Drugs / Emtricitabine/tenofovir disoproxil fumarate
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT00298363 | Apr 2006 → Apr 2011 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| 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). |
| 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). |
| 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 ↗
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. |
| 2021-07-17 | 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. |
| 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. |
| 2020-07-07 | GlaxoSmithKline | Results ViiV Healthcare announces superior efficacy of investigational, long-acting injectable formulation of cabotegravir dosed every two months over daily oral PrEP gsk.com ↗
Final analysis has since confirmed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets. |
| 2020-07-07 | ViiV Healthcare | Results ViiV Healthcare announces superior efficacy of investigational, long-acting injectable formulation of cabotegravir dosed every two months over daily oral PrEP viivhealthcare.com ↗
Final analysis has since confirmed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets. |
| 2020-05-18 | GlaxoSmithKline | Results Global HIV prevention study to stop early after ViiV Healthcare’s long-acting injectable formulation of cabotegravir dosed every two months shows higher efficacy than daily oral PrEP gsk.com ↗ |
| 2020-05-18 | ViiV Healthcare | Results Global HIV prevention study to stop early after ViiV Healthcare’s long-acting injectable formulation of cabotegravir dosed every two months shows higher efficacy than daily oral PrEP viivhealthcare.com ↗
The study achieved its primary objective of non-inferiority with the difference approaching superiority in favour of cabotegravir, pending final analysis. |
| 2020-03-10 | Gilead Sciences | Results Gilead Presents 96-week DISCOVER Trial Data Demonstrating Favorable Renal and Bone Safety Profile of Descovy® for HIV PrEP in At-Risk Populations gilead.com ↗
At both Weeks 48 and 96, Descovy for PrEP demonstrated non-inferior efficacy to Truvada for PrEP. |
| 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. |
| 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. |
| 2012-03-07 | Gilead Sciences | Results Gilead’s Quad Single Tablet Regimen for HIV Non-Inferior to Atripla® in Pivotal Phase 3 Study gilead.com ↗
These data show that the Quad is as effective as a current standard of care in HIV therapy. |
| 2012-02-13 | Gilead Sciences | Regulatory U.S. FDA Grants Priority Review for Truvada® for Reducing the Risk of Acquiring HIV Infection gilead.com ↗ |
| 2011-12-23 | Gilead Sciences | Regulatory U.S. FDA Accepts New Drug Application for Gilead’s Once-Daily, Single-Tablet Quad HIV Regimen gilead.com ↗ |
| 2011-12-20 | Gilead Sciences | Regulatory Gilead Files European Marketing Application for the Quad, a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the Marketing Authorisation Application (MAA) for the Quad single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults, submitted on November 24, 2011 , has been validated by the European Medicines Agency (EMA). |
| 2011-12-15 | Gilead Sciences | Regulatory 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 ↗ |
| 2011-10-27 | 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) |
| 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 mean 48-week increase in CD4 cell count from baseline was 239 cells/mm 3 in the Quad arm compared to 206 cells/mm 3 in the Atripla arm (p=0.009). |
| 2006-12-15 | 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) Published in Journal of Acquired Immune Deficiency Syndrome gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced the publication of 96-week data from an ongoing clinical trial, Study 934, in the Journal of Acquired Immune Deficiency Syndrome (JAIDS). |
All press releases naming this drug 26 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Emtricitabine/tenofovir disoproxil fumarate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00298363 ↗ |
| Known as | FTC/TDF | “Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)” NCT00298363 ↗ |