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Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.
Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir 200 mg (Genotype 1) | Experimental | Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
|
| Sofosbuvir 400 mg (Genotype 1) | Experimental | Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
|
| Placebo (Genotype 1) | Active Comparator | Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
|
| Sofosbuvir 400 mg (Genotype 2/3) | Experimental | Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir | Drug | Sofosbuvir tablets were administered orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period | Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event. | Baseline to Week 12 plus 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HCV RNA From Baseline to Week 12 | Baseline to Week 12 | |
| Percentage of Participants With Rapid Virologic Response at Week 4 | Rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert H. Hyland, DPhil | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Liver and Digestive Specialists | Montgomery | Alabama | United States | |||
| Advanced Clinical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23499158 | Derived | Lawitz E, Lalezari JP, Hassanein T, Kowdley KV, Poordad FF, Sheikh AM, Afdhal NH, Bernstein DE, Dejesus E, Freilich B, Nelson DR, Dieterich DT, Jacobson IM, Jensen D, Abrams GA, Darling JM, Rodriguez-Torres M, Reddy KR, Sulkowski MS, Bzowej NH, Hyland RH, Mo H, Lin M, Mader M, Hindes R, Albanis E, Symonds WT, Berrey MM, Muir A. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis. 2013 May;13(5):401-8. doi: 10.1016/S1473-3099(13)70033-1. Epub 2013 Mar 15. |
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147 participants were randomized, and 146 participants received at least one dose of study drug, and comprise the Safety Analysis Set.
Subjects were enrolled in a total of 22 study sites in the United States. The first participant was screened on 16 August 2010. The last participant observation was on 11 May 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sofosbuvir 200 mg (Genotype 1) | Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+pegylated interferon alfa-2a (PEG)+ribavirin (RBV) for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo to match sofosbuvir | Drug | Placebo tablets to match sofosbuvir were administered orally once daily. |
|
| PEG | Drug | Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection. |
|
|
| RBV | Drug | Ribavirin (RBV) was administered as a tablet orally according to package insert dosing recommendations (Genotype 1: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg; Genotype 2/3: 800 mg). |
|
|
| Week 4 |
| Percentage of Participants With Complete Early Virologic Response at Week 12 | Complete early virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 12 | Week 12 |
| Percentage of Participants With Extended Rapid Virologic Response | Extended rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) which was maintained through Week 12. | Week 4 to Week 12 |
| Percentage of Participants With Virologic Response at the End of Treatment | End-of-treatment virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at the last on-treatment visit. | Week 48 (genotype 1) or Week 12 (genotype 2/3) |
| Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24) | SVR12 and SVR24 were defined as HCV RNA below the limit of detection (< 15 IU/mL) at post-treatment Weeks 12 and 24, respectively. | Post-treatment Weeks 12 and 24 |
| Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | 1, 2, 4, 8, and 12 hours postdose |
| Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | 1, 2, 4, 8, and 12 hours postdose |
| Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | 1, 2, 4, 8, and 12 hours postdose |
| Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | 1, 2, 4, 8, and 12 hours postdose |
| Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | 1, 2, 4, 8, and 12 hours postdose |
| Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | 1, 2, 4, 8, and 12 hours postdose |
| Percentage of Participants Who Developed Resistance to Sofosbuvir | Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24. | Baseline to Week 12 |
| Anaheim |
| California |
| United States |
| SCTI Research Foundation | Coronado | California | United States |
| Cedars Sinai Medical Center | Los Angeles | California | United States |
| Dr. Jay Lalezari | San Francisco | California | United States |
| Dr. Natalie Bzowej | San Francisco | California | United States |
| Dr. David Nelson | Gainesville | Florida | United States |
| Orlando Immunology Center | Orlando | Florida | United States |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | United States |
| University of Chicago | Chicago | Illinois | United States |
| Dr. Mark Sulkowski | Lutherville | Maryland | United States |
| Liver Research Center Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | United States |
| Dr. Bruce Bacon | St Louis | Missouri | United States |
| North Shore University Hospital | Manhasset | New York | United States |
| Dr. Ira Jacobson | New York | New York | United States |
| Mount Sinai School of Medicine | New York | New York | United States |
| Dr. Jama Darling | Chapel Hill | North Carolina | United States |
| Dr. Raj Reddy | Philadelphia | Pennsylvania | United States |
| Columbia Gastroenterology and Liver Associates | Columbia | South Carolina | United States |
| Dr. Eric Lawitz | San Antonio | Texas | United States |
| Digestive Disease Institute Virginia Mason Medical Center | Seattle | Washington | United States |
| Fundacion de Investigacion de Diego | Santurce | Puerto Rico | Puerto Rico |
| Sofosbuvir 400 mg (Genotype 1) |
Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
| FG002 | Placebo (Genotype 1) | Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
| FG003 | Sofosbuvir 400 mg (Genotype 2/3) | Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks. |
| Randomized and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who were randomized and at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Sofosbuvir 200 mg (Genotype 1) | Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks |
| BG001 | Sofosbuvir 400 mg (Genotype 1) | Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks |
| BG002 | Placebo (Genotype 1) | Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks |
| BG003 | Sofosbuvir 400 mg (Genotype 2/3) | Sofosbuvir 400 mg+PEG+RBV for 12 weeks |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Hepatitis C (HCV) RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| Liver Biopsy Fibrosis Score | Number | participants |
| ||||||||||||||||
| Alanine Aminotransferase (ALT) | Mean | Standard Deviation | IU/L |
| |||||||||||||||
| IL28b Genotype | 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 Who Experienced Adverse Events During the Sofosbuvir Treatment Period | Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event. | Safety Analysis Set: participants were randomized and received at least one dose of study drug | Posted | Number | percentage of participants | Baseline to Week 12 plus 30 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in HCV RNA From Baseline to Week 12 | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Rapid Virologic Response at Week 4 | Rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) | Safety Analysis Set | Posted | Number | percentage of participants | Week 4 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Early Virologic Response at Week 12 | Complete early virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 12 | Safety Analysis Set | Posted | Number | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Extended Rapid Virologic Response | Extended rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) which was maintained through Week 12. | Safety Analysis Set | Posted | Number | percentage of participants | Week 4 to Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Response at the End of Treatment | End-of-treatment virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at the last on-treatment visit. | Participants in the Safety Analysis Set with available data were analyzed. One participant in the Sofosbuvir 400 mg (Genotype 2/3) Group was lost to follow up before the end of treatment and is not included in this analysis. | Posted | Number | percentage of participants | Week 48 (genotype 1) or Week 12 (genotype 2/3) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24) | SVR12 and SVR24 were defined as HCV RNA below the limit of detection (< 15 IU/mL) at post-treatment Weeks 12 and 24, respectively. | Safety Analysis Set | Posted | Number | percentage of participants | Post-treatment Weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed. | Posted | Mean | Standard Deviation | ng/mL | 1, 2, 4, 8, and 12 hours postdose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed. | Posted | Mean | Standard Deviation | ng/mL | 1, 2, 4, 8, and 12 hours postdose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed. | Posted | Mean | Standard Deviation | ng/mL | 1, 2, 4, 8, and 12 hours postdose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed. | Posted | Mean | Standard Deviation | ng•h/mL | 1, 2, 4, 8, and 12 hours postdose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed. | Posted | Mean | Standard Deviation | ng•h/mL | 1, 2, 4, 8, and 12 hours postdose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29) | The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites. | Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed. | Posted | Mean | Standard Deviation | ng•h/mL | 1, 2, 4, 8, and 12 hours postdose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Resistance to Sofosbuvir | Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24. | Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed. | Posted | Number | percentage of participants | Baseline to Week 12 |
|
|
Baseline to last dose or sofosbovir/placebo plus 30 days
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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 | Sofosbuvir 200 mg (Genotype 1) | Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks | 1 | 48 | 47 | 48 | ||
| EG001 | Sofosbuvir 400 mg (Genotype 1) | Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks | 3 | 47 | 46 | 47 | ||
| EG002 | Placebo (Genotype 1) | Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks | 1 | 26 | 26 | 26 | ||
| EG003 | Sofosbuvir 400 mg (Genotype 2/3) | Sofosbuvir 400 mg+PEG+RBV for 12 weeks | 0 | 25 | 24 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mood Swings | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | 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, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| 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 |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black or African American |
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| Other |
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| White |
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| Portal Fibrosis |
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| Bridging Fibrosis |
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| Cirrhosis |
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| CT |
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| TT |
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| Drug-related AE |
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| Grade 3 or higher AE |
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| AE leading to drug discontinuation |
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| Serious AE |
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Sofosbuvir 400 mg+PEG+RBV for 12 weeks
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