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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001942-16 | EudraCT Number |
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This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo 12 Weeks (GT2/3) | Placebo Comparator | Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection. |
|
| SOF 12 Weeks (GT2/3) | Experimental | Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection. |
|
| SOF 24 Weeks (GT3) | Experimental | SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | Sofosbuvir (SOF) 400 mg tablet administered orally once daily |
|
| 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, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group. | Posttreatment Week 12 |
| Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group. | Posttreatment Weeks 4 and 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rob Hyland, DPhil | Gilead Sciences Study Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitat Graz | Graz | A-8036 | Austria | |||
| Medizinische Universitat Wien |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24795201 | Result | Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hezode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4. | |
| 25583164 |
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Participants were enrolled at a total of 77 study sites in Europe. The first participant was screened on 19 September 2012. The last participant observation occurred on 08 January 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo 12 Weeks (GT2/3) | Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection. |
| FG001 | SOF 12 Weeks (GT2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| RBV | Drug | Ribavirin (RBV) 200 mg 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) |
|
| Placebo to match SOF | Drug | Placebo to match SOF administered orally once daily |
|
| Placebo to match RBV | Drug | Placebo to match RBV administered orally in a divided daily dose |
|
| Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse | Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment. Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group. | Up to Posttreatment Week 24 |
| Vienna |
| 1090 |
| Austria |
| Wilhelminenspital | Vienna | 1160 | Austria |
| West Tallinn Central Hospital | Tallinn | 10617 | Estonia |
| Tartu University Hospital | Tartu | 51014 | Estonia |
| CHRU de Lille, Hopital Claude Huriez | CHRU Lille | 59037 | France |
| CHU Estaing | Clermont-Ferrand | 63003 | France |
| Hopital Beaujon | Clichy | 92110 | France |
| Hopital Henri Mondor | Créteil | 94000 | France |
| Département Hépatogastroentérologie - CHU de Grenoble | Grenoble | 38043 | France |
| Hopital Saint Joseph | Marseille | 13008 | France |
| Hopital Saint Eloi | Montpellier | 34295 | France |
| Hopital de l Archet 2 | Nice | 6202 | France |
| Hopital Saint Antoine | Paris | 75012 | France |
| Hopital Pitie Salpetriere | Paris | 75013 | France |
| Hopitaux Universitaires | Paris | 75679 | France |
| Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN | Pessac | 33604 | France |
| CHU Pontchaillou - Hématologie Clinique | Rennes | 35033 | France |
| Centre Hospitalier Universitaire de Strasbourg | Strasbourg | 67091 | France |
| CHU de Nancy, Hôpital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Praxiszentrum | Freiburg im Breisgau | Baden-Wurttemberg | 79098 | Germany |
| Leber- and Studienzentrum am Checkpoint | Berlin | 10969 | Germany |
| Universitaetsklinikum Bonn | Bonn | 53125 | Germany |
| Heinrich Heine Unversitat | Düsseldorf | 40225 | Germany |
| JWG-Universität Frankfurt | Frankfurt am Main | 60590 | Germany |
| Asklepios Klinik Sankt Georg H | Hamburg | 20099 | Germany |
| Universitatsklinikum | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannov | Hanover | 30625 | Germany |
| Medizinische Klinik IV, Dep. o | Heidelberg | 69120 | Germany |
| Gastroenterologische Gemeinsch | Herne | 44623 | Germany |
| Leberstudienzentrum Kiel | Kiel | 24146 | Germany |
| Universitaetsklinikum Leipzig | Leipzig | 4103 | Germany |
| Klinikum der Universität Münch | München | 81377 | Germany |
| Centrum fuer interdisziplinaere Medizin Muenster GmbH | Münster | D-48143 | Germany |
| Ospedale Casa Sollievo | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi | Bologna | 40138 | Italy |
| Ospedale S. Annunziata | Florence | 50011 | Italy |
| Ente Ospedaliero Ospedali Galliera | Genova | 16128 | Italy |
| Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Azienda Ospedaliera Ospedale Niguarda Cà Granda | Milan | 20162 | Italy |
| University of Padova | Padova | 35100 | Italy |
| University of Palermo | Palermo | 90127 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | 43100 | Italy |
| Fondazione PTV - Policlinico Tor Vergata | Roma | 133 | Italy |
| INMI "Lazzaro Spallanzani" I.R.C.C.S. | Roma | 149 | Italy |
| Azienda Ospedaliera Universitaria San Giovanni Battista di Torino | Torino | 10126 | Italy |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Leids Universitair Medisch Centrum | Leiden | 2300 RC | Netherlands |
| UMC St. Radboud - Gastroenterology | Nijmegen | 6500 HB | Netherlands |
| Erasmus MC | Rotterdam | 3015 CE | Netherlands |
| Wojewodzki Szpital Specjalistyczny im Dluskeigo | Bialystok | 15-540 | Poland |
| Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego | Lodz | 91-347 | Poland |
| SP ZOZ Wojewodzki Szpital Zakazny w Warszawie | Warsaw | 01-201 | Poland |
| NZOZ Centrum Badan Klinicznych | Wroclaw | 50-349 | Poland |
| Hospital Universitari Vall d'H | Barcelona | 08035 | Spain |
| Hospital Casa de la Maternidad | Barcelona | 08036 | Spain |
| Hospital Carlos III | Madrid | 28029 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Puerta de Hierro Maja | Majadahonda | 28222 | Spain |
| Complejo Hospitalario de Especialidades Virgen de la Victoria | Málaga | 29071 | Spain |
| Hospital Universitario Marques | Santander | 39008 | Spain |
| Valme Hospital | Seville | 41014 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Sahlgrenska University Hospital | Gothenburg | 41685 | Sweden |
| Skånes Universitetssjukhus, Lund | Lund | 22185 | Sweden |
| Skanes Universitetssjukhus | Malmö | 20502 | Sweden |
| Karolinska Instituet | Stockholm | 14186 | Sweden |
| University of Birmingham | Edgbaston | Birmingham | B15 2TH | United Kingdom |
| Southampton University Hospital NHS Trust | Southhampton | Hampshire | SO41 3QP | United Kingdom |
| King's College Hospital | Denmark Hill | London | SE5 9RS | United Kingdom |
| The Liver Unit | Paddington | London | W2 1NY | United Kingdom |
| North Manchester General Hospital | Crumpsall | Manchester | M8 5RB | United Kingdom |
| Bristol Royal Infirmary | Bristol | BS2 8HW | United Kingdom |
| Queen Marys University of London | London | E1 2AT | United Kingdom |
| Royal Free Hospital and University College London Hospital | London | NW3 2PF | United Kingdom |
| Chelsea & Westminster Hospital | London | SW109NH | United Kingdom |
| Nottingham University Hospitals-NHS | Nottingham | NG7 2UH | United Kingdom |
| Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12. |
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
| FG002 | SOF 12 Weeks (GT3) | SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection. |
| FG003 | SOF 24 Weeks (GT3) | SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection. |
| Included in Full Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo 12 Weeks (GT2/3) | Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection. |
| BG001 | SOF 12 Weeks (GT2) | SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection. |
| BG002 | SOF 12 Weeks (GT3) | SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection. |
| BG003 | SOF 24 Weeks (GT3) | SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection. |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| HCV Genotype | Number | participants |
| ||||||||||||||||
| Liver Cirrhosis | Number | participants |
| ||||||||||||||||
| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| |||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Number | participants |
| ||||||||||||||||
| Prior HCV Treatment Experience | Number | participants |
| ||||||||||||||||
| Response to prior HCV treatment | Only participants who were treatment-experienced at baseline were analyzed. | Number | participants |
| |||||||||||||||
| Interferon Eligibility | Only participants who were treatment-naive at baseline were analyzed. | 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 Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group. | Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF. | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Adverse Events Leading to Permanent Discontinuation of Study Drug(s) | The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed. | Safety Analysis Set: participants were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to 24 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group. | Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF. | Posted | Number | percentage of participants | Posttreatment Weeks 4 and 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse | Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment. Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group. | Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF. | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
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 | Placebo 12 Weeks (GT2/3) | Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection. | 2 | 85 | 60 | 85 | ||
| EG001 | SOF 12 Weeks (GT2/3) | SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection. | 0 | 84 | 72 | 84 | ||
| EG002 | SOF 24 Weeks (GT3) | SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection. | 10 | 250 | 229 | 250 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Adenocarcinoma of colon | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Complex regional pain syndrome | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | 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 |
| 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 |
|
| Not Permitted |
|
| White |
|
| Asian |
|
| Not permitted |
|
| Estonia |
|
| Spain |
|
| Poland |
|
| Austria |
|
| Netherlands |
|
| Germany |
|
| United Kingdom |
|
| Italy |
|
| Sweden |
|
| Genotype 3 |
|
| Yes |
|
| CT |
|
| TT |
|
| ≥ 6 log10 IU/mL |
|
| Naive |
|
| Nonresponse |
|
| Relapse/Breakthrough |
|
| Interferon ineligible |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|