Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001249-26 | EudraCT Number |
Not provided
Not provided
Not provided
The study stopped early because the study objectives were met.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for HCV infection.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV | Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years. |
| |
| LDV/SOF | Participants who were previously treated with ledipasvir/sofosbuvir (LDV/SOF) will be followed up to 5 years. |
| |
| LDV/SOF+RBV | Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years. |
| |
| SOF/VEL | Participants who were previously treated with sofosbuvir/velpatasvir (SOF/VEL) will be followed up to 5 years. |
| |
| SOF/VEL+RBV | Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years. |
| |
| SOF/VEL/VOX | Participants who were previously treated with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) with or without RBV will be followed up to 5 years. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir | Drug | Exposure of interest for participants who received sofosbuvir in a previous Gilead study for chronic HCV infection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | SVR at Week 240 was defined as HCV RNA< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter [IU/mL]) or last available HCV RNA< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model. | Week 240 |
| Percentage of Participants With Any Liver-Associated Events | The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model. | Enrollment up to 240 weeks |
| Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240 | Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model. | Enrollment up to 240 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240 | Enrollment up to 240 weeks | |
| Number of Participants With Detectable HCV Resistance Mutations Through Week 240 | Enrollment up to 240 weeks |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Participants with cirrhosis who have achieved an SVR after receiving a SOF-based regimen without interferon (IFN) while participating in a Gilead-sponsored HCV study. In addition, participants with cirrhosis who have achieved SVR after an all-oral SOF-based regimen outside a clinical study may be eligible to enroll in this registry at sites preselected by Gilead.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States | |||
| Scripps Clinic Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Dunn W, Koestler D, Ni L, Kersey K, Kreter B, Hammond K et al. Cirrhosis regression based on both Enhanced Liver Fibrosis (ELF) and Fibrotest after Direct-acting Hepatitis C therapeutics corresponds to a lower incidence rate of hepatocellular carcinoma below the cost-effective threshold for surveillance [Poster 1289]. The International Liver Congressâ„¢ EASL - European Association for the Study of the Liver (EASL); 2021 23-26 June. | ||
| 32707225 | Background | Fan R, Papatheodoridis G, Sun J, Innes H, Toyoda H, Xie Q, Mo S, Sypsa V, Guha IN, Kumada T, Niu J, Dalekos G, Yasuda S, Barnes E, Lian J, Suri V, Idilman R, Barclay ST, Dou X, Berg T, Hayes PC, Flaherty JF, Zhou Y, Zhang Z, Buti M, Hutchinson SJ, Guo Y, Calleja JL, Lin L, Zhao L, Chen Y, Janssen HLA, Zhu C, Shi L, Tang X, Gaggar A, Wei L, Jia J, Irving WL, Johnson PJ, Lampertico P, Hou J. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis. J Hepatol. 2020 Dec;73(6):1368-1378. doi: 10.1016/j.jhep.2020.07.025. Epub 2020 Jul 21. | |
| Background | Jacobson I, Muir AJ, Lawitz EJ, Gane E, Conway B, Ruane PJ, et al. Course of Cirrhosis Regression: Lessons From Patients With HCV Cirrhosis Following Successful Sofosbuvir-Based Treatment [Poster 537]. AASLD: The Liver Meeting® 2019, November 11-15. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
18 months after study completion
A secured external environment with username, password, and RSA code.
1609 participants were enrolled in the registry. 36 participants who were enrolled but did not meet the eligibility criteria (including 19 participants in the 'Enrolled from Ineligible Parent Treatment Group') were not included in the Full Analysis Set and Safety Analysis Set, and thus, are not included in the Baseline Characteristics, Outcome Measures and Serious and Other Adverse Event modules.
Participants were enrolled at study sites in Australia, Canada, France, Germany, Italy, New Zealand, Spain, the United Kingdom, and the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SOF+RBV | Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) were followed up to 5 years. |
| FG001 | LDV/SOF | Participants who were previously treated with ledipasvir (LDV)/SOF were followed up to 5 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2017 | Nov 3, 2022 |
Not provided
Not provided
Not provided
Not provided
Blood samples
|
| Other SOF-Based | Participants who previously received other SOF based regimen will be followed up to 5 years. |
|
| Enrolled From Ineligible Parent Treatment Group | Participants were enrolled from ineligible parent treatment group. |
|
| Ribavirin | Drug |
|
| LDV/SOF | Drug | Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection. |
|
|
| SOF/VEL | Drug | Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection. |
|
|
| SOF/VEL/VOX | Drug | Exposure of interest for participants who received SOF/VEL/VOX in a previous Gilead study for chronic HCV infection. |
|
|
| Other SOF-Based Regimen | Drug | The other SOF-based regimens may have included the following:
|
|
| Ineligible parent treatment | Other | Participants were enrolled from ineligible parent treatment group. |
|
| Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240 | Reinfection was defined as HCV RNA > LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study. | Enrollment up to 240 weeks |
| La Jolla |
| California |
| United States |
| V.A. Long Beach Medical Center | Long Beach | California | United States |
| Cedars Sinai Medical Center | Los Angeles | California | United States |
| Kaiser Permanente Medical Center | Los Angeles | California | United States |
| Tarrant County ID Associates | Los Angeles | California | United States |
| The Liver Center | Pasadena | California | United States |
| Inland Empire Liver Foundation | Rialto | California | United States |
| University of California, Davis Medical Center | Sacramento | California | United States |
| Kaiser Permanente | San Diego | California | United States |
| Medical Associates Research Group | San Diego | California | United States |
| Quest Clinical Research | San Francisco | California | United States |
| University of California at San Francisco Medical Center | San Francisco | California | United States |
| Stanford University | Stanford | California | United States |
| University of Colorado | Aurora | Colorado | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | United States |
| Whitman-Walker Health | Washington D.C. | District of Columbia | United States |
| UF Hepatology Research at CTRB | Gainesville | Florida | United States |
| Borland-Groover Clinic | Jacksonville | Florida | United States |
| University of Miami Miller School of Medicine | Miami | Florida | United States |
| Orlando Immunology Center | Orlando | Florida | United States |
| Tampa General Hospital | Tampa | Florida | United States |
| South Florida Center of Gastroenterology | Wellington | Florida | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | United States |
| Atlanta Medical Center | Atlanta | Georgia | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | United States |
| Northwestern University | Chicago | Illinois | United States |
| Indiana University | Indianapolis | Indiana | United States |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | United States |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | United States |
| Delta Research Partners | Monroe | Louisiana | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | United States |
| Mercy Medical Center | Baltimore | Maryland | United States |
| Digestive Disease Associates, PA | Catonsville | Maryland | United States |
| Johns Hopkins Hospital/University | Lutherville | Maryland | United States |
| Community Research Initiative of New England | Boston | Massachusetts | 02129 | United States |
| BIDMC Liver Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | United States |
| Henry Ford Health System | Detroit | Michigan | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | United States |
| Mayo Clinic | Rochester | Minnesota | United States |
| Minnesota Gastroenterology, PA | Saint Paul | Minnesota | United States |
| Kansas City Research Institute, LLC | Kansas City | Missouri | United States |
| Saint Louis University | St Louis | Missouri | United States |
| ID Care, Inc | Hillsborough | New Jersey | 08844 | United States |
| Southwest CARE Center | Santa Fe | New Mexico | United States |
| Binghamton Gastroenterology Associates, PC | Binghamton | New York | United States |
| North Shore Health Inc. | Manhasset | New York | United States |
| Columbia University Medical Center | New York | New York | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | United States |
| New York University Medical Center | New York | New York | United States |
| Weill Cornell Medical College | New York | New York | United States |
| Asheville Gastroenterology Associates, PA | Asheville | North Carolina | United States |
| Carolinas Medical Center | Charlotte | North Carolina | United States |
| Duke University Medical Center | Durham | North Carolina | United States |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | United States |
| University of Pittsburgh Medical Center | Philadelphia | Pennsylvania | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Gastroenterology Center of the MidSouth, P.C. | Germantown | Tennessee | United States |
| Nashville Gastrointestinal Specialists, Inc. | Nashville | Tennessee | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | United States |
| The North Texas Clinical Research Institute | Arlington | Texas | United States |
| Baylor Endocrine Center | Dallas | Texas | United States |
| North Texas Research Institute | Dallas | Texas | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | United States |
| The Texas Liver Institute | San Antonio | Texas | United States |
| Intermountain Medical Center | Murray | Utah | United States |
| INOVA Fairfax Hospital | Annandale | Virginia | United States |
| Bon Secours St. Mary's Hospital of Richmond | Newport News | Virginia | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | United States |
| Harborview Medical Center | Seattle | Washington | United States |
| Virginia Mason Medical Center | Seattle | Washington | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia |
| Kirby Institute | Sydney | New South Wales | Australia |
| Westmead Hospital | Westmead | New South Wales | Australia |
| Royal Brisbane & Women's Hospital | Herston | Queensland | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Australia |
| St Vincents Hospital Sydney | Fitzroy | Victoria | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Monash Medical Centre Clayton Campus | Melbourne | Victoria | Australia |
| The Alfred Hospital | Prahran | Victoria | Australia |
| Fiona Stanley Hospital | Fremantle | Western Australia | Australia |
| Royal Perth Hospital | Perth | Western Australia | Australia |
| University of Calgary | Calgary | Alberta | Canada |
| GI Research Institute | Vancouver | British Columbia | Canada |
| Vancouver Infectious Disease Research and Care Centre | Vancouver | British Columbia | Canada |
| London Health Sciences Centre - University Campus | London | Ontario | Canada |
| University Health Network | Toronto | Ontario | Canada |
| CRCHUM | Montreal | Quebec | Canada |
| University of Alberta | Edmonton | T6G 2B7 | Canada |
| Hôpital Pontchaillou | Rennes | Brittany Region | France |
| CHU Montpellier - Hopital St. Eloi | Montpellier | Languedoc-Rousillon | France |
| Hôpital Universitaire Dupuytren | Limoges | Limousin | France |
| Hopital Purpan | Toulouse | Midi-Pyrenees | France |
| Groupe Hospitalier Archet I Et II | Nice | Provence Alpes Cote D'Azu | 06202 | France |
| Hopital Saint Joseph | Marseille | Provence-Alpes-Côte d'Azur Region | France |
| Hopital Haut Leveque | Bordeaux | France |
| CHU Estaing | Clermont-Ferrand | France |
| Hôpital Beaujon | Clichy | France |
| Hopital Henri Mondor | Créteil | France |
| CHU de Grenoble- Hopital Michallon | Grenoble | France |
| Hopital Cochin | Paris | France |
| Hopital Tenon | Paris | France |
| Hôpital de la Croix Rousse | Paris | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | France |
| CHU de Nancy-Hopital Brabois Adulte | Vandœuvre-lès-Nancy | France |
| Hôpital Paul Brousse | Villejuif | France |
| Hopital de La Pitié-Salpêtrière | Paris | Île-de-France Region | France |
| Universitatsklinikum Koln | Cologne | Germany |
| Klinikum der Johann Wolfgang Goethe Universitat | Frankfurt am Main | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20251 | Germany |
| Asklepios Klinik St. Georg | Hamburg | Germany |
| Technische Universität München | Mücheln | Germany |
| Azienda Ospedaliera Ospedale Niguarda CÃ Granda | Milan | Italy |
| Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico | Milan | Italy |
| Ospedale Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo | Italy |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | Italy |
| Auckland Clinical Studies Ltd | Auckland | North Island | New Zealand |
| Waikato Hospital | Hamilton | North Island | New Zealand |
| Christchurch Hospital | Christchurch | South Island | New Zealand |
| Fundacion de Investigation de Diego | San Juan | 00927 | Puerto Rico |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08028 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Virgen de Valme | Seville | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | Spain |
| Barts Health NHS Trust | London | England | United Kingdom |
| Kings College Hospital | London | England | United Kingdom |
| St Georges University of London | London | England | United Kingdom |
| North Manchester General Hospital | Manchester | England | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | England | United Kingdom |
| Gartnavel General Hospital | Glasgow | Scotland | United Kingdom |
| Queen Alexandra Hospital | Portsmouth | United Kingdom |
| Background | Mangia A, Lawitz E, Gane E Conway B, Ruane PJ, Abergel A, et al. Long-Term Follow-up of Patients with Chronic HCV Infection and Compensated or Decompensated Cirrhosis Following Treatment with Sofosbuvir-Based Regimens. The International Liver Congressâ„¢ EASL - European Association for the Study of the Liver (EASL); 2018 April 11-15. |
| Background | Muir AJ, Buti M, Nahass R, Agarwal K, Gane EJ, Strasser SI, et al. Long-term Follow-up of Patients With Chronic HCV Infection and Compensated or Decompensated Cirrhosis Following Treatment With Sofosbuvir-Based Regimens [Poster 880]. AASLD: The Liver Meeting® 2019, November 11-15. |
| Background | Reddy KR, Bourlière M, Agarwal K, Lawitz E, Osinusi A, Kersey K, et al. Sustained Viral Response Following Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C and the Risk of Hepatocellular Carcinoma [Poster FRI-185]. The International Liver Congress™ EASL - European Association for the Study of the Liver (EASL); 2017 19-23 April. |
| Background | Reddy R, Muir A, Naggie S, Lawitz E, Gane E, Conway B et al. Noninvasive Tests of Fibrosis and Risk of Liver-Related Complications: Lessons From Patients With HCV Cirrhosis Following Successful Sofosbuvir-Based Treatment [Poster 452]. The International Liver Congressâ„¢ EASL - European Association for the Study of the Liver (EASL); 2020 27-29 August. |
| Background | Reddy R, Muir A, Naggie S, Lawitz E, Gane E, Conway B et al. Non-invasive tests of fibrosis and risk of liver-related complications: observations following successful sofosbuvir-based treatment in patients with HCV cirrhosis. J Hepatology 2020;73: S401-S652. |
| 33493697 | Derived | Younossi ZM, Racila A, Muir A, Bourliere M, Mangia A, Esteban R, Zeuzem S, Colombo M, Manns M, Papatheodoridis GV, Buti M, Chokkalingam A, Gaggar A, Nader F, Younossi I, Henry L, Stepanova M. Long-term Patient-Centered Outcomes in Cirrhotic Patients With Chronic Hepatitis C After Achieving Sustained Virologic Response. Clin Gastroenterol Hepatol. 2022 Feb;20(2):438-446. doi: 10.1016/j.cgh.2021.01.026. Epub 2021 Jan 22. |
| FG002 | LDV/SOF+RBV | Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years. |
| FG003 | SOF/VEL | Participants who were previously treated with SOF/velpatasvir (VEL) were followed up to 5 years. |
| FG004 | SOF/VEL+RBV | Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years. |
| FG005 | SOF/VEL/VOX | Participants who were previously treated with SOF/VEL/voxilaprevir (VOX) with or without RBV were followed up to 5 years. |
| FG006 | Other SOF-Based | Participants who previously received other SOF based regimen were followed up to 5 years. |
| FG007 | Enrolled From Ineligible Parent Treatment Group | Participants were enrolled from ineligible parent treatment group. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set included participants who met all inclusion criteria and did not meet any of the exclusion criteria, and with at least one post-enrollment visit measurement available.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SOF+RBV | Participants who were previously treated with SOF along with RBV were followed up to 5 years. |
| BG001 | LDV/SOF | Participants who were previously treated with SOF/LDV were followed up to 5 years. |
| BG002 | LDV/SOF+RBV | Participants who were previously treated with SOF/LDV along with RBV were followed up to 5 years. |
| BG003 | SOF/VEL | Participants who were previously treated with SOF/VEL were followed up to 5 years. |
| BG004 | SOF/VEL+RBV | Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years. |
| BG005 | SOF/VEL/VOX | Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years. |
| BG006 | Other SOF-Based | Participants who previously received other SOF based regimen were followed up to 5 years. |
| BG007 | 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 | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 Maintaining Sustained Virologic Response (SVR) at Week 240 | SVR at Week 240 was defined as HCV RNA< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter [IU/mL]) or last available HCV RNA< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model. | Full Analysis Set included all participants who met all inclusion criteria and did not meet any of the exclusion criteria, and with at least one post-enrollment visit measurement available. | Posted | Number | percentage of participants | Week 240 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Any Liver-Associated Events | The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model. | Participants in Full Analysis Set who did not develop liver-associated event prior to entering the registry were analyzed. | Posted | Number | percentage of participants | Enrollment up to 240 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240 | Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model. | Participants in the Full Analysis Set with no HCC prior to this registry study were analyzed. | Posted | Number | percentage of participants | Enrollment up to 240 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240 | Participants in Full Analysis Set were analyzed. | Posted | Count of Participants | Participants | Enrollment up to 240 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Detectable HCV Resistance Mutations Through Week 240 | Participants in Full Analysis Set were analyzed. | Posted | Count of Participants | Participants | Enrollment up to 240 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240 | Reinfection was defined as HCV RNA > LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study. | Participants in Full Analysis Set were analyzed. | Posted | Count of Participants | Participants | Enrollment up to 240 weeks |
|
All-Cause Mortality and Adverse Events (AEs): From enrollment up to maximum duration of 5 years
All-Cause Mortality: Included participants who signed informed consent and enrolled into study.
AEs: Included all participants who met all inclusion criteria and did not meet any of exclusion criteria, and with at least one post-enrollment visit measurement available; no participants were included in 'Enrolled from Ineligible Parent Treatment Group'. No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
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+RBV | Participants who were previously treated with SOF along with RBV were followed up to 5 years. | 3 | 95 | 0 | 94 | 0 | 94 |
| EG001 | LDV/SOF | Participants who were previously treated with LDV/SOF were followed up to 5 years. | 11 | 277 | 0 | 275 | 4 | 275 |
| EG002 | LDV/SOF+RBV | Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years. | 16 | 265 | 0 | 263 | 1 | 263 |
| EG003 | SOF/VEL | Participants who were previously treated with SOF/VEL were followed up to 5 years. | 22 | 374 | 0 | 372 | 1 | 372 |
| EG004 | SOF/VEL+RBV | Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years. | 8 | 100 | 0 | 98 | 0 | 98 |
| EG005 | SOF/VEL/VOX | Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years. | 17 | 338 | 0 | 332 | 1 | 332 |
| EG006 | Other SOF-Based | Participants who previously received other SOF based regimen were followed up to 5 years. | 3 | 141 | 0 | 139 | 1 | 139 |
| EG007 | Enrolled From Ineligible Parent Treatment Group | Participants were enrolled from ineligible parent treatment group. | 0 | 19 | 0 | 0 | 0 | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel puncture site haematoma | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Incision site rash | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 24.1 | 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 | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 13, 2022 | Nov 3, 2022 | SAP_001.pdf |
| 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 |
|---|---|
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| C000595958 | ledipasvir, sofosbuvir drug combination |
| C000611331 | sofosbuvir-velpatasvir drug combination |
| C000654129 | sofosbuvir velpatasvir voxilaprevir drug combination |
| 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 |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Canada |
|
| United States |
|
| Italy |
|
| United Kingdom |
|
| Australia |
|
| France |
|
| Germany |
|
| Spain |
|
| OG004 |
| SOF/VEL+RBV |
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years. |
| OG005 | SOF/VEL/VOX | Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years. |
| OG006 | Other SOF-Based | Participants who previously received other SOF based regimen were followed up to 5 years. |
|
|
| OG004 | SOF/VEL+RBV | Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years. |
| OG005 | SOF/VEL/VOX | Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years. |
| OG006 | Other SOF-Based | Participants who previously received other SOF based regimen were followed up to 5 years. |
|
|
| OG005 | SOF/VEL/VOX | Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years. |
| OG006 | Other SOF-Based | Participants who previously received other SOF based regimen were followed up to 5 years. |
|
|
| OG005 | SOF/VEL/VOX | Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years. |
| OG006 | Other SOF-Based | Participants who previously received other SOF based regimen were followed up to 5 years. |
|
|
| SOF/VEL+RBV |
Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years. |
| OG005 | SOF/VEL/VOX | Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years. |
| OG006 | Other SOF-Based | Participants who previously received other SOF based regimen were followed up to 5 years. |
|
|