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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 | 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 |
|---|---|---|
| Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at 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 as measured by HCV RNA RT-qPCR | 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 | Cairo | 11796 | Egypt | |||
| Atea Study Site |
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|
| Sofosbuvir-Velpatasvir | Drug | SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks |
|
|
| Nice |
| Alpes Maritimes |
| 06202 |
| France |
| Atea Study Site | Strasbourg | Bas Rhin | 67091 | France |
| Atea Study Site | Clichy | Hauts De Seine | 92110 | France |
| Atea Study Site | Montpellier | Herault | 34295 | France |
| Atea Study Site | Clermont-Ferrand | Puy De Dome | 63003 | France |
| Atea Study Site | Créteil | Val De Marne | 94010 | France |
| Atea Study Site | Frankfurt am Main | Hesse | 60590 | Germany |
| Atea Study Site | Leipzig | Saxony | 04103 | Germany |
| Atea Study Site | Hamburg | 20246 | Germany |
| Atea Study Site | Alexandroupoli | 68100 | Greece |
| Atea Study Site | Athens | 10676 | Greece |
| Atea Study Site | Athens | 11527 | Greece |
| Atea Study Site | Heraklion | 71110 | Greece |
| Atea Study Site | Rhodes | 85100 | Greece |
| Atea Study Site | Hyderabad | Andhra Pradesh | 500082 | India |
| Atea Study Site | Patna | Bihar | 800014 | India |
| Atea Study Site | Rajkot | Gujarat | 360005 | India |
| Atea Study Site | Surat | Gujarat | 395002 | India |
| Atea Study Site | Shimla | Himachal Pradesh | 171006 | India |
| Atea Study Site | Belagavi | Karnataka | 590010 | India |
| Atea Study Site | Kochi | Kerala | 682041 | India |
| Atea Study Site | Mumbai | Maharashtra | 400008 | India |
| Atea Study Site | Mumbai | Maharashtra | 400012 | India |
| Atea Study Site | Nagpur | Maharashtra | 440010 | India |
| Atea Study Site | Pune | Maharashtra | 411004 | India |
| Atea Study Site | Pune | Maharashtra | 411023 | India |
| Atea Study Site | Chandigarh | Punjab | 151001 | India |
| Atea Study Site | Ludhiana | Punjab | 141001 | India |
| Atea Study Site | Agra | Uttar Pradesh | 282002 | India |
| Atea Study Site | Kanpur | Uttar Pradesh | 208002 | India |
| Atea Study Site | Lucknow | Uttar Pradesh | 226010 | India |
| Atea Study Site | Varanasi | Uttar Pradesh | 221005 | India |
| Atea Study Site | Kolkata | West Bengal | 700020 | India |
| Atea Study Site | Kota Bharu | Kelantan | 15586 | Malaysia |
| Atea Study Site | Kota Bharu | Kelantan | 16150 | Malaysia |
| Atea Study Site | Ampang | Kuala Lumpur | 68000 | Malaysia |
| Atea Study Site | Kuantan | Pahang | 25100 | Malaysia |
| Atea Study Site | Kota Kinabalu | Sabah | 88586 | Malaysia |
| Atea Study Site | Kuala Lumpur | 50586 | Malaysia |
| Atea Clinical Study Site | Chisinau | 2025 | Moldova |
| Atea Study Site | Islamabad | 44000 | Pakistan |
| Atea Study Site | Islamabad | 45600 | Pakistan |
| Atea Study Site | Karachi | 74800 | Pakistan |
| Atea Study Site | Karachi | 75190 | Pakistan |
| Atea Study Site | Karachi | 75300 | Pakistan |
| Atea Study Site | Karachi | 75600 | Pakistan |
| Atea Study Site | Lahore | 53100 | Pakistan |
| Atea Study Site | Lahore | 54700 | Pakistan |
| Atea Study Site | Lahore | 54800 | Pakistan |
| Atea Study Site | Peshawar | 25000 | Pakistan |
| Atea Study Site | Rawalpindi | 0000 | Pakistan |
| Atea Study Site | Krakow | 30-901 | Poland |
| Atea Study Site | Kłodzko | 57-300 | Poland |
| Atea Study Site | Lublin | 20-582 | Poland |
| Atea Study Site | Mysłowice | 41-400 | Poland |
| Atea Study Site | Warsaw | 00-124 | Poland |
| Atea Study Site | Wroclaw | 51-162 | Poland |
| Atea Study Site | Bucharest | 020125 | Romania |
| Atea Study Site | Bucharest | 021105 | Romania |
| Atea Study Site | Bucharest | 022328 | Romania |
| Atea Study Site | Bucharest | 030303 | Romania |
| Atea Study Site | Constanța | 900709 | Romania |
| Atea Study Site | Craiova | 200642 | Romania |
| Atea Study Site | Galati | 800179 | Romania |
| Atea Study Site | Iași | 700503 | Romania |
| Atea Study Site | Sibiu | 550245 | Romania |
| Atea Study Site | Suceava | 720201 | Romania |
| Atea Study Site | Port Elizabeth | Eastern Cape | 6001 | South Africa |
| Atea Study Site | Bloemfontein | Free State | 9301 | South Africa |
| Atea Study Site | Johannesburg | Gauteng | 1827 | South Africa |
| Atea Study Site | Johannesburg | Gauteng | 2092 | South Africa |
| Atea Study Site | Johannesburg | Gauteng | 2193 | South Africa |
| Atea Study Site | Pretoria | Gauteng | 0152 | South Africa |
| Atea Study Site | Brits | North West | 0250 | South Africa |
| Atea Study Site | Somerset West | Western Cape | 7130 | South Africa |
| Atea Study Site | Seoul | Gyeonggi-do | 120-752 | South Korea |
| Atea Study Site | Yangsan | Gyeongsangnam-do | 626-770 | South Korea |
| Atea Study Site | Busan | 47392 | South Korea |
| Atea Study Site | Busan | 49241 | South Korea |
| Atea Study Site | Seoul | 05505 | South Korea |
| Atea Study Site | Santander | Cantabria | 39008 | Spain |
| Atea Study Site | Málaga | Malaga | 29010 | Spain |
| Atea Study Site | Vigo | Pontevedra | 36211 | Spain |
| Atea Study Site | Barcelona | 08035 | Spain |
| Atea Study Site | Pathum Wan | Bangkok | 10330 | Thailand |
| Atea Study Site | Ratchathewi | Bangkok | 10400 | Thailand |
| Atea Study Site | Mueang Nonthaburi | Changwat Khon Kaen | 40002 | Thailand |
| Atea Study Site | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| Atea Study Site | Mueang Nonthaburi | Chiang Mai | 50200 | Thailand |
| Atea Study Site | Bangkok | 10330 | Thailand |
| Atea Study Site | Adana | 01790 | Turkey (Türkiye) |
| Atea Study Site | Ankara | 06100 | Turkey (Türkiye) |
| Atea Study Site | Ankara | 06800 | Turkey (Türkiye) |
| Atea Study Site | Bursa | 16310 | Turkey (Türkiye) |
| Atea Study Site | Denizli | 20070 | Turkey (Türkiye) |
| Atea Study Site | Diyarbakır | 2128 | Turkey (Türkiye) |
| Atea Study Site | Istanbul | 34785 | Turkey (Türkiye) |
| Atea Study Site | Kayseri | 38080 | Turkey (Türkiye) |
| Atea Study Site | Samsun | 55270 | Turkey (Türkiye) |
| Atea Study Site | Kyiv | 08173 | Ukraine |
| Atea Study Site | Lviv | 79000 | Ukraine |
| Atea Study Site | Haiphong | 180000 | Vietnam |
| Atea Study Site | Hanoi | 10000 | Vietnam |
| Atea Study Site | Ho Chi Minh City | 700000 | Vietnam |
| Atea Study Site | Ho Chi Minh City | 70000 | Vietnam |
| Atea Study Site | Ho Chi Minh City | 748806 | Vietnam |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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