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The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bemnifosbuvir-Ruzasvir (BEM/RZR) | Experimental |
| |
| Sofosbuvir-Velpatasvir (SOF/VEL) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bemnifosbuvir-Ruzasvir (BEM/RZR) | Drug | BEM/RZR Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 8 weeks (in those without cirrhosis) or 12 weeks (in those with compensated cirrhosis) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24. | Day 1 through Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs. | Day 1 through 12 weeks after the end of treatment | |
| Proportion of subjects experiencing virologic failure. | Day 1 through Week 24 |
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Key Inclusion Criteria:
Use of adequate contraception for females of childbearing potential
Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV)
Documented medical history compatible with chronic HCV
Either no liver cirrhosis or with compensated liver cirrhosis
If HIV-1-positive, must meet the following 2 criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atea Study Site | Birmingham | Alabama | 35215 | United States | ||
| Atea Study Site |
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| Sofosbuvir-Velpatasvir (SOF/VEL) | Drug | SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks |
|
| Dothan |
| Alabama |
| 36301 |
| United States |
| Atea Study Site | Chandler | Arizona | 85225 | United States |
| Atea Study Site | Flagstaff | Arizona | 86001 | United States |
| Atea Study Site | Mesa | Arizona | 85210 | United States |
| Atea Study Site | Phoenix | Arizona | 85006 | United States |
| Atea Study Site | Phoenix | Arizona | 85015 | United States |
| Atea Study Site | Tucson | Arizona | 85745 | United States |
| Atea Study Site | Little Rock | Arkansas | 72204 | United States |
| Atea Study Site | Bakersfield | California | 93301 | United States |
| Atea Study Site | Coronado | California | 92118 | United States |
| Atea Study Site | Escondido | California | 92025 | United States |
| Atea Study Site | Fresno | California | 93711 | United States |
| Atea Study Site | Long Beach | California | 98015 | United States |
| Atea Study Site | Los Angeles | California | 90048 | United States |
| Atea Study Site | Los Angeles | California | 90067 | United States |
| Atea Study Site | Orange | California | 92868 | United States |
| Atea Study Site | Pasadena | California | 91105 | United States |
| Atea Study Site | Sacramento | California | 95817 | United States |
| Atea Study Site | Torrance | California | 90502 | United States |
| Atea Study Site | Valencia | California | 91355 | United States |
| Atea Study Site | Colorado Springs | Colorado | 80907 | United States |
| Atea Study Site | Washington D.C. | District of Columbia | 20017 | United States |
| Atea Study Site | Washington D.C. | District of Columbia | 20037 | United States |
| Atea Study Site | Coral Gables | Florida | 33134 | United States |
| Atea Study Site | DeLand | Florida | 32720 | United States |
| Atea Study Site | Fort Lauderdale | Florida | 33308 | United States |
| Atea Study Site | Ft. Pierce | Florida | 34982 | United States |
| Atea Study Site | Gainesville | Florida | 32610 | United States |
| Atea Study Site | Inverness | Florida | 34452 | United States |
| Atea Study Site | Jupiter | Florida | 33458 | United States |
| Atea Study Site | Lauderdale Lakes | Florida | 33313 | United States |
| Atea Study Site | Maitland | Florida | 32751 | United States |
| Atea Study Site | Miami | Florida | 33125 | United States |
| Atea Study Site | Miami Lakes | Florida | 33014 | United States |
| Atea Study Site | Orlando | Florida | 32803 | United States |
| Atea Study Site | Pembroke Pines | Florida | 33024 | United States |
| Atea Study Site | Sarasota | Florida | 34237 | United States |
| Atea Study Site | West Palm Beach | Florida | 33407 | United States |
| Atea Study Site | Macon | Georgia | 31201 | United States |
| Atea Study Site | Marietta | Georgia | 30060 | United States |
| Atea Study Site | Chicago | Illinois | 60613 | United States |
| Atea Study Site | New Albany | Indiana | 47150 | United States |
| Atea Study Site | Fairway | Kansas | 66205 | United States |
| Atea Study Site | Topeka | Kansas | 66606 | United States |
| Atea Study Site | Louisville | Kentucky | 40218 | United States |
| Atea Study Site | New Iberia | Louisiana | 70560 | United States |
| Atea Study Site | New Orleans | Louisiana | 70112 | United States |
| Atea Study Site | Baltimore | Maryland | 21201 | United States |
| Atea Study Site | Baltimore | Maryland | 21287 | United States |
| Atea Study Site | Boston | Massachusetts | 02114 | United States |
| Atea Study Site | Boston | Massachusetts | 02118 | United States |
| Atea Study Site | Springfield | Massachusetts | 01105 | United States |
| Atea Study Site | Worcester | Massachusetts | 01655 | United States |
| Atea Study Site | Detroit | Michigan | 48201 | United States |
| Atea Study Site | Grosse Pointe Woods | Michigan | 48236 | United States |
| Atea Study Site | Novi | Michigan | 48377 | United States |
| Atea Study Site | Wyoming | Michigan | 49519 | United States |
| Atea Study Site | Tupelo | Mississippi | 38801 | United States |
| Atea Study Site | Camden | New Jersey | 08103 | United States |
| Atea Study Site | Hackensack | New Jersey | 07601 | United States |
| Atea Study Site | Hillsborough | New Jersey | 08844 | United States |
| Atea Study Site | Newark | New Jersey | 07102 | United States |
| Atea Study Site | Newark | New Jersey | 07103 | United States |
| Atea Study Site | Brooklyn | New York | 11215 | United States |
| Atea Study Site | New York | New York | 10016 | United States |
| Atea Study Site | Yonkers | New York | 10701 | United States |
| Atea Study Site | Asheville | North Carolina | 28801 | United States |
| Atea Study Site | Charlotte | North Carolina | 28204 | United States |
| Atea Study Site | Fayetteville | North Carolina | 28304 | United States |
| Atea Study Site | Beavercreek | Ohio | 45440 | United States |
| Atea Study Site | Cincinnati | Ohio | 45267 | United States |
| Atea Study Site | Tulsa | Oklahoma | 74104 | United States |
| Atea Study Site | Allentown | Pennsylvania | 18103 | United States |
| Atea Study Site | DuBois | Pennsylvania | 15801 | United States |
| Atea Study Site | Philadelphia | Pennsylvania | 19104 | United States |
| Atea Study Site | Philadelphia | Pennsylvania | 19107 | United States |
| Atea Study Site | Charleston | South Carolina | 29425 | United States |
| Atea Study Site | Chattanooga | Tennessee | 37421 | United States |
| Atea Study Site | Cordova | Tennessee | 38018 | United States |
| Atea Study Site | Jackson | Tennessee | 38301 | United States |
| Atea Study Site | Arlington | Texas | 76012 | United States |
| Atea Study Site | Dallas | Texas | 75203 | United States |
| Atea Study Site | Dallas | Texas | 75242 | United States |
| Atea Study Site | Denison | Texas | 75020 | United States |
| Atea Study Site | Houston | Texas | 77030 | United States |
| Atea Study Site | Plano | Texas | 75093 | United States |
| Atea Study Site | San Antonio | Texas | 78215 | United States |
| Atea Study Site | Temple | Texas | 76508 | United States |
| Atea Study Site | Waco | Texas | 76710 | United States |
| Atea Study Site | Ogden | Utah | 84405 | United States |
| Atea Study Site | Chesapeake | Virginia | 23320 | United States |
| Atea Study Site | Norfolk | Virginia | 23502 | United States |
| Atea Study Site | Richmond | Virginia | 23226 | United States |
| Atea Study Site | Richmond | Virginia | 23298 | United States |
| Atea Study Site | Seattle | Washington | 98101 | United States |
| Atea Study Site | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Atea Study Site | Moncton | New Brunswick | E1C6Z8 | Canada |
| Atea Study Site | St. John's | Newfoundland and Labrador | A1B3V6 | Canada |
| Atea Study Site | Brampton | Ontario | L6R 3J7 | Canada |
| Atea Study Site | Ottawa | Ontario | K1H8L6 | Canada |
| Atea Study Site | Toronto | Ontario | M5G2C4 | Canada |
| Atea Study Site | Montreal | Quebec | H4A3J1 | Canada |
| Atea Study Site | Québec | Quebec | G1V 4T3 | Canada |
| Atea Study Site | Québec | Quebec | G1V4G2 | Canada |
| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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