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This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir+RBV | Experimental | Participants were randomized to receive sofosbuvir+RBV for 12 weeks. |
|
| PEG+RBV | Active Comparator | Participants were randomized to receive PEG+RBV for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir | Drug | Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation. | Post-treatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities | Up to 24 weeks plus 30 days following the last dose of study drug | |
| Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Alabama Liver & Digestive Specialist |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25040192 | Derived | Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15. | |
| 23607594 | Derived |
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666 participants were screened and 527 were randomized; 499 participants received at least 1 dose of study drug, and comprise the Safety Analysis Set. The 496 participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug comprise the Full Analysis Set.
Subjects were enrolled in a total of 90 study sites in the United States, Australia, New Zealand, Canada, Sweden, Italy, and the Netherlands. The first participant was screened on 19 December 2011. The last participant observation was on 08 April 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sofosbuvir+RBV | Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks. |
| FG001 | PEG+RBV | Participants were randomized to receive PEG+RBV for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PEG | Drug | Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection |
|
|
| RBV | Drug | Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose
|
|
SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.
| Post-treatment Week 24 |
| Percentage of Participants With HCV RNA < LLOQ on Treatment | Up to 12 Weeks |
| Change From Baseline in HCV RNA | Baseline to Week 12 |
| Percentage of Participants With Virologic Failure During Treatment | Virologic failure was defined as either
| Baseline up to Week 24 |
| Percentage of Participants With Viral Relapse Following Treatment | Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement. | Up to Post-treatment Week 24 |
| Montgomery |
| Alabama |
| 36116 |
| United States |
| Franco Felizarta, MD | Bakersfield | California | 93301 | United States |
| California Liver Institute | Beverly Hills | California | 90210 | United States |
| Arrowhead Regional Medical Center | Colton | California | 92324 | United States |
| SCTI Research Foundation | Coronado | California | 92118 | United States |
| eStudy Site | La Mesa | California | 91940 | United States |
| Peter J. Ruane, M.D. Inc. | Los Angeles | California | 90036 | United States |
| eStudySite | Oceanside | California | 92056 | United States |
| University of California, Davis - Health System | Sacramento | California | 95817 | United States |
| University of California San Diego Medical Center | San Diego | California | 92103 | United States |
| Research and Education, Inc. | San Diego | California | 92105 | United States |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| South Denver Gastroenterology, PC | Englewood | Colorado | 80113 | United States |
| Pointe West Infectious Diseases | Bradenton | Florida | 34209 | United States |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | 34982 | United States |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
| Borland-Groover Clinic Baptist | Jacksonville | Florida | 32256 | United States |
| University of Miami, School of Medicine | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Internal Medicine Specialists | Orlando | Florida | 32806 | United States |
| Advanced Research Institute | Trinity | Florida | 34655 | United States |
| South Florida Center of Gastroenterology | Wellington | Florida | 33414 | United States |
| AIDS Research Consortium of Atlanta, Inc. | Atlanta | Georgia | 30308 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | United States |
| Digestive Disease Associates, P.A. | Baltimore | Maryland | 21229 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| The Research Institute | Springfield | Massachusetts | 01105 | United States |
| Partners in Internal Medicine, PC | Worcester | Massachusetts | 01608-1320 | United States |
| University of Massachusetts, Worcester | Worcester | Massachusetts | 01655 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Digestive Health Specialists, PA | Tupelo | Mississippi | 38801 | United States |
| Veterans Affairs Medical Center | East Orange | New Jersey | 07018 | United States |
| AGA Clinical Research Associates, LLC | Egg Harbor | New Jersey | 08234 | United States |
| ID Care | Hillsborough | New Jersey | 08844 | United States |
| Atlantic Research Affiliates, LLC | Morristown | New Jersey | 07960 | United States |
| Southwest C.A.R.E. Center | Santa Fe | New Mexico | 87505 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of Rochester | Rochester | New York | 14662 | United States |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Carolinas Center for Liver Disease | Statesville | North Carolina | 28677 | United States |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Gastroenterology United of Tulsa | Tulsa | Oklahoma | 74135 | United States |
| Schleinitz Research and Gastroenterology LLC | Medford | Oregon | 97504 | United States |
| Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster | Pennsylvania | 17604 | United States |
| UPMC Center For Liver Diseases | Pittsburgh | Pennsylvania | 15213 | United States |
| University Gastroenterology | Warwick | Rhode Island | 02886 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Nashville Gastrointestinal Specialists Inc. | Nashville | Tennessee | 37211 | United States |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Kelsey-Seybold Clinic PA | Houston | Texas | 77005 | United States |
| Research Specialists of Texas | Houston | Texas | 77030 | United States |
| VAMC & Baylor College | Houston | Texas | 77030 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Digestive and Liver Disease Specialist, Ltd. | Norfolk | Virginia | 23502 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Concord Repatriation General Hospital | Concord | New South Wales | 2137 | Australia |
| St. George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Gallipoli MRF | Greenslopes | Queensland | 4120 | Australia |
| Royal Brisbane Hospital Research Foundation | Herston | Queensland | 4029 | Australia |
| Princess Alexandria | Woollongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| The Alfred | Melbourne | Victoria | 3004 | Australia |
| Fremantle Hospital | Fremantle | Western Australia | 6160 | Australia |
| Sir Charles Gairdner | Nedlands | Western Australia | 6009 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| (G.I.R.I.) Gastrointestinal Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| University Health Network-Toronto Western Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| Toronto Digestive Disease Associates, Inc. | Vaughan | Ontario | L4L 4Y7 | Canada |
| Casa Sollievo della Sofferenza Hospital | San Giovanni Rotondo | 71013 | Italy |
| Academish Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Auckland City Hospital | Grafton | Auckland | New Zealand |
| Tauranga Hospital | Tauranga | BOP | 3143 | New Zealand |
| Christchurch Hospital | Chrischurch | Canterbury | 8001 | New Zealand |
| Mercy Hospital | Dunedin | OTA | 9010 | New Zealand |
| Waikato Hospital (District Health Board) | Hamilton | Waikato Region | 3240 | New Zealand |
| Wellington Hospital | Newtown | WGN | 6021 | New Zealand |
| Fundacion de Investigacion de Diego | San Juan | Puerto Rico | 00927 | Puerto Rico |
| Sahlgrenska Universitetssjukhuset, Östra Sjukhus | Gothenburg | 41685 | Sweden |
| Karolinska Universitetssjukhuset, Solna | Stockholm | 171 76 | Sweden |
| Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23. |
| Randomized But Not Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Sofosbuvir+RBV | Participants were randomized to receive sofosbuvir+RBV for 12 weeks. |
| BG001 | PEG+RBV | Participants were randomized to receive PEG+RBV for 24 weeks. |
| BG002 | 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hepatitis C Virus (HCV) genotype | Number | participants |
| ||||||||||||||||
| Baseline HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| Baseline HCV RNA Category | Number | participants |
| ||||||||||||||||
| IL28b genotype | Number | participants |
| ||||||||||||||||
| Cirrhosis | 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 12 Weeks After Stopping All Study Drugs (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation. | Full Analysis Set | Posted | Number | percentage of participants | Post-treatment Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities | Safety Analysis Set | Posted | Number | participants | Up to 24 weeks plus 30 days following the last dose of study drug |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) | SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation. | Full Analysis Set | Posted | Number | percentage of participants | Post-treatment Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Up to 12 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure During Treatment | Virologic failure was defined as either
| Full Analysis Set | Posted | Number | percentage of participants | Baseline up to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Relapse Following Treatment | Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Up to Post-treatment Week 24 |
|
|
Up to 24 weeks plus 30 days following the last dose of study drug
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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+RBV | Participants were randomized to receive sofosbuvir+RBV for 12 weeks. | 7 | 256 | 219 | 256 | ||
| EG001 | PEG+RBV | Participants were randomized to receive PEG+RBV for 24 weeks. | 3 | 243 | 233 | 243 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Atrioventriclar shock | Cardiac disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Osteomyelitis chronic | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | 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 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C100416 | peginterferon alfa-2a |
| 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 |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Asian |
|
| American Indian/Alaska Native/First Nations |
|
| Hawaiian or Pacific Islander |
|
| Black and White |
|
| South American |
|
| Canada |
|
| Australia |
|
| Netherlands |
|
| Italy |
|
| New Zealand |
|
| Sweden |
|
| Genotype 2 |
|
| Genotype 3 |
|
| ≥ 6 log10 IU/mL |
|
| CT |
|
| TT |
|
| Missing |
|
| Yes |
|
| Missing |
|
|
|
|
|
|
|