emtricitabine
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 6 milestones | |||||
| Filed | EU (EMA) | — | HIV infectious disease | 2017-07-13 | “Marketing Authorization Application for BIC/FTC/TAF has been fully validated and is now under evaluation by the European Medicines Agency” gilead.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2015-08-20 | “Marketing Authorization Application (MAA) for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and...” gilead.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2015-05-28 | “MAA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) has been fully validated” gilead.com ↗ |
| Filed | US (FDA) | Emtriva | HIV infectious disease | 2015-04-07 | “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for two doses of an investigational fixed-dose combination of emtricitabine” gilead.com ↗ “Emtricitabine for the treatment of HIV were submitted to U.S. and European regulatory authorities in September and December of 2002, respectively” gilead.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2014-12-23 | “elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF) was fully validated on December 23, 2014” gilead.com ↗ |
| Filed | EU (EMA) | Emtriva | HIV infectious disease | 2011-12-20 | “Gilead’s marketing application for the Quad single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate was validated by EMA on December...” gilead.com ↗ “The Marketing Authorisation Application (MAA) for Emtriva was submitted for review under the centralized procedure in January 2003 by Triangle Pharmaceuticals.” gilead.com ↗ “Emtricitabine for the treatment of HIV were submitted to U.S. and European regulatory authorities in September and December of 2002, respectively” gilead.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | EMTRIVA | — | 2006-12-22 – 2008-05-16 | fda.gov ↗ |
| Approved | EU (EMA) | Emtriva | — | 2003-10-24 | europa.eu ↗ |
| Approved | US (FDA) | EMTRIVA | — | 2003-07-02 | fda.gov ↗ |
Trials 269 · started per year
News releases announcing trial results or a regulatory action · 120
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | GlaxoSmithKline | Results Cabenuva demonstrates superiority to daily oral therapy in adolescents living with HIV, as ViiV Healthcare highlights new long-acting injectable data at AIDS 2026 gsk.com ↗
New real-world data from the US-based OPERA cohort showed CAB+RPV LA dosed every two months maintained virologic suppression comparable to daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in nearly 6,800 virologically suppressed adults living with HIV. |
| 2026-07-29 | ViiV Healthcare | Results CABENUVA DEMONSTRATES SUPERIORITY TO DAILY ORAL THERAPY IN ADOLESCENTS LIVING WITH HIV, AS ViiV HEALTHCARE HIGHLIGHTS NEW LONG-ACTING INJECTABLE DATA AT AIDS 2026 viivhealthcare.com ↗
New real-world data from the US-based OPERA cohort showed CAB+RPV LA dosed every two months maintained virologic suppression comparable to daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in nearly 6,800 virologically suppressed adults living with HIV. |
| 2026-07-27 | GlaxoSmithKline | Results ViiV Healthcare’s 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy in first-of-its-kind head-to-head study in treatment-naïve adults living with HIV gsk.com ↗
Data show that Dovato (dolutegravir/lamivudine (DTG/3TC)) demonstrated non-inferior efficacy to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)) in treatment-naïve adults living with HIV, including people with high viral loads or a low CD4+ cell count1. |
| 2026-06-11 | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Results 再下一城! 艾迪药业ACC017、艾诺米替首次亮相美国微生物学会年会 aidea.com.cn ↗
进入联合治疗期后(联合FTC/TAF),至第29天,超过90%的参研者实现HIV-1 RNA < 50 copies/mL的病毒学抑制。 |
| 2026-05-25 | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Results INTEREST 2026 | 艾迪药业三项成果亮相非洲顶级HIV学术舞台 aidea.com.cn ↗
进入联合治疗(联合FTC/TAF)至第29天,各组病毒载量降幅均为2.82-2.83 log10 copies/mL,且80%-90%的受试者HIV-1 RNA <50 copies/mL。 |
| 2025-11-19 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Topline Results from the Pivotal Phase 3 Trial Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) in Treatment-Naïve Adults with HIV-1 Infection merck.com ↗
The success criterion for the primary efficacy hypothesis, as measured by the percentage of participants with HIV-1 RNA levels <50 copies/mL at Week 48, was met, with DOR/ISL demonstrating non-inferiority to once-daily oral bictegravir/emtricitabine/tenofovir alafenamide i [BIC/FTC/TAF (50 mg/200 mg/25 mg)]. |
| 2025-10-19 | Gilead Sciences | Results Gilead to Spotlight New Virology Data Across HIV, Viral Hepatitis and Respiratory Diseases at IDWeek 2025 gilead.com ↗
New Data Show Higher Treatment Satisfaction After Switching from IM CAB+RPV to Biktarvy ® |
| 2025-10-15 | Gilead Sciences | Results Gilead Presents New HIV Research Data at EACS 2025 – Driving Scientific Innovation in Treatment and Prevention gilead.com ↗
In the group of BICSTaR study participants with 5 years of real-world follow-up, Biktarvy continued to demonstrate sustained viral suppression, a favorable safety and tolerability profile, and a high barrier to resistance. |
| 2025-04-17 | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Results 民族创新之光!艾诺米替144周数据发布 aidea.com.cn ↗ |
| 2024-11-07 | ViiV Healthcare | Results ViiV HEALTHCARE EXPANDS ON REAL-WORLD DATA SUPPORTING USE OF LONG-ACTING THERAPIES IN DIVERSE PATIENT POPULATIONS AT HIV GLASGOW viivhealthcare.com ↗
RUMBA’s week 144 results confirm reassuring metabolic outcomes in both DTG/3TC and B/FTC/TAF |
| 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). |
| 2024-07-23 | GlaxoSmithKline | Results ViiV Healthcare announces positive new data for Apretude use during pregnancy at AIDS 2024 gsk.com ↗
The findings showed that cabotegravir LA for PrEP was generally well tolerated among pregnant women, and PK findings demonstrated that cabotegravir levels were maintained above those associated with HIV protection throughout the overall pregnancy period. |
| 2024-07-23 | GlaxoSmithKline | Results ViiV Healthcare announces positive data demonstrating 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy for maintenance therapy of HIV-1 gsk.com ↗
Findings showed that switching to DTG/3TC in virologically suppressed adults living with HIV demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF. |
| 2024-07-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES POSITIVE NEW DATA FOR APRETUDE USE DURING PREGNANCY AT AIDS 2024 viivhealthcare.com ↗
The findings showed that cabotegravir LA for PrEP was generally well tolerated among pregnant women, and PK findings demonstrated that cabotegravir levels were maintained above those associated with HIV protection throughout the overall pregnancy period. |
| 2023-09-19 | GlaxoSmithKline | Regulatory European Commission authorises ViiV Healthcare’s Apretude (cabotegravir long-acting and tablets) for HIV prevention gsk.com ↗ |
| 2023-09-19 | ViiV Healthcare | Regulatory EUROPEAN COMMISSION AUTHORISES ViiV HEALTHCARE’S APRETUDE (CABOTEGRAVIR LONG-ACTING AND TABLETS) FOR HIV PREVENTION viivhealthcare.com ↗
today announced that the European Commission has authorised Apretude (cabotegravir long-acting (LA) injectable and tablets) for HIV prevention. |
| 2023-07-24 | GlaxoSmithKline | Regulatory ViiV Healthcare’s cabotegravir for HIV prevention receives positive CHMP opinion from European Medicines Agency gsk.com ↗
GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, welcomed a positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for cabotegravir long-acting (LA) injectable and tablets for HIV prevention. |
| 2023-07-24 | ViiV Healthcare | Regulatory ViiV HEALTHCARE’S CABOTEGRAVIR FOR HIV PREVENTION RECEIVES POSITIVE CHMP OPINION FROM EUROPEAN MEDICINES AGENCY viivhealthcare.com ↗ |
| 2023-07-23 | Gilead Sciences | Results New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from multiple studies reinforcing Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a treatment option for a broad range of people with HIV. |
| 2023-02-23 | GlaxoSmithKline | Results ViiV Healthcare announces positive data demonstrating long-acting injectable Cabenuva (cabotegravir, rilpivirine) is as effective as daily oral Biktarvy (BIC/FTC/TAF) for the treatment of HIV-1 gsk.com ↗
12-month findings from the SOLAR study showed that the every-two-month regimen of CAB+RPV LA demonstrated non-inferior efficacy compared to continuation of daily oral BIC/FTC/TAF |
| 2023-02-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES POSITIVE DATA DEMONSTRATING LONG-ACTING INJECTABLE CABENUVA (CABOTEGRAVIR, RILPIVIRINE) IS AS EFFECTIVE AS DAILY ORAL BIKTARVY (BIC/FTC/TAF) FOR THE TREATMENT OF HIV-1 viivhealthcare.com ↗
Study findings showed that CAB+RPV LA dosed every two months achieved the primary endpoint of non-inferior virologic efficacy versus daily oral BIC/FTC/TAF, while 90% of participants who switched to CAB+RPV LA from BIC/FTC/TAF, and who completed a survey (n=425), preferred the long-acting regimen. |
| 2022-10-28 | GlaxoSmithKline | Regulatory European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV Prevention gsk.com ↗ |
| 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 ↗
No new HIV infections were observed in participants who initiated cabotegravir injections in the year following study unblinding |
| 2021-12-21 | ViiV Healthcare | Regulatory ViiV HEALTHCARE ANNOUNCES FDA APPROVAL OF APRETUDE (CABOTEGRAVIR EXTENDED-RELEASE INJECTABLE SUSPENSION), THE FIRST AND ONLY LONG-ACTING INJECTABLE OPTION FOR HIV PREVENTION viivhealthcare.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved Apretude, the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquired HIV-1. |
| 2021-12-20 | GlaxoSmithKline | Regulatory ViiV Healthcare announces US FDA approval of Apretude (cabotegravir extended-release injectable suspension), the first and only long-acting injectable option for HIV prevention gsk.com ↗
The long-acting injectable was approved for use in adults and adolescents weighing at least 35 kg who are at risk of sexually acquiring HIV and who have a negative HIV-1 test prior to initiation. |
| 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. |
| 2020-07-08 | 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 ↗
Baseline prevalence and longitudinal trends in HIV-associated sexual risk behaviors during the DISCOVER trial suggest that risk compensation, defined as an increase in risk behavior due to a reduction in perceived risk, did not occur among study participants. |
| 2019-11-06 | Gilead Sciences | Results Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials gilead.com ↗
Across all treatment groups no participants developed treatment failure with treatment-emergent resistance. |
| 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. |
| 2019-10-03 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Descovy® for HIV Pre-Exposure Prophylaxis (PrEP) gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). |
| 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. |
| 2019-07-23 | Gilead Sciences | Results Gilead Presents New Findings on Profile of Descovy® for Potential Use as HIV Pre-exposure Prophylaxis Compared With Truvada® gilead.com ↗
At Week 4, levels of TFV-DP in PBMCs were 6.3-fold higher with Descovy compared with Truvada, resulting in 98 percent of participants receiving Descovy had drug levels above the EC90 compared with 68 percent of participants taking Truvada. |
| 2019-07-22 | Gilead Sciences | Results Gilead Presents New Data on Biktarvy® for the Treatment of HIV in Women and in Virologically Suppressed Patients With Known Resistance gilead.com ↗
The studies further demonstrate the potential for Biktarvy to be an important treatment option for appropriate patients. |
| 2019-04-11 | Janssen Research & Development, LLC | Results Janssen Presents New Data from First Phase 3 Trial of a Single-Tablet Regimen in a Rapid Initiation Model of Care Demonstrating Safety and Efficacy with SYMTUZA® through 48 Weeks jnj.com ↗
A secondary endpoint of the study also showed that 97% of patients reported they were satisfied with their treatment. |
| 2019-03-06 | Gilead Sciences | Results Gilead Presents New Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) and TAF-Based Regimens for the Treatment of HIV-1 in Children, Older Adults and Women gilead.com ↗
Through Week 48, Biktarvy maintained high rates of virologic suppression with a low incidence of study drug-related adverse events and no treatment-emergent resistance. |
| 2019-03-06 | Gilead Sciences | Results Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance gilead.com ↗
The studies found high rates of virologic suppression with Biktarvy in treatment-experienced adults, regardless of pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs). |
| 2019-03-06 | Gilead Sciences | Results Gilead Announces Data Demonstrating Non-Inferiority of Once-Daily Descovy® vs. Once-Daily Truvada® for Prevention of HIV Infection gilead.com ↗
Descovy met the pre-established criteria for non-inferiority to Truvada using a stringent rate ratio statistical comparison, as demonstrated by the upper bound of the 95 percent confidence interval for HIV-1 infection rate ratio being less than the predefined non-inferiority margin of 1.62/100 PY. |
| 2018-10-30 | Gilead Sciences | Results Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) (DTG+FTC/TAF) through 96 weeks of therapy. |
| 2018-10-03 | Gilead Sciences | Results Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC /DTG/3TC) through 96 weeks of therapy. |
| 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. |
| 2018-07-24 | Gilead Sciences | Results 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 ↗ |
| 2018-06-25 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the European Commission has granted Marketing Authorization for Biktarvy ® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. |
| 2018-06-14 | GlaxoSmithKline | Results ViiV Healthcare reports landmark phase III studies for dolutegravir and lamivudine, demonstrating the ability to control HIV with a two-drug regimen in treatment naïve patients gsk.com ↗
The studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <50 copies per millilitre (c/mL), a standard measure of HIV control, at Week 48. |
| 2018-05-15 | Gilead Sciences | Regulatory 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 ↗
Truvada for PrEP is now indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. |
| 2018-03-05 | Gilead Sciences | Results Gilead Presents Results from Phase 3 Study Evaluating Patients Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) from Regimen Containing Abacavir, Dolutegravir and Lamivudine gilead.com ↗
Through Week 48, Biktarvy was found to be statistically non-inferior to ABC /DTG/3TC with a numerically lower incidence of mild or moderate study drug-related adverse events and no treatment-emergent resistance. |
| 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 ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to regimens containing a bPI or boosted elvitegravir and demonstrated no treatment-emergent resistance at 48 weeks. |
| 2017-10-25 | Janssen Research & Development, LLC | Results Investigational Darunavir-Based Single-Tablet Regimen Shows Positive Results in Previously Untreated HIV Patients in Pivotal Phase 3 AMBER Clinical Trial jnj.com ↗ |
| 2017-10-04 | Gilead Sciences | Results Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens gilead.com ↗
In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. |
| 2017-08-10 | Gilead Sciences | Regulatory Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has granted priority review for the company’s New Drug Application (NDA) for an investigational, fixed-dose combination |
| 2017-07-25 | Merck Sharp & Dohme LLC | Results Merck’s Investigational NNRTI, Doravirine, Meets Primary Efficacy Endpoint of Non-Inferiority to Efavirenz, Both in Combination with Other Antiretroviral Agents, in Pivotal Phase 3 Trial for Treatment of HIV-1 Infection merck.com ↗
In addition, through 48 weeks, statistically significantly fewer patients taking DOR/3TC/TDF reported pre-specified categories of neuropsychiatric events (dizziness, sleep disorders and disturbances, and inability to think clearly or concentrate) than patients receiving the EFV/FTC/TDF regimen. |
| 2017-07-24 | Gilead Sciences | Results Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗
In the ongoing studies, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing dolutegravir (50mg) (DTG) in combination with a dual-NRTI backbone. |
| 2017-07-13 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗ |
| 2017-06-12 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment gilead.com ↗ |
| 2017-05-30 | Gilead Sciences | Results Gilead’s Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for the Treatment of HIV-1 Meets Primary Endpoint in Four Phase 3 Studies gilead.com ↗ |
| 2017-02-13 | Gilead Sciences | Results Gilead Presents New Phase 2 Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV gilead.com ↗
Results found that the BIC+FTC/TAF and DTG+FTC/TAF regimens both demonstrated high virologic response rates at Week 24 and Week 48. |
| 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. |
| 2016-09-12 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency jnj.com ↗ |
| 2016-07-21 | Gilead Sciences | Results Gilead’s Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) Meets Primary 48-Week Objective in Two Phase 3b Studies gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that two Phase 3b switch studies evaluating Odefsey ® (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) for the treatment of HIV-1 infection met their primary objectives. |
| 2016-07-18 | GlaxoSmithKline | Results ARIA study shows superior efficacy of Triumeq® for treatment-naïve women living with HIV gsk.com ↗
Results show statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48: 82% versus 71% (adjusted difference 10.5%, 95% CI: 3.1%-17.8%, p=0.005) respectively.1 |
| 2016-04-25 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two doses of Descovy ® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. |
| 2016-04-04 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide), Gilead’s Third TAF-Based HIV Therapy gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Descovy ® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. |
| 2016-03-01 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Odefsey ® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. |
| 2016-02-23 | Gilead Sciences | Results Gilead Announces Results From First Study to Evaluate Switching to F/TAF-Based Regimens from Truvada® (F/TDF)-Based Regimens gilead.com ↗
At Week 48, the F/TAF-based regimens were found to be statistically non-inferior to the F/TDF-based regimens, based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. |
| 2016-02-01 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Type II Variation Application for Truvada® for Reducing the Risk of Sexually Acquired HIV gilead.com ↗ |
| 2015-08-20 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Single Tablet Regimen Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) for HIV Treatment gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the company’s Marketing Authorization Application (MAA) for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg (R/F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA). |
| 2015-07-21 | Bristol-Myers Squibb | Results Second-Generation Investigational HIV-1 Maturation Inhibitor Demonstrates Positive New Phase IIa Results, Supporting Continued Development bms.com ↗
The standard of care (SOC) control of atazanavir 300 mg and ritonavir 100 mg plus tenofovir disoproxyl fumarate 300 mg plus emtricitabine 200 mg in a fixed dose combination had a maximum median change in HIV-1 RNA of -2.39 log 10 c/mL from baseline through study discharge (Day 42). |
| 2015-07-01 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) gilead.com ↗ |
| 2015-04-07 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment gilead.com ↗
Today’s filing is Gilead’s second F/TAF-based NDA submitted to the FDA for review. |
| 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). |
| 2014-07-22 | Pfizer | Results ViiV Healthcare presents phase III data comparing once-daily maraviroc in combination with darunavir/ritonavir with emtricitabine/tenofovir plus darunavir/ritonavir in treatment-naïve adults with HIV-1 pfizer.com ↗
The proportion of study participants who were virologically suppressed (HIV-1 RNA <50 copies/mL) at week 48 was 77.3% for MVC+DRV/r compared to 86.8% for FTC /TDF +DRV/r (95% confidence interval -15.0% to -4.4%). |
| 2014-07-22 | GlaxoSmithKline | Results ViiV Healthcare presents phase III data gsk.com ↗
The proportion of study participants who were virologically suppressed (HIV-1 RNA <50 copies/mL) at week 48 was 77.3% for MVC+DRV/r compared to 86.8% for FTC /TDF +DRV/r (95% confidence interval -15.0% to -4.4%). |
| 2013-12-13 | Gilead Sciences | Regulatory U.S. FDA Approves Gilead’s Once-Daily Single Tablet HIV-1 Regimen Complera® for Patients Switching from a Stable Regimen gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved the single tablet HIV-1 regimen Complera ® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA |
| 2013-10-16 | Gilead Sciences | Results Gilead’s Single Tablet HIV Regimen Stribild® Demonstrates Durable Viral Suppression Through Three Years of Therapy gilead.com ↗
In these large-scale clinical trials, Stribild demonstrated high and durable viral suppression and a favorable safety profile over three years of therapy. |
| 2013-05-28 | Gilead Sciences | Regulatory European Commission Approves Stribild®, a New Single Tablet Regimen for the Treatment of HIV-1 Infection gilead.com ↗
This approval allows for the marketing of Stribild in all 27 countries of the European Union . |
| 2012-11-15 | Gilead Sciences | Results Gilead’s Once-Daily Single Tablet Regimen Stribild™ Maintains High Viral Suppression Through Two Years of Therapy Among Treatment-Naïve HIV Patients gilead.com ↗ |
| 2012-11-15 | Gilead Sciences | Results Gilead’s Complera® Non-Inferior to Atripla® Among Treatment-Naïve HIV Patients gilead.com ↗
Complera demonstrated a statistically significant difference in efficacy compared to Atripla among patients with low baseline viral load (≤ 100,000 copies/mL), and was non-inferior to Atripla among patients with high baseline viral load (> 100,000 copies/mL). |
| 2012-07-24 | Gilead Sciences | Results Gilead’s Once-Daily Single Tablet Regimen Complera® Maintains HIV Suppression Among Patients Switching From Protease Inhibitor-Based Regimens gilead.com ↗
The study met its 24-week primary endpoint, which found that switching to Complera was non-inferior to remaining on a ritonavir-boosted protease inhibitor regimen. |
| 2012-05-11 | Gilead Sciences | Regulatory FDA Advisory Committee Supports Approval of Gilead’s Once-Daily Quad Single Tablet Regimen for HIV gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration ( FDA ) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults. |
| 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. |
| 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). |
| 2011-12-05 | Gilead Sciences | Results Gilead’s Boosting Agent, Cobicistat, Meets 48-Week Primary Objective in Pivotal Phase 3 Study gilead.com ↗
Discontinuation rates due to adverse events were 7.3 percent and 7.2 percent in the cobicistat and ritonavir arms of the study, respectively. |
| 2011-11-28 | Gilead Sciences | Regulatory Gilead Receives European Marketing Authorization for Eviplera(R), a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naive Adults gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Eviplera ® (emtricitabine/rilpivirine/tenofovir disoproxil), a complete once-daily single-tablet regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL. |
| 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) for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults. |
| 2011-09-23 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Eviplera(R), a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection gilead.com ↗
The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union (EU). |
| 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. |
| 2011-08-10 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead Sciences' Complera(TM), a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults gilead.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved Complera(TM) (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults. |
| 2011-02-10 | Gilead Sciences | Regulatory Gilead Sciences Refiles New Drug Application with the FDA for Single-Tablet Regimen of Truvada(R) and TMC278 gilead.com ↗
Specifically, the FDA requested additional information on the analytical methodology and qualification data used to establish acceptable levels of recently identified degradants related to emtricitabine; this information has been included in the refiling. |
| 2011-01-25 | Gilead Sciences | Regulatory 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 ↗
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that it has received a "refuse to file" notification from the U.S. Food and Drug Administration (FDA) regarding Gilead's New Drug Application (NDA) for the single-tablet regimen of Truvada (R) (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. |
| 2010-11-23 | Gilead Sciences | Regulatory 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 ↗ |
| 2010-09-13 | Gilead Sciences | Results Gilead's Single-Tablet "Quad" HIV Regimen Maintains High Viral Suppression Through 48 Weeks in Phase II Study gilead.com ↗
At week 48, the proportion of patients who achieved HIV RNA (viral load) less than 50 copies/mL was 90 percent in the Quad arm and 83 percent in the Atripla arm (using an analysis where missing equals failure). |
| 2010-09-03 | Gilead Sciences | Regulatory 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 | Results Gilead Finalizes Selection of Bioequivalent Formulation for the Fixed-Dose Regimen of Truvada(R) and Tibotec Pharmaceuticals' TMC278 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg). |
| 2010-01-06 | Gilead Sciences | Results Phase II Clinical Trial of Gilead's Investigational Integrase-Based, Once-Daily, Fixed-Dose "Quad" Regimen Meets 24-Week Primary Objective gilead.com ↗
GS 9350-boosted atazanavir and Truvada had similar efficacy to ritonavir-boosted atazanavir and Truvada. |
| 2008-10-26 | Bristol-Myers Squibb | Results 96-Week Data From CASTLE Study Continue to Show Similar Efficacy Between Once-Daily REYATAZ(R) (atazanavir sulfate)/Ritonavir and Twice-Daily Lopinavir/Ritonavir In Previously Untreated HIV-1 Infected Adult Patients bms.com ↗
The CASTLE results demonstrated the non-inferiority of REYATAZ/r once daily versus lopinavir/r twice daily, each as part of HIV combination therapy in previously untreated HIV-1 infected adult patients. |
| 2007-12-17 | Gilead Sciences | Regulatory European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection gilead.com ↗ |
| 2007-10-29 | Gilead Sciences | Results Gilead Announces 48-Week Data Evaluating Switching from Combivir(R) To Truvada(R) Among Virologically-Suppressed HIV Patients gilead.com ↗
Patients in both study arms maintained virological suppression at 48 weeks. |
| 2007-07-23 | Gilead Sciences | Results 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 ↗
today announced the presentation of 144-week data from an ongoing clinical trial, Study 934, comparing a once-daily regimen of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Sustiva(R) (efavirenz) |
| 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). |
| 2006-10-09 | Gilead Sciences | Regulatory Bristol-Myers Squibb, Gilead Sciences and Merck & Co. Submit Marketing Authorisation Application for ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) to European Medicines Agency gilead.com ↗
The MAA for ATRIPLA in the European Union was filed jointly by the three companies through a newly established three-way joint venture based in Ireland, Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited. |
| 2006-07-12 | Gilead Sciences | Regulatory U.S. Food and Drug Administration (FDA) Approves ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), The First Once-Daily Single Tablet Regimen for Adults with HIV-1 Infection gilead.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc. (Nasdaq:GILD) today announced the U.S. Food and Drug Administration (FDA) has granted approval of ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) for the treatment of HIV-1 infection in adults. |
| 2006-04-27 | Gilead Sciences | Regulatory 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 | Regulatory 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 ↗
Traditional approval status was granted following FDA review of 48-week data from Study 934, the second confirmatory pivotal study for Viread. |
| 2006-01-18 | Gilead Sciences | Results Data Comparing Viread(R) and Emtriva(R) to Combivir(R) as Part of Combination HIV Therapy Published in New England Journal of Medicine gilead.com ↗
Publication Describes Superior Viral Suppression with Fewer Adverse Events Leading to Discontinuation for Patients Taking Viread and Emtriva at 48 Weeks |
| 2006-01-09 | Gilead Sciences | Results 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 | Results 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 ↗
Hemoglobin levels also increased significantly from baseline. |
| 2005-08-09 | Gilead Sciences | Results Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada(R) (Emtricitabine and Tenofovir Disoproxil Fumarate) and Sustiva(R) (Efavirenz) gilead.com ↗
bioequivalence results from its second formulation of the fixed-dose combination of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Bristol-Myers Squibb's Sustiva(R) (efavirenz) for the treatment of HIV did not demonstrate bioequivalence to the individual products dosed separately. |
| 2005-04-26 | Gilead Sciences | Results Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada -emtricitabine and tenofovir disoproxil fumarate- and Sustiva -efavirenz- gilead.com ↗
Preliminary results from the bioequivalence study of the first formulation indicate that efavirenz levels in the blood are lower than those achieved with the recommended 600 mg dose of Sustiva alone and do not meet the definition of bioequivalence. |
| 2005-02-03 | Gilead Sciences | Results Gilead Announces Preliminary 48-Week Data From Study 934 Comparing Viread and Emtriva to Combivir Both in Combination With Sustiva in Patients With HIV gilead.com ↗
Gilead Sciences (Nasdaq:GILD) today announced preliminary 48-week data from the company's Study 934. |
| 2004-10-31 | Gilead Sciences | Results Interim 24-Week Data from Study 934 Comparing a Regimen of Viread and Emtriva Versus Combivir, Both in Combination with Efavirenz, in Patients with HIV Presented at 44th ICAAC gilead.com ↗
Although both triple-drug regimens are relatively convenient, we observed a difference in the two arms, with more patients discontinuing in the Combivir group due to adverse events. |
| 2004-08-26 | Gilead Sciences | Results Gilead Announces Preliminary 24-Week Data from Study 934 Comparing Viread and Emtriva to Combivir Both in Combination With Efavirenz In Patients With HIV gilead.com ↗
Preliminary results show a statistically significant difference favoring Viread/Emtriva in the percentage of patients who achieved and maintained HIV RNA less than 400 copies/mL at 24 weeks, based on the FDA Time to Loss of Virologic Response algorithm (TLOVR). |
| 2004-07-11 | Gilead Sciences | Results Pivotal Studies of Gilead's Viread and Emtriva Published in Special International Aids Conference Issue of Journal of the American Medical Association gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced the publication of results from two separate studies evaluating the efficacy and safety of Viread(R) (tenofovir disoproxil fumarate) and Emtriva(R) (emtricitabine), respectively, compared with stavudine (d4T), in combination with other antiretroviral agents. |
| 2004-03-15 | Gilead Sciences | Regulatory Gilead Submits Applications to U.S. and European Regulatory Authorities for Fixed Dose Co-Formulation of Viread and Emtriva gilead.com ↗
The company also announced the submission of its Marketing Authorisation Application (MAA) for the fixed dose co-formulation to the European Agency for the Evaluation of Medicinal Products (EMEA). |
| 2003-11-25 | Gilead Sciences | Results Gilead Announces Preliminary Results from 48-Week Phase III Study of Emtricitabine in Patients with Chronic Hepatitis B gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced preliminary results from a Phase III clinical trial (Study FTCB-301) comparing the efficacy and safety of emtricitabine 200 mg once daily versus placebo in patients with chronic hepatitis B. |
| 2003-10-28 | Gilead Sciences | Regulatory Gilead Sciences' HIV Drug Emtriva Approved for Marketing in European Union gilead.com ↗
today announced that the European Commission has granted Marketing Authorisation for Emtriva(TM) (emtricitabine, 200 mg hard capsules and 10 mg/mL oral solution) in all 15 member states of the European Union. |
| 2003-10-28 | Gilead Sciences | Regulatory Gilead Sciences Announces Third Quarter 2003 Financial Results gilead.com ↗
Today, Gilead announced that the European Commission followed the recommendation of the CPMP and has granted Marketing Authorisation for the product. |
| 2003-07-24 | Gilead Sciences | Regulatory European CPMP Gives Positive Opinion on Emtriva, Gilead's New Once-Daily Treatment for HIV gilead.com ↗
The CPMP's positive opinion for Emtriva is the second that Gilead has received from the Committee for a new HIV treatment. |
| 2003-07-14 | Gilead Sciences | Results Phase III Trial of Emtriva, New Once-Daily Capsule for HIV, Shows Continued Response Through 60 Weeks gilead.com ↗
This study suggests that over time Emtriva continues to outperform stavudine, a thymidine-analogue NRTI, in terms of both its efficacy and tolerability, |
| 2003-07-02 | Gilead Sciences | Regulatory U.S. FDA Approves Gilead Sciences' Emtriva, a One-Capsule, Once-Daily Medication for the Treatment of HIV gilead.com ↗
Gilead Sciences (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has cleared for marketing Emtriva(TM) (emtricitabine), a new 200 mg one-capsule, once-daily nucleoside reverse transcriptase inhibitor (NRTI) for the treatment of HIV infection in adults in combination with other antiretroviral medications. |
| 2003-02-11 | Gilead Sciences | Results Phase III Data Show Emtricitabine Maintains Viral Load Suppression as Part of Once-Daily, Protease-Sparing Anti-HIV Regimen gilead.com ↗
At 48 weeks, 94 percent of patients receiving the once-daily regimen of emtricitabine, didanosine and efavirenz had HIV RNA levels (viral load) less than 400 copies/mL, compared to 92 percent randomized to continue therapy in the PI-based arm (intent to treat population, assays performed at local laboratories at investigational centers). |
All press releases naming this drug 149 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 149 releases opens the full record — a long page | ||
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 490 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | emtricitabine | “The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing...” NCT06630286 ↗458“Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗ “DESIGN: ICE-001 is a phase IV, randomized, two-arm unblinded study, comparing the effect on immune reconstitution of open-label ritonavir (RTV)-enhanced lopinavir (LPV) to...” NCT00775606 ↗ “This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide...” NCT02707601 ↗ “This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of...” NCT01632995 ↗ “This single-arm, single-site, open-label trial will explore the safety and efficacy of TAF in a fixed combination with emtricitabine (FTC) (F/TAF, Gilead Sciences Inc.) as part...” NCT02556333 ↗ “The ability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) to maintain virologic suppression in participants with M184V and/or M184I resistance...” PMID 33315694 ↗ Apr 2021 “Participants on any stable second-generation integrase strand transfer inhibitor-based 3DR regimen with HIV-1 RNA < 50 copies/mL plasma for at least 3 months were randomized to...” PMID 39226296 ↗ Feb 2025 “The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how...” NCT04039217 ↗ “A Pilot Randomized Controlled Trial of Switch to Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus Continue TDF/FTC/Efavirenz (EFV) Treatment Among...” NCT02042001 ↗ “The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in...” NCT05140954 ↗ |
| Known as | 524-W-91 | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | BW-524W91 | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Coviracil | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | emtricitabina | “Antiretroviral treatment consisting in Dolutegravir (Tivicay) (50mg) + Tenofovir alafenamide (TAF) (25mg) / Emtricitabina (FTC) (200mg) (Descovy), once daily during 24 weeks.” NCT03577782 ↗ |
| Known as | emtricitabine (FTC) | “emtricitabine (FTC)” NCT01338025 ↗ |
| Known as | Emtricitabine component of atripla | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtricitabine component of biktarvy | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtricitabine component of complera | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtricitabine component of descovy | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtricitabine component of eviplera | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtricitabine component of genvoya | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtricitabine component of odefsey | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtricitabine component of stribild | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtricitabine component of symtuza | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtricitabine component of truvada | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtricitabinum | ChEMBL registry synonym — accepted as the source's own label CHEMBL885 ↗ |
| Known as | Emtriva | “Emtriva (emtricitabine)” NCT00106379 ↗ |
| Known as | Emtriva (Brand for emtricitabine) | “Emtriva (Brand for emtricitabine)” NCT03304717 ↗ |
| Known as | FTC | “DESIGN: ICE-001 is a phase IV, randomized, two-arm unblinded study, comparing the effect on immune reconstitution of open-label ritonavir (RTV)-enhanced lopinavir (LPV) to...” NCT00775606 ↗173“This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of...” NCT01632995 ↗ “This single-arm, single-site, open-label trial will explore the safety and efficacy of TAF in a fixed combination with emtricitabine (FTC) (F/TAF, Gilead Sciences Inc.) as part...” NCT02556333 ↗ “Background Regimen (BR) include Food and Drug Administration (FDA)-approved nucleos(t)ide reverse transcriptase inhibitors (NRTIs) including zidovudine (ZDV), stavudine (d4T),...” NCT02016924 ↗ “The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how...” NCT04039217 ↗ “To conduct a phase 1b trial to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple ascending doses of emtricitabine (FTC) and...” NCT07795307 ↗ “This study aims: (1) to determine the optimal dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for daily oral pre-exposure prophylaxis (PrEP) during pregnancy...” NCT06435026 ↗ “In the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2010/VESTED study, pregnant women were randomized to initiate dolutegravir (DTG) +...” PMID 38877762 ↗ Nov 2024 “Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with...” NCT07075146 ↗ “Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC,...” NCT01363011 ↗ “The antiretroviral treatment consisted in a tenofovir-emtricitabine NRTI backbone (TDF/FTC, 300/200 mg/ml, once a day) plus boosted protease inhibitor, lopinavir/ritonavir...” NCT02097381 ↗ |
| Action | Inhibit | “existing dual nucleoside analogue reverse transcriptase inhibitor therapy to coformulated tenofovir-emtricitabine or abacavir-lamivudine” PMID 24722774 ↗ Apr 2014 |
| Modality | Other / unclassified | “the NRTIs ddI and FTC” NCT00016718 ↗ |
| Route | Oral | “Will be administered as one 200-mg capsule orally daily” NCT00051831 ↗ |