Truvada

also known as FTC/TDF · TDF/FTC · Tenofovir DF/Emtricitabine

Developed for: HIV infectious disease · AIDS
Investigated by: Gilead Sciences · Merck Sharp & Dohme LLC · National Institute of Allergy and Infectious Diseases (NIAID) · Bill and Melinda Gates Foundation · Emory University · FHI 360
+45 more
· Imperial College London · University of North Carolina, Chapel Hill · AVAC · Bar Hostess Empowerment & Support Programme · Boehringer Ingelheim · Brigham and Women's Hospital · Center for AIDS Research (CFAR) · Centres for Disease Control and Prevention, Kenya. · Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT). · Duke University · Family Health Options Kenya · Gay and Lesbian Coalition Kenya · Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux · HIV Prevention Trials Network · Health Options for Young Men with AIDS/STI · ISHTAR MSM · Institute of Tropical Medicine · International AIDS Vaccine Initiative · International Partnership for Microbicides, Inc. · Kenya Sex Workers Alliance · LVCT Health · London School of Hygiene and Tropical Medicine · National AIDS Control Council · National AIDS and STI Control Programme · National Institute of Mental Health (NIMH) · National Institute of Respiratory Diseases · National Institutes of Health (NIH) · Nyanza Western Kenya LGBTI Coalition · O' Neill Institute · Population Council · Projeto Praça Onze · Queen Savang Vadhana Memorial Hospital, Thailand · Results for Development · Réseau Africain de Recherche sur le SIDA · SEARCH Research Foundation · Sex Workers Outreach Programme · Sex Workers Outreach Project · St Stephens Aids Trust · St. Luke's-Roosevelt Hospital Center · Thai Red Cross AIDS Research Centre · University of Hawaii · University of Missouri-Columbia · University of Washington · Westat · World Health Organization

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Truvada	—	2005-02-20	europa.eu ↗
Approved	US (FDA)	TRUVADA	—	2004-08-02	fda.gov ↗

Trials 24

today

US approved 2004

EU approved 2005

NCT04778527 · not/applicable NCT05108935 · not/applicable NCT05072093 · Ph 4 NCT03842436 · Ph 4 NCT03074786 · Ph 2 NCT03218592 · Ph 4 NCT02732730 · Ph 4 NCT02572505 · not/applicable NCT02755350 · not/applicable NCT02474303 · not/applicable NCT02351908 · Ph 4 NCT02333045 · not/applicable NCT01832571 · not/applicable NCT01697046 · Ph 3 NCT01348763 · Ph 1 NCT01114425 · Ph 3 NCT00625404 · Ph 3 NCT00669487 · Ph 3 NCT00737724 · not/applicable NCT00960622 · Ph 4 NCT00224445 · Ph 4 NCT02253901 · Ph 1 NCT00224458 · Ph 4 NCT00323687 · Ph 4

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 12 trials
Phase 1	NCT01348763	Oct 2011 → Feb 2012	HIV infectious disease	Imperial College London	Completed	No outcome recorded
Phase 1	NCT02253901	Mar → May 2005	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 21 trial
Phase 2	NCT03074786	Nov 2017 → Dec 2018	HIV infectious disease	International Partnership for Microbicides, Inc.	Withdrawn	No outcome recorded
Phase 34 trials · 1 missed
Phase 3	NCT01697046	Nov 2012 → Mar 2014	HIV infectious disease	Projeto Praça Onze	Unknown	No outcome recorded
Phase 3	NCT01114425	Nov 2010 → Aug 2012	HIV infectious disease	Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux	Completed	No outcome recorded
Phase 3	NCT00625404	May 2009 → Aug 2012	HIV infectious disease	FHI 360	Completed	Missed primary
Phase 3	NCT00669487	Apr 2008 → Dec 2010	HIV infectious disease	SEARCH Research Foundation	Completed	No outcome recorded
Phase 49 trials · 2 missed
Phase 4	NCT05072093	Nov 2021 → Mar 2025	HIV infectious disease, bacterial sexually transmitted disease	Emory University	Completed	No outcome recorded
Phase 4	NCT03842436	Oct 2018 → Apr 2020	HIV infectious disease, substance-related disorder	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 4	NCT03218592	Jun 2017 → Dec 2018	AIDS	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 4	NCT02732730	Oct 2016 → Oct 2018	HIV infectious disease	HIV Prevention Trials Network	Completed	Missed primary
Phase 4	NCT02351908	Mar 2015 → Apr 2016	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 4	NCT00960622	Aug 2006 → Jul 2009	HIV infectious disease	St. Luke's-Roosevelt Hospital Center	Completed	Missed primary
Phase 4	NCT00224445	Sep 2005 → Jan 2007	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 4	NCT00224458	Sep 2004 → Feb 2006	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 4	NCT00323687	Sep 2004 → Oct 2006	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase not applicable8 trials
—	NCT04778527	Sep 2022 → Jan 2024	HIV infectious disease	Population Council	Unknown	No outcome recorded
—	NCT05108935	Feb 2022 → Mar 2023	HIV infectious disease, hepatitis C virus infection, opiate dependence	Duke University	Completed	No outcome recorded
—	NCT02572505	Nov 2015 → Sep 2017	HIV infectious disease, infertility disorder	University of Missouri-Columbia	Withdrawn	No outcome recorded
—	NCT02755350	Aug 2015 → Nov 2016	HIV infectious disease	LVCT Health	Unknown	No outcome recorded
—	NCT02474303	Jul 2015 → Dec 2016	HIV infectious disease	Réseau Africain de Recherche sur le SIDA	Completed	No outcome recorded
—	NCT02333045	Jan 2015 → Oct 2016	HIV infectious disease	Emory University	Terminated	No outcome recorded
—	NCT01832571	Jun → Jul 2013	HIV infectious disease	FHI 360	Withdrawn	No outcome recorded Stop: Business
—	NCT00737724	Mar 2008 → Feb 2011	AIDS, tuberculosis	National Institute of Respiratory Diseases	Terminated	No outcome recorded
Comparator or background therapy22 trials
Phase 1	NCT03706924 Comparator	Jun → Oct 2018	HIV infectious disease	Viriom	Completed	No outcome recorded
Phase 1	NCT01040091 Comparator	Dec 2009 → Apr 2014	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00667433 Background	Jun 2008 → Dec 2011	HIV infectious disease	David A Wohl, MD	Completed	No outcome recorded
Phase 2	NCT02336074 Background	Nov 2015 → Nov 2017	HIV infectious disease	Imperial College London	Completed	Missed primary
Phase 2	NCT01338883 Comparator	Jun 2011 → Dec 2012	HIV infectious disease	Tobira Therapeutics, Inc.	Completed	Missed primary
Phase 2/3	NCT04742491 Background	Mar 2021 → Aug 2024	—	HIV Prevention Trials Network	Completed	No outcome recorded
Phase 2/3	NCT03227731 Comparator	Sep 2017 → Dec 2021	HIV infectious disease	University of KwaZulu	Completed	No outcome recorded
Phase 2/3	NCT00476983 Background	—	—	The HIV Netherlands Australia Thailand Research Collaboration	Withdrawn	No outcome recorded Stop: Business
Phase 3	NCT05592613 Background	Feb 2023 → Jul 2024	HIV infectious disease	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 3	NCT05378399 Background	Dec 2022 → Feb 2026	HIV infectious disease, substance-related disorder	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 3	NCT03512418 Background	Jun 2019 → Apr 2024	HIV infectious disease, substance-related disorder	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 3	NCT02486133 Comparator	Jul 2015 → May 2018	HIV infectious disease	Technical University of Munich	Completed	No outcome recorded
Phase 3	NCT00745823 Background	Sep 2008 → Oct 2010	HIV infectious disease	Merck Sharp & Dohme LLC	Terminated	No outcome recorded
Phase 3	NCT00708162 Background	Jul 2008 → Dec 2010	HIV infectious disease	Gilead Sciences	Completed	Met primary
Phase 3	NCT00369941 Background	Aug 2006 → May 2009	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 4	NCT03142256 Comparator	Mar 2017 → Jun 2019	—	Desmond Tutu HIV Centre	Unknown	No outcome recorded
Phase 4	NCT02924389 Background	Sep 2016 → Sep 2019	HIV infectious disease	Emory University	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02577042 Comparator	Oct 2015 → Jun 2018	—	Fight AIDS and Infectious Diseases Foundation	Completed	No outcome recorded
Phase 4	NCT02057796 Background	Sep 2014 → Apr 2018	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	Missed primary
Phase 4	NCT01380080 Background	Oct 2011 → Jan 2015	HIV infectious disease	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	Completed	Missed primary
Phase 4	NCT01173510 Background	Aug 2010 → Oct 2012	AIDS	Community Research Initiative of New England	Withdrawn	No outcome recorded
Phase 4	NCT00632970 Background	Feb 2008 → Feb 2010	HIV infectious disease	George Washington University	Terminated	No outcome recorded

Press releases naming this drug 43 releases

Date	Issuer	Release
2024-09-12	Gilead Sciences	Gilead’s Twice-Yearly Lenacapavir for HIV Prevention Reduced HIV Infections by 96% and Demonstrated Superiority to Daily Truvada® in Second Pivotal Phase 3 Trial gilead.com ↗
2024-06-20	Gilead Sciences	Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention gilead.com ↗
2022-07-28	GlaxoSmithKline	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	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 ↗
2020-08-11	Gilead Sciences	China National Medical Products Administration Approves Truvada® for HIV Pre-Exposure Prophylaxis (PrEP) gilead.com ↗
2019-11-06	Gilead Sciences	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 ↗
2019-07-23	Gilead Sciences	Gilead Presents New Findings on Profile of Descovy® for Potential Use as HIV Pre-exposure Prophylaxis Compared With Truvada® gilead.com ↗
2019-05-09	Gilead Sciences	Gilead Sciences to Provide Free Truvada for PrEP® to Support U.S. Initiative to End the HIV Epidemic gilead.com ↗
2019-03-06	Gilead Sciences	Gilead Announces Data Demonstrating Non-Inferiority of Once-Daily Descovy® vs. Once-Daily Truvada® for Prevention of HIV Infection gilead.com ↗
2018-07-24	Gilead Sciences	Gilead Announces New Data on the Impact of Truvada® (Emtricitabine and Tenofovir Disoproxil Fumarate) for Pre-Exposure Prophylaxis (PrEP) on the Number of HIV Diagnoses in the United States gilead.com ↗
2018-05-15	Gilead Sciences	U.S. Food and Drug Administration Approves Expanded Indication for Truvada® (Emtricitabine and Tenofovir Disoproxil Fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents gilead.com ↗
2016-10-24	Gilead Sciences	Gilead Presents Results from Phase 3 Studies Evaluating Switching to Descovy® (FTC/TAF)-Based Regimens from Truvada® (FTC/TDF)-Based Regimens gilead.com ↗
2016-08-22	Gilead Sciences	European Commission Grants Marketing Authorization for Gilead’s Once-Daily Truvada® For Reducing the Risk of Sexually Acquired HIV-1 gilead.com ↗
2016-07-22	Gilead Sciences	European CHMP Adopts Positive Opinion on Gilead’s Type II Variation Application for Truvada® for Reducing the Risk of Sexually Acquired HIV gilead.com ↗
2016-02-23	Gilead Sciences	Gilead Announces Results From First Study to Evaluate Switching to F/TAF-Based Regimens from Truvada® (F/TDF)-Based Regimens gilead.com ↗
2016-02-01	Gilead Sciences	European Medicines Agency Validates Gilead’s Type II Variation Application for Truvada® for Reducing the Risk of Sexually Acquired HIV gilead.com ↗
2012-07-16	Gilead Sciences	U.S. Food and Drug Administration Approves Gilead’s Truvada® for Reducing the Risk of Acquiring HIV gilead.com ↗
2012-05-10	Gilead Sciences	FDA Advisory Committee Supports Approval of Gilead’s Truvada® for Reducing the Risk of Acquiring HIV gilead.com ↗
2012-02-13	Gilead Sciences	U.S. FDA Grants Priority Review for Truvada® for Reducing the Risk of Acquiring HIV Infection gilead.com ↗
2011-12-15	Gilead Sciences	Gilead Sciences Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Truvada® for Reducing the Risk of Acquiring HIV gilead.com ↗
2011-02-10	Gilead Sciences	Gilead Sciences Refiles New Drug Application with the FDA for Single-Tablet Regimen of Truvada(R) and TMC278 gilead.com ↗
2011-01-25	Gilead Sciences	Gilead Sciences Receives Refuse to File Notification From U.S. FDA on New Drug Application for Single-Tablet Regimen of Truvada(R) and TMC278 gilead.com ↗
2011-01-25	Gilead Sciences	Gilead Sciences Receives Refuse to File Notification From U.S. FDA on New Drug Application for Single-Tablet Regimen of Truvada(R) and TMC278 gilead.com ↗
2010-11-23	Gilead Sciences	Gilead Sciences Submits New Drug Application to U.S. FDA for Once-Daily Single-Tablet Regimen of Truvada(R) and TMC278 for HIV gilead.com ↗
2010-09-03	Gilead Sciences	Gilead Sciences Submits European Marketing Application for Once-Daily Single-Tablet Regimen of Truvada(R) and TMC278 for the Treatment of HIV Infection gilead.com ↗
2010-04-27	Gilead Sciences	Gilead Finalizes Selection of Bioequivalent Formulation for the Fixed-Dose Regimen of Truvada(R) and Tibotec Pharmaceuticals' TMC278 gilead.com ↗
2010-04-20	Gilead Sciences	Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada(R) and Tibotec Pharmaceuticals' TMC278 gilead.com ↗
2009-07-16	Gilead Sciences	Gilead Sciences Announces Agreement With Tibotec Pharmaceuticals to Develop and Commercialize New Fixed-Dose Combination of Truvada(R) and TMC278 gilead.com ↗
2008-11-14	Gilead Sciences	Gilead Sciences Announces Notification of ANDA Filing for Truvada gilead.com ↗
2007-10-29	Gilead Sciences	Gilead Announces 48-Week Data Evaluating Switching from Combivir(R) To Truvada(R) Among Virologically-Suppressed HIV Patients gilead.com ↗
2007-07-23	Gilead Sciences	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 ↗
2006-04-27	Gilead Sciences	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	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 ↗
2006-01-09	Gilead Sciences	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 ↗
2005-11-17	Gilead Sciences	Preliminary 24-Week Data Evaluating the Impact of Switching from Twice-Daily Combivir(R) to Once-Daily Truvada(R) in Patients with HIV Presented at 10th European AIDS Conference gilead.com ↗
2005-08-29	Gilead Sciences	Gilead Reduces Prices for Viread(R) and Truvada(R) in the Developing World gilead.com ↗
2005-08-09	Gilead Sciences	Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada(R) (Emtricitabine and Tenofovir Disoproxil Fumarate) and Sustiva(R) (Efavirenz) gilead.com ↗
2005-04-26	Gilead Sciences	Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada -emtricitabine and tenofovir disoproxil fumarate- and Sustiva -efavirenz- gilead.com ↗
2005-04-25	Gilead Sciences	Gilead Sciences and Aspen Pharmacare Sign Letter of Intent to Establish Non-Exclusive Licensing and Distribution Agreement for Antiretrovirals Truvada and Viread in Developing World Countries gilead.com ↗
2005-02-23	Gilead Sciences	European Commission Approves Truvada, a Once-a-Day Tablet Containing Gilead Sciences' Anti-HIV Drugs Emtriva and Viread gilead.com ↗
2004-11-18	Gilead Sciences	European CHMP Gives Positive Opinion on Gilead's Truvada as Part of Combination HIV Therapy gilead.com ↗
2004-08-18	Gilead Sciences	Gilead Expands Initiatives Providing Access to New HIV Therapy Truvada in United States and Abroad gilead.com ↗
2004-08-02	Gilead Sciences	U.S. FDA Approves Gilead's Truvada, a One-Tablet, Once-a-Day Fixed-Dose Co-Formulation of Viread and Emtriva as Part of HIV Combination Therapy gilead.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 46 sources stand behind the page.

Field	Value	Cited text
Known as	Truvada	“For men who are not interested in daily oral PrEP or plan to discontinue daily oral PrEP, the investigators will offer on-demand oral PrEP (Truvada) which will allow them to...” NCT05072093 ↗ 45 “one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil...” NCT04742491 ↗ “Likely consisting of an Nucleoside reverse-transcriptase inhibitor (NRTI) backbone i.e. Truvada plus a ritonavir-boosted protease inhibitor (PI) e.g. Darunavir” NCT02336074 ↗ “Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks.” NCT02577042 ↗ “tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV” NCT00708162 ↗ “bulk pills (Truvada and Zinnia F) for encapsulation” NCT04778527 ↗ “Truvada” NCT00737724 ↗ NCT02732730 ↗ NCT02486133 ↗ NCT02351908 ↗ NCT02057796 ↗ Show 35 more sources
Known as	FTC/TDF	“one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil...” NCT04742491 ↗ 2 “Participants will take one tablet of Emtricitabine 200mg/tenofovir disoproxil fumarate 300mg (FTC/TDF, Truvada) administered orally once daily with or without food.” NCT01380080 ↗ “FTC/TDF will be administered as open-label study drug in a fixed-dose combination formulation (Truvada).” NCT01338883 ↗
Known as	TDF/FTC	“HIV-infected participants will receive Truvada (TDF/FTC) and EFV for the first 30 days.” NCT01040091 ↗ 1 “daily oral PrEP with Truvada (TDF/FTC) for 12 months” NCT02474303 ↗
Known as	Tenofovir DF/Emtricitabine	“The objective of the proposed demonstration project with Tenofovir DF/Emtricitabine (TDF/FTC) among Female Sex Workers (FSW) in Dakar Senegal is to build a sustainable HIV PrEP...” NCT02474303 ↗
Route	Oral	“administered orally once daily (QD)” NCT00224445 ↗