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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldiâ„¢; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response [SVR]) versus risk (safety and resistance).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV 12 Weeks | Experimental | Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks. |
|
| SOF+RBV 24 Weeks | Experimental | Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks. |
|
| GS-0938 Alone | Experimental | Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks. |
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| GS-0938+SOF | Experimental | Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks. |
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| GS-0938+SOF+RBV | Experimental | Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 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 (SVR) 12 weeks after discontinuation of study drug (SVR12) | SVR12 was defined as HCV RNA < LLOQ 12 weeks after the last dose of all study drugs. | Post-treatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Adverse Events | Adverse events (AEs) were summarized across the participant population. A participant was counted once if they had a qualifying event. | Baseline to Week 24 plus 30 days |
| Change from baseline in HCV RNA |
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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 & Digestive Specialists | Montgomery | Alabama | 36116 | United States | ||
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| Placebo |
| Experimental |
Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks. |
|
| Retreatment Group - SOF+RBV 24 Weeks | Experimental | After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks. |
|
|
| GS-0938 | Drug | GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily |
|
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| RBV | Drug | Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
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| Placebo to match sofosbuvir | Drug | Placebo to match sofosbuvir administered orally once daily |
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| Placebo to match GS-0938 | Drug | Placebo to match GS-0938 administered orally once daily |
|
| Baseline to Week 12 |
| Percentage of Participants With HCV RNA < LLOQ during treatment | Baseline to Week 12 |
| Percentage of Participants With ALT Normalization | ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at a subsequent visit. | Baseline to post-treatment Week 4 |
| Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24) | SVR4 and SVR24 was defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of all study drugs, respectively. | Post-treatment Weeks 4 and 24 |
| Percentage of Participants Who Developed Resistance to Sofosbuvir | Baseline to Week 24 |
| Bakersfield |
| California |
| 93301 |
| United States |
| Coronado | California | 92118 | United States |
| La Mesa | California | 91942 | United States |
| Los Angeles | California | 90036 | United States |
| CLI | Los Angeles | California | 90048 | United States |
| UCSD Antiviral Research Center | San Diego | California | 92103 | United States |
| eStudy Site | San Diego | California | 92120 | United States |
| Medical Associates Research Group | San Diego | California | 92193 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| Denver | Colorado | 80220 | United States |
| Engelwood | Colorado | 80113 | United States |
| South Denver Gastroenterology | Englewood | Colorado | 80113 | United States |
| Washington D.C. | District of Columbia | 20009 | United States |
| Avail Clinical Research | DeLand | Florida | 32720 | United States |
| University of Florida Hepatology | Gainesville | Florida | 32610 | United States |
| University of Miami Center for Liver Diseases | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Internal Medicine Specialists | Orlando | Florida | 32806 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | 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 | Atlanta | Georgia | 30308 | United States |
| Atlanta | Georgia | 30308 | United States |
| Marietta | Georgia | 30060 | United States |
| Digestive Health Services | Downers Grove | Illinois | 60515 | United States |
| Investigative Clinical Research | Annapolis | Maryland | 21401 | United States |
| Baltimore | Maryland | 21229 | United States |
| ID Care | Hillsborough | New Jersey | 08844 | United States |
| Concorde Medical Group | New York | New York | 10016 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Ashville Gastroenterology Associates | Ashville | North Carolina | 28801 | United States |
| Carolina's Center for Liver Disease | Statesville | North Carolina | 28677 | United States |
| Digestive Health Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati | Ohio | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Nashville Gastrointestinal Specialists | Nashville | Tennessee | 37211 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| San Juan | Puerto Rico | 00909 | Puerto Rico |
| Fundacion de Investigacion de Diego | San Juan | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| 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 |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C556498 | PSI 352938 |
| 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 |
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