Drugs / FTC/TDF
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02121795 | May 2014 → Aug 2015 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 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). |
| 2024-06-20 | Gilead Sciences | Results Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention gilead.com ↗
PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada ® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV). |
| 2020-08-11 | Gilead Sciences | Regulatory China National Medical Products Administration Approves Truvada® for HIV Pre-Exposure Prophylaxis (PrEP) gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the China National Medical Products Administration (NMPA) has approved a pre-exposure prophylaxis indication for Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg,FTC/TDF). |
| 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 ↗
Through 96 weeks, study participants reported a stable number of total and condomless sexual partners. |
| 2019-10-04 | Gilead Sciences | Results Gilead Presents New Data From the Company’s HIV Clinical Development Program and Latest Findings on the Impact of HIV Pre-exposure Prophylaxis (PrEP) at IDWeek 2019 gilead.com ↗
Results from DISCOVER Trial Provide Bone and Renal Safety Profile Data from Participants who Switched from Truvada for PrEP ® to Descovy for PrEP ™ |
| 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 ↗ |
| 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. |
| 2016-08-22 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Once-Daily Truvada® For Reducing the Risk of Sexually Acquired HIV-1 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for once-daily Truvada ® (emtricitabine 200 mg/tenofovir disoproxil 245 mg; FTC/TDF) in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. |
| 2015-09-02 | Gilead Sciences | Results Gilead’s Investigational Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide (F/TAF) Meets Primary 48-Week Objective in Phase 3 Study gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that a Phase 3 study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of HIV-1 infection met its primary objective. |
All press releases naming this drug 9 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FTC/TDF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02121795 ↗ |
| Known as | emtricitabine with tenofovir disoproxil fumarate | “Emtricitabine with tenofovir disoproxil fumarate is a standard-of-care nucleoside reverse transcriptase inhibitor (NRTI) backbone.” PMID 27036991 ↗ Mar 2016 |
| Modality | Small molecule | “Emtricitabine with tenofovir disoproxil fumarate is a standard-of-care nucleoside reverse transcriptase inhibitor (NRTI) backbone.” PMID 27036991 ↗ Mar 2016 |
| Route | Oral | “200/300 mg FDC tablets administered orally once daily” NCT02121795 ↗ |