 Weeks (Group 2) | SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| RBV | Drug | Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
| Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
| Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as
| Up to Posttreatment Week 24 |
| Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score | Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. | Baseline to Posttreatment Week 24 |
| Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score | CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease. | Baseline to Posttreatment Week 24 |
| La Jolla |
| California |
| United States |
| Los Angeles | California | 90048 | United States |
| Los Angeles | California | United States |
| Pasadena | California | United States |
| San Francisco | California | United States |
| Aurora | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Gainesville | Florida | United States |
| Jacksonville | Florida | 32256 | United States |
| Miami | Florida | United States |
| Tampa | Florida | United States |
| Marietta | Georgia | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | 46202 | United States |
| Indianapolis | Indiana | 46237 | United States |
| Kansas City | Kansas | United States |
| Monroe | Louisiana | 71280 | United States |
| New Orleans | Louisiana | United States |
| Baltimore | Maryland | United States |
| Boston | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Detroit | Michigan | United States |
| Rochester | Minnesota | United States |
| Jackson | Mississippi | United States |
| St Louis | Missouri | United States |
| Santa Fe | New Mexico | 87505 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10029 | United States |
| New York | New York | 10032 | United States |
| Chapel Hill | North Carolina | United States |
| Charlotte | North Carolina | 28204 | United States |
| Durham | North Carolina | United States |
| Cleveland | Ohio | 44195 | United States |
| Cleveland | Ohio | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Pittsburgh | Pennsylvania | United States |
| Providence | Rhode Island | 02905 | United States |
| Germantown | Tennessee | 38138 | United States |
| Nashville | Tennessee | 37211 | United States |
| Arlington | Texas | 76012 | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Murray | Utah | United States |
| Fairfax | Virginia | United States |
| Norfolk | Virginia | 23502 | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| San Juan | 00927 | Puerto Rico |
| 28404069 | Derived | Younossi ZM, Stepanova M, Charlton M, Curry MP, O'Leary JG, Brown RS, Hunt S. Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial. Lancet Gastroenterol Hepatol. 2016 Oct;1(2):122-132. doi: 10.1016/S2468-1253(16)30009-7. Epub 2016 Aug 3. |
| 27847279 | Derived | Younossi ZM, Stepanova M, Feld J, Zeuzem S, Sulkowski M, Foster GR, Mangia A, Charlton M, O'Leary JG, Curry MP, Nader F, Henry L, Hunt S. Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2017 Mar;15(3):421-430.e6. doi: 10.1016/j.cgh.2016.10.037. Epub 2016 Nov 12. |
| FG002 | SOF/VEL 24 Weeks (Group 3) | SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL 12 Weeks (Group 1) | SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks |
| BG001 | SOF/VEL+RBV 12 Weeks (Group 2) | SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks |
| BG002 | SOF/VEL 24 Weeks ((Group 3) | SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks |
| BG003 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| HCV RNA Category | Number | participants |
| ||||||||||||||||
| HCV RNA | Mean | Standard Deviation | log 10 IU/mL |
| |||||||||||||||
| HCV Genotype | Number | participants |
| ||||||||||||||||
| IL28B | The CC, CT, and TT alleles are different forms of the IL28b gene. | Number | 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) 12 weeks following the last dose of study drug. | The Full Analysis Set (FAS): participants who were randomized into the study and 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 24 weeks plus 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as
| Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Posttreatment Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score | Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Baseline to Posttreatment Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score | CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Baseline to Posttreatment Week 24 |
|
|
Up to 24 weeks plus 30 days
Safety Analysis Set
Not provided
| 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 (Group 1) | SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks | 17 | 90 | 65 | 90 | ||
| EG001 | SOF/VEL+RBV 12 Weeks (Group 2) | SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks | 14 | 87 | 74 | 87 | ||
| EG002 | SOF/VEL 24 Weeks (Group 3) | SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks | 16 | 90 | 61 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Bone abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
There were no limitations affecting the analysis or results.
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 |
| D005355 | Fibrosis |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Pacific Islander |
|
| Other |
|
| Not Disclosed |
|
| ≥ 800,000 IU/mL |
|
| Genotype 2 |
|
| Genotype 3 |
|
| Genotype 4 |
|
| Genotype 6 |
|
| CT |
|
| TT |
|
| Missing |
|
|
A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167. |
| Binomial test |
P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 weeks (Group 2) over prespecified rate of 1%. |
| <0.001 |
| Superiority or Other |
| A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167. | Binomial test | P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 24 weeks (Group 3) over prespecified rate of 1%. | <0.001 | Superiority or Other |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|