Tenofovir

also known as TDF · TFV · tenofovir disoproxil fumarate · tenofovir DF · PMPA · tenofovir (viread) · Viread · 9-\[(R)-2-(phosphonomethoxy) propyl\]adenine monohydrate · +9 more

Small molecule

Developed for: HIV infectious disease · chronic hepatitis B virus infection · hepatitis B virus infection · AIDS · hepatitis D virus infection · Aicardi-Goutieres syndrome · Epstein-Barr virus infection · Epstein-Barr virus-associated lymphoproliferative disorder
+8 more
· herpes simplex type 2 infectious disease · liver failure · lymphoma · cirrhosis of liver · COVID-19 · disease arising from reactivation of latent virus · hepatocellular carcinoma · primary biliary cholangitis
Investigated by: National Institute of Allergy and Infectious Diseases (NIAID) · CONRAD · Gilead Sciences · Bristol-Myers Squibb · Merck Sharp & Dohme LLC · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
+154 more
· National Institute of Mental Health (NIMH) · French National Agency for Research on AIDS and Viral Hepatitis · Johns Hopkins University · University of North Carolina, Chapel Hill · Centre for the AIDS Programme of Research in South Africa · Microbicide Trials Network · ViiV Healthcare · ANRS, Emerging Infectious Diseases · Abbott · Boehringer Ingelheim · GlaxoSmithKline · Hoffmann-La Roche · National Institutes of Health (NIH) · St Stephens Aids Trust · United States Agency for International Development (USAID) · University of Washington · Yonsei University · Agility Clinical, Inc. · Centers for Disease Control and Prevention · FHI 360 · Ian McGowan · Imperial College London · Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · Institute of Liver and Biliary Sciences, India · Kirby Institute · Kyungpook National University Hospital · Novartis Pharmaceuticals · Oswaldo Cruz Foundation · Pfizer · Pusan National University Hospital · Seoul St. Mary's Hospital · Shanghai Public Health Clinical Center · The Affiliated Hospital of Xuzhou Medical University · The Catholic University of Korea · University of California, Los Angeles · University of Cape Town · University of Maryland, Baltimore · University of Pittsburgh · AIDS Project Los Angeles · African Poverty Related Infection Oriented Research Initiative · Andrew Carr · Antios Therapeutics, Inc · Asan Medical Center · Bader, Ted, M.D. · Bamrasnaradura Infectious Diseases Institute · British Columbia Centre for Disease Control · California HIV/AIDS Research Program · Catholic University of the Sacred Heart · Centre Hospitalier Universitaire Saint Pierre · Centro de Referência e Treinamento DST/Aids · Chang Gung Memorial Hospital · Changi General Hospital · Children's Hospital of Philadelphia · Chonbuk National University Hospital · Chulalongkorn University · Columbia University · Community Research Initiative of New England · Daegu Catholic University Medical Center · Data Matrix Solutions · David Garcia Cinca · DongGuk University · Eastern Virginia Medical School · Emerson Resources · Emory University · European and Developing Countries Clinical Trials Partnership (EDCTP) · Fenway Community Health · Fight AIDS and Infectious Diseases Foundation · Follow-on African Consortium for Tenofovir Studies (FACTS) · French National Institute of Health and Medical Research · Friends Research Institute, Inc. · Fundacion Clinic per a la Recerca Biomédica · Fundación Huésped · Germans Trias i Pujol Hospital · HIV Prevention Trials Network · all 160 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed	US (FDA)	Quad	HIV infectious disease	2011-10-27	“accepted for review the New Drug Application (NDA) for the Quad, a complete single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir...” gilead.com ↗
Filed	US (FDA)	Viread	HIV infectious disease	2001-05-01	“Gilead submitted a New Drug Application (NDA) for tenofovir DF for the treatment of HIV infection to the U.S. Food and Drug Administration (FDA) on May 1, 2001.” gilead.com ↗ “submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of tenofovir disoproxil fumarate” gilead.com ↗ “The approval comes six months after Gilead submitted the Viread New Drug Application (NDA) to the FDA.” gilead.com ↗
Filed	EU (EMA)	Viread	HIV infectious disease	—	“In May 2001, Gilead submitted a Marketing Authorisation Application to the European Agency for the Evaluation of Medicinal Products (EMEA).” gilead.com ↗ “Gilead submitted its Marketing Authorisation Application (MAA) for Viread for review by the EMEA in May 2001.” gilead.com ↗

Trials 138 · started per year

today

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT04898699	Nov 2021 → Jul 2022	HIV infectious disease	Columbia University	Completed	No outcome recorded
Phase 137 trials · 1 missed
Phase 1	NCT05850728	Apr 2023 → Jun 2024	HIV infectious disease	University of Washington	Completed	No outcome recorded
Phase 1	NCT04283656	Jan → Oct 2022	HIV infectious disease	Thomas Jefferson University	Completed	Missed primary
Phase 1	NCT05137548	Oct → Dec 2021	—	Antios Therapeutics, Inc	Completed	No outcome recorded
Phase 1	NCT04195776	Jun 2021 → Dec 2022	HIV infectious disease	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT04686279	Apr 2021 → Nov 2022	HIV infectious disease	University of Pennsylvania	Completed	No outcome recorded
Phase 1	NCT04016233	Jan 2020 → Apr 2021	AIDS	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT03917420	Mar → Sep 2019	HIV infectious disease	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 1	NCT03670355	Jan → Sep 2019	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT03719053	Oct 2018 → Jun 2020	—	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT03279120	Sep 2017 → Dec 2018	—	CONRAD	Completed	No outcome recorded
Phase 1	NCT02722343	Apr → Aug 2016	HIV infectious disease	CONRAD	Completed	No outcome recorded
Phase 1	NCT02235662	Oct 2014 → Dec 2015	HIV infectious disease	CONRAD	Completed	No outcome recorded
Phase 1	NCT02039323	Feb → Apr 2014	—	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 1	NCT01813162	Dec 2013 → Dec 2014	—	CONRAD	Completed	No outcome recorded
Phase 1	NCT01989663	Nov 2013 → Jan 2015	HIV infectious disease	CONRAD	Completed	No outcome recorded
Phase 1	NCT01810315	Sep 2013 → Oct 2014	—	CONRAD	Completed	No outcome recorded
Phase 1	NCT01575405	Mar → Nov 2013	—	Ian McGowan	Completed	No outcome recorded
Phase 1	NCT01575418	Mar → Nov 2013	—	Ian McGowan	Completed	No outcome recorded
Phase 1	NCT01525628	Apr 2012 → Dec 2013	chronic hepatitis C virus infection	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT01421368	Mar 2012 → Mar 2014	—	CONRAD	Completed	No outcome recorded
Phase 1	NCT01369303	Jan 2012 → May 2013	—	CONRAD	Completed	No outcome recorded
Phase 1	NCT01368783	Jun 2011 → ?	—	Asan Medical Center	Unknown	No outcome recorded
Phase 1	NCT01340196	Apr → Jun 2011	HIV infectious disease	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT01136759	Mar 2011 → Sep 2013	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT01276600	Jan → Oct 2011	HIV infectious disease	HIV Prevention Trials Network	Completed	No outcome recorded
Phase 1	NCT01232803	Oct 2010 → Jul 2011	—	CONRAD	Completed	No outcome recorded
Phase 1	NCT01108926	Jun → Oct 2010	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 1	NCT00994773	Dec 2009 → Oct 2011	hepatitis B virus infection	Bader, Ted, M.D.	Completed	No outcome recorded
Phase 1	NCT00984971	Sep 2009 → Jun 2010	HIV infectious disease	CONRAD	Completed	No outcome recorded
Phase 1	NCT00962871	Aug 2009 → Feb 2012	chronic hepatitis B virus infection	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT00726336	Aug → Oct 2008	—	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00561496	Mar 2007 → Apr 2008	HIV infectious disease	CONRAD	Completed	No outcome recorded
Phase 1	NCT00002180	—	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 1	NCT00028132	? → Dec 2005	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT02245945	? → Apr 2015	—	CONRAD	Withdrawn	No outcome recorded
Phase 1	NCT00540605	? → Jan 2010	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00594373	? → Nov 2009	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 1/23 trials
Phase 1/2	NCT03304717	Dec 2025 → Dec 2029	Aicardi-Goutieres syndrome	Children's Hospital of Philadelphia	Withdrawn	No outcome recorded
Phase 1/2	NCT07133763	Sep 2025 → Sep 2027 expected	Epstein-Barr virus-associated lymphoproliferative disorder	The Affiliated Hospital of Xuzhou Medical University	Not yet recruiting	No outcome recorded
Phase 1/2	NCT07133776	Sep 2025 → Sep 2027 expected	Epstein-Barr virus infection	The Affiliated Hospital of Xuzhou Medical University	Not yet recruiting	No outcome recorded
Phase 226 trials · 1 met primary · 2 missed
Phase 2	NCT06560684	Oct 2024 → Jun 2026	—	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT04734652	Feb 2022 → Jan 2024	HIV infectious disease, pulmonary tuberculosis	Centre for the AIDS Programme of Research in South Africa	Completed	No outcome recorded
Phase 2	NCT03986970	Nov 2019 → Feb 2021	HIV infectious disease	Wits Health Consortium (Pty) Ltd	Completed	No outcome recorded
Phase 2	NCT03762382	Dec 2018 → Aug 2019	HIV infectious disease	CONRAD	Unknown	No outcome recorded
Phase 2	NCT03602690	Oct 2018 → Apr 2022	HIV infectious disease	ANRS, Emerging Infectious Diseases	Unknown	No outcome recorded
Phase 2	NCT02652260	Mar 2016 → Aug 2018	central nervous system disorder	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 2	NCT03546621	Feb 2016 → Jan 2018	hepatitis D virus infection	Hepatera Ltd.	Completed	Met primary
Phase 2	NCT02386098	Jul 2015 → Jun 2017	HIV infectious disease	ViiV Healthcare	Terminated	No outcome recorded
Phase 2	NCT01772823	Nov 2012 → Nov 2015	HIV infectious disease	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 2	NCT01125696	May 2012 → May 2018	HIV infectious disease, hepatitis B virus infection	Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 2	NCT01489046	Feb 2011 → Mar 2013	HIV infectious disease	Bristol-Myers Squibb	Terminated	No outcome recorded
Phase 2	NCT01140880	May 2010 → Mar 2013	substance abuse	Friends Research Institute, Inc.	Completed	No outcome recorded
Phase 2	NCT00949234	Mar → Jun 2010	HIV infectious disease	University of California, Los Angeles	Completed	No outcome recorded
Phase 2	NCT00705679	Aug 2009 → Aug 2012	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 2	NCT00958100	Aug 2009 → Nov 2010	AIDS	Catholic University of the Sacred Heart	Completed	No outcome recorded
Phase 2	NCT00820118	May 2009 → May 2012	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 2	NCT00827112	Mar 2009 → Jul 2010	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 2	NCT00474435	Nov 2008 → Dec 2009	HIV infectious disease, pulmonary tuberculosis	African Poverty Related Infection Oriented Research Initiative	Unknown	No outcome recorded
Phase 2	NCT00592124	Jun 2008 → Jul 2010	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00799136	Feb 2008 → Dec 2012	HIV infectious disease, lymphoma	Ontario Clinical Oncology Group (OCOG)	Completed	No outcome recorded
Phase 2	NCT00441298	May 2007 → Dec 2009	HIV infectious disease	Centre for the AIDS Programme of Research in South Africa	Completed	No outcome recorded
Phase 2	NCT00334256	Oct 2006 → Jul 2009	HIV infectious disease	French National Agency for Research on AIDS and Viral Hepatitis	Completed	No outcome recorded
Phase 2	NCT00122577	Mar 2002 → Jul 2004	HIV infectious disease	French National Agency for Research on AIDS and Viral Hepatitis	Terminated	No outcome recorded
Phase 2	NCT01490671	? → Aug 2015	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Withdrawn	No outcome recorded
Phase 2	NCT00036452	? → Jan 2006	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 2	NCT00111943	? → Oct 2007	HIV infectious disease, chronic hepatitis B virus infection	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 2/32 trials · 1 missed
Phase 2/3	NCT01691768	Oct 2012 → Apr 2015	HIV infectious disease	Centre for the AIDS Programme of Research in South Africa	Completed	No outcome recorded
Phase 2/3	NCT00624195	Mar 2007 → Feb 2012	HIV infectious disease	University of California, San Diego	Completed	Missed primary
Phase 317 trials · 2 met primary · 3 missed
Phase 3	NCT04539119	Jul 2020 → Sep 2022	B-cell non-Hodgkin lymphoma, hepatitis B virus infection	Ruijin Hospital	Unknown	No outcome recorded
Phase 3	NCT04051970	Nov 2019 → Jun 2022	HIV infectious disease	ANRS, Emerging Infectious Diseases	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT03988452	Jul 2019 → Sep 2020	HIV infectious disease	Makerere University	Unknown	Met primary
Phase 3	NCT02588820	Apr 2016 → Nov 2018	HIV infectious disease	David Garcia Cinca	Unknown	No outcome recorded
Phase 3	NCT03236610	Jan 2016 → Jun 2018	—	Uijeongbu St. Mary Hospital	Unknown	No outcome recorded
Phase 3	NCT01369212	Nov 2012 → Mar 2021	hepatitis B virus infection	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	Missed primary
Phase 3	NCT01701882	Sep 2012 → Nov 2013	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 3	NCT01386294	Oct 2011 → Aug 2014	—	CONRAD	Completed	Missed primary
Phase 3	NCT01195467	Oct 2010 → Jun 2013	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 3	NCT01063036	May 2010 → Nov 2012	chronic hepatitis B virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 3	NCT01088659	Feb 2010 → Dec 2017	hepatitis D virus infection	Hoffmann-La Roche	Completed	Missed primary
Phase 3	NCT00605384	Aug 2008 → Feb 2009	chronic hepatitis B virus infection	Bristol-Myers Squibb	Terminated	No outcome recorded Stop: Business
Phase 3	NCT00573001	Jul 2008 → Jul 2011	HIV infectious disease	French National Agency for Research on AIDS and Viral Hepatitis	Completed	No outcome recorded
Phase 3	NCT00495651	Mar 2008 → Jan 2015	HIV infectious disease, tuberculosis	French National Agency for Research on AIDS and Viral Hepatitis	Completed	Met primary
Phase 3	NCT00234910	Jan 2005 → Jun 2007	HIV infectious disease	Abbott	Completed	No outcome recorded
Phase 3	NCT00158457	Jun 2004 → Dec 2006	HIV infectious disease	French National Agency for Research on AIDS and Viral Hepatitis	Completed	No outcome recorded
Phase 3	NCT00053638	Feb 2003 → Oct 2004	HIV infectious disease	GlaxoSmithKline	Completed	No outcome recorded

Phase 440 trials · 2 met primary · 4 missed
Phase 4	NCT06104306	Dec 2023 → Jan 2025	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 4	NCT04240509	Nov 2019 → Dec 2021	HIV infectious disease	The Miriam Hospital	Unknown	No outcome recorded
Phase 4	NCT02844634	May 2018 → May 2020	HIV infectious disease, syphilis	British Columbia Centre for Disease Control	Completed	No outcome recorded
Phase 4	NCT02945163	Mar 2018 → Jun 2019	HIV infectious disease	Shanghai Public Health Clinical Center	Completed	No outcome recorded
Phase 4	NCT03220152	Jul 2017 → Jul 2019	—	Oswaldo Cruz Foundation	Unknown	No outcome recorded
Phase 4	NCT02973646	Jan 2016 → Dec 2018	chronic hepatitis B virus infection	Third Affiliated Hospital, Sun Yat-Sen University	Unknown	No outcome recorded
Phase 4	NCT03033836	Dec 2015 → Jun 2019	HIV infectious disease	Fundación Huésped	Completed	No outcome recorded
Phase 4	NCT07084948	Nov 2015 → Oct 2025	hepatitis B virus infection	Trieu, Nguyen Thi, M.D.	Completed	No outcome recorded
Phase 4	NCT02585947	Nov 2015 → Jun 2018	Burkitt lymphoma	Seoul National University Hospital	Unknown	No outcome recorded
Phase 4	NCT02505009	May 2015 → Dec 2018	chronic hepatitis B virus infection	Chang Gung Memorial Hospital	Completed	No outcome recorded
Phase 4	NCT02632474	Apr 2015 → Dec 2016	HIV infectious disease	Shanghai Public Health Clinical Center	Completed	No outcome recorded
Phase 4	NCT02211690	Aug 2014 → Nov 2015	HIV infectious disease	Andrew Carr	Completed	No outcome recorded
Phase 4	NCT01928511	Jan 2014 → Dec 2018	chronic hepatitis B virus infection	Seng Gee Lim	Completed	Met primary
Phase 4	NCT02093585	Jan 2014 → Apr 2016	HIV infectious disease	Jan Gerstoft	Completed	No outcome recorded
Phase 4	NCT01727271	Aug 2013 → Aug 2017	chronic hepatitis B virus infection	Merck Sharp & Dohme LLC	Withdrawn	No outcome recorded
Phase 4	NCT01367236	Jan 2013 → Oct 2015	HIV infectious disease, cognitive disorder	Imperial College London	Completed	Missed primary
Phase 4	NCT01732367	Nov 2012 → Mar 2016	chronic hepatitis B virus infection	Keimyung University Dongsan Medical Center	Completed	Met primary
Phase 4	NCT01597934	Aug 2012 → May 2014	chronic hepatitis B virus infection	Yonsei University	Unknown	No outcome recorded
Phase 4	NCT01594905	Aug 2012 → Apr 2014	chronic hepatitis B virus infection	Yonsei University	Unknown	No outcome recorded
Phase 4	NCT01588912	Apr 2012 → Dec 2013	chronic hepatitis B virus infection	Pusan National University Yangsan Hospital	Unknown	No outcome recorded
Phase 4	NCT01595633	Mar 2012 → Feb 2014	chronic hepatitis B virus infection	Yonsei University	Unknown	No outcome recorded
Phase 4	NCT01448616	Feb 2012 → Jun 2015	herpes simplex type 2 infectious disease	University of Washington	Completed	Missed primary
Phase 4	NCT01214759	May 2011 → Dec 2013	HIV infectious disease	The University of Texas Health Science Center, Houston	Completed	No outcome recorded
Phase 4	NCT00955968	Jan 2010 → Aug 2016	HIV infectious disease	International Maternal Pediatric Adolescent AIDS Clinical Trials Group	Completed	No outcome recorded
Phase 4	NCT01025427	Dec 2009 → Nov 2012	HIV infectious disease	University of California, San Francisco	Completed	No outcome recorded
Phase 4	NCT01014481	Oct 2009 → May 2011	HIV infectious disease, tuberculosis	Bamrasnaradura Infectious Diseases Institute	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00869960	Mar 2009 → Dec 2010	—	University of Alabama at Birmingham	Completed	No outcome recorded
Phase 4	NCT01772940	Dec 2008 → Oct 2011	HIV infectious disease	Centre Hospitalier Universitaire Saint Pierre	Completed	Missed primary
Phase 4	NCT00651209	Feb 2008 → Dec 2011	chronic hepatitis B virus infection	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT00414635	Aug 2006 → Dec 2009	HIV infectious disease	Community Research Initiative of New England	Completed	No outcome recorded
Phase 4	NCT00358696	Jul 2006 → Oct 2009	HIV infectious disease	University of British Columbia	Completed	No outcome recorded
Phase 4	NCT00885664	Oct 2005 → Sep 2009	HIV infectious disease	University of Cincinnati	Completed	Missed primary
Phase 4	NCT00356616	Sep 2005 → Jun 2007	HIV infectious disease	Germans Trias i Pujol Hospital	Terminated	No outcome recorded
Phase 4	NCT00924898	Jan 2005 → Nov 2013	HIV infectious disease	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 4	NCT00344461	Mar 2004 → Jul 2008	HIV infectious disease	University of Maryland, Baltimore	Completed	No outcome recorded
Phase 4	NCT00127959	Mar 2004 → Aug 2006	HIV infectious disease, hepatitis B virus infection	International Antiviral Therapy Evaluation Center	Completed	No outcome recorded
Phase 4	NCT00192595	Jan 2004 → Jan 2007	HIV infectious disease, hepatitis B virus infection	Kirby Institute	Completed	No outcome recorded
Phase 4	NCT00192660	Feb 2003 → Oct 2006	cardiovascular disorder, lipodystrophy	Kirby Institute	Completed	No outcome recorded
Phase 4	NCT00038506	Mar 2002 → Aug 2004	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 4	NCT00409019	? → Mar 2011	chronic hepatitis B virus infection	Novartis Pharmaceuticals	Withdrawn	No outcome recorded Stop: Enrollment

Phase not applicable11 trials · 2 missed
—	NCT04431375	Jun 2020 → Jun 2022	hepatitis B virus infection	Institute of Liver and Biliary Sciences, India	Unknown	No outcome recorded
—	NCT02689245	Feb 2016 → Mar 2018	liver failure	Institute of Liver and Biliary Sciences, India	Completed	No outcome recorded
—	NCT02495779	Jul 2015 → Nov 2017	HIV infectious disease	James Egan	Completed	No outcome recorded
—	NCT01989611	Jun 2014 → Mar 2016	HIV infectious disease	Oswaldo Cruz Foundation	Unknown	No outcome recorded
—	NCT01387022	Jun 2011 → Nov 2014	—	Centre for the AIDS Programme of Research in South Africa	Completed	Missed primary
—	NCT01283555	Jan → Jun 2011	—	PATH	Completed	Missed primary
—	NCT02404259	Jun 2010 → May 2012	HIV infectious disease	The HIV Netherlands Australia Thailand Research Collaboration	Completed	No outcome recorded
—	NCT02097381	Apr 2010 → Mar 2014	HIV infectious disease	University of Roma La Sapienza	Unknown	No outcome recorded
—	NCT01044771	Jan → Dec 2010	HIV infectious disease, proteinuria	Metropolis Medical	Completed	No outcome recorded
—	NCT00346567	Jun 2006 → Oct 2010	HIV infectious disease	Rigshospitalet, Denmark	Completed	No outcome recorded
—	NCT00344981	Jun 2003 → Nov 2006	AIDS	University of Maryland, Baltimore	Completed	No outcome recorded

Phase not stated1 trial
—	NCT01198860	—	chronic hepatitis B virus infection	Nguyen Thi Trieu, MD	Approved for marketing	No outcome recorded
Comparator or background therapy138 trials
Phase 0	NCT05523648 Background	Jan 2020 → Dec 2021	NAFLD1, chronic hepatitis B virus infection	Sichuan Leshan Traditional Chinese Medicine Hospital	Completed	No outcome recorded
Phase 0	NCT02280109 Comparator	Nov 2014 → Dec 2015	HIV infectious disease	CONRAD	Completed	No outcome recorded
Phase 1	NCT02832778 Background	Nov 2016 → Jan 2018	HIV infectious disease	St Stephens Aids Trust	Unknown	No outcome recorded
Phase 1	NCT02750540 Comparator	Oct 2016 → May 2019	—	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT02797522 Background	Jun → Nov 2016	hepatitis B virus infection	Arrowhead Pharmaceuticals	Terminated	No outcome recorded
Show all 138 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 118

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.
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 ↗ Week 96 results from the LATA trial, led by University College London, showed CAB+RPV LA dosed every two months was superior to daily oral dolutegravir/tenofovir disoproxil fumarate/lamivudine (DTG/TDF/3TC) in 476 virologically suppressed adolescents aged 12 to 19 years living with HIV in Kenya, South Africa, Uganda and Zimbabwe.
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.
2026-07-27	ViiV Healthcare	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 viivhealthcare.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 count.
2026-02-23	ViiV Healthcare	Results ViiV HEALTHCARE ANNOUNCES DATA SHOWING SWITCHING TO DOVATO WAS ASSOCIATED WITH A LOWER PROPORTION OF STEATOTIC LIVER DISEASE VERSUS BIKTARVY FOR HIV-1 TREATMENT viivhealthcare.com ↗ Steatotic liver disease, an increasingly recognised comorbidity in people living with HIV, was reported in 49% (n=26/53) of participants switching to BIC/FTC/TAF versus 29% (n=17/58) switching to DTG/3TC
2025-12-18	Jiangsu Aidea Pharmaceutical Group Co., Ltd.	Results 高分引用｜复邦德系列临床研究获Nature子刊全文引用 aidea.com.cn ↗
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 ↗ Dolutegravir-based antiretroviral therapy does not reduce plasma levonorgestrel or medroxyprogesterone acetate concentrations among contraceptive users living with HIV compared with HIV-negative controls
2024-07-25	Gilead Sciences	Results Gilead Presents Research Data Across Its Broad and Innovative HIV Treatment Portfolio and Pipeline gilead.com ↗ Specifically, results of the subgroup analysis showed that at five years, Biktarvy treatment was generally well tolerated and maintained high virologic suppression.
2024-07-24	Gilead Sciences	Results Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir for HIV Prevention Presented at AIDS 2024 gilead.com ↗ Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF).
2024-07-23	GlaxoSmithKline	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 gsk.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.
2024-07-23	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.
2024-05-22	Gilead Sciences	Results Gilead to Present Latest Research Across Key Liver Disease Indications at the European Association for the Study of the Liver Congress 2024 gilead.com ↗ Tenofovir-based antiviral therapy reduces long-term incidence of hepatocellular carcinoma in chronic hepatitis B patients
2022-07-28	GlaxoSmithKline	Results ViiV Healthcare announces new data at AIDS 2022 from unblinded phase of HPTN 084 study in women in sub Saharan Africa showing continued superior efficacy of injectable cabotegravir long-acting for PrEP over daily, oral TDF/FTC tablets gsk.com ↗
2022-07-28	ViiV Healthcare	Results ViiV HEALTHCARE ANNOUNCES NEW DATA AT AIDS 2022 FROM UNBLINDED PHASE OF HPTN 084 STUDY IN WOMEN IN SUB SAHARAN AFRICA SHOWING CONTINUED SUPERIOR EFFICACY OF INJECTABLE CABOTEGRAVIR LONG-ACTING FOR PREP OVER DAILY, ORAL TDF/FTC TABLETS viivhealthcare.com ↗ Overall, Grade 2 adverse events were comparable between study groups, with 20% assessed as related to study product (19% for cabotegravir arm, 21% for FTC/TDF arm).
2022-02-16	Gilead Sciences	Results New Clinical Data Support the Sustained Efficacy of Long-acting Lenacapavir, Gilead’s Investigational HIV-1 Capsid Inhibitor gilead.com ↗ In the oral lenacapavir + F/TAF arm, 85% achieved an undetectable viral load.
2022-02-11	Gilead Sciences	Results Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression at Five Years, in Treatment-Naïve Adults gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of cumulative 5-year results from two Phase 3 studies (Study 1489 and Study 1490) of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF).
2022-02-08	Gilead Sciences	Results Gilead to Present Latest Antiviral Research and Development Data at CROI 2022 Addressing Urgent Global Needs gilead.com ↗ These results demonstrate Biktarvy’s long-term safety and tolerability profile, and sustained efficacy with a high barrier to resistance in participants who initiated treatment with the guidelines-recommended, once-daily, single-tablet regimen.
2021-09-29	GlaxoSmithKline	Results ViiV Healthcare presents three-year switch data for Dovato (dolutegravir/lamivudine) confirming long-term, non-inferior efficacy with no virologic failure versus continuation of TAF-based regimens of at least three drugs gsk.com ↗ At three years, no participants on dolutegravir/lamivudine (0% [0/369]) met confirmed protocol-defined virologic failure, versus three participants (<1% [3/372]) on the TAF-based regimen.
2021-09-29	ViiV Healthcare	Results ViiV Healthcare presents three-year switch data for Dovato (dolutegravir/lamivudine) confirming long-term, non-inferior efficacy with no virologic failure versus continuation of TAF-based regimens of at least three drugs viivhealthcare.com ↗ At three years, no participants on dolutegravir/lamivudine (0% [0/369]) met confirmed protocol-defined virologic failure, versus three participants (<1% [3/372]) on the TAF-based regimen.
2021-07-17	GlaxoSmithKline	Results ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021 gsk.com ↗ Changes in metabolic health parameters were similar between the dolutegravir/lamivudine and TBR arms, with changes in lipids generally continuing to favour the dolutegravir/lamivudine arm.
2021-07-17	ViiV Healthcare	Results ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021 viivhealthcare.com ↗ CAB-LA and FTC/TDF tablets were both well tolerated throughout the study, with most adverse events being mild or moderate in severity and with the frequency largely balanced between both treatment arms.
2021-06-25	Lupin Limited	Regulatory Lupin Launches Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in the United States lupin.com ↗ Global pharma major Lupin Limited (Lupin) today announced the launch of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg, having received an approval from the United States Food and Drug Administration (FDA).
2021-03-25	Zydus Lifesciences Limited	Regulatory Zydus Cadila receives tentative approval from the USFDA for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets zyduslife.com ↗ Zydus Cadila has received tentative approval from the USFDA to market Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 100 mg/150 mg, 133 mg/200 mg and 167 mg/250 mg (US RLD: TRUVADA® Tablets).
2020-11-09	GlaxoSmithKline	Results ViiV Healthcare announces investigational injectable cabotegravir is superior to oral standard of care for HIV prevention in women gsk.com ↗ The study showed cabotegravir was 89% more effective than daily oral FTC/TDF for pre-exposure prophylaxis (PrEP).
2020-10-08	GlaxoSmithKline	Results ViiV Healthcare presents long-term switch data for Dovato demonstrating non-inferior efficacy in adults with HIV-1 and zero cases of virologic failure versus continuation of a 3-drug TAF-based regimen gsk.com ↗ Data from the study revealed that no participants on Dovato (0/369, 0%) and three participants (3/372, <1%) on the TAF-based regimen met protocol-defined virologic failure, and no participants developed resistance mutations upon failure.
2020-10-08	ViiV Healthcare	Results ViiV HEALTHCARE PRESENTS LONG-TERM SWITCH DATA FOR DOVATO DEMONSTRATING NON-INFERIOR EFFICACY IN ADULTS WITH HIV-1 AND ZERO CASES OF VIROLOGIC FAILURE VERSUS CONTINUATION OF A 3-DRUG TAF-BASED REGIMEN viivhealthcare.com ↗ Data from the study revealed that no participants on Dovato (0/369, 0%) and three participants (3/372, <1%) on the TAF-based regimen met protocol-defined virologic failure, and no participants developed resistance mutations upon failure.
2020-10-05	GlaxoSmithKline	Results ViiV Healthcare announces dolutegravir plus lamivudine three-year data confirming long-term viral suppression non-inferior to a 3-drug regimen for treatment-naïve adults with HIV-1 gsk.com ↗ Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression.
2020-10-05	ViiV Healthcare	Results ViiV HEALTHCARE ANNOUNCES DOLUTEGRAVIR PLUS LAMIVUDINE THREE-YEAR DATA CONFIRMING LONG-TERM VIRAL SUPPRESSION NON-INFERIOR TO A 3-DRUG REGIMEN FOR TREATMENT-NAÏVE ADULTS WITH HIV-1 viivhealthcare.com ↗ Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression.
2020-10-02	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Launches First Generic Versions of HIV-1 Treatments TRUVADA® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets in the U.S. tevapharm.com ↗ Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA), today announced the availability of the first Food and Drug Administration (FDA)-approved generic versions of TRUVADA®i and ATRIPLA®i tablets.
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.
2020-06-11	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Regulatory 正大天晴恩曲他滨替诺福韦片首仿获批 cttq.com ↗ 近日，正大天晴恩曲他滨替诺福韦片获国家药监局批准，为国内首仿，视同通过一致性评价。
2020-03-04	Zydus Lifesciences Limited	Regulatory Zydus receives final approval from the USFDA for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg zyduslife.com ↗ Zydus Cadila has received final approval from the USFDA to market Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg (US RLD: Truvada ® Tablets) and tentative approval for the strengths of 100 mg/150 mg, 133 mg/200 mg, and 167 mg/250 mg, of the same drug.
2020-01-15	GlaxoSmithKline	Regulatory Dovato (dolutegravir/lamivudine), the once-daily, single-pill, 2-drug regimen for the treatment of HIV-1 infection, granted marketing approval by Japan Ministry of Health, Labour and Welfare gsk.com ↗ With the authorisation of Dovato, people living with HIV in Japan can - for the first time - start treatment on a once-daily, single-pill, 2-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen.
2019-11-06	GlaxoSmithKline	Results EACS 2019: ViiV Healthcare to present 17 abstracts from its portfolio addressing the diverse needs of people living with HIV gsk.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
2019-09-20	Merck Sharp & Dohme LLC	Regulatory Merck’s PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive US FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed merck.com ↗
2019-07-24	GlaxoSmithKline	Results ViiV Healthcare presents GEMINI 1 & 2 studies through Week 96 showing 2-drug regimen of dolutegravir plus lamivudine continues to demonstrate high efficacy rates and no cases of treatment emergent resistance gsk.com ↗ Both the GEMINI 1 & 2 studies showed that dolutegravir plus lamivudine continued to offer non-inferior efficacy to dolutegravir plus TDF/FTC at Week 96.
2019-07-24	GlaxoSmithKline	Results ViiV Healthcare announces positive Week 48 results in first study to evaluate treatment switch from TAF-containing regimen with three or more drugs to 2-drug regimen of dolutegravir/lamivudine for HIV-1 infection gsk.com ↗ Today ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that data from the phase III TANGO study showed that the 2-drug regimen (2DR) of Dovato▼ (dolutegravir/lamivudine) has similar efficacy to a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs in virally supressed and stable adults with HIV-1.
2019-07-24	ViiV Healthcare	Results ViiV HEALTHCARE PRESENTS GEMINI 1 & 2 STUDIES THROUGH WEEK 96 SHOWING 2-DRUG REGIMEN OF DOLUTEGRAVIR PLUS LAMIVUDINE CONTINUES TO DEMONSTRATE HIGH EFFICACY RATES AND NO CASES OF TREATMENT EMERGENT RESISTANCE viivhealthcare.com ↗ Both the GEMINI 1 & 2 studies showed that dolutegravir plus lamivudine continued to offer non-inferior efficacy to dolutegravir plus TDF/FTC at Week 96.
2019-07-24	ViiV Healthcare	Results ViiV Healthcare announces positive Week 48 results in first study to evaluate treatment switch from TAF-containing regimen with three or more drugs to 2-drug regimen of dolutegravir/lamivudine for HIV-1 infection viivhealthcare.com ↗ Today ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that data from the phase III TANGO study showed that the 2-drug regimen (2DR) of Dovato▼ (dolutegravir/lamivudine) has similar efficacy to a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs in virally suppressed adults with HIV-1.
2019-07-23	Gilead Sciences	Results Gilead Presents New Findings on Profile of Descovy® for Potential Use as HIV Pre-exposure Prophylaxis Compared With Truvada® gilead.com ↗ Pharmacokinetic data from separate PK studies demonstrate that after using drugs for 14-28 days, F/TAF users who stop drug still maintain TFV-DP concentrations above the EC90 for at least 60 percent longer than F/TDF users.
2019-07-10	ViiV Healthcare	Results ViiV Healthcare announces phase III study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen viivhealthcare.com ↗ The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48.
2019-07-03	GlaxoSmithKline	Regulatory ViiV Healthcare receives EU Marketing Authorisation for Dovato (dolutegravir/lamivudine), a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection gsk.com ↗
2019-04-27	ViiV Healthcare	Regulatory ViiV HEALTHCARE ANNOUNCES CHMP POSITIVE OPINION FOR DOVATO® (DOLUTEGRAVIR/LAMIVUDINE) AS A ONCE-DAILY, SINGLE-PILL, TWO-DRUG REGIMEN FOR THE TREATMENT OF HIV INFECTION viivhealthcare.com ↗
2019-04-26	GlaxoSmithKline	Regulatory ViiV Healthcare announces CHMP Positive Opinion for Dovato® (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection gsk.com ↗ Today’s CHMP Positive Opinion for Dovato is an important step towards providing treatment-naïve people living with HIV in Europe the first once-daily, single-pill, complete 2-drug regimen for the treatment of HIV.
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.
2019-04-09	ViiV Healthcare	Regulatory US FDA APPROVES ViiV HEALTHCARE’S DOVATO (DOLUTEGRAVIR/LAMIVUDINE), THE FIRST, ONCE-DAILY, SINGLE-TABLET, TWO-DRUG REGIMEN FOR TREATMENT-NAÏVE HIV-1 ADULTS viivhealthcare.com ↗
2019-04-08	GlaxoSmithKline	Regulatory US FDA approves ViiV Healthcare’s Dovato (dolutegravir/lamivudine), the first, once-daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults gsk.com ↗ ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC.
2019-03-27	Gilead Sciences	Results Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 gilead.com ↗ Ledipasvir/sofosbuvir for 8, 12, or 24 weeks is safe and effective in patients undergoing dialysis (poster #0144)
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.
2018-10-03	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.
2018-08-30	Merck Sharp & Dohme LLC	Regulatory FDA Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients merck.com ↗ Today’s approvals of DELSTRIGO and PIFELTRO provide two new options for the treatment of HIV-1 in appropriate treatment-naïve adult patients.
2018-07-24	GlaxoSmithKline	Results ViiV Healthcare presents phase III data at AIDS 2018 from landmark GEMINI studies showing two-drug regimen of dolutegravir and lamivudine has similar efficacy to a three-drug regimen in treatment naïve HIV patients, with no emergence of resistance gsk.com ↗ The studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <50c/mL, a standard measure of HIV control, at Week 48.
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.
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 ↗
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.
2017-08-10	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
2017-07-28	Gilead Sciences	Regulatory European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗ Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for Vosevi ® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), as a once-daily single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.
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.
2017-02-13	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.
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.
2016-09-06	GlaxoSmithKline	Results GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress gsk.com ↗ In addition, the proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on closed triple and 41% on budesonide/formoterol (odds ratio 1.41; p<0.001).
2016-07-18	GlaxoSmithKline	Results ARIA study shows superior efficacy of Triumeq® for treatment-naïve women living with HIV gsk.com ↗ Results show statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48: 82% versus 71% (adjusted difference 10.5%, 95% CI: 3.1%-17.8%, p=0.005) respectively.1
2016-06-20	GlaxoSmithKline	Results FULFIL study shows superiority of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients gsk.com ↗ The proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on FF/UMEC/VI and 41% on budesonide/formoterol.
2015-11-12	Gilead Sciences	Regulatory U.S. FDA Approves New Indications for Harvoni®, Gilead’s Once-Daily Single Tablet Regimen for Chronic Hepatitis C gilead.com ↗ In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.
2014-11-03	Merck Sharp & Dohme LLC	Results Merck Announces Data from 48-Week Phase 2b Study of Investigational HIV Therapy Doravirine (MK-1439) in Treatment-Naive Patients merck.com ↗ The results showed a significantly lower incidence of one or more of reported CNS AEs (all causality) among the doravirine-treated group compared to the efavirenz-treated group (22.2 % vs. 43.5 %, respectively; p<0.001).
2014-07-22	Pfizer	Results ViiV Healthcare presents phase III data comparing once-daily maraviroc in combination with darunavir/ritonavir with emtricitabine/tenofovir plus darunavir/ritonavir in treatment-naïve adults with HIV-1 pfizer.com ↗ The proportion of study participants who were virologically suppressed (HIV-1 RNA <50 copies/mL) at week 48 was 77.3% for MVC+DRV/r compared to 86.8% for FTC /TDF +DRV/r (95% confidence interval -15.0% to -4.4%).
2014-07-22	GlaxoSmithKline	Results ViiV Healthcare presents phase III data gsk.com ↗ The proportion of study participants who were virologically suppressed (HIV-1 RNA <50 copies/mL) at week 48 was 77.3% for MVC+DRV/r compared to 86.8% for FTC /TDF +DRV/r (95% confidence interval -15.0% to -4.4%).
2013-12-13	Gilead Sciences	Regulatory U.S. FDA Approves Gilead’s Once-Daily Single Tablet HIV-1 Regimen Complera® for Patients Switching from a Stable Regimen gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved the single tablet HIV-1 regimen Complera ® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA
2012-11-27	Gilead Sciences	Regulatory European Commission Approves Viread® for HIV-1 Infection in Children and Adolescents and for Chronic Hepatitis B in Adolescents gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two new indications for once-daily Viread ® (tenofovir disoproxil fumarate).
2012-07-11	GlaxoSmithKline	Results Shionogi-ViiV Healthcare announces positive initial data from phase III study of dolutegravir-based regimen vs Atripla in HIV gsk.com ↗ The study demonstrated superiority of the dolutegravir-based regimen compared to the single tablet regimen Atripla®.
2012-03-08	Gilead Sciences	Results Data Show Gilead’s Quad Regimen for HIV Non-Inferior to Protease-Based Regimen at 48 Weeks in Second Pivotal Phase 3 Study gilead.com ↗ The study found that the Quad was non-inferior to a protease-based regimen of ritonavir-boosted atazanavir (ATV/r) plus Truvada ® (emtricitabine/tenofovir disoproxil fumarate) at 48 weeks of therapy among HIV-1 infected treatment-naïve adults.
2012-01-18	Gilead Sciences	Regulatory U.S. Food and Drug Administration Approves New Formulations of Viread® for Use by Children Living With HIV gilead.com ↗ Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the U.S. Food and Drug Administration ( FDA ) has approved Viread ® (tenofovir disoproxil fumarate) in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12.
2011-12-05	Gilead Sciences	Results Gilead’s Boosting Agent, Cobicistat, Meets 48-Week Primary Objective in Pivotal Phase 3 Study gilead.com ↗ Discontinuation rates due to adverse events were 7.3 percent and 7.2 percent in the cobicistat and ritonavir arms of the study, respectively.
2011-11-08	Bristol-Myers Squibb	Results Phase IIIb Comparison of BARACLUDE® (entecavir) Monotherapy Versus BARACLUDE Plus Tenofovir Combination Shows No Statistical Difference Between Study Arms bms.com ↗ Overall, both study arms had similar safety profiles.
2011-11-05	Gilead Sciences	Results Gilead Announces Positive Five-Year Data Showing Effect of Viread(R) on Liver Fibrosis and Cirrhosis Caused by Chronic Hepatitis B gilead.com ↗ Results show that Viread maintains long-term viral suppression of HBV and is associated with a reduction in liver fibrosis and a reversal of cirrhosis.
2011-10-27	Gilead Sciences	Regulatory Gilead Submits New Drug Application to U.S. FDA for Once-Daily, Single-Tablet "Quad" HIV Regimen gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults.
2011-09-23	Gilead Sciences	Regulatory European CHMP Adopts Positive Opinion for Eviplera(R), a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection gilead.com ↗ The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union (EU).
2011-08-15	Gilead Sciences	Results Gilead's Investigational Antiretroviral Quad Regimen Meets 48-Week Primary Objective in Pivotal Phase 3 Clinical Study 102 gilead.com ↗ The primary endpoint analysis indicated that 88 percent of patients in the Quad arm compared to 84 percent in the Atripla (95% CI for the difference: -1.6% to 8.8%) achieved HIV RNA (viral load) of less than 50 copies/mL through week 48.
2011-08-10	Gilead Sciences	Regulatory U.S. Food and Drug Administration Approves Gilead Sciences' Complera(TM), a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults gilead.com ↗ today announced that the U.S. Food and Drug Administration (FDA) has approved Complera(TM) (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.
2011-02-10	Gilead Sciences	Regulatory Gilead Sciences Refiles New Drug Application with the FDA for Single-Tablet Regimen of Truvada(R) and TMC278 gilead.com ↗ Specifically, the FDA requested additional information on the analytical methodology and qualification data used to establish acceptable levels of recently identified degradants related to emtricitabine; this information has been included in the refiling.
2010-09-13	Gilead Sciences	Results Gilead's Single-Tablet "Quad" HIV Regimen Maintains High Viral Suppression Through 48 Weeks in Phase II Study gilead.com ↗ At week 48, the proportion of patients who achieved HIV RNA (viral load) less than 50 copies/mL was 90 percent in the Quad arm and 83 percent in the Atripla arm (using an analysis where missing equals failure).
2010-04-27	Gilead Sciences	Results Gilead Finalizes Selection of Bioequivalent Formulation for the Fixed-Dose Regimen of Truvada(R) and Tibotec Pharmaceuticals' TMC278 gilead.com ↗ Gilead Sciences, Inc. (Nasdaq:GILD) announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).
2010-01-06	Gilead Sciences	Results Phase II Clinical Trial of Gilead's Investigational Integrase-Based, Once-Daily, Fixed-Dose "Quad" Regimen Meets 24-Week Primary Objective gilead.com ↗ GS 9350-boosted atazanavir and Truvada had similar efficacy to ritonavir-boosted atazanavir and Truvada.
2009-07-21	Gilead Sciences	Results Landmark Five-Year African Study Indicates That HIV Therapy May Be Given Safely in Resource-Limited Settings Without Routine Laboratory Monitoring gilead.com ↗ The results indicated that Viread was well tolerated and that the incidence of renal adverse events was low.
2008-12-03	Gilead Sciences	Results Data Demonstrating Significant Efficacy of Viread(R) in Treating Chronic Hepatitis B Published in New England Journal of Medicine gilead.com ↗ Data also indicate that at week 48, Viread was superior to Hepsera in reducing HBV DNA levels to below 400 copies/mL and was comparable to Hepsera in achieving histological response.
2008-11-14	Gilead Sciences	Regulatory Gilead Sciences Announces Notification of ANDA Filing for Truvada gilead.com ↗
2008-10-26	Bristol-Myers Squibb	Results 96-Week Data From CASTLE Study Continue to Show Similar Efficacy Between Once-Daily REYATAZ(R) (atazanavir sulfate)/Ritonavir and Twice-Daily Lopinavir/Ritonavir In Previously Untreated HIV-1 Infected Adult Patients bms.com ↗ The CASTLE results demonstrated the non-inferiority of REYATAZ/r once daily versus lopinavir/r twice daily, each as part of HIV combination therapy in previously untreated HIV-1 infected adult patients.
2007-11-02	Gilead Sciences	Results Gilead Announces 48-Week Data from Two Pivotal Phase III Studies Evaluating Viread(R) For the Treatment of Chronic Hepatitis B gilead.com ↗ In addition, three percent of Viread patients (n=153) compared to zero percent of Hepsera patients (n=80; p=0.018) experienced "s" antigen (HBsAg) loss, which can indicate that a patient has cleared chronic hepatitis B infection.
2007-10-11	Gilead Sciences	Regulatory Gilead Submits Marketing Applications in the United States and European Union for Viread(R) (Tenofovir Disoproxil Fumarate) for the Treatment of Chronic Hepatitis B gilead.com ↗ today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a Type II variation to the European Medicines Agency (EMEA)
2007-07-23	Gilead Sciences	Results 144-Week Data from Gilead's Study 934 Comparing Truvada(R) to Combivir(R) Both in Combination with Sustiva(R) Presented At International AIDS Society Meeting in Sydney gilead.com ↗ today announced the presentation of 144-week data from an ongoing clinical trial, Study 934, comparing a once-daily regimen of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Sustiva(R) (efavirenz)
2007-06-25	Gilead Sciences	Results Second Phase III Study Evaluating Gilead's Viread(R) for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint gilead.com ↗ Gilead Sciences, Inc. (Nasdaq:GILD) today announced that Study 103, a Phase III clinical trial evaluating the company's once-daily anti-HIV drug Viread(R) (tenofovir disoproxil fumarate or tenofovir DF) 300 mg as a potential treatment for chronic hepatitis B virus (HBV) infection, met its primary efficacy endpoint.
2007-06-06	Gilead Sciences	Results Phase III Study Evaluating Gilead's Viread(R) for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint gilead.com ↗ The study shows that Viread is non-inferior to the company's once-daily antiviral drug Hepsera(R) (adefovir dipivoxil) among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic HBV infection.
2006-10-09	Gilead Sciences	Regulatory Bristol-Myers Squibb, Gilead Sciences and Merck & Co. Submit Marketing Authorisation Application for ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) to European Medicines Agency gilead.com ↗ The MAA for ATRIPLA in the European Union was filed jointly by the three companies through a newly established three-way joint venture based in Ireland, Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited.
2006-09-27	Gilead Sciences	Results Landmark Five-Year Data on Gilead's Anti-HIV Drug Viread(R) Presented at 8th International Workshop on Adverse Drug Reactions and Lipodystrophy gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) today announced two presentations of long-term efficacy and safety data from Study 903E on the company's leading once-daily anti-HIV medication, Viread(R) (tenofovir disoproxil fumarate).
2006-08-14	Gilead Sciences	Results 96-Week Data from Gilead's Study 934 Comparing Viread(R) and Emtriva(R) to Combivir(R) Both in Combination with Sustiva(R) Presented at XVI International AIDS Conference gilead.com ↗
2006-07-12	Gilead Sciences	Regulatory U.S. Food and Drug Administration (FDA) Approves ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), The First Once-Daily Single Tablet Regimen for Adults with HIV-1 Infection gilead.com ↗ Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc. (Nasdaq:GILD) today announced the U.S. Food and Drug Administration (FDA) has granted approval of ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) for the treatment of HIV-1 infection in adults.
2006-04-27	Gilead Sciences	Regulatory Bristol-Myers Squibb and Gilead Sciences Submit New Drug Application to U.S. FDA for a Once-Daily Single Tablet Regimen of Sustiva(R) (Efavirenz) and Truvada(R) (Emtricitabine and Tenofovir Disoproxil Fumarate) for HIV Treatment gilead.com ↗
2006-03-08	Gilead Sciences	Regulatory U.S. FDA Grants Traditional Approval for Gilead's Once-Daily HIV Medications Truvada(R) and Viread(R); 48-Week Data from Pivotal Study 934 Added to U.S. Prescribing Information for Both Products gilead.com ↗
2006-01-18	Gilead Sciences	Results Data Comparing Viread(R) and Emtriva(R) to Combivir(R) as Part of Combination HIV Therapy Published in New England Journal of Medicine gilead.com ↗ Publication Describes Superior Viral Suppression with Fewer Adverse Events Leading to Discontinuation for Patients Taking Viread and Emtriva at 48 Weeks
2006-01-09	Gilead Sciences	Results Bristol-Myers Squibb and Gilead Announce Data Supporting Bioequivalence for Single-Pill Fixed-Dose Regimen of Sustiva(R) (efavirenz) and Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) gilead.com ↗
2005-07-26	Vertex Pharmaceuticals Incorporated	Results Study Results Presented on Pharmacokinetics of Once-Daily HIV Combination Therapy vrtx.com ↗ Results showed that plasma levels of all four drugs remained within previously described pharmacokinetic parameters, supporting the potential for this combination to be a useful once-daily regimen for the treatment of HIV infection.
2005-04-26	Gilead Sciences	Results Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada -emtricitabine and tenofovir disoproxil fumarate- and Sustiva -efavirenz- gilead.com ↗ Preliminary results from the bioequivalence study of the first formulation indicate that efavirenz levels in the blood are lower than those achieved with the recommended 600 mg dose of Sustiva alone and do not meet the definition of bioequivalence.
2004-10-31	Gilead Sciences	Results Interim 24-Week Data from Study 934 Comparing a Regimen of Viread and Emtriva Versus Combivir, Both in Combination with Efavirenz, in Patients with HIV Presented at 44th ICAAC gilead.com ↗ Although both triple-drug regimens are relatively convenient, we observed a difference in the two arms, with more patients discontinuing in the Combivir group due to adverse events.
2004-08-26	Gilead Sciences	Results Gilead Announces Preliminary 24-Week Data from Study 934 Comparing Viread and Emtriva to Combivir Both in Combination With Efavirenz In Patients With HIV gilead.com ↗ Preliminary results show a statistically significant difference favoring Viread/Emtriva in the percentage of patients who achieved and maintained HIV RNA less than 400 copies/mL at 24 weeks, based on the FDA Time to Loss of Virologic Response algorithm (TLOVR).
2004-03-15	Gilead Sciences	Regulatory Gilead Submits Applications to U.S. and European Regulatory Authorities for Fixed Dose Co-Formulation of Viread and Emtriva gilead.com ↗ The company also announced the submission of its Marketing Authorisation Application (MAA) for the fixed dose co-formulation to the European Agency for the Evaluation of Medicinal Products (EMEA).
2004-02-04	Gilead Sciences	Results Gilead Announces Data from Landmark Three-Year Clinical Trial of Viread; 144-Week Data Highlight Viread Efficacy, Safety and Side Effect Profile gilead.com ↗ FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 4, 2004--Gilead Sciences, Inc. (Nasdaq:GILD) today announced preliminary three-year (144-week) data from a double-blind Phase III clinical trial (Study 903) suggesting that Viread(R) (tenofovir disoproxil fumarate) is associated with similar levels of viral load suppression and a similar renal safety profile when compared to treatment with stavudine (d4T).
2003-02-11	Gilead Sciences	Results 96-Week Data From Phase III Study Show Long-Term Efficacy With Reduced Risk of Lipid and Metabolic Changes for Viread Versus Stavudine in Treatment-Naive HIV Patients gilead.com ↗ The 96-week results presented today show that the Viread and stavudine arms reduced HIV RNA to less than 400 copies/mL in 82 and 78 percent of patients respectively, using the most conservative "missing equals failure" analysis.
2002-07-11	Gilead Sciences	Results 48-Week Data Demonstrate Ability of Viread to Suppress Viral Load in Patients With Multiple Treatment-Resistant HIV Mutations gilead.com ↗ Patients with no TAMs who received the Viread-containing regimen experienced a significant reduction in mean HIV RNA level of 0.80 log10 copies/mL at 24 weeks (p less than 0.001; n=68).
2002-05-07	Gilead Sciences	Results Gilead Announces Preliminary 48-Week Study Results Showing Viread Comparable to Stavudine in Treatment-Naive HIV Patients gilead.com ↗ These data demonstrate that as a part of combination therapy for 48 weeks Viread can provide efficacy and safety comparable to stavudine, one of the most commonly prescribed nucleoside reverse transcriptase inhibitors.
2002-02-27	Gilead Sciences	Results Gilead Announces Data From Study of Viread in Patients Co-infected With HIV and HBV; Data Presented at 9th Conference on Retroviruses and Opportunistic Infections gilead.com ↗ Following 24 weeks of Viread treatment, the mean change in serum HBV DNA from baseline was a reduction of 4.81 log10 copies/mL for patients receiving Viread and an increase of 1.23 log10 copies/mL for patients on placebo (p=0.04).
2002-02-25	Gilead Sciences	Results Viread Demonstrates Anti-HIV Potency Similar to the Protease Inhibitor Ritonavir in Short-Term Study of Treatment-Naive Patients gilead.com ↗ After three weeks, patients treated with Viread monotherapy experienced a mean reduction in HIV RNA of 1.5 log10 copies/mL (range: 0.6 to 2.7).
2002-02-07	Gilead Sciences	Regulatory Gilead Sciences' New HIV Drug Viread Approved for Marketing in European Union gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Evaluation Agency (EMEA) has granted the Marketing Authorisation for Viread(R) (tenofovir disoproxil fumarate) in all 15 member states of the European Union.
2001-09-25	Gilead Sciences	Results Gilead’s Investigational Antiretroviral Agent Viread™ Reduces Viral Load in HIV Patients with Resistant Virus in Pivotal Phase III Study gilead.com ↗ Gilead Sciences (Nasdaq: GILD) today released 24-week efficacy and safety results from a pivotal Phase III study of its investigational one tablet, once daily antiretroviral agent Viread™ (tenofovir disoproxil fumarate).
2001-06-05	Gilead Sciences	Results Gilead Sciences Presents Data Characterizing Resistance Profile of Tenofovir DF, Investigational Agent for the Treatment of HIV gilead.com ↗ Results of this study indicate that over 88 percent of the samples were fully susceptible to tenofovir and were within the normal three-fold range.
2000-09-18	Gilead Sciences	Results Gilead Sciences Announces Results from 48-Week Study of Once-Daily Anti-HIV Agent Tenofovir DF gilead.com ↗ Confirming earlier efficacy results, tenofovir DF was associated with significant and sustained antiviral activity.
2000-04-16	Gilead Sciences	Results Gilead Sciences Presents 48-Week Phase II Safety and Efficacy Results for Once-Daily Anti-HIV Agent, Tenofovir DF gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) today announced preliminary results from a Phase II dose-ranging clinical trial (Study 902) evaluating the safety and efficacy of once-daily tenofovir disoproxil fumarate (tenofovir DF) when used to intensify a stable background antiretroviral regimen in 189 treatment-experienced HIV patients.

All press releases naming this drug 243 releases

Date	Issuer	Release
Show all 243 releases opens the full record — a long page

Evidence & citations 21 cited values

Every value below carries the sentence it was read from. 305 sources stand behind the page.

Field	Value	Cited text
Known as	Tenofovir	“Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗ 272 “DESIGN: ICE-001 is a phase IV, randomized, two-arm unblinded study, comparing the effect on immune reconstitution of open-label ritonavir (RTV)-enhanced lopinavir (LPV) to...” NCT00775606 ↗ “Tenofovir / emtricitabine + efavirenz for all HIV-1-infected men and all HIV-1-infected women who meet the following requirements: on effective contraception and no history of...” NCT00495651 ↗ “Patients will be on their existing nucleosid(t)e analogue therapy comprising lamivudine 100mg daily, adefovir 10mg daily, entecavir 0.5mg or 1.0mg daily or tenofovir 300mg...” NCT01928511 ↗ “one tablet of Truvada a day at standard dose of Tenofovir 300mg and Emtricitabine 200mg and four tablets of Kaletra once a day for a total dose of lopinavir 800mg and ritonavir...” NCT01614405 ↗ “Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive patients infected by CCR5 HIV-1 previously treated for 6 months with a...” NCT01291459 ↗ “This study aims to investigate the clinical efficacy of Ganshuang granules combined with tenofovir, an antiviral drug, in the treatment of chronic hepatitis B complicated with...” PMID 36588741 ↗ Dec 2022 “women used a placebo or tenofovir (TFV) and levonorgestrel (LNG) intravaginal ring (IVR), either continuously or cyclically (three, 28-day cycles with a 3 day interruption in...” PMID 36215267 ↗ Oct 2022 “Otherwise, patients can be initiated on a preferred regimen of tenofovir (TDF), emtricitabine (FTC), and efavirenz (EFV) according to the US Department of Health and Human...” NCT00799136 ↗ “The purpose of this trial is to assess the safety and acceptability of Tenofovir (TFV) 1% gel in adolescent females over 12 weeks of a minimum of twice weekly dosing following...” NCT02245945 ↗ “Tenofovir - inhibits HIV-1 reverse transcriptase activity by competing with the natural substrate, deoxyadenosine 5'-triphosphate and, upon incorporation into DNA, causes DNA...” NCT06676410 ↗ Show 262 more sources
Known as	9-\[(R)-2-(phosphonomethoxy) propyl\]adenine monohydrate	“The original VF is a transparent, viscous gel formulation containing 1% (weight/weight) of tenofovir (PMPA, 9-\[(R)-2-(phosphonomethoxy) propyl\]adenine monohydrate),...” NCT01575405 ↗
Known as	PEG-IFN alfa-2a, Tenofovir	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00932971 ↗
Known as	PMPA	“PMPA gel, also known as tenofovir, is an anti-microbe agent that may fight against sexual transmission of HIV and other sexually transmitted diseases (STDs).” NCT00028132 ↗ 2 “containing 1% (w/w) of tenofovir (PMPA) formulated in purified water” NCT01575418 ↗ “containing 1% (w/w) of tenofovir (PMPA) formulated in purified water” NCT01575405 ↗
Known as	TAF	“tenofovir (TDF ou TAF)” NCT03256422 ↗
Known as	TDF	“DESIGN: ICE-001 is a phase IV, randomized, two-arm unblinded study, comparing the effect on immune reconstitution of open-label ritonavir (RTV)-enhanced lopinavir (LPV) to...” NCT00775606 ↗ 54 “BACKGROUND: The efficacy of switching to tenofovir disoproxil fumarate (TDF) monotherapy from lamivudine (LAM) plus adefovir dipivoxil (ADV) combination therapy (stable...” PMID 29329305 ↗ Jan 2018 “This randomized, three-period crossover, open-label, phase I trial assessed the effects of doravirine (DOR) and tenofovir disoproxil fumarate (TDF) on the pharmacokinetics...” PMID 38421210 ↗ Mar 2024 “All received a single 300-mg dose of oral tenofovir disoproxil fumarate (TDF) and were then randomized 2:1 to receive single and then seven daily rectal exposures of...” PMID 25350119 ↗ Oct 2014 “The antiretroviral treatment consisted in a tenofovir-emtricitabine NRTI backbone (TDF/FTC, 300/200 mg/ml, once a day) plus boosted protease inhibitor, lopinavir/ritonavir...” NCT02097381 ↗ “the presence of low level nucleoside reverse-transcriptase inhibitor-resistant human immunodeficiency virus in subjects receiving failing first-line regimens consisting of...” PMID 19032103 ↗ Jan 2009 “Tenofovir disoproxil fumarate (TDF) is a potent, rapidly acting, oral acyclic nucleotide analogue, reverse transcriptase inhibitor that has been shown to be highly effective in...” NCT01074645 ↗ “Treatment-naive adults were randomized to nevirapine (NVP) or ritonavir-boosted lopinavir (LPV/r) regimens each in combination with tenofovir (TDF)/emtricitabine (FTC) or...” PMID 25028911 ↗ May 2014 “A single tablet FDC containing doravirine 100 mg, lamivudine (3TC) 300 mg and tenofovir disoproxil fumarate (TDF) 300 mg administered orally, once daily for 12 weeks during the...” NCT02652260 ↗ “A phase 2 randomized, controlled trial of a regimen containing tenofovir (TDF)/lamivudine (3TC) and a regimen containing 3TC in HIV/HBV-coinfected pregnant women in China.” PMID 27658693 ↗ Sep 2016 “Abacavir sulfate/lamivudine (ABC/3TC) and tenofovir DF/emtricitabine (TDF/FTC) are widely used nucleoside reverse transcriptase inhibitors for initial HIV-1 treatment.” PMID 19542866 ↗ Jul 2009 Show 44 more sources
Known as	tenofovir (viread)	“tenofovir (viread)” NCT01711567 ↗ 2 “Tenofovir (Viread)” NCT01373684 ↗ “Tenofovir = Viread” NCT00441298 ↗
Known as	Tenofovir 300mg - Viread	“Tenofovir 300mg - Viread” NCT01594905 ↗
Known as	tenofovir DF	“Abacavir sulfate/lamivudine (ABC/3TC) and tenofovir DF/emtricitabine (TDF/FTC) are widely used nucleoside reverse transcriptase inhibitors for initial HIV-1 treatment.” PMID 19542866 ↗ Jul 2009 3 “Arms A, B, and C receive the same daily dosage of lopinavir/ritonavir (LPV/r), emtricitabine (FTC), and stavudine extended release (d4T XR) or tenofovir DF (TDF).” NCT00036452 ↗ “300mg tenofovir df + 200 mg emtricitabine by mouth daily” NCT00414635 ↗ “* tenofovir DF 300 mg” NCT00474435 ↗
Known as	tenofovir disoproxil	“tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg” NCT03546621 ↗
Known as	tenofovir disoproxil fumarate	“BACKGROUND: The efficacy of switching to tenofovir disoproxil fumarate (TDF) monotherapy from lamivudine (LAM) plus adefovir dipivoxil (ADV) combination therapy (stable...” PMID 29329305 ↗ Jan 2018 16 “Tenofovir disoproxil fumarate (TDF) is a potent, rapidly acting, oral acyclic nucleotide analogue, reverse transcriptase inhibitor that has been shown to be highly effective in...” NCT01074645 ↗ “A single tablet FDC containing doravirine 100 mg, lamivudine (3TC) 300 mg and tenofovir disoproxil fumarate (TDF) 300 mg administered orally, once daily for 12 weeks during the...” NCT02652260 ↗ “ritonavir-boosted darunavir with either raltegravir or tenofovir disoproxil fumarate and emtricitabine in antiretroviral therapy (ART)-naive adults.” PMID 33794182 ↗ Apr 2021 “All participants will undergo an open label tenofovir tablet single dose administration (i.e. Tenofovir Disoproxil Fumarate 300 mg, aka Viread®)” NCT00984971 ↗ “Switching to Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will result in faster and greater antiviral activity” NCT01597934 ↗ “oral tenofovir disoproxil fumarate (TDF)/placebo vaginal gel, oral placebo/tenofovir (TFV) vaginal gel, or double placebo” PMID 26044291 ↗ Jun 2015 “Efficacy of daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for PrEP is strongly dependent on the adherence.” PMID 31430318 ↗ Aug 2019 “Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will show effective antiviral activity” NCT01594905 ↗ “emtricitabine with tenofovir disoproxil fumarate (FTC/TDF, 200/300 mg given orally for 10 days)” PMID 34957385 ↗ Dec 2021 “tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg” NCT03546621 ↗ Show 6 more sources
Known as	Tenofovir disoproxilfumarat	“Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally” NCT00932971 ↗
Known as	Tenofovir Film	“Drug: Tenofovir Film” NCT02280109 ↗
Known as	Tenofovir Gel	“Drug: Tenofovir Gel” NCT02280109 ↗
Known as	tenofovir td	“300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine” NCT00414635 ↗
Known as	TFV	“All received a single 300-mg dose of oral tenofovir disoproxil fumarate (TDF) and were then randomized 2:1 to receive single and then seven daily rectal exposures of...” PMID 25350119 ↗ Oct 2014 23 “The concordance of quantifiable FTC-TP in DBS with tenofovir (TFV)/FTC in plasma was evaluated by utilizing paired plasma-DBS samples from participants enrolled in 2 large...” PMID 27572401 ↗ Oct 2016 “women used a placebo or tenofovir (TFV) and levonorgestrel (LNG) intravaginal ring (IVR), either continuously or cyclically (three, 28-day cycles with a 3 day interruption in...” PMID 36215267 ↗ Oct 2022 “This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability...” PMID 27362788 ↗ Jun 2016 “In this Phase 1 vaginal film study, the safety, acceptability, pharmacokinetics and pharmacodynamics of two doses of tenofovir (TFV) film and TFV 1% gel were compared to...” PMID 30101439 ↗ Aug 2018 “The purpose of this trial is to assess the safety and acceptability of Tenofovir (TFV) 1% gel in adolescent females over 12 weeks of a minimum of twice weekly dosing following...” NCT02245945 ↗ “Our team developed an intravaginal ring (IVR) that delivers tenofovir (TFV) (8-10 mg/day) alone or with levonorgestrel (LNG) (20 ug/day).” PMID 31107913 ↗ May 2019 “oral tenofovir disoproxil fumarate (TDF)/placebo vaginal gel, oral placebo/tenofovir (TFV) vaginal gel, or double placebo” PMID 26044291 ↗ Jun 2015 “systemic exposure to tenofovir (TFV) 1% gel and a given commonly used vaginal product are impacted by concomitant use” NCT01813162 ↗ “randomized 2:2:1 to continuous use of a tenofovir/levonorgestrel (TFV/LNG), TFV, or placebo intravaginal ring (IVR).” PMID 37383290 ↗ Jun 2023 “Tenofovir (TFV) gel partially protected against human immunodeficiency virus (HIV) in one but not subsequent trials.” PMID 26508513 ↗ Oct 2015 Show 13 more sources
Known as	TFV RG	“tenofovir reduced-glycerin (TFV RG) 1% gel” NCT01768962 ↗
Known as	Viread	“All participants will undergo an open label tenofovir tablet single dose administration (i.e. Tenofovir Disoproxil Fumarate 300 mg, aka Viread®)” NCT00984971 ↗ 2 “Tenofovir, with potent activity against retroviruses \[1\], was developed for oral use as Viread®, which is widely used for HIV treatment.” NCT01387022 ↗ “Viread (300 mg Tenofovir disoproxil fumarate) once daily” NCT00356616 ↗
Action	Inhibit	“existing dual nucleoside analogue reverse transcriptase inhibitor therapy to coformulated tenofovir-emtricitabine or abacavir-lamivudine” PMID 24722774 ↗ Apr 2014
Modality	Small molecule	“an acyclic nucleoside phosphonate, tenofovir (TDF)” NCT00214890 ↗
Route	Oral	“Active Comparator, Capsules, tablets, Oral” NCT00035932 ↗