Drugs / emtricitabine/tenofovir disoproxil fumarate
emtricitabine/tenofovir disoproxil fumarate
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00458393 | Jun 2007 → Feb 2014 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Mixed |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
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). |
| 2022-07-28 | 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). |
| 2022-07-25 | GlaxoSmithKline | Results ViiV Healthcare to present new data from innovative HIV treatment and prevention portfolio at AIDS 2022 gsk.com ↗
Findings to be presented at AIDS 2022 will report on outcomes from the 12-month period following trial unblinding, including the rate of reduction in HIV incidence of cabotegravir, an updated efficacy reading compared to emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets, and pregnancy outcomes. |
| 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. |
| 2020-11-09 | 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). |
| 2020-11-09 | ViiV Healthcare | Results ViiV Healthcare announces investigational injectable cabotegravir is superior to oral standard of care for HIV prevention in women viivhealthcare.com ↗
The study showed cabotegravir was 89% more effective than daily oral FTC/TDF for pre-exposure prophylaxis (PrEP). |
| 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 ↗
The percentage of individuals with protocol-defined confirmed virologic withdrawal (CVW) was 1.7% (12/716) in the dolutegravir plus lamivudine arm and 1.3% (9/717) in the dolutegravir plus TDF/FTC arm. |
| 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 ↗
At both the primary and secondary endpoints, Descovy for PrEP ® demonstrated non-inferior efficacy to Truvada for PrEP ® . |
| 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. |
| 2020-05-18 | 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 ↗
The study achieved its primary objective of non-inferiority with the difference approaching superiority in favour of cabotegravir, pending final analysis. |
| 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. |
| 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.[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. |
| 2018-10-04 | Merck Sharp & Dohme LLC | Results Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-AHEAD Study Evaluating DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) for the Treatment of HIV-1 in Treatment-Naïve Patients merck.com ↗
The efficacy findings at Week 96 in DRIVE-AHEAD were consistent with the findings at Week 48 in which DELSTRIGO demonstrated non-inferior efficacy in comparison to a fixed-dose combination of efavirenz (EFV, 600 mg), emtricitabine (FTC, 200 mg) and TDF (300 mg). |
| 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. |
| 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). |
All press releases naming this drug 19 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | emtricitabine/tenofovir disoproxil fumarate | “The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men” NCT00458393 ↗ |
| Known as | FTC/TDF | “The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men” NCT00458393 ↗ |
| Known as | TDF/FTC | “Drug. Daily oral tablet of co-formulated 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate (TDF/FTC).” NCT00458393 ↗ |
| Known as | tenofovir/emtricitabine | “an 18-month open-label, multi-site PrEP cohort taking daily oral co-formulated tenofovir/emtricitabine” PMID 26797207 ↗ Jan 2016 |
| Route | Oral | “We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir...” PMID 21091279 ↗ Nov 2010 |