Drugs / Tenofovir disoproxil fumarate
Tenofovir disoproxil fumarate
also known as
TDF · tenofovir disoproxil · tenofovir DF · Viread · tenofovir · Tenofovir disoproxil fumarate (TDF) · PMPA prodrug · BR-TND Tablet · +9 more
Regulatory milestones approvals, filings & regulatory actions · 24 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis B virus infection 2 milestones | |||||
| Filed | US (FDA) | Viread | chronic hepatitis B virus infection | 2007-10-11 | “filings of marketing applications for Viread for the treatment of chronic HBV in the United States and European Union” gilead.com ↗ |
| Filed | EU (EMA) | Viread | chronic hepatitis B virus infection | 2007-10-11 | “filings of marketing applications for Viread for the treatment of chronic HBV in the United States and European Union” gilead.com ↗ |
| Filed HIV infectious disease 6 milestones | |||||
| Filed | EU (EMA) | ATRIPLA | HIV infectious disease | 2006-10-09 | “submission of a Marketing Authorisation Application (MAA) for ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) in the European Union” gilead.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2004-03-15 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of a fixed dose co-formulation of the...” gilead.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2004-03-15 | “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...” gilead.com ↗ |
| Filed | EU (EMA) | Viread | HIV infectious disease | 2001-05-04 | “submitted a Marketing Authorisation Application (MAA) to the European Agency for the Evaluation of Medicinal Products (EMEA) seeking approval of tenofovir disoproxil fumarate” gilead.com ↗ “In May 2001, Gilead submitted a Marketing Authorisation Application to the European Agency for the Evaluation of Medicinal Products (EMEA).” gilead.com ↗ |
| Filed | US (FDA) | Viread | HIV infectious disease | 2001-05-01 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of tenofovir disoproxil fumarate” gilead.com ↗ “Gilead submitted a New Drug Application (NDA) for tenofovir DF for the treatment of HIV infection to the U.S. Food and Drug Administration (FDA) on May 1, 2001.” gilead.com ↗ “Gilead submitted the Viread New Drug Application (NDA) to the FDA.” gilead.com ↗ |
| Filed | Other | Viread | HIV infectious disease | — | “With regulatory filings submitted for Viread in the United States, the European Union and Australia” gilead.com ↗ “In August, Gilead submitted an application seeking regulatory approval of Viread in Australia.” gilead.com ↗ “Regulatory filings for the drug also have been completed in Australia and Canada” gilead.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (14) | US (FDA) | VIREAD | — | 2003-08-15 – 2018-12-11 | fda.gov ↗ |
| Approved | EU (EMA) | Viread | — | 2002-02-04 | europa.eu ↗ |
| Approved | US (FDA) | VIREAD | — | 2001-10-26 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 156
| 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 ↗
Confirmed viral rebound occurred in 0.9% (n=2/235) of adolescents receiving CAB+RPV LA versus 6.4% (n=15/241) receiving daily oral therapy. |
| 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 ↗
Week 96 results from the LATA trial, led by University College London, showed CAB+RPV LA dosed every two months was superior to daily oral dolutegravir/tenofovir disoproxil fumarate/lamivudine (DTG/TDF/3TC) in 476 virologically suppressed adolescents aged 12 to 19 years living with HIV in Kenya, South Africa, Uganda and Zimbabwe. |
| 2026-07-21 | Merck Sharp & Dohme LLC | Results Investigational Once-weekly Oral HIV Treatment Regimen of Islatravir and Lenacapavir Maintained Virological Suppression in Adults With HIV Who Switched Antiretroviral Therapy merck.com ↗ |
| 2025-12-18 | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Results 高分引用｜复邦德系列临床研究获Nature子刊全文引用 aidea.com.cn ↗ |
| 2025-11-11 | Hansoh BioMedical R&D Company | Results AASLD│翰森制药恒沐®6项成果发布，肝硬化研究获评“杰出壁报” hansoh.cn ↗ |
| 2025-08-05 | Hansoh BioMedical R&D Company | Results WJG│翰森制药恒沐®144周研究结果发表，证实其长期治疗血脂稳定且肾脏安全 hansoh.cn ↗ |
| 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 ↗
Participants who initiated treatment with Biktarvy (n=121) or DTG+F/TDF (n=122) had similarly high and sustained rates of viral suppression. |
| 2022-11-03 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results NOTEWORTHY ADVANCEMENT | 96-WEEK DATA FROM LARGE-SCALE PHASE III CLINICAL TRIAL OF HANSOH PHARMA'S HENGMU PUBLISHED IN JCTH hspharm.com ↗
Compared with the existing first-line standard-of-care drug TDF, TMF demonstrated a comparable virologic suppression rate and a higher ALT normalization rate. |
| 2022-11-01 | Gilead Sciences | Results Gilead to Present Data Across Viral Hepatitis and Liver Fibrosis at The Liver Meeting® 2022, Reinforcing Gilead as a Leader in Addressing Treatment Needs for People Living With Liver Disease gilead.com ↗
Gilead will present data from the Phase 2b ATLAS Study utilizing SomaScan ® plasma proteome analysis in people with NASH with advanced fibrosis, demonstrating specific activity of combination therapy with investigational compounds, cilofexor and firsocostat, compared to monotherapies (OS-75). |
| 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). |
| 2022-07-25 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results JOINT RELEASE IN SIX CITIES | ANNIVERSARY CELEBRATION FOR LAUNCH OF HANSOH PHARMA'S HENGMU SUCCESSFULLY HELD hspharm.com ↗
the decrease in bone mineral density from baseline was significantly superior to that in TDF group |
| 2021-11-09 | Gilead Sciences | Results Gilead to Present Data From Liver Disease Development Programs at The Liver Meeting® gilead.com ↗
In another analysis, treatment with Vemlidy compared to tenofovir disoproxil fumarate (TDF) revealed a similar low risk for atherosclerotic cardiovascular disease (ASCVD) using a validated risk calculator, despite differences in their fasting lipid profiles (PO-771). |
| 2021-10-27 | Merck Sharp & Dohme LLC | Results Merck Presents New Data from Ongoing Phase 2b Clinical Trial Evaluating Efficacy and Safety of Investigational Islatravir in Combination With Doravirine Through 144 Weeks for HIV-1 Treatment at EACS 2021 merck.com ↗
Phase 2b data through 144 weeks demonstrated that islatravir combined with doravirine continued to maintain viral suppression, as measured by the number of study participants achieving HIV-1 RNA levels <50 copies/mL, similar to DOR/3TC/TDF. |
| 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. |
| 2020-10-05 | 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 ↗
Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression. |
| 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. |
| 2020-06-11 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴恩曲他滨替诺福韦片首仿获批 cttq.com ↗
近日，正大天晴恩曲他滨替诺福韦片获国家药监局批准，为国内首仿，视同通过一致性评价。 |
| 2020-03-09 | Replicor Inc. | Results Replicor announces publication of the REP 401 study achieving high rates of virologic control and functional cure in patients with chronic hepatitis B infection replicor.com ↗
Importantly 78% of participants achieved virologic control of HBV of whom 39% further achieved functional cure. |
| 2019-11-08 | Gilead Sciences | Results Gilead Announces New Data from Viral Hepatitis Research Programs at The Liver Meeting® 2019 gilead.com ↗
® (sofosbuvir/velpatasvir) resulted in a cure rate (SVR12) of 95 percent (97/102) in patients 12 to < 12 years="" old. |
| 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. |
| 2019-10-04 | 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 ™ |
| 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). |
| 2019-09-20 | Merck Sharp & Dohme LLC | Regulatory Merck’s PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive US FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed merck.com ↗ |
| 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. |
| 2019-07-24 | 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. |
| 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 ↗
Pharmacokinetic data from separate PK studies demonstrate that after using drugs for 14-28 days, F/TAF users who stop drug still maintain TFV-DP concentrations above the EC90 for at least 60 percent longer than F/TDF users. |
| 2019-04-11 | Gilead Sciences | Results Gilead Presents New Data on Viral Hepatitis at the International Liver Congress™ 2019 gilead.com ↗
In a Phase 3 study, 488 virologically suppressed adult patients with chronic HBV infection receiving once-daily TDF (300 mg) were randomized to remain on TDF or switch to Vemlidy (TAF 25 mg) for 48 weeks. |
| 2019-03-27 | Gilead Sciences | Results Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 gilead.com ↗
A Phase 3 study comparing switching from tenofovir disoproxil fumarate to tenofovir alafenamide with continued TDF treatment in virologically-suppressed patients with chronic hepatitis B (CHB): week 48 efficacy and safety results (poster #0183) |
| 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 ↗
Among the 2,693 participants (4,386 patient-years) who were at risk of HIV-1 infection and received Truvada, 15 HIV infections (0.34/100 PY) were reported. |
| 2019-02-11 | Replicor Inc. | Results Replicor to update analysis of high rates of functional cure of HBV at APASL 2019 replicor.com ↗
demonstrating further treatment is no longer required in 85% of patients completing therapy |
| 2019-01-22 | Merck Sharp & Dohme LLC | Regulatory U.S. FDA Accepts sNDAs for PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review supplemental New Drug Applications (sNDAs) for PIFELTRO™ and DELSTRIGO™. |
| 2018-11-28 | Merck Sharp & Dohme LLC | Regulatory European Commission Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in… merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved DELSTRIGO™ and PIFELTRO™ for the treatment of HIV-1 infection. |
| 2018-11-09 | Gilead Sciences | Results Gilead Presents Latest Data from Viral Hepatitis Research Programs at The Liver Meeting® 2018 gilead.com ↗
Through three years of treatment, patients originally randomized to receive TAF continued to show an improved bone and renal safety profile compared to treatment with tenofovir disoproxil fumarate 300mg (TDF) with maintained viral suppression. |
| 2018-11-06 | Replicor Inc. | Results Replicor to disclose achievement of high rates of functional cure of HBV at AASLD 2018 replicor.com ↗
Replicor’s poster presentation (Poster 393), to be presented on Friday, November 9, 2018, will showcase the on-going follow-up analysis after removal of all treatment (now beyond 24 weeks in most patients) indicating normalization of liver function |
| 2018-10-15 | Replicor Inc. | Results Replicor showcases HBV functional cure data with REP 2139-Mg replicor.com ↗
In the latest REP 401 study, 48 weeks of triple combination therapy with tenofovir disoproxil fumarate, pegylated interferon and REP 2139-Mg has currently allowed 85% of patients to achieve this goal |
| 2018-10-11 | Gilead Sciences | Results Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting® 2018 gilead.com ↗
Sofosbuvir/velpatasvir for 12 weeks is safe and effective in patients undergoing dialysis (late-breaking poster #LB-15) |
| 2018-10-04 | Merck Sharp & Dohme LLC | Results Merck’s HIV Therapy DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) Meets Primary Efficacy Endpoint in Phase 3 DRIVE-SHIFT Study Evaluating Switch to DELSTRIGO from Other Antiretroviral Treatment Regimens merck.com ↗
The study met its primary endpoint of non-inferior efficacy as measured by the proportion of participants who switched to DELSTRIGO and had plasma HIV-1 RNA levels <50 copies/mL at Week 48 compared to the proportion of participants who continued on their baseline regimen and had HIV-1 RNA levels <50 copies/mL at Week 24. |
| 2018-09-20 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive CHMP Opinion for DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) and PIFELTRO™ (doravirine) in the European Union for the Treatment of HIV-1 Infection merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting of marketing authorization for two HIV-1 medicines: DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg); and PIFELTRO™ (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines. |
| 2018-08-30 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients merck.com ↗ |
| 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 ↗ |
| 2018-06-18 | Replicor Inc. | Results Replicor demonstrates high rates of persistent functional control of HBV infection following cessation of all therapy replicor.com ↗
Liver function is normal in 92% of these patients. |
| 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 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 ↗ |
| 2017-12-20 | Replicor Inc. | Results Replicor announces publication of its latest pre-clinical hepatitis B study: replicor.com ↗
REP 2139 and TDF/ETV combine synergistically to establish control of cccDNA in the liver |
| 2017-10-23 | Replicor Inc. | Results Replicor discloses the persistence of functional control off-therapy in 80% of patients with chronic hepatitis B from the REP 401 study at AASLD 2017 replicor.com ↗
This functional control is persisting in all patients (80%) after removal of all therapy with data available for 24 weeks in 4 patients, 12 weeks in 3 patients and 4 weeks in 1 patient. |
| 2017-10-20 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread® gilead.com ↗
In addition, updated results from two Phase 3 studies demonstrating improved long-term bone and renal safety in HBV-infected patients one year after switching from Viread ® (tenofovir disoproxil fumarate 300mg) to Vemlidy ® (tenofovir alafenamide 25mg) will be presented on October 21 . |
| 2017-10-10 | Replicor Inc. | Results Replicor to disclose late-breaking follow-up data from its REP 401 study at AASLD 2017 replicor.com ↗
control of HBV infection (HBsAg, anti-HBs and HBV DNA) and normalization of liver function is currently persisting for up to 24 weeks after withdrawal of all therapy |
| 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. |
| 2017-07-25 | 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. |
| 2017-02-20 | Replicor Inc. | Results Replicor discloses high rates of HBsAg loss with NAP combination therapy at APASL 2017 replicor.com ↗
In patients receiving NAPs in combination with TDF and peg-IFN, 8/9 patients receiving REP 2139 have experienced HBsAg reductions > 4 logs with HBsAg loss (HBsAg ≤ 0.01 IU / ml) in 7 of these patients. |
| 2016-11-15 | Replicor Inc. | Results Replicor discloses late breaking HBV and follow-up HBV / HDV clinical data at AASLD 2016 replicor.com ↗
Control patients receiving peg-IFN + TDF exhibited minimal antiviral response beyond suppression of serum HBV DNA. |
| 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. |
| 2016-07-18 | GlaxoSmithKline | Results ARIA study shows superior efficacy of Triumeq® for treatment-naïve women living with HIV gsk.com ↗
ViiV Healthcare today presented 48-week data from the phase IIIb, open-label, international, multi-centre ARIA study which showed superior efficacy for Triumeq® (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naïve women living with HIV. |
| 2016-04-16 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies gilead.com ↗ |
| 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 ↗ |
| 2016-01-05 | Gilead Sciences | Results Gilead Announces Top-Line Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection gilead.com ↗
The studies demonstrated that TAF was non-inferior to Gilead’s Viread ® (tenofovir disoproxil fumarate, TDF) based on the percentage of patients with HBV DNA levels below 29 IU/mL at 48 weeks of therapy. |
| 2015-12-01 | Replicor Inc. | Results Replicor to present pre-clinical and clinical data on REP 2139-Ca based combination therapy in chronic HBV / HDV co-infection at HEPDART 2015 replicor.com ↗
Poster #114 will present the preclinical assessment of interferon-free combination therapy with REP 2139-Ca and tenofovir disoproxil fumarate (TDF) and entecavir (ETV) to establish control of HBV infection in the liver using the duck model of HBV infection. |
| 2015-11-14 | Gilead Sciences | Results Gilead Presents New Data at The Liver Meeting 2015 gilead.com ↗
Five-year data presented this week support the durable antiviral efficacy and consistent safety and resistance profile of Viread (Posters #2004 and #1678). |
| 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). |
| 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 |
| 2012-11-27 | Gilead Sciences | Regulatory European Commission Approves Viread® for HIV-1 Infection in Children and Adolescents and for Chronic Hepatitis B in Adolescents gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two new indications for once-daily Viread ® (tenofovir disoproxil fumarate). |
| 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. |
| 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. |
| 2012-02-20 | Samjin Pharmaceutical Co., Ltd. | Results 삼진제약(주), 항에이즈 신물질, 해외 유수 에이즈치료제 개발에 활용, 연구 성과 속속 발표 samjinpharm.co.kr ↗
연구팀은 삼진제약의 피리미딘디온 화합물과 길리야드의 테노포비어 제제가 서로 다른 기전에 의해 상승효과를 낼 수 있다는데 착안, 이 두 물질을 겔 형태로 혼합하여 여성에게 도포했을 때 이물감과 독성이 없고, 매우 안정적이고 탁월한 항HIV 효과를 보인다고 밝혔다. |
| 2012-01-18 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves New Formulations of Viread® for Use by Children Living With HIV gilead.com ↗
The FDA approved a supplemental New Drug Application (sNDA) for three lower-strength once-daily tablets of Viread in doses of 150 mg, 200 mg and 250 mg for children ages 6-12. |
| 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). |
| 2011-12-05 | 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. |
| 2011-11-08 | Bristol-Myers Squibb | Results Phase IIIb Comparison of BARACLUDE® (entecavir) Monotherapy Versus BARACLUDE Plus Tenofovir Combination Shows No Statistical Difference Between Study Arms bms.com ↗
Overall, both study arms had similar safety profiles. |
| 2011-11-05 | Gilead Sciences | Results Gilead Announces Positive Five-Year Data Showing Effect of Viread(R) on Liver Fibrosis and Cirrhosis Caused by Chronic Hepatitis B gilead.com ↗
Results show that Viread maintains long-term viral suppression of HBV and is associated with a reduction in liver fibrosis and a reversal of cirrhosis. |
| 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) |
| 2011-09-23 | 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 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). |
| 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 ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of 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. |
| 2010-10-30 | Gilead Sciences | Results Viread(R) for Hepatitis B Maintains Antiviral Suppression with No Development of Resistance Through Four Years of Treatment gilead.com ↗
In an on-treatment analysis, 99 percent of patients in Study 102 and 96 percent of patients in Study 103 who were originally randomized to receive Viread through 192 weeks achieved viral suppression below 400 copies/mL. |
| 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 ↗
The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP). |
| 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). |
| 2010-02-17 | Gilead Sciences | Results Gilead's Single-Tablet "Quad" Regimen for HIV Achieves a High Rate of Virologic Suppression in Phase II Study gilead.com ↗
These positive efficacy and safety results indicate that the Quad has the potential to become an important new treatment option in HIV therapy. |
| 2010-01-27 | Gilead Sciences | Regulatory Gilead Sciences Announces Notification of ANDA Filing for Viread® gilead.com ↗
Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Viread(R) (tenofovir disoproxil fumarate). |
| 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 ↗
The study met its primary objective of achieving HIV RNA levels (viral load) of less than 50 copies/mL at 24 weeks of treatment. |
| 2009-10-31 | Gilead Sciences | Results Gilead Announces Long-Term Data from Two Pivotal Phase III Studies Evaluating Viread(R) For Chronic Hepatitis B gilead.com ↗
These new data show that the majority of patients who received Viread for up to 144 weeks experienced sustained suppression of HBV DNA levels in the blood to below 400 copies/mL (87 percent in Study 102 and 71 percent in Study 103). |
| 2009-07-21 | Gilead Sciences | Results Landmark Five-Year African Study Indicates That HIV Therapy May Be Given Safely in Resource-Limited Settings Without Routine Laboratory Monitoring gilead.com ↗
The results indicated that Viread was well tolerated and that the incidence of renal adverse events was low. |
| 2008-12-03 | Gilead Sciences | Results Data Demonstrating Significant Efficacy of Viread(R) in Treating Chronic Hepatitis B Published in New England Journal of Medicine gilead.com ↗
Data also indicate that at week 48, Viread was superior to Hepsera in reducing HBV DNA levels to below 400 copies/mL and was comparable to Hepsera in achieving histological response. |
| 2008-11-01 | Gilead Sciences | Results Gilead Announces Two-Year Data from Pivotal Phase III Studies Evaluating Viread(R) for Chronic Hepatitis B gilead.com ↗
These new data show that patients who received Viread for up to 96 weeks experienced sustained suppression of HBV levels in the blood (91 percent and 78 percent for Studies 102 and 103, respectively). |
| 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. |
| 2008-08-11 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Viread(R) for Chronic Hepatitis B in Adults gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Viread(R) (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B, a serious liver disease caused by the hepatitis B virus (HBV). |
| 2008-04-25 | Gilead Sciences | Regulatory European Commission Approves Viread(R) for Chronic Hepatitis B gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorisation for Viread(R) (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B in all 27 member states of the European Union. |
| 2008-04-24 | Gilead Sciences | Results Gilead Announces 72-Week Data From Two Pivotal Phase III Studies Evaluating Viread(R) for the Treatment of Chronic Hepatitis B gilead.com ↗
The 72-week data demonstrate that the majority of patients in each study who were originally randomized to receive Viread had a virologic response below 400 copies/mL through week 72 (91 percent and 79 percent, respectively). |
| 2008-03-19 | Gilead Sciences | Regulatory European CHMP Issues Positive Opinion for Viread(R) for the Treatment of Chronic Hepatitis B gilead.com ↗
The CHMP's positive opinion will be forwarded to the European Commission, which will amend the Marketing Authorisation for Viread in the 27 countries of the European Union to reflect the Type II variation. |
| 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 ↗ |
| 2007-11-02 | Gilead Sciences | Results Gilead Announces 48-Week Data from Two Pivotal Phase III Studies Evaluating Viread(R) For the Treatment of Chronic Hepatitis B gilead.com ↗
In addition, three percent of Viread patients (n=153) compared to zero percent of Hepsera patients (n=80; p=0.018) experienced "s" antigen (HBsAg) loss, which can indicate that a patient has cleared chronic hepatitis B infection. |
| 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 ↗
In the SWEET (Simplification With Easier Emtricitabine and Tenofovir) study, patients who switched from Combivir to Truvada, both in combination with once-daily Sustiva(R) (efavirenz), experienced improvements in a number of treatment-related side effects. |
| 2007-10-11 | Gilead Sciences | Regulatory Gilead Submits Marketing Applications in the United States and European Union for Viread(R) (Tenofovir Disoproxil Fumarate) for the Treatment of Chronic Hepatitis B gilead.com ↗
today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a Type II variation to the European Medicines Agency (EMEA) |
| 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 ↗
Gilead Sciences, Inc. (Nasdaq:GILD) 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) to a twice-daily regimen of Combivir(R) (lamivudine/zidovudine) with Sustiva once daily in treatment-naive adults with HIV. |
| 2007-06-25 | Gilead Sciences | Results Second Phase III Study Evaluating Gilead's Viread(R) for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that Study 103, a Phase III clinical trial evaluating the company's once-daily anti-HIV drug Viread(R) (tenofovir disoproxil fumarate or tenofovir DF) 300 mg as a potential treatment for chronic hepatitis B virus (HBV) infection, met its primary efficacy endpoint. |
| 2007-06-06 | Gilead Sciences | Results Phase III Study Evaluating Gilead's Viread(R) for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint gilead.com ↗
The study shows that Viread is non-inferior to the company's once-daily antiviral drug Hepsera(R) (adefovir dipivoxil) among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic HBV infection. |
| 2007-04-24 | Aspen USA Inc | Regulatory Key ARV Products Viread® and Truvada® Registered by MCC aspenpharma.com ↗
JSE listed Aspen, a leading global manufacturer and distributor of anti-retroviral (ARV) medicines, today announced that it has been granted certification from the Medicines Control Council of South Africa (MCC) to manufacture and distribute the two key ARV products Viread® (tenofovir disoproxil fumarate) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) in the South African market. |
| 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). |
| 2006-09-27 | Gilead Sciences | Results Landmark Five-Year Data on Gilead's Anti-HIV Drug Viread(R) Presented at 8th International Workshop on Adverse Drug Reactions and Lipodystrophy gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced two presentations of long-term efficacy and safety data from Study 903E on the company's leading once-daily anti-HIV medication, Viread(R) (tenofovir disoproxil fumarate). |
| 2006-08-14 | 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) Presented at XVI International AIDS Conference gilead.com ↗ |
| 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 ↗ |
| 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 ↗ |
| 2005-08-09 | 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. |
| 2005-04-29 | Vertex Pharmaceuticals Incorporated | Results New Pharmacokinetic Data on Co-Administration of the PI LEXIVA/r With the NRTI Tenofovir vrtx.com ↗
There also were no significant safety findings when combining LEXIVA/r with TDF in the 35 healthy male volunteers studied. |
| 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. |
| 2005-02-28 | Gilead Sciences | Results 48-Week Data Comparing Viread Versus Abacavir as Replacement for Thymidine Analogue in Lipoatraphic HIV Patients Presented at the 12th Conference on Retroviruses and Opportunistic Infections gilead.com ↗
Gilead Sciences (Nasdaq:GILD) today announced the presentation of preliminary 48-week data from the RAVE (Randomized Abacavir Viread Evaluation) study at the 12th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. |
| 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). |
| 2004-02-04 | Gilead Sciences | Results Gilead Announces Data from Landmark Three-Year Clinical Trial of Viread; 144-Week Data Highlight Viread Efficacy, Safety and Side Effect Profile gilead.com ↗
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 4, 2004--Gilead Sciences, Inc. (Nasdaq:GILD) today announced preliminary three-year (144-week) data from a double-blind Phase III clinical trial (Study 903) suggesting that Viread(R) (tenofovir disoproxil fumarate) is associated with similar levels of viral load suppression and a similar renal safety profile when compared to treatment with stavudine (d4T). |
| 2003-10-28 | Gilead Sciences | Results New Data Highlight Safety and Tolerability Profile of Gilead's Viread for Periods up to Four Years; Data Presented at European AIDS Conference in Warsaw gilead.com ↗
Results show that Viread was associated with a low incidence and severity of adverse events and laboratory abnormalities. |
| 2003-06-13 | Gilead Sciences | Results 96-Week Data from Gilead's Study 903 Show Low Rate of Virologic Failure among Patients Taking Viread gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced 96-week data from an ongoing clinical trial demonstrating that resistance to Viread(R) (tenofovir disoproxil fumarate) among treatment-naive patients occurs infrequently. |
| 2003-05-27 | Gilead Sciences | Regulatory European Commission Expands the Indication of Viread, Gilead's Once-Daily Treatment for HIV, to Include Treatment-Naive Patients gilead.com ↗
The Commission's decision to expand Viread's indication is based on 48-week results from Gilead's Study 903 in 600 treatment-naive patients infected with HIV, including patients with a high viral load (greater than 100,000 copies/mL). |
| 2003-02-21 | Gilead Sciences | Regulatory European CPMP Gives Positive Opinion to Extend the Indication of Viread, Gilead's Once-Daily Treatment for HIV Infection gilead.com ↗
The indication recommended by the CPMP is for Viread to be taken in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults over 18 years of age. |
| 2003-02-11 | Gilead Sciences | Results 96-Week Data From Phase III Study Show Long-Term Efficacy With Reduced Risk of Lipid and Metabolic Changes for Viread Versus Stavudine in Treatment-Naive HIV Patients gilead.com ↗
The 96-week results presented today show that the Viread and stavudine arms reduced HIV RNA to less than 400 copies/mL in 82 and 78 percent of patients respectively, using the most conservative "missing equals failure" analysis. |
| 2002-09-27 | Gilead Sciences | Results Phase III Study of Viread Shows Favorable Lipid and Mitochondrial DNA Profile in Treatment-naive HIV Patients; Data Presented in Late-Breaker Session at 42nd ICAAC gilead.com ↗
In addition, the incidence of nucleoside analogue-associated toxicities, such as peripheral neuropathy and lipodystrophy, was three percent in the Viread-containing arm, compared with 10 percent in the stavudine-containing arm (p less than 0.001) after 48 weeks of treatment. |
| 2002-07-11 | Gilead Sciences | Results 48-Week Data Demonstrate Ability of Viread to Suppress Viral Load in Patients With Multiple Treatment-Resistant HIV Mutations gilead.com ↗
Patients with no TAMs who received the Viread-containing regimen experienced a significant reduction in mean HIV RNA level of 0.80 log10 copies/mL at 24 weeks (p less than 0.001; n=68). |
| 2002-07-08 | Gilead Sciences | Results 48-Week Data Compare Viread to Stavudine When Used as Part of Patients' First Anti-HIV Regimen; Data Presented at XIV International AIDS Conference in Barcelona gilead.com ↗
Importantly, analyses of measurements of laboratory markers reveal that patients in the stavudine arm of the study experienced significant increases in triglyceride and cholesterol levels compared to those in the Viread arm through 48 weeks. |
| 2002-05-07 | Gilead Sciences | Results Gilead Announces Preliminary 48-Week Study Results Showing Viread Comparable to Stavudine in Treatment-Naive HIV Patients gilead.com ↗
These data demonstrate that as a part of combination therapy for 48 weeks Viread can provide efficacy and safety comparable to stavudine, one of the most commonly prescribed nucleoside reverse transcriptase inhibitors. |
| 2002-02-27 | Gilead Sciences | Results Gilead Announces Data From Study of Viread in Patients Co-infected With HIV and HBV; Data Presented at 9th Conference on Retroviruses and Opportunistic Infections gilead.com ↗
Following 24 weeks of Viread treatment, the mean change in serum HBV DNA from baseline was a reduction of 4.81 log10 copies/mL for patients receiving Viread and an increase of 1.23 log10 copies/mL for patients on placebo (p=0.04). |
| 2002-02-25 | Gilead Sciences | Results Viread Demonstrates Anti-HIV Potency Similar to the Protease Inhibitor Ritonavir in Short-Term Study of Treatment-Naive Patients gilead.com ↗
After three weeks, patients treated with Viread monotherapy experienced a mean reduction in HIV RNA of 1.5 log10 copies/mL (range: 0.6 to 2.7). |
| 2002-02-25 | Gilead Sciences | Results Gilead Sciences' Viread Suppresses HIV Viral Load Through 48 Weeks in Phase III Clinical Trial gilead.com ↗
At 48 weeks, study results demonstrated that patients who received Viread 300 mg in addition to their existing antiretroviral regimen (n=368) achieved a significant mean HIV RNA reduction (DAVG48) of 0.57 log(10) copies/mL, similar to that observed at week 24. |
| 2002-02-07 | Gilead Sciences | Regulatory Gilead Sciences' New HIV Drug Viread Approved for Marketing in European Union gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Evaluation Agency (EMEA) has granted the Marketing Authorisation for Viread(R) (tenofovir disoproxil fumarate) in all 15 member states of the European Union. |
| 2001-10-26 | Gilead Sciences | Regulatory U.S. FDA Approves Gilead Sciences’ Anti-HIV Drug Viread™ gilead.com ↗
Gilead Sciences (Nasdaq: GILD) today announced that it has received U.S. Food and Drug Administration (FDA) approval for its antiretroviral agent Viread™ (tenofovir disoproxil fumarate) for the treatment of human immunodeficiency virus (HIV) infection when taken in combination with other antiretroviral agents. |
| 2001-10-18 | Gilead Sciences | Regulatory European CPMP Gives Positive Opinion on Viread™, Gilead’s New Once-Daily Treatment for HIV Infection gilead.com ↗
On the basis of the safety and efficacy data submitted for Viread, the committee has recommended the granting of a Marketing Authorisation under exceptional circumstances. |
| 2001-10-03 | Gilead Sciences | Regulatory Gilead Announces FDA Advisory Committee Supports Use of Viread™ in Treatment-Experienced Patients with HIV Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee unanimously supports use of the company's investigational antiviral agent Viread™ (tenofovir disoproxil fumarate) for the treatment of HIV infection in adult patients who have received prior antiretroviral therapy. |
| 2001-09-25 | Gilead Sciences | Results Gilead’s Investigational Antiretroviral Agent Viread™ Reduces Viral Load in HIV Patients with Resistant Virus in Pivotal Phase III Study gilead.com ↗
Gilead Sciences (Nasdaq: GILD) today released 24-week efficacy and safety results from a pivotal Phase III study of its investigational one tablet, once daily antiretroviral agent Viread™ (tenofovir disoproxil fumarate). |
| 2001-06-05 | Gilead Sciences | Results Gilead Sciences Presents Data Characterizing Resistance Profile of Tenofovir DF, Investigational Agent for the Treatment of HIV gilead.com ↗
Results of this study indicate that over 88 percent of the samples were fully susceptible to tenofovir and were within the normal three-fold range. |
| 2001-05-04 | Gilead Sciences | Regulatory Gilead Sciences Submits Marketing Authorisation Application to European Regulatory Authorities for Tenofovir DF for the Treatment of HIV Infection gilead.com ↗ |
| 2001-05-01 | Gilead Sciences | Regulatory Gilead Sciences Submits New Drug Application to U.S. FDA for Tenofovir DF for the Treatment of HIV Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of tenofovir disoproxil fumarate (tenofovir DF), an investigational reverse transcriptase inhibitor in development for the treatment of human immunodeficiency virus (HIV) infection. |
| 2001-02-20 | Gilead Sciences | Results Gilead Sciences Announces Preliminary Results from Phase III Study of Investigational Anti-HIV Agent Tenofovir DF gilead.com ↗
It is promising to see an investigational agent that offers this level of antiviral effect along with a favorable safety profile in heavily treatment-experienced patients, |
| 2000-10-22 | Gilead Sciences | Results Gilead Sciences Presents 48-Week Viral Resistance Data From Phase II Study of Investigational Anti-HIV Agent, Tenofovir DF gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced 48-week data characterizing the viral resistance profile of tenofovir disoproxil fumarate (tenofovir DF), the company’s investigational, once-daily agent for the treatment of HIV infection. |
| 2000-09-18 | Gilead Sciences | Results Gilead Sciences Announces Results from 48-Week Study of Once-Daily Anti-HIV Agent Tenofovir DF gilead.com ↗
Confirming earlier efficacy results, tenofovir DF was associated with significant and sustained antiviral activity. |
| 2000-04-16 | Gilead Sciences | Results Gilead Sciences Presents 48-Week Phase II Safety and Efficacy Results for Once-Daily Anti-HIV Agent, Tenofovir DF gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced preliminary results from a Phase II dose-ranging clinical trial (Study 902) evaluating the safety and efficacy of once-daily tenofovir disoproxil fumarate (tenofovir DF) when used to intensify a stable background antiretroviral regimen in 189 treatment-experienced HIV patients. |
| 1999-09-27 | Gilead Sciences | Results Preliminary Phase II Clinical Results For Once-Daily Anti-HIV Agent, Tenofovir DF, Presented At ICAAC gilead.com ↗
In this study, treatment with tenofovir DF was well tolerated and associated with dose-related antiviral activity. |
All press releases naming this drug 253 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 253 releases opens the full record — a long page | ||
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 480 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tenofovir disoproxil fumarate | “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 ↗371“The main objective of this study is to compare the mother-to-infant transmission rates of hepatitis B between pregnant women receiving treatment with tenofovir alafenamide and...” NCT06947356 ↗ “Patients chronically infected with the hepatitis B virus rarely achieve loss of serum hepatitis B surface antigen (HBsAg) with the standard of care. We evaluated HBsAg loss in...” PMID 26453773 ↗ Oct 2015 “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 primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in...” NCT02836236 ↗ “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 ↗ “Tenofovir Disoproxil Fumarate (nucleotide reverse transcriptase inhibitor) + Emtricitabine (nucleoside reverse transcriptase inhibitor) + third agent (boosted protease...” NCT02302547 ↗ “Both HIV and HBV can be treated with tenofovir disoproxil fumarate (TDF) and lamivudine (3TC), so we evaluated the safety and efficacy of combination antiretroviral therapy...” PMID 26831232 ↗ Feb 2016 “Participants who are already taking tenofovir disoproxil fumarate 300 mg (in the form of Viread or Truvada) in combination with either a ritonavir- or cobicistat-boosted...” NCT03126370 ↗ “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 ↗ |
| Known as | BR-TND Tablet | “A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir...” NCT02920931 ↗ |
| Known as | GSK548470 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01475851 ↗ |
| Known as | HUG116 | “HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir Disoproxil Fumarate)” NCT02902523 ↗ |
| Known as | PMPA prodrug | “In this double-blind, placebo-controlled study, a total of 60 patients are randomized to receive PMPA prodrug at 1 of 5 doses or matching placebo tablets.” NCT00002396 ↗1“formerly known as PMPA prodrug” NCT00024986 ↗ |
| Known as | Qingzhong | “Qingzhong, a brand name of TDF, commercialized by Jiangsu Chia-tai Tianqing Pharmaceutical Co Ltd., and Viread, another brand name of TDF, commercialized by GlaxoSmithKline,...” PMID 34222435 ↗ Jun 2021 |
| Known as | TDF | “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 ↗191“Patients chronically infected with the hepatitis B virus rarely achieve loss of serum hepatitis B surface antigen (HBsAg) with the standard of care. We evaluated HBsAg loss in...” PMID 26453773 ↗ Oct 2015 “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 primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in...” NCT02836236 ↗ “BACKGROUND: New regimens may provide better tolerability, convenience, and safety for nonoccupational human immunodeficiency virus (HIV) postexposure prophylaxis (PEP). For...” PMID 37539061 ↗ Jul 2023 “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 ↗ “Both HIV and HBV can be treated with tenofovir disoproxil fumarate (TDF) and lamivudine (3TC), so we evaluated the safety and efficacy of combination antiretroviral therapy...” PMID 26831232 ↗ Feb 2016 “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 ↗ |
| Known as | tenofovir | “This study was designed to compare the efficacy between peg-IFN alpha combined with tenofovir (TDF) and TDF monotherapy for the clearance of HBsAg in NA-experienced patients...” PMID 34697111 ↗ Oct 20214“For this study, the following HIV treatment (or HAART) were provided in the form of a single tablet that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF).” NCT01403051 ↗ “In all groups, tenofovir disoproxil fumarate (henceforth tenofovir) was dosed at 245 mg once daily” PMID 38740027 ↗ May 2024 “emtricitabine plus tenofovir disoproxil fumarate (tenofovir) regimen” PMID 24908551 ↗ Jun 2014 “start taking tenofovir (co-formulated with emtricitabine as Truvada)” NCT00998582 ↗ |
| Known as | tenofovir DF | “The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated...” NCT00007436 ↗37“NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF,...” NCT01252940 ↗ “Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily” NCT01286740 ↗ “A single tablet regimen (STR) of efavirenz, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) is the first complete HAART that is offered as one tablet once a day.” NCT00615745 ↗ “Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily” NCT00525733 ↗ “Tenofovir DF (oral powder or tablet): 300-mg tablets for participants \> 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg.” NCT00528957 ↗ “This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug.” NCT00002453 ↗ “Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily” NCT01254656 ↗ “Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet administered orally once daily” NCT00737568 ↗ “UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.” NCT00824421 ↗ “Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily” NCT01147107 ↗ |
| Known as | tenofovir disoproxil | “Each tablet contains 200 mg emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg tenofovir disoproxil fumarate or 201.22 mg tenofovir disproxil phosphate),...” NCT04644029 ↗50“Patients randomised to the immediate arm (ARM A) will receive a 5 day PEPSE 'Home pack' containing Truvada® (tenofovir disoproxil -as fumarate- 245 mg, emtricitabine 200 mg),...” NCT04965662 ↗ “One was excluded, 200 were assigned to receive a single oral dose of 300 mg tenofovir disoproxil fumarate with 200 mg emtricitabine under direct observation, and 199 to receive...” PMID 17997151 ↗ Nov 2007 “The first line regimen proposed will be Atripla (R), a fixed dose combination containing tenofovir disoproxil (245 mg)/emtricitabine (200 mg)/efavirenz (600 mg)(FTC/TDF/EFV).” NCT01509508 ↗ “PrEP was prescribed as a fixed-dose combination of tenofovir disoproxil and emtricitabine (245 mg and 200 mg, respectively, per pill).” PMID 35772417 ↗ Jun 2022 “Each tablet of Truvada contains 245mg of tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)” NCT04066881 ↗ “HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir Disoproxil Fumarate)” NCT02902523 ↗ “Fixed dose combination of doravirine, lamivudine and tenofovir disoproxil” NCT05630638 ↗ |
| Known as | Tenofovir disoproxil fumarate (TDF) | “Tenofovir disoproxil fumarate (TDF)” NCT03576066 ↗2“Tenofovir disoproxil fumarate (TDF)” NCT03357822 ↗ “Tenofovir disoproxil fumarate (TDF)” NCT04820686 ↗ |
| Known as | Tenofovir Disoproxil Fumarate (TDF) - brand name: Viread | “Tenofovir Disoproxil Fumarate (TDF) - brand name: Viread” NCT03780543 ↗ |
| Known as | Tenofovir Disoproxil Fumarate Tablets | “Tenofovir Disoproxil Fumarate Tablets, Nucleotide reverse transcriptase inhibitors;” NCT06566248 ↗ |
| Known as | tenofovir disoproxil fumarato | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01458977 ↗ |
| Known as | Tenofovir disoproxil;TDF | “Tenofovir disoproxil;TDF” NCT02560649 ↗ |
| Known as | Tenolid Tab | “Switching to Tenolid Tab (Tenofovir Disoproxil) From Viread Tab (Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients” NCT05286346 ↗ |
| Known as | Viread | “Participants who are already taking tenofovir disoproxil fumarate 300 mg (in the form of Viread or Truvada) in combination with either a ritonavir- or cobicistat-boosted...” NCT03126370 ↗18“Qingzhong, a brand name of TDF, commercialized by Jiangsu Chia-tai Tianqing Pharmaceutical Co Ltd., and Viread, another brand name of TDF, commercialized by GlaxoSmithKline,...” PMID 34222435 ↗ Jun 2021 “A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet and Viread® tablet in Chronic hepatitis...” NCT02805738 ↗ “those in the TDF group receive TDF tablets(Viread, Aspen Port Elizabeth, China) 300 mg/d orally starting from 2-4 weeks before surgery.” NCT04032860 ↗ “Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other anti-HIV drugs to treat HIV infection.” NCT00078182 ↗ “HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir Disoproxil Fumarate)” NCT02902523 ↗ “DTG/tenofovir disoproxil fumarate (TDF; Viread®)/3TC” NCT06630299 ↗ “Viread® tablet(Tenofovir Disoproxil Fumarate)” NCT02589457 ↗ “Tenofovir disoproxil fumarate (TDF; Viread®)” NCT03491553 ↗ “Viread (tenofovir DF)” NCT00106379 ↗ |
| Known as | Viread 245 mg | “Tenofovir disoproxil fumarate (TDF) 300 mg (Viread® 245 mg)” NCT02273765 ↗ |
| Action | Inhibit | “a potent nucleotide analogue HIV-1 reverse transcriptase (RT) inhibitor” NCT00024986 ↗ |
| Modality | Small molecule | “a potent nucleotide analogue HIV-1 reverse transcriptase (RT) inhibitor” NCT00024986 ↗ |
| Route | Oral | “administered orally” NCT00002396 ↗ |