Drugs / FTC/TDF
FTC/TDF
also known as
emtricitabine/tenofovir disoproxil fumarate · TDF/FTC · Tenofovir/Emtricitabine · Truvada
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Truvada | HIV-1 infection prevention | 2011-12-15 | “submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration ( FDA ) for the approval of once-daily Truvada ®” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT00931346 | Oct 2009 → Oct 2010 | HIV infectious disease | International AIDS Vaccine Initiative | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2021-12-13 | Merck Sharp & Dohme LLC | Regulatory Merck Announces Clinical Holds on Studies Evaluating Islatravir for the Treatment and Prevention of HIV-1 Infection merck.com ↗
Additionally, participants in studies of DOR/ISL who were started on treatment will continue to receive study medication (partial clinical hold). |
| 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. |
| 2020-07-07 | 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. |
| 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. |
| 2019-11-06 | Gilead Sciences | Results 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 ↗
Descovy demonstrated non-inferior efficacy to Truvada through 96 weeks and statistically significant differences over Truvada for certain key measurements of bone and renal safety assessed in the study, which were pre-specified secondary endpoints. |
| 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. |
| 2018-07-24 | Merck Sharp & Dohme LLC | Results Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-FORWARD Study of Its Investigational HIV Therapy Doravirine merck.com ↗
At Week 96, 73.1 percent (277/379) of the group treated with once-daily DOR achieved viral suppression as measured by the proportion of patients who achieved HIV-1 RNA of less than 50 copies/mL, compared to 66.0 percent (248/376) of the group treated with once-daily ritonavir-boosted darunavir (DRV+r) (treatment difference: 7.1%, 95% confidence interval: 0.5, 13.7). |
| 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). |
| 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration ( FDA ) has accepted for review the New Drug Application (NDA) for the Quad, a complete single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. |
| 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 ↗ |
| 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 ↗
The NDA is also supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components of the Quad and the co-formulated single-tablet regimen. |
| 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. |
| 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 ↗
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 15, 2006--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). |
| 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. |
All press releases naming this drug 34 releases
Evidence & citations 6 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 NCT00931346 ↗ |
| Known as | emtricitabine/tenofovir disoproxil fumarate | “with FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) in HIV discordant couples” NCT00931346 ↗ |
| Known as | TDF/FTC | “daily oral Tenofovir/Emtricitabine (TDF/FTC-Truvada) or placebo” PMID 24086333 ↗ Sep 2013 |
| Known as | Tenofovir/Emtricitabine | “daily oral Tenofovir/Emtricitabine (TDF/FTC-Truvada) or placebo” PMID 24086333 ↗ Sep 2013 |
| Known as | Truvada | “daily oral Tenofovir/Emtricitabine (TDF/FTC-Truvada) or placebo” PMID 24086333 ↗ Sep 2013 |
| Route | Oral | “daily oral Tenofovir/Emtricitabine (TDF/FTC-Truvada) or placebo” PMID 24086333 ↗ Sep 2013 |