Drugs / tenofovir alafenamide
tenofovir alafenamide
also known as
TAF · TENOFOVIR ALAFENAMIDE FUMARATE · VEMLIDY · Tenofovir alafenamide (TAF) · GS-7340 · alafenamide tenofovir · GS-7340 HEMIFUMARATE · GS-7340-03 · +11 more
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 2 milestones | |||||
| Filed | US (FDA) | — | HIV infectious disease | 2015-07-01 | “In November 2014 , Gilead filed an NDA for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF...” gilead.com ↗ “Gilead filed another NDA in April 2015 for two doses of an investigational, fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF)” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2015-04-07 | “Announced that Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for two doses of an investigational fixed-dose combination of...” gilead.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | VEMLIDY | — | 2018-07-03 – 2024-03-27 | fda.gov ↗ |
| Approved | EU (EMA) | Genvoya | — | 2015-11-19 | europa.eu ↗ |
| Approved | US (FDA) | GENVOYA | — | 2015-11-05 | fda.gov ↗ |
Trials 150 · started per year
today
US approved 2015
EU approved 2015
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04302896 | Aug 2020 → Sep 2021 | HIV infectious disease | Rhonda Brand | Completed | No outcome recorded |
| Phase 0 | NCT04507607 | Aug → Dec 2020 | chronic hepatitis B virus infection | Third Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 123 trials | ||||||
| Phase 1 | NCT07349758 | Jan 2026 → Jan 2027 expected | — | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 1 | NCT07295873 | Dec 2025 → Jun 2026 overdue | fibrotic liver disease | Beijing Continent Pharmaceutical Co, Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06278389 | Jan → Apr 2024 | — | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT06274398 | Jan 2024 → Mar 2025 | — | Eastern Virginia Medical School | Completed | No outcome recorded |
| Phase 1 | NCT06087913 | Nov 2023 → Dec 2024 | — | Eastern Virginia Medical School | Completed | No outcome recorded |
| Phase 1 | NCT04950530 | Dec 2022 → Feb 2024 | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1 | NCT05489406 | Oct 2022 → Mar 2023 | HIV infectious disease | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT04906109 | Jul → Oct 2021 | hepatitis B virus infection | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04853524 | May → Jun 2021 | — | Janssen Research & Development, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04236453 | Jan → Apr 2020 | — | Janssen Pharmaceutica N.V., Belgium | Terminated | No outcome recorded |
| Phase 1 | NCT04047420 | Dec 2019 → Mar 2021 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT04424264 | Dec 2019 → Oct 2020 | HIV infectious disease, tuberculosis | Professor Francois Venter | Completed | No outcome recorded |
| Phase 1 | NCT03960645 | Jun 2019 → Jul 2022 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02437110 | Apr 2019 → Nov 2022 | amyotrophic lateral sclerosis | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 1 | NCT03836729 | Feb → Mar 2019 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT03762772 | Dec 2018 → Mar 2019 | HIV infectious disease | CONRAD | Completed | No outcome recorded |
| Phase 1 | NCT03510468 | Jun 2018 → Nov 2022 | — | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 1 | NCT02984852 | Dec 2016 → Feb 2017 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02904369 | Oct 2016 → Nov 2017 | HIV infectious disease | CONRAD | Completed | No outcome recorded |
| Phase 1 | NCT02475135 | Jun → Aug 2015 | — | Janssen Sciences Ireland UC | Completed | No outcome recorded |
| Phase 1 | NCT02357602 | Mar → Oct 2015 | — | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT02296853 | Dec 2014 → Apr 2015 | hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01671787 | Mar 2012 → Apr 2013 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06122454 | Nov 2022 → Jun 2024 | — | Xi'an Xintong Pharmaceutical Research Co.,Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT03251144 | Apr 2019 → Jul 2021 | AIDS, mitochondrial disease, poisoning | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 1/2 | NCT00036634 | Mar 2002 → Feb 2003 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT06589518 | Mar 2025 → Mar 2026 overdue | hepatitis B virus infection, impaired renal function disease | Jongman Kim | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06338826 | Feb 2025 → Sep 2027 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05993767 | Dec 2024 → Jun 2025 | HIV infectious disease | PENTA Foundation | Completed | No outcome recorded |
| Phase 2 | NCT04880577 | Sep 2022 → Feb 2024 | relapsing-remitting multiple sclerosis | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05404919 | Sep 2022 → Aug 2024 | hepatitis B virus infection | University of Pennsylvania | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05052996 | Oct 2021 → Dec 2023 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04483674 | Dec 2020 → Nov 2022 | primary viral infectious disease | Anna Cruceta | Unknown | No outcome recorded |
| Phase 2 | NCT03804372 | Jul 2020 → May 2024 | diffuse large B-cell lymphoma, lymphoid leukemia | GIMEMA Foundation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03115736 | May 2017 → Dec 2019 | hepatitis B virus infection | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 2 | NCT02932150 | Nov 2016 → Sep 2026 overdue | chronic hepatitis B virus infection | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02862548 | Sep 2016 → Feb 2018 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02556333 | Sep 2015 → Aug 2016 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT02397694 | Mar → Nov 2015 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/36 trials | ||||||
| Phase 2/3 | NCT05140954 | Apr → Dec 2023 | HIV infectious disease | University of Washington | Completed | No outcome recorded |
| Phase 2/3 | NCT02881320 | Sep 2016 → Mar 2025 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT02285114 | Jan 2015 → Nov 2019 | — | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT02276612 | Dec 2014 → Nov 2016 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT02016924 | Jan 2014 → Jun 2025 overdue | AIDS | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT01854775 | May 2013 → May 2020 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 331 trials · 13 met primary | ||||||
| Phase 3 | NCT06630286 | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT05813964 | Jun 2024 → Dec 2027 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT06333808 | Mar 2024 → Oct 2025 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT05735535 | Oct 2023 → Sep 2025 | HIV infectious disease | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Unknown | No outcome recorded |
| Phase 3 | NCT05630755 | Feb 2023 → Oct 2024 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | Met primary |
| Phase 3 | NCT05457530 | Aug 2022 → May 2023 | HIV infectious disease, abdominal obesity-metabolic syndrome, obesity disorder | Prism Health North Texas | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04937881 | Jun 2022 → Apr 2023 | HIV infectious disease | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 3 | NCT04994509 | Aug 2021 → May 2024 overdue | — | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04416906 | Oct 2020 → May 2023 | HIV infectious disease | Judit Pich Martínez | Completed | No outcome recorded |
| Phase 3 | NCT04653194 | Sep 2020 → Jul 2023 | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Completed | No outcome recorded |
| Phase 3 | NCT04405271 | Jul → Nov 2020 | COVID-19 | Hospital Italiano de Buenos Aires | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04155554 | Jan → Aug 2020 | HIV infectious disease | University Hospital of Siena | Unknown | No outcome recorded |
| Phase 3 | NCT03887702 | Jan 2020 → Dec 2022 | cancer, hepatitis B virus infection | SWOG Cancer Research Network | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04051970 | Nov 2019 → Jun 2022 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03727152 | May 2019 → Apr 2023 | HIV infectious disease | The HIV Netherlands Australia Thailand Research Collaboration | Completed | No outcome recorded |
| Phase 3 | NCT03048422 | Jan 2018 → Oct 2020 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Mixed |
| Phase 3 | NCT03489239 | Nov 2017 → Aug 2020 overdue | chronic hepatitis B virus infection | Thomas Jefferson University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02842086 | Sep 2016 → Jan 2019 | — | Gilead Sciences | Terminated | Met primary |
| Phase 3 | NCT02707601 | Apr 2016 → Sep 2017 | HIV infectious disease, hepatitis C virus infection | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02616029 | Dec 2015 → Oct 2018 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02603107 | Nov 2015 → May 2017 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02431247 | Jul 2015 → Mar 2017 | immunodeficiency disease | Janssen Sciences Ireland UC | Completed | Met primary |
| Phase 3 | NCT02469246 | Jun 2015 → Dec 2017 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02836249 | Jun 2015 → Mar 2017 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02836236 | Jun 2015 → Apr 2017 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02269917 | Mar 2015 → Feb 2017 | HIV infectious disease | Janssen R&D Ireland | Completed | Met primary |
| Phase 3 | NCT02345226 | Jan 2015 → Jun 2016 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02071082 | Feb 2014 → Jan 2015 | HIV infectious disease, hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01967940 | Oct 2013 → May 2015 | AIDS | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01940341 | Sep 2013 → Sep 2015 | chronic hepatitis B virus infection | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01940471 | Sep 2013 → Nov 2015 | chronic hepatitis B virus infection | Gilead Sciences | Completed | Met primary |
| Phase 460 trials · 4 met primary · 2 missed | ||||||
| Phase 4 | NCT07476339 | Jun 2026 → Jun 2027 expected | HIV infectious disease | CAN Community Health | Recruiting | No outcome recorded |
| Phase 4 | NCT07258251 | Jan 2026 → Dec 2028 expected | chronic hepatitis B virus infection | The Task Force for Global Health | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07678268 | Jul 2025 → Jul 2026 overdue | HIV infectious disease | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT07542951 | Dec 2024 → Dec 2028 expected | chronic hepatitis B virus infection | The Third Affiliated Hospital of Guangzhou Medical University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06337032 | Aug 2024 → Mar 2034 expected | HIV infectious disease | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT06602622 | Aug 2024 → Nov 2025 overdue | HIV wasting syndrome | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT06375304 | May 2024 → Jun 2026 overdue | HIV infectious disease | McGill University Health Centre/Research Institute of the McGill University Health Centre | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06374758 | Apr 2024 → May 2026 overdue | HIV infectious disease | University of Missouri-Columbia | Recruiting | No outcome recorded |
| Phase 4 | NCT06221657 | Feb 2024 → Dec 2026 expected | — | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06000657 | Aug 2023 → Feb 2025 | chronic hepatitis B virus infection | Daewoong Pharmaceutical Co. LTD. | Completed | Met primary |
| Phase 4 | NCT05898841 | May 2023 → Jul 2025 | HIV infectious disease, metabolic dysfunction-associated steatotic liver disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT04944654 | Jan → May 2023 | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT05663892 | Nov 2022 → Nov 2024 overdue | HIV infectious disease | Maple Leaf Research | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05243602 | Feb 2022 → Apr 2023 | HIV infectious disease | University of Nairobi | Completed | No outcome recorded |
| Phase 4 | NCT05182463 | Jan 2022 → Dec 2026 expected | chronic hepatitis B virus infection | Third Affiliated Hospital, Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 4 | NCT04388904 | Sep 2021 → Apr 2024 | HIV infectious disease | The Crofoot Research Center, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04780204 | Aug 2021 → Jan 2027 expected | chronic hepatitis B virus infection | Asan Medical Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05001672 | Aug 2021 → Jun 2025 | arthritic joint disease, chronic hepatitis B virus infection | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
| Phase 4 | NCT04997564 | Aug 2021 → Dec 2023 | chronic hepatitis B virus infection, chronic hepatitis C virus infection | Peking University First Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05063071 | Jul 2021 → Jul 2022 | hepatitis B virus infection | Fudan University | Unknown | No outcome recorded |
| Phase 4 | NCT04619082 | Jul 2021 → Dec 2024 overdue | disease arising from reactivation of latent virus | Chiayi Christian Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05147740 | Jul 2021 → Dec 2022 | HIV infectious disease | Tulika Singh, MD | Unknown | No outcome recorded |
| Phase 4 | NCT05410496 | Jun 2021 → May 2024 overdue | chronic hepatitis B virus infection | Taichung Veterans General Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05853718 | May 2021 → Dec 2025 overdue | chronic hepatitis B virus infection | First People's Hospital of Hangzhou | Recruiting | No outcome recorded |
| Phase 4 | NCT04201808 | May 2021 → Sep 2023 | chronic hepatitis B virus infection | New Discovery LLC | Unknown | No outcome recorded |
| Phase 4 | NCT04850950 | Apr 2021 → Dec 2022 | chronic hepatitis B virus infection | The First Affiliated Hospital of Zhengzhou University | Unknown | No outcome recorded |
| Phase 4 | NCT04939441 | Apr 2021 → May 2024 | chronic hepatitis B virus infection | Jidong Jia | Unknown | No outcome recorded |
| Phase 4 | NCT05177926 | Apr 2021 → Dec 2023 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT04530630 | Nov 2020 → Aug 2024 | HIV infectious disease, transplant rejection | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT06177574 | Oct 2020 → Oct 2023 | HIV infectious disease | Carmen Hidalgo Tenorio | Completed | No outcome recorded |
| Phase 4 | NCT04290936 | Oct 2020 → Dec 2023 | — | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
| Phase 4 | NCT04496882 | Sep 2020 → Jan 2025 overdue | chronic hepatitis B virus infection | National Taiwan University Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04683341 | Sep 2020 → Jan 2021 | chronic hepatitis B virus infection | Kaohsiung Medical University Chung-Ho Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04311957 | Sep 2020 → May 2022 | HIV infectious disease | Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic | Unknown | Met primary |
| Phase 4 | NCT04674423 | May 2020 → Dec 2025 | chronic hepatitis B virus infection | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04295460 | Mar 2020 → Jan 2022 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Unknown | Missed primary |
| Phase 4 | NCT04054089 | Jan 2020 | HIV infectious disease | Cristina Mussini | Completed | Missed primary |
| Phase 4 | NCT04538040 | Dec 2019 → Nov 2021 | HIV infectious disease | Quest Clinical Research | Completed | No outcome recorded |
| Phase 4 | NCT03858478 | Nov 2019 → Mar 2021 | — | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | Unknown | No outcome recorded |
| Phase 4 | NCT04039217 | Sep 2019 → Aug 2020 | HIV infectious disease | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT04034368 | Aug 2019 → Jun 2021 | chronic hepatitis B virus infection | The First Hospital of Jilin University | Unknown | No outcome recorded |
| Phase 4 | NCT03797014 | Apr 2019 → Nov 2022 | HIV infectious disease, hepatitis B virus infection | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT03798119 | Feb 2019 → Aug 2020 | chronic hepatitis B virus infection, fibrotic liver disease | Kaohsiung Medical University Chung-Ho Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03753074 | Feb 2019 → Dec 2031 expected | chronic hepatitis B virus infection | Young-Suk Lim | Active not recruiting | Met primary |
| Phase 4 | NCT04070079 | Jan 2019 → Aug 2022 | chronic hepatitis B virus infection | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 4 | NCT03499483 | Jan 2019 → Mar 2020 | — | Fenway Community Health | Completed | No outcome recorded |
| Phase 4 | NCT03348163 | Jun 2018 → Dec 2020 | HIV infectious disease | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04225325 | May 2018 → Sep 2019 | HIV infectious disease | ADRIANO LAZZARIN, MD | Unknown | No outcome recorded |
| Phase 4 | NCT03471624 | May 2018 → Apr 2022 | chronic hepatitis B virus infection | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT03693508 | Apr 2018 → May 2020 | HIV infectious disease, immunodeficiency disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT03126370 | Jan 2018 → Jul 2019 | coinfection, hepatitis C virus infection | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT03356834 | Dec 2017 → Oct 2024 | chronic hepatitis B virus infection | Humanity and Health Research Centre | Completed | No outcome recorded |
| Phase 4 | NCT03350672 | Nov 2017 → Mar 2018 | HIV infectious disease | Philadelphia Fight | Completed | No outcome recorded |
| Phase 4 | NCT03241641 | Oct 2017 → Mar 2021 | chronic hepatitis B virus infection | Young-Suk Lim | Completed | Met primary |
| Phase 4 | NCT02815566 | Sep 2017 → Feb 2021 | HIV infectious disease, osteoporosis | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 4 | NCT02957994 | Dec 2016 → Jun 2017 | hepatitis B virus infection | Asian Pacific Liver Center at Coalition of Inclusive Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT02957864 | Oct 2016 → Jun 2020 | HIV infectious disease, chronic kidney disease, poisoning | Erasmus Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02771054 | May 2016 → Jul 2018 | HIV infectious disease | Göteborg University | Completed | No outcome recorded |
| Phase 4 | NCT02656511 | Dec 2015 → May 2027 expected | HIV infectious disease | University of California, San Francisco | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03695029 | Dec 2010 → Dec 2020 | hepatitis B virus infection | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase not applicable12 trials | ||||||
| — | NCT06947356 | May 2025 → May 2028 expected | hepatitis B virus infection | Guangzhou 8th People's Hospital | Recruiting | No outcome recorded |
| — | NCT05453448 | May 2022 | interferon antiviral depressor | Xiangya Hospital of Central South University | Completed | No outcome recorded |
| — | NCT06707922 | Mar 2022 → May 2029 expected | chronic hepatitis B virus infection | Xiamen Amoytop Biotech Co., Ltd. | Enrolling by invitation | No outcome recorded |
| — | NCT05195450 | Feb 2022 → Dec 2027 expected | chronic hepatitis B virus infection | Institute of Liver and Biliary Sciences, India | Recruiting | No outcome recorded |
| — | NCT04593680 | Jan 2022 → Oct 2023 overdue | — | Thai Red Cross AIDS Research Centre | Active not recruiting | No outcome recorded |
| — | NCT04703465 | Apr 2021 → Apr 2022 | hepatitis B virus infection | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT04501224 | Aug 2020 → Oct 2021 | chronic hepatitis B virus infection, cirrhosis of liver | Third Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| — | NCT03877536 | Mar 2019 → Sep 2023 | HIV infectious disease | Henry M. Jackson Foundation for the Advancement of Military Medicine | Withdrawn | No outcome recorded |
| — | NCT03920618 | Feb 2019 → Dec 2024 overdue | hepatitis B virus infection | Third Affiliated Hospital, Sun Yat-Sen University | Recruiting | No outcome recorded |
| — | NCT04195074 | Jan 2019 → Dec 2023 | chronic hepatitis B virus infection | Third Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| — | NCT04196998 | Jan 2019 → Dec 2023 | cirrhosis of liver, hepatitis B virus infection | Third Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| — | NCT03512964 | Nov 2016 → Sep 2020 | HIV infectious disease | Johns Hopkins University | Completed | No outcome recorded |
| Comparator or background therapy73 trials | ||||||
| Phase 0 | NCT07553767 Background | Mar 2026 → Dec 2034 expected | chronic hepatitis B virus infection, hepatocellular carcinoma | Ningbo No.2 Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05763576 Background | Apr 2023 → Dec 2024 | chronic hepatitis B virus infection | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT04629976 Comparator | Jan 2021 → Sep 2022 | chronic hepatitis B virus infection | Nucorion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03186482 Comparator | Jun 2017 → Jan 2018 | HIV infectious disease | St. Stephens Clinical Research | Completed | No outcome recorded |
| Phase 1 | NCT02962739 Comparator | Mar 2016 → May 2019 | — | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1/2 | NCT07711223 Comparator | Nov 2025 → Aug 2028 expected | HIV infectious disease | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06150014 Comparator | Dec 2023 → Dec 2025 overdue | chronic hepatitis B virus infection | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03577782 Background | Sep 2018 → May 2020 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Unknown | No outcome recorded |
| Phase 2 | NCT05652478 Comparator | Sep 2026 → Jan 2028 expected | — | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT07202546 Background | Feb 2026 → Jul 2027 expected | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 2 | NCT05719441 Background | Aug 2024 → Apr 2028 expected | — | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT06566248 Comparator | Mar → Sep 2024 | chronic hepatitis B virus infection | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05729568 Background | May 2023 → Jul 2024 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05467553 Background | Feb 2023 → Feb 2025 | hepatitis D virus infection | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05244057 Background | Aug 2022 → Jun 2024 | chronic hepatitis B virus infection | Shanghai HEP Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05275023 Background | Jun 2022 → Dec 2023 | chronic hepatitis B virus infection | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT05458765 Comparator | Jun 2022 → Dec 2023 | — | Eastern Virginia Medical School | Completed | No outcome recorded |
| Phase 2 | NCT05256823 Background | Feb 2022 → Nov 2023 | — | Lai Wei | Unknown | No outcome recorded |
| Phase 2 | NCT04891770 Background | Aug 2021 → Jan 2024 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT04820686 Background | May 2021 → Mar 2023 | chronic hepatitis B virus infection | Assembly Biosciences | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04585789 Background | Mar 2021 → Feb 2023 | chronic hepatitis B virus infection | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04667104 Background | Feb 2021 → May 2022 | chronic hepatitis B virus infection | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04454567 Background | Nov 2020 → Apr 2021 | chronic hepatitis B virus infection | Assembly Biosciences | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04535544 Background | Sep 2020 → Oct 2023 | hepatitis D virus infection | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT04439539 Background | Sep 2020 → Aug 2023 | chronic hepatitis B virus infection | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT04097925 Background | Feb → Aug 2020 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 2 | NCT04129554 Background | Nov 2019 → Jul 2021 | chronic hepatitis B virus infection | Janssen Sciences Ireland UC | Completed | Missed primary |
| Phase 2 | NCT04059198 Background | Oct 2019 → Apr 2020 | chronic hepatitis B virus infection | F-star Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03549689 Comparator | Aug 2019 → Jul 2021 | AIDS | Philip Grant | Withdrawn | No outcome recorded |
| Phase 2 | NCT03982186 Background | Aug 2019 → Mar 2021 | chronic hepatitis B virus infection | Janssen Sciences Ireland UC | Completed | Met primary |
| Phase 2 | NCT04012931 Background | Jul 2019 → Feb 2023 | HIV infectious disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT03780543 Comparator | Dec 2018 → Apr 2021 | chronic hepatitis B virus infection | Assembly Biosciences | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03615066 Background | Aug 2018 → Dec 2019 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT03576066 Background | Jun 2018 → Jul 2019 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | Missed primary |
| Phase 2 | NCT03491553 Background | Apr 2018 → Mar 2019 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT06613685 Comparator | Oct 2024 → Mar 2026 | HIV infectious disease | Gilead Sciences | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT06544733 Comparator | Aug 2024 → Jan 2028 expected | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07797231 Background | Sep 2026 → Sep 2028 expected | chronic hepatitis B virus infection | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07683000 Background | Jul 2026 → Mar 2029 expected | HIV infectious disease | Gilead Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07095855 Background | Aug 2025 → Jan 2028 expected | chronic hepatitis B virus infection | Shanghai Zhimeng Biopharma, Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07075146 Comparator | May 2025 → Jun 2026 overdue | HIV infectious disease, obesity disorder | José Antonio Mata Marín | Recruiting | No outcome recorded |
| Phase 3 | NCT06630299 Comparator | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT05979311 Comparator | Feb 2024 → Apr 2026 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | Met primary |
| Phase 3 | NCT05154747 Comparator | Jun 2023 → Mar 2025 | HIV infectious disease | University College, London | Unknown | Met primary |
| Phase 3 | NCT05705349 Comparator | Mar 2023 → Oct 2025 overdue | HIV infectious disease | Merck Sharp & Dohme LLC | Active not recruiting | Met primary |
| Phase 3 | NCT06544551 Background | Dec 2021 → Nov 2023 | chronic hepatitis B virus infection | Beijing Kawin Technology Share-Holding Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04925752 Background | Jun 2021 → Aug 2024 overdue | — | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT04542070 Comparator | Nov 2020 → Jul 2022 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT04079452 Background | Feb → Aug 2020 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 3 | NCT04223791 Comparator | Feb 2020 → Aug 2021 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT03227861 Background | Jul 2017 → Jan 2019 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT03122262 Comparator | Jan 2017 → Apr 2022 | HIV infectious disease | Professor Francois Venter | Completed | No outcome recorded |
| Phase 4 | NCT07138144 Comparator | Jul 2025 → Feb 2026 overdue | HIV infectious disease | José Antonio Mata Marín | Recruiting | No outcome recorded |
| Phase 4 | NCT07031063 Comparator | Apr 2025 → Dec 2026 expected | HIV infectious disease, metabolic syndrome X | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT07573943 Background | May 2024 → Dec 2026 expected | chronic hepatitis B virus infection | The Second Affiliated Hospital of Chongqing Medical University | Recruiting | No outcome recorded |
| Phase 4 | NCT04636437 Comparator | Jul 2021 → Oct 2024 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | Missed primary |
| Phase 4 | NCT04884139 Comparator | Jul 2021 → Feb 2024 | HIV infectious disease | Fundacion SEIMC-GESIDA | Completed | Met primary |
| Phase 4 | NCT04249037 Comparator | Dec 2020 → Jul 2023 | HIV infectious disease | University of Colorado, Denver | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04442737 Comparator | Jul 2020 → Aug 2023 | — | Janssen Scientific Affairs, LLC | Completed | Missed primary |
| Phase 4 | NCT04553081 Comparator | May 2020 → Mar 2026 | HIV infectious disease | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT03986697 Comparator | Feb 2020 → Mar 2021 | HIV infectious disease, coronary atherosclerosis | University of Liverpool | Withdrawn | No outcome recorded |
| Phase 4 | NCT04391608 Comparator | Nov 2019 → Jul 2022 | impaired renal function disease, poisoning | Mahidol University | Unknown | No outcome recorded |
| Phase 4 | NCT03933384 Comparator | Aug 2019 → Dec 2027 expected | hepatitis B virus infection | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT03604016 Comparator | Sep 2018 → Jul 2020 | hepatitis B virus infection | IlDong Pharmaceutical Co Ltd | Unknown | No outcome recorded |
| Phase 4 | NCT03447873 Comparator | Jun 2017 → Sep 2020 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Completed | No outcome recorded |
| — | NCT07809165 Comparator | Sep 2026 → Sep 2029 expected | chronic hepatitis B virus infection | Beijing 302 Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06323681 Comparator | Feb 2024 → Feb 2027 expected | chronic hepatitis B virus infection | Qing XIe | Recruiting | No outcome recorded |
| — | NCT05721300 Background | Feb 2023 → Dec 2024 | chronic hepatitis B virus infection, hepatocellular carcinoma | Zhongshan Hospital (Xiamen), Fudan University | Unknown | No outcome recorded |
| — | NCT05793268 Comparator | Dec 2022 → Dec 2025 overdue | chronic hepatitis B virus infection | E-DA Hospital | Active not recruiting | No outcome recorded |
| — | NCT05490836 Background | Sep 2022 → Aug 2024 | chronic hepatitis B virus infection | Huashan Hospital | Unknown | No outcome recorded |
| — | NCT04231565 Comparator | Jun 2020 → Jun 2024 overdue | chronic hepatitis B virus infection | Third Affiliated Hospital, Sun Yat-Sen University | Recruiting | No outcome recorded |
| — | NCT03825523 Background | Jan 2018 → Aug 2025 | HIV infectious disease | Gustavo Reyes-Teran | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 81
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | GlaxoSmithKline | Results Cabenuva demonstrates superiority to daily oral therapy in adolescents living with HIV, as ViiV Healthcare highlights new long-acting injectable data at AIDS 2026 gsk.com ↗
New real-world data from the US-based OPERA cohort showed CAB+RPV LA dosed every two months maintained virologic suppression comparable to daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in nearly 6,800 virologically suppressed adults living with HIV.2 |
| 2026-07-29 | ViiV Healthcare | Results CABENUVA DEMONSTRATES SUPERIORITY TO DAILY ORAL THERAPY IN ADOLESCENTS LIVING WITH HIV, AS ViiV HEALTHCARE HIGHLIGHTS NEW LONG-ACTING INJECTABLE DATA AT AIDS 2026 viivhealthcare.com ↗
New real-world data from the US-based OPERA cohort showed CAB+RPV LA dosed every two months maintained virologic suppression comparable to daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in nearly 6,800 virologically suppressed adults living with HIV. |
| 2026-07-27 | GlaxoSmithKline | Results ViiV Healthcare’s 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy in first-of-its-kind head-to-head study in treatment-naïve adults living with HIV gsk.com ↗
Data show that Dovato (dolutegravir/lamivudine (DTG/3TC)) demonstrated non-inferior efficacy to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)) in treatment-naïve adults living with HIV, including people with high viral loads or a low CD4+ cell count1. |
| 2026-06-11 | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Results 再下一城！ 艾迪药业ACC017、艾诺米替首次亮相美国微生物学会年会 aidea.com.cn ↗
进入联合治疗期后（联合FTC/TAF），至第29天，超过90%的参研者实现HIV-1 RNA < 50 copies/mL的病毒学抑制。 |
| 2026-05-25 | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Results INTEREST 2026 | 艾迪药业三项成果亮相非洲顶级HIV学术舞台 aidea.com.cn ↗
进入联合治疗（联合FTC/TAF）至第29天，各组病毒载量降幅均为2.82-2.83 log10 copies/mL，且80%-90%的受试者HIV-1 RNA <50 copies/mL。 |
| 2025-11-19 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Topline Results from the Pivotal Phase 3 Trial Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) in Treatment-Naïve Adults with HIV-1 Infection merck.com ↗
The success criterion for the primary efficacy hypothesis, as measured by the percentage of participants with HIV-1 RNA levels <50 copies/mL at Week 48, was met, with DOR/ISL demonstrating non-inferiority to once-daily oral bictegravir/emtricitabine/tenofovir alafenamide i [BIC/FTC/TAF (50 mg/200 mg/25 mg)]. |
| 2025-10-29 | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Regulatory HIV新药阵营+1！艾迪药业ADC118片首次获批临床 aidea.com.cn ↗
10月28日，国家药监局药品审评中心官网显示，艾迪药业（上交所代码：688488）自主研发的 抗 HIV 领域 1 类新药 ADC118 获准开展临床试验 ，适用于作为完整方案治疗人类免疫缺陷病毒1型（HIV-1）感染的成人。 |
| 2025-10-15 | Gilead Sciences | Results Gilead Presents New HIV Research Data at EACS 2025 – Driving Scientific Innovation in Treatment and Prevention gilead.com ↗
In the group of BICSTaR study participants with 5 years of real-world follow-up, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance. |
| 2025-04-17 | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Results 民族创新之光！艾诺米替144周数据发布 aidea.com.cn ↗ |
| 2024-12-18 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Emtricitabine and Tenofovir Alafenamide Tablets lupin.com ↗ |
| 2024-11-07 | Gilead Sciences | Results Late-Breaking Clinical Data and Real-World Evidence Presented at HIV Glasgow as Gilead Extends Leadership Efforts Toward Ending the Epidemic gilead.com ↗
Four-Year Outcomes From Real-World BICSTaR Study Further Demonstrate the Consistent Efficacy and Safety Profile of Biktarvy, Providing Insights for HIV Clinical Care |
| 2024-11-07 | ViiV Healthcare | Results ViiV HEALTHCARE EXPANDS ON REAL-WORLD DATA SUPPORTING USE OF LONG-ACTING THERAPIES IN DIVERSE PATIENT POPULATIONS AT HIV GLASGOW viivhealthcare.com ↗
RUMBA’s week 144 results confirm reassuring metabolic outcomes in both DTG/3TC and B/FTC/TAF |
| 2024-07-31 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Emtricitabine and Tenofovir Alafenamide Tablets lupin.com ↗ |
| 2024-07-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES POSITIVE DATA DEMONSTRATING 2-DRUG REGIMEN DOVATO IS AS EFFECTIVE AS 3-DRUG REGIMEN BIKTARVY FOR MAINTENANCE THERAPY OF HIV-1 viivhealthcare.com ↗
Findings showed that switching to DTG/3TC in virologically suppressed adults living with HIV demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF. |
| 2024-03-28 | Gilead Sciences | Regulatory FDA Expands Indication for Gilead's Vemlidy (Tenofovir Alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy ® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease. |
| 2023-11-03 | Gilead Sciences | Results Gilead to Present Late Breaking Data and Real World Evidence Highlighting Key Hepatitis Indications at The Liver Meeting® 2023 gilead.com ↗
No resistance to tenofovir alafenamide (TAF) in adult, HBeAg-positive and HBeAg-negative participants with chronic hepatitis B infection treated with TAF for up to 8 years |
| 2023-03-31 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Tenofovir Alafenamide Tablets lupin.com ↗ |
| 2023-02-23 | GlaxoSmithKline | Results ViiV Healthcare announces positive data demonstrating long-acting injectable Cabenuva (cabotegravir, rilpivirine) is as effective as daily oral Biktarvy (BIC/FTC/TAF) for the treatment of HIV-1 gsk.com ↗
12-month findings from the SOLAR study showed that the every-two-month regimen of CAB+RPV LA demonstrated non-inferior efficacy compared to continuation of daily oral BIC/FTC/TAF |
| 2023-02-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES POSITIVE DATA DEMONSTRATING LONG-ACTING INJECTABLE CABENUVA (CABOTEGRAVIR, RILPIVIRINE) IS AS EFFECTIVE AS DAILY ORAL BIKTARVY (BIC/FTC/TAF) FOR THE TREATMENT OF HIV-1 viivhealthcare.com ↗
Study findings showed that CAB+RPV LA dosed every two months achieved the primary endpoint of non-inferior virologic efficacy versus daily oral BIC/FTC/TAF, while 90% of participants who switched to CAB+RPV LA from BIC/FTC/TAF, and who completed a survey (n=425), preferred the long-acting regimen. |
| 2022-11-02 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Vemlidy® (tenofovir alafenamide) for Treatment of Chronic Hepatitis B Virus Infection in Pediatric Patients gilead.com ↗ |
| 2022-04-18 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Tenofovir Alafenamide Tablets lupin.com ↗ |
| 2021-11-09 | Gilead Sciences | Results Gilead to Present Data From Liver Disease Development Programs at The Liver Meeting® gilead.com ↗
In HBV, Gilead continues to expand upon the established safety and efficacy profile of Vemlidy ® (tenofovir alafenamide 25mg, TAF) with data demonstrating a sustained virological response in heavily pre-treated patients with multidrug-resistant HBV for up to 144 weeks (PO-812). |
| 2020-07-08 | Gilead Sciences | Results Gilead Sciences Presents Survey Findings on PrEP Access and Utilization in the U.S. During COVID-19 Shelter-in-Place Orders gilead.com ↗
Baseline prevalence and longitudinal trends in HIV-associated sexual risk behaviors during the DISCOVER trial suggest that risk compensation, defined as an increase in risk behavior due to a reduction in perceived risk, did not occur among study participants. |
| 2020-03-10 | Gilead Sciences | Results Gilead Presents 96-week DISCOVER Trial Data Demonstrating Favorable Renal and Bone Safety Profile of Descovy® for HIV PrEP in At-Risk Populations gilead.com ↗
The longer-term efficacy and safety outcomes from the DISCOVER trial continue to demonstrate that Descovy is effective for HIV prevention with non-inferior efficacy to Truvada, and that Descovy has an improved bone and renal safety profile compared with Truvada. |
| 2019-11-08 | Gilead Sciences | Results Gilead Announces New Data from Viral Hepatitis Research Programs at The Liver Meeting® 2019 gilead.com ↗
The HCC incidence observed in this study was significantly lower than the predicted incidence using the REACH-B model, particularly for patients without cirrhosis. |
| 2019-11-06 | Gilead Sciences | Results Gilead Presents 96-week Discover Trial Data Supporting Non-inferior Efficacy and Key Safety Differences of Descovy For PrEP™ Compared With Truvada For PrEP® gilead.com ↗
Descovy demonstrated non-inferior efficacy to Truvada through 96 weeks and statistically significant differences over Truvada for certain key measurements of bone and renal safety assessed in the study, which were pre-specified secondary endpoints. |
| 2019-11-06 | ViiV Healthcare | Results EACS 2019: ViiV HEALTHCARE TO PRESENT 17 ABSTRACTS FROM ITS PORTFOLIO ADDRESSING THE DIVERSE NEEDS OF PEOPLE LIVING WITH HIV viivhealthcare.com ↗
Week 48 data showing that switching to dolutegravir/lamivudine from a 3-drug TAF-based regimen was not associated with a higher frequency of intermittent viremia |
| 2019-10-04 | Gilead Sciences | Results Gilead Presents New Data From the Company’s HIV Clinical Development Program and Latest Findings on the Impact of HIV Pre-exposure Prophylaxis (PrEP) at IDWeek 2019 gilead.com ↗
showing significant improvements in key measures of bone and renal safety parameters |
| 2019-10-03 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Descovy® for HIV Pre-Exposure Prophylaxis (PrEP) gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). |
| 2019-07-22 | Gilead Sciences | Results Gilead Presents New Data on Biktarvy® for the Treatment of HIV in Women and in Virologically Suppressed Patients With Known Resistance gilead.com ↗
The studies further demonstrate the potential for Biktarvy to be an important treatment option for appropriate patients. |
| 2019-04-11 | Janssen Research & Development, LLC | Results Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks jnj.com ↗
A secondary endpoint of the study also showed that 97% of patients reported they were satisfied with their treatment. |
| 2019-04-11 | Gilead Sciences | Results Gilead Presents New Data on Viral Hepatitis at the International Liver Congress™ 2019 gilead.com ↗
In a Phase 3 study, 488 virologically suppressed adult patients with chronic HBV infection receiving once-daily TDF (300 mg) were randomized to remain on TDF or switch to Vemlidy (TAF 25 mg) for 48 weeks. |
| 2019-03-06 | Gilead Sciences | Results Gilead Presents New Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) and TAF-Based Regimens for the Treatment of HIV-1 in Children, Older Adults and Women gilead.com ↗
Through Week 48, Biktarvy maintained high rates of virologic suppression with a low incidence of study drug-related adverse events and no treatment-emergent resistance. |
| 2019-03-06 | Gilead Sciences | Results Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance gilead.com ↗
The studies found high rates of virologic suppression with Biktarvy in treatment-experienced adults, regardless of pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs). |
| 2019-03-06 | Gilead Sciences | Results Gilead Announces Data Demonstrating Non-Inferiority of Once-Daily Descovy® vs. Once-Daily Truvada® for Prevention of HIV Infection gilead.com ↗
Descovy met the pre-established criteria for non-inferiority to Truvada using a stringent rate ratio statistical comparison, as demonstrated by the upper bound of the 95 percent confidence interval for HIV-1 infection rate ratio being less than the predefined non-inferiority margin of 1.62/100 PY. |
| 2018-12-04 | Gilead Sciences | Regulatory China National Medical Products Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the China National Medical Products Administration (NMPA) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2018-11-18 | Gilead Sciences | Regulatory China National Medical Products Administration (NMPA) Approves Gilead’s Vemlidy® (Tenofovir Alafenamide) for Chronic Hepatitis B Virus (HBV) Infection gilead.com ↗ |
| 2018-11-09 | Gilead Sciences | Results Gilead Presents Latest Data from Viral Hepatitis Research Programs at The Liver Meeting® 2018 gilead.com ↗
Through three years of treatment, patients originally randomized to receive TAF continued to show an improved bone and renal safety profile compared to treatment with tenofovir disoproxil fumarate 300mg (TDF) with maintained viral suppression. |
| 2018-10-30 | Gilead Sciences | Results Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) (DTG+FTC/TAF) through 96 weeks of therapy. |
| 2018-10-03 | Gilead Sciences | Results Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC /DTG/3TC) through 96 weeks of therapy. |
| 2018-08-06 | Gilead Sciences | Regulatory China National Drug Administration Approves Gilead’s Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), a Single Tablet Regimen for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Drug Administration (CNDA) has approved Genvoya ® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. |
| 2018-06-25 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the European Commission has granted Marketing Authorization for Biktarvy ® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. |
| 2018-03-05 | Gilead Sciences | Results Gilead Presents Results from Phase 3 Study Evaluating Patients Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) from Regimen Containing Abacavir, Dolutegravir and Lamivudine gilead.com ↗
Through Week 48, Biktarvy was found to be statistically non-inferior to ABC /DTG/3TC with a numerically lower incidence of mild or moderate study drug-related adverse events and no treatment-emergent resistance. |
| 2018-03-05 | Gilead Sciences | Results Gilead Presents Data From Phase 3 Study Evaluating Women Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) From a Boosted Protease Inhibitor-Based Regimen or Boosted Elvitegravir-Containing Regimen gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to regimens containing a bPI or boosted elvitegravir and demonstrated no treatment-emergent resistance at 48 weeks. |
| 2018-02-07 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Biktarvy ® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. |
| 2017-10-25 | Janssen Research & Development, LLC | Results Investigational Darunavir-Based Single-Tablet Regimen Shows Positive Results in Previously Untreated HIV Patients in Pivotal Phase 3 AMBER Clinical Trial jnj.com ↗ |
| 2017-10-20 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread® gilead.com ↗
In addition, updated results from two Phase 3 studies demonstrating improved long-term bone and renal safety in HBV-infected patients one year after switching from Viread ® (tenofovir disoproxil fumarate 300mg) to Vemlidy ® (tenofovir alafenamide 25mg) will be presented on October 21 . |
| 2017-10-04 | Gilead Sciences | Results Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens gilead.com ↗
In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. |
| 2017-09-26 | Janssen Research & Development, LLC | Regulatory European Commission Approves Symtuza® for the Treatment of HIV-1 In Adults and Adolescents in Europe jnj.com ↗
European Commission Approves Symtuza® for the Treatment of HIV-1 In Adults and Adolescents in Europe |
| 2017-08-10 | Gilead Sciences | Regulatory Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has granted priority review for the company’s New Drug Application (NDA) for an investigational, fixed-dose combination |
| 2017-07-24 | Gilead Sciences | Results Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗
In the ongoing studies, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing dolutegravir (50mg) (DTG) in combination with a dual-NRTI backbone. |
| 2017-07-13 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗ |
| 2017-06-12 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment gilead.com ↗ |
| 2017-05-30 | Gilead Sciences | Results Gilead’s Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for the Treatment of HIV-1 Meets Primary Endpoint in Four Phase 3 Studies gilead.com ↗ |
| 2017-04-20 | Gilead Sciences | Results Gilead Presents Data at the International Liver Congress™ 2017 Supporting the Efficacy and Safety of Vemlidy in Patients with Chronic Hepatitis B After 96 Weeks, and Also After Switching From Viread gilead.com ↗ |
| 2017-02-13 | Gilead Sciences | Results Gilead Presents New Phase 2 Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV gilead.com ↗
Results found that the BIC+FTC/TAF and DTG+FTC/TAF regimens both demonstrated high virologic response rates at Week 24 and Week 48. |
| 2017-01-11 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Vemlidy® (Tenofovir Alafenamide, TAF) for the Treatment of Chronic Hepatitis B Virus Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Vemlidy ® (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (aged 12 years and older with body weight at least 35 kg). |
| 2016-12-19 | Gilead Sciences | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Vemlidy® for Patients With Chronic Hepatitis B Virus Infection gilead.com ↗ |
| 2016-11-11 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Vemlidy® (Tenofovir Alafenamide, TAF) for the Treatment of Chronic Hepatitis B Virus Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vemlidy ® (tenofovir alafenamide, TAF) 25 mg, an investigational, once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (≥ 12 years and ≥ 35 kg body weight). |
| 2016-11-10 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Vemlidy® (Tenofovir Alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Vemlidy ® (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. |
| 2016-10-24 | Gilead Sciences | Results Gilead Presents Results from Phase 3 Studies Evaluating Switching to Descovy® (FTC/TAF)-Based Regimens from Truvada® (FTC/TDF)-Based Regimens gilead.com ↗
Results demonstrated regimens containing Descovy to be statistically non-inferior to regimens containing Truvada, with improvements in certain renal and bone laboratory parameters among patients receiving Descovy (FTC/TAF)-based regimens. |
| 2016-09-12 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency jnj.com ↗ |
| 2016-07-21 | Gilead Sciences | Results Gilead’s Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) Meets Primary 48-Week Objective in Two Phase 3b Studies gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that two Phase 3b switch studies evaluating Odefsey ® (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) for the treatment of HIV-1 infection met their primary objectives. |
| 2016-04-25 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two doses of Descovy ® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. |
| 2016-04-15 | Gilead Sciences | Results Gilead Announces Full 48-Week Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection gilead.com ↗
Both studies met their primary endpoints of non-inferiority to Gilead’s Viread ® (tenofovir disoproxil fumarate, TDF) 300 mg based on the percentage of patients with HBV DNA levels below 29 IU/mL at 48 weeks of therapy. |
| 2016-04-04 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide), Gilead’s Third TAF-Based HIV Therapy gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2016-03-31 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Tenofovir Alafenamide (TAF) for Patients with Chronic Hepatitis B Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for tenofovir alafenamide (TAF) 25 mg, an investigational once-daily treatment for adults with chronic hepatitis B virus (HBV) infection. |
| 2016-03-01 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Odefsey ® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. |
| 2016-02-26 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV gilead.com ↗ |
| 2016-02-25 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B gilead.com ↗
“The validation of this application represents the latest step in our continued efforts to advance the care of people living with progressive liver diseases like HBV.” |
| 2016-02-23 | Gilead Sciences | Results Gilead Announces Results From First Study to Evaluate Switching to F/TAF-Based Regimens from Truvada® (F/TDF)-Based Regimens gilead.com ↗
At Week 48, the F/TAF-based regimens were found to be statistically non-inferior to the F/TDF-based regimens, based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. |
| 2016-01-12 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for tenofovir alafenamide (TAF) 25 mg, an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection. |
| 2016-01-05 | Gilead Sciences | Results Gilead Announces Top-Line Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that two Phase 3 clinical trials (Studies 108 and 110) evaluating investigational use of once-daily tenofovir alafenamide (TAF) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infection met their primary objectives. |
| 2015-11-23 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Genvoya is the first TAF-based regimen to receive marketing authorization in the European Union (EU). |
| 2015-10-22 | Gilead Sciences | Results Gilead Announces Phase 3 Results for Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV gilead.com ↗
Patients receiving Genvoya also had improved renal and bone laboratory parameters compared to those treated with Stribild. |
| 2015-08-20 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Single Tablet Regimen Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) for HIV Treatment gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the company’s Marketing Authorization Application (MAA) for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg (R/F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA). |
| 2015-07-01 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) gilead.com ↗ |
| 2015-04-07 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment gilead.com ↗
Today’s filing is Gilead’s second F/TAF-based NDA submitted to the FDA for review. |
| 2014-09-24 | Gilead Sciences | Results Gilead’s Investigational Tenofovir Alafenamide (TAF)-Based Single Tablet HIV Regimen Meets 48-Week Primary Objective in Two Phase 3 Studies gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that two Phase 3 clinical trials (Studies 104 and 111) evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults met their primary objectives. |
| 2013-09-12 | Gilead Sciences | Results Gilead’s Tenofovir Alafenamide (TAF)-Based Single Tablet HIV Regimen Maintains High Viral Suppression Through 48 Weeks in Phase 2 Study gilead.com ↗
In this study, the TAF-based regimen matched Stribild’s high viral suppression and demonstrated a favorable safety profile with respect to renal and bone changes. |
| 2013-03-05 | Gilead Sciences | Results Gilead Announces Full 24-Week Phase 2 Results for Once-Daily Single Tablet HIV Regimen Containing Novel Prodrug Tenofovir Alafenamide (TAF) gilead.com ↗
A regimen of TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg was found to be similar to Stribild ® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on the percentage of patients with HIV RNA levels less than 50 copies/mL at 24 weeks of treatment. |
All press releases naming this drug 96 releases
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 235 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tenofovir alafenamide | “The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing...” NCT06630286 ↗201“This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide...” NCT02707601 ↗ “The main objective of this study is to compare the mother-to-infant transmission rates of hepatitis B between pregnant women receiving treatment with tenofovir alafenamide and...” NCT06947356 ↗ “The ability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) to maintain virologic suppression in participants with M184V and/or M184I resistance...” PMID 33315694 ↗ Apr 2021 “Participants on any stable second-generation integrase strand transfer inhibitor-based 3DR regimen with HIV-1 RNA < 50 copies/mL plasma for at least 3 months were randomized to...” PMID 39226296 ↗ Feb 2025 “The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how...” NCT04039217 ↗ “The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in...” NCT02836236 ↗ “The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in...” NCT05140954 ↗ “Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with...” NCT07075146 ↗ “Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir...” NCT05729568 ↗ “To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a...” NCT05147740 ↗ |
| Known as | alafenamide tenofovir | “Second generation integrase inhibitor 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC); 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine...” NCT06602622 ↗ |
| Known as | GS-7340 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02357602 ↗ |
| Known as | GS-7340 HEMIFUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107825 ↗ |
| Known as | GS-7340-03 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107825 ↗ |
| Known as | TAF | “Background Regimen (BR) include Food and Drug Administration (FDA)-approved nucleos(t)ide reverse transcriptase inhibitors (NRTIs) including zidovudine (ZDV), stavudine (d4T),...” NCT02016924 ↗101“The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how...” NCT04039217 ↗ “The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in...” NCT02836236 ↗ “In the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2010/VESTED study, pregnant women were randomized to initiate dolutegravir (DTG) +...” PMID 38877762 ↗ Nov 2024 “Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with...” NCT07075146 ↗ “Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir (TFV) that is converted intracellularly to the active form, resulting in higher concentrations of TFV diphosphate in...” NCT05735535 ↗ “tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic...” NCT02836249 ↗ “Our goal was to study the impact of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on bone mineral density (BMD) in peri- and early...” PMID 36511389 ↗ Jan 2023 “The Effect of Rifampicin on the Plasma Pharmacokinetics of Emtricitabine (FTC) and Tenofovir Alafenamide Fumarate (TAF) and Intracellular Tenofovir-diphosphate (TFV-DP) and...” NCT03186482 ↗ “Participants will be switched from tenofovir disoproxil fumarate to tenofovir alafenamide (TAF) 25 mg/emtricitabine (FTC) 200 mg (Descovy) with a boosted protease inhibitor for...” NCT03126370 ↗ “Tenofovir Alafenamide Fumarate (TAF) is a newer, more potent prodrug of tenofovir (TFV), and in combination with FTC, has recently been approved for prevention of HIV through...” PMID 34041459 ↗ May 2021 |
| Known as | Tenofovir alafenamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107825 ↗ |
| Known as | Tenofovir alafenamide (TAF) | “Patients will receive Vemlidy (tenofovir alafenamide, TAF) 25mg, daily for 48 weeks” NCT04496882 ↗ |
| Known as | Tenofovir Alafenamide (TAF) - brand name: Descovy | “Tenofovir Alafenamide (TAF) - brand name: Descovy” NCT03780543 ↗ |
| Known as | TENOFOVIR ALAFENAMIDE FUMARATE | “Relative Bioavailability Study to Investigate a Potential Interaction Between Dolutegravir (DTG) and Tenofovir Alafenamide Fumarate/Emtricitabine (F/TAF) Administered as...” NCT05489406 ↗21“Tenofovir Alafenamide Fumarate (TAF) is a newer, more potent prodrug of tenofovir (TFV), and in combination with FTC, has recently been approved for prevention of HIV through...” PMID 34041459 ↗ May 2021 “First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally,...” NCT06323681 ↗ “100 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long unless the patient achieves HBsAg loss.” NCT04231565 ↗ “a fixed-dose combination of tenofovir alafenamide fumarate (TAF) 10 mg plus emtricitabine (FTC) 200 mg, darunavir 800 mg, and cobicistat 150 mg once daily (group A)” PMID 37752816 ↗ Sep 2023 “Oral nucleos(t)ide analogues (NAs) (Entecavir(ETV), Tenofovir disoproxil fumarate tablets(TDF) or Tenofovir Alafenamide Fumarate(TAF)) is used for 12-24 weeks” NCT05182463 ↗ “pregnant women with HBV DNA of 5.3-9.0 log 10 IU/mL who received tenofovir alafenamide fumarate (TAF) from the first day of 33 gestational weeks to delivery” PMID 39382852 ↗ Oct 2024 “Patients will continue ongoing nucleos(t)ide analogue (Entecavir or Tenofovir Disoproxil Fumarate or Tenofovir Alafenamide Fumarate) therapy for 48 weeks” NCT05256823 ↗ “Tenofovir alafenamide Fumarate Tablets(TAF) will be take orally for at least 48 weeks, not more than 72 weeks.” NCT06544551 ↗ “Dolutegravir 50mg oral with tenofovir alafenamide fumarate (25mg) and lamivudine (300mg)” NCT05154747 ↗ “Tenofovir Alafenamide Fumarate (TAF) Effect on Residual Intrathecal Immune Activation” NCT02771054 ↗ |
| Known as | Tenofovir alafenamide fumarate component of biktarvy | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107825 ↗ |
| Known as | Tenofovir alafenamide fumarate component of descovy | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107825 ↗ |
| Known as | Tenofovir alafenamide fumarate component of genvoya | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107825 ↗ |
| Known as | Tenofovir alafenamide fumarate component of odefsey | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107825 ↗ |
| Known as | Tenofovir alafenamide fumarate component of symtuza | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107825 ↗ |
| Known as | Tenofovir Alafenamide Fumarate Tablets | “Tenofovir Alafenamide Fumarate Tablets, Inhibit HBV replication.” NCT06566248 ↗ |
| Known as | Tenofovir Alafenamide Hemitartrate | “Chronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate)” NCT06000657 ↗ |
| Known as | tenofovir alefenamide fumerate | “100 mg of doravirine + 200 mg emtricitabine (FTC) and 25 mg of tenofovir alefenamide fumerate (TAF)” NCT05457530 ↗ |
| Known as | VEMLIDY | “Tenofovir alafenamide (TAF, brand name: Vemlidy) is a hepatitis B virus nucleotide reverse transcriptase inhibitor oral medication for the treatment of chronic hepatitis B...” NCT05001672 ↗6“TENOFOVIR ALAFENAMIDE FUMARATE 25 Mg ORAL TABLET [VEMLIDY]” NCT04880577 ↗ “Vemlidy® (Tenofovir Alafenamide; TAF)” NCT04290936 ↗ “Tenofovir alafenamide (TAF; Vemlidy®)” NCT03491553 ↗ |
| Known as | Vemliver | “Efficacy and Safety of Switching to Vemliver (Tenofovir Alafenamide) From Entecavir in Chronic Hepatitis B: A Multi-Center, Phase IV, Open-Label, Randomized, Active-Controlled,...” NCT06000657 ↗ |
| Action | Inhibit | “It acts as a nucleoside reverse transcriptase inhibitor.” NCT02437110 ↗ |
| Modality | Small molecule | “the antiviral nucleoside analogue, Tenofovir alafenamide (TAF)” NCT04070079 ↗ |
| Route | Oral | “Tenofovir alafenamide tablet(s) administered orally once daily” NCT00036634 ↗ |